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Effect Profile (effect + profile)
Kinds of Effect Profile Selected AbstractsInterferon Alfa-2b or Not 2b?DERMATOLOGIC SURGERY, Issue 1 2007Significant Differences Exist in the Decision-Making Process between Melanoma Patients Who Accept or Decline High-Dose Adjuvant Interferon Alfa-2b Treatment BACKGROUND Patients with thick (Breslow >4 mm) primary melanoma and/or regional nodal metastasis have a high risk of tumor recurrence. High-dose adjuvant interferon (IFN) alfa-2b offers ,10% improvement in relapse-free survival and overall survival with significant toxicity. OBJECTIVE The objective was to determine which prognostic factors and patient characteristics are significant in the decision to undergo IFN therapy. METHODS Of 781 patients who underwent sentinel lymph node (SLN) biopsy, 135 of 781 (17.3%) had positive SLN or thick melanomas and were informed of a ,50% risk of recurrence/disease-related mortality and offered IFN. Telephone surveys delineated reasons behind patients' decisions to accept IFN. RESULTS Acceptors, 60 of 135 (45%), decided to take IFN alfa-2b whereas 75 of 135 (55%) declined. Being female (OR, 2.4; 95% CI, 1.17,5.03; p=.017) and positive SLN status (OR, 2.2; 95% CI, 1.01,4.97; p=.048) were strongly associated with patients who chose IFN. Acceptors of IFN were younger, more influenced by physicians, and less affected by depression and side effect profile (p<.05 for all). Decliners were more concerned by strained relationships with family and social life (p<.05). CONCLUSIONS Gender and positive SLN were predictive of high-risk melanoma patients' acceptance of IFN treatment. Physician insight into melanoma patients' therapeutic decision-making process can guide patients through this difficult disease. [source] Injectable Hyaluronic Acid Implant for Malar and Mental EnhancementDERMATOLOGIC SURGERY, Issue 7 2006FRCP, NICHOLAS J. LOWE MD BACKGROUND The use of a thicker injectable implant version of one of the hyaluronic acid dermal fillers (Restylane SubQ, Q-Med, Uppsala, Sweden) is described. OBJECTIVE A group of treated patients has been studied for more than 1 year. Restylane SubQ was injected to the submuscular plane of the upper cheeks and chin to observe efficacy of augmentation and side effect profile, and further observations were made of the duration of benefit. METHODS Patient details,72 patients were treated, 68 for upper cheek augmentation, 2 for chin augmentation, and 2 for both areas. Four patients received second injections 8 weeks after the first to increase augmentation. RESULTS Patients all showed a persistence of benefit during the posttreatment observation period of up to 64 weeks. Four patients had minor side effects that resolved with local treatment and time. Four patients had second injections to complete augmentation without complications. CONCLUSIONS Restylane SubQ is a useful injectable agent to augment and lift upper cheeks and recontour chins. Further efficacy studies seem justified. [source] Comparison of Long-Pulsed Diode and Long-Pulsed Alexandrite Lasers for Hair Removal: A Long-Term Clinical and Histologic StudyDERMATOLOGIC SURGERY, Issue 7 2001Christiane Handrick MD Background. Unwanted facial and body hair is a common problem, generating a high level of interest for treatment innovations. Advances in laser technology over the past several years has led to the development and distribution of numerous red and infrared lasers and light sources to address this issue. Despite the impressive clinical results that have been reported with the use of individual laser hair removal systems, long-term comparative studies have been scarce. Objective. To compare the clinical and histologic efficacy, side effect profile, and long-term hair reduction of long-pulsed diode and long-pulsed alexandrite laser systems. Methods. Twenty women with Fitzpatrick skin types I,IV and dark terminal hair underwent three monthly laser-assisted hair removal sessions with a long-pulsed alexandrite laser (755 nm, 2-msec pulse, 10 mm spot) and a long-pulsed diode laser (800 nm, 12.5 msec or 25 msec, 9 mm spot). Axillary areas were randomly assigned to receive treatment using each laser system at either 25 J/cm2 or 40 J/cm2. Follow-up manual hair counts and photographs of each area were obtained at each of the three treatment visits and at 1, 3, and 6 months after the final laser session. Histologic specimens were obtained at baseline, immediately after the initial laser treatment, and 1 and 6 months after the third treatment session. Results. After each laser treatment, hair counts were successively reduced and few patients found it necessary to shave the sparsely regrown hair. Optimal clinical response was achieved 1 month after the second laser treatment, regardless of the laser system or fluence used. Six months after the third and final treatment, prolonged clinical hair reduction was observed with no significant differences between the laser systems and fluences used. Histologic tissue changes supported the clinical responses observed with evidence of initial follicular injury followed by slow follicular regeneration. Side effects, including treatment pain and vesiculation, were rare after treatment with either laser system, but were observed more frequently with the long-pulsed diode system at the higher fluence of 40 J/cm2. Conclusion. Equivalent clinical and histologic responses were observed using a long-pulsed alexandrite and a long-pulsed diode laser for hair removal with minimal adverse sequelae. While long-term hair reduction can be obtained in most patients after a series of laser treatments, partial hair regrowth is typical within 6 months, suggesting the need for additional treatments to improve the rate of permanent hair removal. [source] Second- and third-generation antihistamines in the treatment of urticariaDERMATOLOGIC THERAPY, Issue 4 2000Anne K. Ellis ABSTRACT: Chronic urticaria is mainly idiopathic in nature and can be difficult to treat. While less responsive to antihistamine therapy than acute urticaria, antihistamines still play a key role in the management of symptomatology. While many of the antihistamines still commonly used to treat urticaria are first generation H1 antagonists (e.g., diphenhydramine, hydroxyzine), the more recently developed second-generation agents (e.g., loratadine, cetirizine) and their metabolites,the third-generation antihistamines (e.g., fexofenadine, norastemizole, descarboxyloratadine),possess many of the desirable clinical