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Selected AbstractsTolerability of High Doses of Lercanidipine versus High Doses of Other Dihydropyridines in Daily Clinical Practice: The TOLERANCE StudyCARDIOVASCULAR THERAPEUTICS, Issue