effects of the first-generation agents with a more tolerable side effect profile. This review discusses the advantages and disadvantages of each of the various second- and third-generation agents available, and presents some of the data showing the differences among these agents in the treatment of chronic urticaria. [source] The Modified Atkins DietEPILEPSIA, Issue 2008Eric H. Kossoff Summary In 2003, a case series was published describing the benefits of a less restrictive ketogenic diet (KD) started as an outpatient without a fast and without any restrictions on calories, fluids, or protein. This "Modified Atkins Diet" (MAD) restricts carbohydrates to 10 g/day (15 g/day in adults) while encouraging high fat foods. Now 5 years later, there have been eight prospective and retrospective studies published on this alternative dietary therapy, both in children as well as adults. In these reports, 45 (45%) have had 50,90% seizure reduction, and 28 (28%) >90% seizure reduction, which is remarkably similar to the traditional KD. This review will discuss basics and tips to best provide the MAD, evidence for its efficacy, suggestions about the role of ketosis in dietary treatment efficacy, and its side effect profile. Lastly, the possible future benefits of this treatment for new-onset seizures, adults, neurologic conditions other than epilepsy, and developing countries of the world will be discussed. [source] Clinical correlates of clozapine prescription for schizophrenia in ChinaHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 1 2007Yu-tao Xiang Abstract Aims Few studies have investigated the prescription patterns of clozapine in outpatients with schizophrenia in China. It is an important issue due to clozapine's high efficacy and potentially fatal side effect profile. This study examined the use of clozapine and its correlates in China. Methods Three hundred ninety-eight clinically stable outpatients with schizophrenia were randomly selected and interviewed in Hong Kong (HK) and Beijing (BJ). Assessment instruments included the Structured Clinical Interview for DSM-IV, Brief Psychiatric Rating Scale, Simpson and Angus Scale of Extrapyramidal Symptoms, Barnes Akathisia Rating Scale and the Hong Kong and Mainland China World Health Organization Quality of Life Schedule-Brief version. Assessments were performed by the same investigator in both sites. Results Clozapine was prescribed to 15.6% of (n,=,62) patients. There was a wide inter-site variation between HK and BJ. Use of clozapine was associated with age, age at onset, extrapyramidal side effects (EPS), having health insurance, use of depot and typical antipsychotic and anticholinergic drugs and benzodiazepines as well as history of suicidal attempts. On multiple logistic regression analysis, the number of hospitalizations, site (HK vs. BJ), use of typical antipsychotics, polypharmacy and co-prescription with anticholinergics were significantly associated with the prescription of clozapine. No significant differences were found between the clozapine and non-clozapine groups with regard to any of the quality of life domains. Conclusion A combination of economical and clinical factors, health policies and the characteristics of the treatment settings plays important roles in determining clozapine use. Clozapine appears to have little significant influence on quality of life in clinical stable Chinese patients with schizophrenia. Copyright © 2007 John Wiley & Sons, Ltd. [source] Maximising antihypertensive effects of angiotensin II receptor blockers with thiazide diuretic combination therapy: focus on irbesartan/hydrochlorothiazideINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2007J. M. Flack Summary Background:, Evidence-based guidelines for the management of hypertension are now well established. Studies have shown that more than 60% of patients with hypertension will require two or more drugs to achieve current treatment targets. Discussion:, Combination therapy is recommended as first-line treatment by the JNC-7 guidelines for patients with a blood pressure > 20 mmHg above the systolic goal or 10 mmHg above the diastolic goal, while the International Society of Hypertension in Blacks recommends combination therapy when BP exceeds targets by > 15/10 mmHg. Current European Society of Hypertension-European Society of Cardiology guidelines also recommend the use of low-dose combination therapy in the first-line setting. Furthermore, JNC-7 recommends that a thiazide-type diuretic should be part of initial first-line combination therapy. Thiazide/diuretic combinations are available for a variety of classes of antihypertensive, including ACE inhibitors, angiotensin receptor blockers (ARBs), beta blockers and centrally acting agents. This article focuses on clinical data investigating the combination of an ARB, irbesartan, with the diuretic, hydrochlorothiazide. Conclusions:, These data indicate that the ARB/HCTZ combination has greater potency and a similar side effect profile to ARB monotherapy and represents a highly effective approach for attaining goal BP levels using a therapeutic strategy that very effectively lowers BP, is well tolerated and minimises diuretic-induced metabolic effects. [source] The Role of Benzodiazepines in the Treatment of InsomniaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2001Meta-Analysis of Benzodiazepine Use in the Treatment of Insomnia PURPOSE: To obtain a precise estimate of the efficacy and common adverse effects of benzodiazepines for the treatment of insomnia compared with those of placebo and other treatments. BACKGROUND: Insomnia, also referred to as disorder of initiating or maintaining sleep, is a common problem and its prevalence among older people is estimated to be 23% to 34%.1 The total direct cost in the United States for insomnia in 1995 was estimated to be $13.9 billion.2 The complaint of insomnia in older people is associated with chronic medical conditions; psychiatric problems, mainly depression, chronic pain, and poor perceived general condition;1,3,4 and use of sleep medications.5 Thus in most cases, insomnia is due to some other underlying problem and is not just a consequence of aging.6 Accordingly, the management of insomnia should focus on addressing the primary problem and not just short-term treatment of the insomnia. Benzodiazepines belong to the drug class of choice for the symptomatic treatment of primary insomnia.7 This abstract will appraise a meta-analysis that compared the effect of benzodiazepines for short-term treatment of primary insomnia with placebo or other treatment. DATA SOURCES: Data sources included articles listed in Medline from 1966 to December 1998 and the Cochrane Controlled Trials Registry. The medical subject heading (MeSH) search terms used were "benzodiazepine" (exploded) or "benzodiazepine tranquillizers" (exploded) or "clonazepam,""drug therapy,""randomized controlled trial" or "random allocation" or "all random,""human," and "English language." In addition, bibliographies of retrieved articles were scanned for additional articles and manufacturers of brand-name benzodiazepines were asked for reports of early trials not published in the literature. STUDY SELECTION CRITERIA: Reports of randomized controlled trials of benzodiazepine therapy for primary insomnia were considered for the meta-analysis if they compared a benzodiazepine with a placebo or an alternative active drug. DATA EXTRACTION: Data were abstracted from 45 randomized controlled trials representing 2,672 patients, 47% of whom were women. Fifteen studies included patients age 65 and older and four studies involved exclusively older patients. Twenty-five studies were based in the community and nine involved inpatients. The duration of the studies ranged from 1 day to 6 weeks, with a mean of 12.2 days and median of 7.5 days. The primary outcome measures analyzed were sleep latency and total sleep duration after a sleep study, subjects' estimates of sleep latency and sleep duration, and subjects' report of adverse effects. Interrater reliability was checked through duplicate, independent abstraction of the first 21 articles. Overall agreement was between 95% and 98% (kappa value of 0.90 and 0.95 accordingly) for classification of the studies and validity of therapy, and 76% (kappa value of 0.51) for study of harmful effects. A scale of 0 to 5 was used to rate the individual reports, taking into account the quality of randomization, blinding, follow-up, and control for baseline differences between groups. Tests for homogeneity were applied across the individual studies and, when studies were found to be heterogeneous, subgroup analysis according to a predefined group was performed. MAIN RESULTS: The drugs used in the meta-analysis included triazolam in 16 studies; flurazepam in 14 studies; temazepam in 13 studies; midazolam in five studies; nitrazepam in four studies; and estazolam, lorazepam, and diazepam in two studies each. Alternative drug therapies included zopiclone in 13 studies and diphenhydramine, glutethimide, and promethazine in one study each. Only one article reported on a nonpharmacological treatment (behavioral therapy). The mean age of patients was reported in 33 of the 45 studies and ranged between 29 and 82. SLEEP LATENCY: In four studies involving 159 subjects, there was sleep-record latency (time to fall asleep) data for analysis. The pooled difference indicated that the latency to sleep for patients receiving a benzodiazepine was 4.2 minutes (95% CI = (,0.7) (,9.2)) shorter than for those receiving placebo. Patient's estimates of sleep latency examined in eight studies showed a difference of 14.3 minutes (95% CI = 10.6,18.0) in favor of benzodiazepines over placebo. TOTAL SLEEP DURATION: Analysis of two studies involving 35 patients in which total sleep duration using sleep-record results was compared indicated that patients in the benzodiazepine groups slept for an average of 61.8 minutes (95% CI = 37.4,86.2) longer than those in the placebo groups. Patient's estimates of sleep duration from eight studies (566 points) showed total sleep duration to be 48.4 minutes (95% CI = 39.6,57.1) longer for patients taking benzodiazepines than for those on placebo. ADVERSE EFFECTS: Analysis of eight studies (889 subjects) showed that those in the benzodiazepine groups were more likely than those in the placebo groups to complain of daytime drowsiness (odds ratio (OR) 2.4, 95% confidence interval (CI) = 1.8,3.4). Analysis of four studies (326 subjects) also showed that subjects in the benzodiazepine groups were more likely to complain of dizziness or lightheadedness than the placebo groups. (OR 2.6, 95% CI = 0.7,10.3). Despite the increased reported side effects in the benzodiazepine groups, drop-out rates were similar in the benzodiazepine and placebo groups. For patient reported outcome, there was no strong correlation found for sleep latency data, (r = 0.4, 95% CI = (,0.3) (,0.9)) or for sleep duration (r = 0.2, 95% CI = ,0.8,0.4) between benzodiazepine dose and outcome. COMPARISON WITH OTHER DRUGS AND TREATMENTS: In three trials with 96 subjects, meta-analysis of the results comparing benzodiazepines with zopiclone, did not show significant difference in sleep latency in the benzodiazepine and placebo groups, but the benzodiazepine groups had increased total sleep duration (23.1 min. 95% CI = 5.6,40.6). In four trials with 252 subjects, the side effect profile did not show a statistically significant difference (OR 1.5, CI 0.8,2.9). There was only one study comparing the effect of behavioral therapy with triazolam. The result showed that triazolam was more effective than behavioral therapy in decreasing sleep latency, but its efficacy declined by the second week of treatment. Behavioral therapy remained effective throughout the 9-week follow-up period. There were four small trials that involved older patients exclusively, with three of the studies having less than 2 weeks of follow-up. The results were mixed regarding benefits and adverse effects were poorly reported. CONCLUSION: The result of the meta-analysis shows that the use of benzodiazepines results in a decrease in sleep latency and a significant increase in total sleep time as compared with placebo. There was also a report of significantly increased side effects, but this did not result in increased discontinuation rate. There was no dose-response relationship for beneficial effect seen with the use of benzodiazepines, although the data are scant. Zopiclone was the only alternative pharmacological therapy that could be studied with any precision. There was no significant difference in the outcome when benzodiazepines were compared with zopiclone. There was only one study that compared the effect of benzodiazepines with nonpharmacological therapy; thus available data are insufficient to comment. [source] Is brimonidine ophthalmic a safe therapy for infants?JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2006G. P. Daubert MD Summary Brimonidine is a topical alpha-2 agonist commonly used in the treatment of glaucoma. Brimonidine toxicity resembles that of clonidine overdose and is probably due to both imidazoline and alpha-2 adrenergic receptor effects. We report a case of a 6-week-old infant with congenital glaucoma who developed bradycardia and hypotension following the administration of brimonidine 0·15% ophthalmic solution. There are occasional reports of brimonidine toxicity in the paediatric population but its overall safety profile in children <2 years of age remains uncertain. Brimonidine is not dosed by weight and therefore paediatric patients may be at increased risk for systemic toxicity. It is recommended that the use of this medication be carefully considered in children <2 years of age. Physicians should be aware of its side effect profile because of its general use in the paediatric population. [source] Anticholinergics and Ketamine Sedation in Children: A Secondary Analysis of Atropine Versus GlycopyrrolateACADEMIC EMERGENCY MEDICINE, Issue 2 2010Steven M. Green MD Abstract Objectives:, Adjunctive anticholinergics are commonly administered during emergency department (ED) ketamine sedation in children under the presumption that drying oral secretions should decrease the likelihood of airway and respiratory adverse events. Pharmacologic considerations suggest that glycopyrrolate might exhibit a superior adverse effect profile to atropine. The authors contrasted the adverse events noted with use of each of these anticholinergics in a large multicenter observational database of ketamine sedations. Methods:, This was a secondary analysis of an observational database of 8,282 ED ketamine sedations assembled from 32 prior series. The authors compared the relative incidence of six adverse events (airway and respiratory adverse events, laryngospasm, apnea, emesis, recovery agitation, and clinically important recovery agitation) between children who received coadministered atropine, glycopyrrolate, or no anticholinergic. Multivariable analysis using the specific anticholinergic as a covariate was performed, while controlling for other known predictors. Results:, Atropine was associated with less vomiting (5.3%) than either glycopyrrolate (10.7%) or no anticholinergic (11.4%) in both unadjusted and multivariable analyses. Glycopyrrolate was associated with significantly more airway and respiratory adverse events (6.4%) than either atropine (3.3%) or no anticholinergic (3.0%) and similarly more clinically important recovery agitation (2.1% vs. 1.2 and 1.3%). There were, however, no differences noted in odds of laryngospasm and apnea. Conclusions:, This secondary analysis unexpectedly found that the coadministered anticholinergic atropine exhibited a superior adverse event profile to glycopyrrolate during ketamine sedation. Any such advantage requires confirmation in a separate trial; however, our data cast doubt on the traditional premise that glycopyrrolate might be superior. Further, neither anticholinergic showed efficacy in decreasing airway and respiratory adverse events. ACADEMIC EMERGENCY MEDICINE 2010; 17:157,162 © 2010 by the Society for Academic Emergency Medicine [source] Opioid Rotation in the Management of Chronic Pain: Where Is the Evidence?PAIN PRACTICE, Issue 2 2010K.C.P. Vissers MD Abstract The management of chronic pain remains a challenge because of its complexity and unpredictable response to pharmacological treatment. In addition, accurate pain management may be hindered by the prejudice of physicians and patients that strong opioids, classified as step 3 medications in the World Health Organization ladder for cancer pain management, are reserved for the end stage of life. Recent information indicates the potential value of strong opioids in the treatment of chronic nonmalignant pain. There are, up until now, insufficient data to provide indications about which opioid to use to initiate treatment or the dose to be used for any specific pain syndrome. The strong inter-patient variability in opioid receptor response and in the pharmacokinetic and pharmacodynamic behavior of strong opioids justifies an individual selection of the appropriate opioid and stepwise dose titration. Clinical experience shows that switching from one opioid to another may optimize pain control while maintaining an acceptable side effect profile or even improving the side effects. This treatment strategy, described as opioid rotation or switch, requires a dose calculation for the newly started opioid. Currently, conversion tables and equianalgesic doses are available. However, those recommendations are often based on data derived from studies designed to evaluate acute pain relief, and sometimes on single dose studies, which reduces this information to the level of an indication. In daily practice, the clinician needs to titrate the optimal dose during the opioid rotation from a reduced calculated dose, based on the clinical response of the patient. Further research and studies are needed to optimize the equianalgesic dosing tables. [source] UV Erythema Reducing Capacity of Mizolastine Compared to Acetyl-salicylic Acid or both Combined in Comparison to Indomethacin,,PHOTOCHEMISTRY & PHOTOBIOLOGY, Issue 4 2001Jens-Uwe Grundmann ABSTRACT UV light exerts hazardous effects such as induction of skin cancer and premature skin aging. In this study we evaluated an assumptive anti-inflammatory effect of the nonsedative histamine H1-receptor antagonist, mizolastine, on UV-induced acute sunburn reaction. Therefore, a clinical, randomized, double-blind, four-arm, crossover study was conducted in healthy young female volunteers (skin type II) comparing the UV sensitivity under mizolastine, acetyl-salicylic acid (ASA), indomethacin or a mizolastine/ASA combination. Moreover, HaCaT keratinocytes were incubated with mizolastine under various UV treatment modalities in vitro to study its effect on the release of inflammatory cytokines, i.e. interleukin (IL)-1,, IL-6 and tumor necrosis factor , (TNF-,). All three drugs were effective in suppressing the UVB-, UVA- and combined UVA/UVB-erythema. However, the strongest effects were observed using the combined treatment with both 250 mg ASA and 10 mg mizolastine. An inhibitory effect in vitro of 10 nM mizolastine upon UV-induced cytokine release from HaCaT keratinocytes was observed for IL-1, at 24 h after 10 J/cm2 UVA1, for IL-6 at 48 h after 10 J/cm2 UVA1 and 30 mJ/cm2 UVB, and also for TNF-, at 4 h after 10 J/cm2 UVA, 10 J/cm2 UVA1 and 30 mJ/cm2 UVB, respectively. The combination of mizolastine and ASA can be strongly recommended as a protective measure against UV erythema development with a lower unwanted side effect profile than that of the hitherto treatment modality, i.e. indomethacin. [source] Clinical Experience with Trastuzumab (Herceptin)THE BREAST JOURNAL, Issue 6 2003Charles L. Vogel MD Abstract: Trastuzumab is a humanized monoclonal antibody against the epidermal growth factor family oncogene, Her-2/neu. It has revolutionized therapy for the 15,20% of patients with metastatic breast cancer whose tumors have gene amplification for Her-2/neu. Results of clinical trials with single agent trastuzumab and in combination with paclitaxel, docetaxel, vinorelbine, gemcitabine and platinum salts have been encouraging. Durable remissions in excess of 5 years have occasionally been reported. Subjectively the side effect profile of this novel, targeted therapy, has been mild. Cardiac toxicity, while reported in combination regimens with anthracyclines tend to be easily manageable and not absolute contradictions to continuation of trastuzumab. Outside of clinical trials, however, anthracycline/trastuzumab combinations should be avoided. Preliminary results of trials with various combinations of chemotherapeutic agents have been promising while combinations with hormonal and other biologic therapy are ongoing. Trastuzumab is an exciting new monoclonal antibody with interesting anti-tumor activity in patients with Her-2/neu gene amplified breast cancer. We look forward to ongoing clinical trials combining trastuzumab with a broad array of other chemotherapeutic, hormonal and biological agents. [source] Effectiveness of Amitriptyline Versus Cough Suppressants in the Treatment of Chronic Cough Resulting From Postviral Vagal Neuropathy,THE LARYNGOSCOPE, Issue 12 2006Anita Jeyakumar MD Abstract Objective: The objective of this prospective, randomized, controlled study (N = 28) was to evaluate the effectiveness of amitriptyline versus cough suppressants in the treatment of chronic cough resulting from postviral vagal neuropathy. Methods: Patients were selected based on a clinical history consistent with postviral vagal neuropathy and a history of an antecedent upper respiratory tract infection. All patients had been tried on antireflux medication (proton pump inhibitors) and had a negative chest x-ray before presentation. All were nonsmokers without a history of asthma. Patients on angiotensin-converting enzyme inhibitors were excluded from the study. All patients completed a pretreatment, validated cough-specific quality-of-life (QOL) survey. Patients were randomized by chart numbers to either 10 mg amitriptyline at bedtime or 10 to 100 mg/5 mL, 10 mL codeine/guaifenesin every 6 hours standing dose while awake. Both groups were instructed to complete 10 days of therapy and then asked to subjectively rate the reduction in the frequency and severity of their cough by 100%, 75%, 50%, 25%, or 0% as well as completing the posttreatment cough QOL questionnaire. Those patients experiencing a 75% to 100% reduction were recorded as having a complete response, 25% to 50% a partial response, and 0% as having no response. Final results and the cough QOL survey were recorded and used for statistical analysis. Results: A majority of patients in the amitriptyline group achieved a complete response on the initial dose of 10 mg. None of the codeine/guaifenesin group achieved a complete response. The data were analyzed using a logistic regression model, and amitriptyline was found to be a highly significant predictor of a greater than 50% response when compared with codeine/guaifenesin (P = .0007). The same data were analyzed using a proportional odds model and similar results were noted. Conclusions: Chronic cough can have a profound impact on the psychosocial function of patients. The most common causes of a persisting cough in the absence of infection or chronic smoking are laryngopharyngeal reflux, asthma, particularly the cough variant, allergy, rhinosinusitis, bronchitis, and medications, in particular angiotensin-converting enzyme inhibitors. Currently, there are few effective treatments for cough with an acceptable therapeutic ratio and more selective drugs with a more favorable side effect profile are needed. This is this first prospective, randomized, controlled study comparing the effectiveness of amitriptyline versus codeine/guaifenesin for select cases of chronic cough resulting from suspected postviral vagal neuropathy. [source] Auditory Brainstem Implantation in Patients with Neurofibromatosis Type 2,THE LARYNGOSCOPE, Issue 12 2004Seth J. Kanowitz MD Abstract Objectives: Multichannel auditory brainstem implants (ABI) are currently indicated for patients with neurofibromatosis type II (NF2) and schwannomas involving the internal auditory canal (IAC) or cerebellopontine angle (CPA), regardless of hearing loss (HL). The implant is usually placed in the lateral recess of the fourth ventricle at the time of tumor resection to stimulate the cochlear nucleus. This study aims to review the surgical and audiologic outcomes in 18 patients implanted by our Skull Base Surgery Team from 1994 through 2003. Study Design: A retrospective chart review of 18 patients with ABIs. Methods: We evaluated demographic data including age at implantation, number of tumor resections before implantation, tumor size, surgical approach, and postoperative surgical complications. The ABI auditory results at 1 year were then evaluated for number of functioning electrodes and channels, hours per day of use, nonauditory side effect profile and hearing results. Audiologic data including Monosyllable, Spondee, Trochee test (MTS) Word and Stress scores, Northwestern University Children's Perception of Speech (NU-CHIPS), and auditory sensitivity are reported. Results: No surgical complications caused by ABI implantation were revealed. A probe for lateral recess and cochlear nucleus localization was helpful in several patients. A range of auditory performance is reported, and two patients had no auditory perceptions. Electrode paddle migration occurred in two patients. Patient education and encouragement is very important to obtain maximum benefit. Conclusions: ABIs are safe, do not increase surgical morbidity, and allow most patients to experience improved communication as well as access to environmental sounds. Nonauditory side effects can be minimized by selecting proper stimulation patterns. The ABI continues to be an emerging field for hearing rehabilitation in patients who are deafened by NF2. [source] Fumaric acid esters in the management of severe psoriasisCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 3 2007L. Brewer Summary Background., Fumaric acid esters (FAEs) offer an effective alternative to patients with psoriasis in whom other systemic agents are contraindicated or have failed. Objective., We assessed the efficacy and side effect profile of FAEs in a group of patients with psoriasis. Methods., A retrospective study was carried out on patients treated with FAEs over 21 months. Information was gathered from patients' notes. Dosage, response and side effects were recorded. Results., In total, 31 patients were included. The mean age was 46.8 years. All patients had been treated with other modalities and 61.5% had received previous systemic treatment. There was good to excellent response in 58.6% of patients. Subjective side-effects were common (87.1%), and lymphopenia occurred in 61.3%. The drug was not tolerated by one-fifth of patients. Conclusion., The relatively low toxicity and absence of hepatotoxicity makes FAEs a reasonable first-line systemic treatment in selected patients with difficult psoriasis. [source] Combination Surgical Lifting with Ablative Laser Skin Resurfacing of Facial Skin: A Retrospective AnalysisDERMATOLOGIC SURGERY, Issue 9 2004Tina S. Alster MD Background. Cutaneous aging is manifested by rhytides, dyschromias, and skin laxity. Ablative laser skin resurfacing can effectively improve many signs of skin aging; however, the photoaged patient with facial laxity often requires a surgical lifting procedure in order to obtain optimal results. Concerns with delayed or impaired wound healing has led to reluctance to perform both procedures simultaneously. Objective. To report the clinical results and side effect profiles after concomitant surgical facial lifting procedures and ablative carbon dioxide or erbium:YAG laser resurfacing in a series of patients. Methods. A retrospective analysis and chart review was performed in 34 consecutive patients who underwent combination CO2 or erbium:YAG laser skin resurfacing and surgical lifting procedures, including S-lift rhytidectomy, blepharoplasty, and brow lift. Side effects and complication rates were tabulated. Results. The side effect profile of the combined surgical-laser procedures was similar to that reported after a laser-only procedure. The most common side effect was transient hyperpigmentation which occurred in 20.6% of treated patients. None of the patients experienced delayed reepithelialization, skin necrosis, or prolonged healing times. Conclusions. Concurrent laser skin resurfacing and surgical lifting of facial skin maximizes aesthetic results without increased incidence of adverse effects. Patients benefit from the consolidation of anesthesia and convalescent times as well as enhanced global clinical outcomes. [source] Effectiveness of Corticosteroid Treatment in Acute Pharyngitis: A Systematic Review of the LiteratureACADEMIC EMERGENCY MEDICINE, Issue 5 2010Andrew Wing Abstract Objectives:, The objective was to examine the effectiveness of corticosteroid treatment for the relief of pain associated with acute pharyngitis potentially caused by group A beta-hemolytic Streptococcus (GABHS). Methods:, This was a systematic review of the literature. Data sources used were electronic databases (Cochrane Library, MEDLINE, EMBASE, Biosis Previews, Scopus, and Web of Science), controlled trial registration websites, conference proceedings, study references, experts in the field, and correspondence with authors. Selection criteria consisted of randomized controlled trials (RCTs) in which corticosteroids, alone or in combination with antibiotics, were compared to placebo or any other standard therapy for treatment of acute pharyngitis in adult patients, pediatric patients, or both. Two reviewers independently assessed for relevance, inclusion, and study quality. Weighted mean differences (WMDs) were calculated and are reported with corresponding 95% confidence intervals (CIs). Results:, From 272 potentially relevant citations, 10 studies met the inclusion criteria. When compared to placebo, corticosteroids reduced the time to clinically meaningful pain relief (WMD = ,4.54 hours; 95% CI = ,7.19 to ,1.89); however, they provided only a small reduction in pain scores at 24 hours (WMD = ,0.90 on a 0,10 visual analog scale; 95% CI = ,1.5 to ,0.3). Heterogeneity among pooled studies was identified for both outcomes (I2 = 81 and 74%, respectively); however, the GABHS-positive subgroup receiving corticosteroid treatment did have a significant mean reduction in time to clinically meaningful pain relief of 5.22 hours (95% CI = ,7.02 to ,3.42; I2 = 0%). Short-term side effect profiles between corticosteroids and placebo groups were similar. Conclusions:, Corticosteroid administration for acute pharyngitis was associated with a relatively small effect in time to clinically meaningful pain relief (4.5-hour reduction) and in pain relief at 24 hours (0.9-point reduction), with significant heterogeneity in the pooled results. Decision-making should be individualized to determine the risks and benefits; however, corticosteroids should not be used as routine treatment for acute pharyngitis. ACADEMIC EMERGENCY MEDICINE 2010; 17:476,483 © 2010 by the Society for Academic Emergency Medicine [source] Routine use of Xeomin® in patients previously treated with Botox®: long term resultsEUROPEAN JOURNAL OF NEUROLOGY, Issue 2009D. Dressler Background and purpose:, Based upon large and carefully performed studies Xeomin® was first registered in 2005. However, its real potential can only be assessed, when it is used outside of study design restrictions, in an independent setting, in off-label indications and during continued use. Methods and results:, Two hundred and sixty-three patients (91 with dystonia, 84 with spasticity, 17 with hemifacial spasm and re-innervation synkinesias, 64 with hyperhidrosis, 7 with hypersalivation), who were previously treated with Botox® for at least 1 year under stable conditions, were converted in a blinded fashion to Xeomin® using a 1:1 conversion ratio and identical treatment parameters. Therapeutic outcome and adverse effects were monitored by neurological examination and structuralised interviews. In 223 patients (all except those with axillary hyperhidrosis) Xeomin® was used continuously throughout a 3 year period. Altogether 1050 injection series were performed. Patients with dystonia received 261.5 ± 141.0 MU Botox®/Xeomin®, patients with spasticity 450.5 ± 177.1 MU, patients with hemifacial spasm and reinnervation synkinesias 44.7 ± 19.5 MU and patients with hyperhidrosis 286.9 ± 141.6 MU. The maximum botulinum toxin dose applied was 840 MU. There were no subjective or objective differences between Botox® and Xeomin® treatments with respect to onset latency, maximum and duration of their therapeutic effects and their adverse effect profiles. Long-term use did not reveal additional safety relevant aspects. None of the patients lost therapeutic efficacy during the observation period. Conclusions:, Xeomin® can be used safely in doses of up to 840 MU. Even when applied in high doses it did not produce secondary therapy failure. There were no diffusion differences between Botox® and Xeomin®. Using a conversion ratio of 1:1 Xeomin® and Botox® can easily be exchanged in a continued treatment. [source] Differential time effect profiles of amlodipine, as compared to valsartan, revealed by ambulatory blood pressure monitoring, self blood pressure measurements and dose omission protocolFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 4 2004Anca Radauceanu Abstract Amlodipine and valsartan are once-daily antihypertensive agents. To date, no comparison between these agents given as monotherapies was reported. This study was aimed to evaluate the therapeutic coverage and safety of amlodipine and valsartan in mild-to-moderate hypertensive patients. Multicenter, double-blind, randomized, comparative study. After a 4-week placebo wash-out period, 246 outpatients with office diastolic blood pressure 95 , DBP ,110 mmHg and systolic blood pressure (SBP) < 180 mmHg, in addition to a mean daytime SBP and/or DBP > 135/85 mmHg on 24-h ambulatory blood pressure monitoring (ABPM), were randomly allocated to once-daily amlodipine 5,10 mg or valsartan 40,80 mg, for 12 weeks. In a subgroup of patients, 48-h ABPM were performed at the end of the treatment period. Dose omission was simulated by a single-blind placebo dosing. The primary efficacy end-point was the 24-h trough office BP after 12 weeks of active therapy. The reductions in 24-h trough BP were more pronounced in amlodipine compared with valsartan group as well in office [SBP: ,17.8 ± 10.9 vs. ,14.6 ± 11.2, P = 0.025, DBP: ,12.7 ± 7.2 vs. ,10.9 ± 7.8 mmHg, P = 0.06) as in ambulatory BP (SBP/DBP: ,13.0 ± 13.7/,10.8 ± 9.1 vs. ,7.2 ± 19.4/,4.9 ± 13.4 mmHg, P < 0.05). Forty-eight hours after the last active dose, the slope of the morning BP surge (4,9 h) was less steep with amlodipine vs. valsartan [DBP (P < 0.04), SBP (n.s.)]. Ankle edema were more often reported in amlodipine group. These results suggest a superior BP lowering and a longer duration of action with amlodipine compared with valsartan. [source] Combined exposures to anti-androgenic chemicals: steps towards cumulative risk assessmentINTERNATIONAL JOURNAL OF ANDROLOGY, Issue 2 2010A. Kortenkamp Summary There is widespread exposure to anti-androgens, a group of chemicals able to disrupt androgen action in foetal life, with irreversible de-masculinizing consequences. Substances of concern include certain phthalates, pesticides and chemicals used in cosmetics and personal care products. Although people come into contact with several anti-androgens, chemicals risk assessment normally does not take account of the effects of combined exposures. However, a disregard for combination effects may lead to underestimations of risks and for this reason, we have assessed the feasibility of conducting cumulative risk assessment, where the focus is on considering the effects of exposure to multiple chemicals, via multiple routes and pathways. Following recent recommendations by the US National Research Council, we have, for the first time, included phthalates and other anti-androgenic chemicals, a total of 15 substances. On the basis of exposure estimates for the individual chemicals and reference doses for anti-androgenicity, we have used the hazard index approach. We show that the cumulative risks from anti-androgen exposures exceed acceptable levels for people on the upper end of exposure levels. The value obtained for median exposures to the 15 substances can be judged tolerable. However, significant knowledge gaps exist that prevent us from arriving at definitive conclusions. Of greatest concern is an absence of appropriate in vivo toxicity data about large numbers of in vitro androgen receptor antagonists. Knowledge about the effect profiles of these chemicals will lead to higher risk estimates. Our analysis suggests that risk reductions can be achieved by limiting exposures to the plasticizer diethyl hexyl phthalate, the cosmetic ingredients butyl- and propyl paraben, the pesticides vinclozolin, prochloraz and procymidone and bisphenol A. [source] Adding Gabapentin to a multimodal regimen does not reduce acute pain, opioid consumption or chronic pain after total hip arthroplastyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2009H. CLARKE Background: Gabapentin (GPN) is effective in reducing post-operative pain and opioid consumption, but its effects with regional anesthesia for total hip arthroplasty (THA) are not known. We designed this study to determine whether (1) gabapentin administration reduces pain and opioid use after THA using a multimodal analgesic regimen including spinal anesthesia; (2) pre-operative administration of gabapentin is more effective than post-operative administration. Methods: After REB approval and informed consent, 126 patients were enrolled in a double-blinded, randomized-controlled study. Patients received acetaminophen 1 g per os (p.o.), celecoxib 400 mg p.o. and dexamethasone 8 mg intravenously, 1,2 h pre-operatively. Patients were randomly assigned to one of three treatment groups (G1: Placebo/Placebo; G2: GPN/Placebo; G3: Placebo/GPN). Patients received gabapentin 600 mg (G2) or placebo (G1 and G3) 2 h before surgery. All patients had spinal anesthesia [15 mg (3cc) of 0.5% hypobaric bupivacaine with 10 ,g of fentanyl]. In the post-anesthetic care unit, patients received gabapentin 600 mg (G3) or placebo (G1 and G2). On the ward, patients received acetaminophen 1000 mg p.o. q6h, celecoxib 200 mg p.o. q12h and a morphine PCA device. Patients were interviewed 6 months post-surgery to determine the incidence and severity of chronic post-surgical pain. Results: Mean±SD cumulative morphine (mg) consumption (G1=49.4±24.8, G2=47.2±30.1 and G3=56.1±38.2) at 48 h and pain scores at 12, 24, 36 and 48 h post-surgery were not significantly different among the groups [G1 (n=38), G2 (n=38) and G3 (n=38)]. Side effect profiles were similar across groups. Six months after surgery, the number of patients who reported chronic post-surgical pain (G1=10, G2=12 and G3=9) and the severity of the pain (G1=4.2±2.9, G2=4.1±2.2 and G3=4.9±2.2) did not differ significantly among the groups (P>0.05). Conclusions: A single 600 mg dose of gabapentin given pre-operatively or post-operatively does not reduce morphine consumption or pain scores in hospital or at 6 months after hip arthroplasty within the context of spinal anesthesia and a robust multimodal analgesia regimen. [source] Solar keratosis: Epidemiology, pathogenesis, presentation and treatmentAUSTRALASIAN JOURNAL OF DERMATOLOGY, Issue 2 2007Cara Holmes SUMMARY Solar keratosis is a common problem encountered by dermatologists, particularly in Australia. Solar keratosis is most commonly found on sun-exposed areas such as the scalp, face and forearms. UV radiation is thought to be the major aetiological factor, with age, immunosuppression and human papillomavirus being important contributing factors. Solar keratosis usually presents as a discrete, variably erythematous and irregular lesion with a scaly surface. Although the exact rate of malignant transformation to squamous cell carcinoma is unknown, the majority of squamous cell carcinomas appear to arise from within solar keratosis. For this reason, solar keratosis is commonly treated and, consequently, an increasing number of therapeutic options is now available. Traditional therapies, such as liquid nitrogen cryotherapy, are still popular, but newer choices, such as photodynamic therapy and imiquimod cream, are now providing further options with similar efficacy and superior adverse effect profiles, albeit at a higher cost. [source] Pediatric Procedural Sedation with Ketamine: Time to Discharge after Intramuscular versus Intravenous AdministrationACADEMIC EMERGENCY MEDICINE, Issue 2 2009Preeti Ramaswamy MBBS Abstract Objectives:, Ketamine is an attractive agent for pediatric procedural sedation. There are limited data on time to discharge comparing intramuscular (IM) vs. intravenous (IV) ketamine. The authors set out to determine whether IM or IV ketamine leads to quicker discharge from the emergency department (ED) and how side effect profiles compare. Methods:, All patients who had received ketamine IM or IV at a tertiary children's hospital ED during the 3-year study period (2004,2007) were identified. Prospective sedation registry data, retrospective medical records, and administrative data were reviewed for drug dosages, use of additional agents, time of drug administration to discharge, total ED time (triage to discharge), and adverse events. A subgroup analysis for patients requiring five or fewer sutures (short suture group) was performed. Results:, A total of 229 patients were enrolled (60% male) with median age of 2.8 years (IQR =1.8,4.3 years) and median weight of 15.7 kg (range = 8.7,74 kg). Ketamine was most frequently employed for laceration repair (80%) and foreign body removal (9%). Overall, 48% received ketamine IM and 52% received it IV. In the short-suture subgroup, 52% received ketamine IM, while 48% received it IV. Multivariate linear regression analysis determined time from drug administration to patient discharge as 21 minutes shorter for IV compared with IM administration, adjusted for age and number of additional doses (R2 = ,0.35; 95% CI = ,0.5 to ,0.19; p < 0.001). Total time in the ED (triage to discharge) comparing IV versus IM administration, adjusting for age and gender and number of additional doses, was not significantly different (p = 0.16). In the short-suture subgroup, time to discharge from administration was also shorter in the IV ketamine group (R2 = ,0.454; 95%CI = ,0.66 to ,0.25; p < 0.001) but similar for total time in ED (p = 0.16). Overall, adverse events occurred in 35% (95% CI = 27% to 45%) of the IM group and 20% (95% CI = 13% to 28%) of the IV group (p = 0.01). Only one patient required brief bag-mask ventilation. Conclusions:, In this institution, time from drug injection to discharge was shorter in the IV compared to IM ketamine group, both overall and for the short-suture group. However, time from triage to discharge was similar. [source] A Double-blind Randomized Clinical Trial Evaluating the Analgesic Efficacy of Ketorolac versus Butorphanol for Patients with Suspected Biliary Colic in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 8 2008Jon C. Olsen MD Abstract Objectives:, Patients presenting to the emergency department (ED) with suspected biliary colic often require intravenous (IV) analgesia. The choice of IV analgesia typically includes opioids and ketorolac. Although ultrasound (US) is the initial diagnostic study in these patients, nondiagnostic scans and a high clinical suspicion may require the patient to undergo hepatobiliary scintigraphy (HIDA). Opioids such as morphine interfere with the HIDA scan and thus may limit its value as an analgesic in the ED for these patients. Analgesics that do not interfere with HIDA scanning include ketorolac and butorphanol, an opioid agonist,antagonist. This study evaluates the efficacy of IV ketorolac compared to butorphanol for the treatment of biliary colic pain in the ED. Methods:, Between June 2005 and February 2007, a convenience sample of patients presenting to the ED with abdominal pain suspected to be biliary colic were randomized to receive either 30 mg of IV ketorolac or 1 mg of IV butorphanol. Pain level was assessed using a 1 to 10 "faces" visual analog pain scale initially, as well as 15 and 30 minutes after medication infusion. Side effect profiles and the need for rescue analgesia were also assessed. Patients and clinicians were blinded to the study drug given. Results:, Forty-six patients were enrolled in the study. Both groups had similar demographics and baseline pain scores. The mean (±standard deviation [SD]) pain score in the butorphanol group decreased from 7.1 (±1.7) to 2.1 (±2.2) after 30 minutes. The mean (±SD) pain score in the ketorolac group decreased from 7.4 (±2.0) to 3.1 (±3.3) after 30 minutes. Both groups had similar needs for rescue analgesia. Side effects included dizziness and sedation with butorphanol and nausea with ketorolac. Conclusions:, Although limited by small sample size and convenience sample, this study demonstrates that both ketorolac and butorphanol provide pain relief in biliary colic. Both agents should be considered reasonable options in the ED treatment of biliary colic, especially in patients that may undergo HIDA. [source] |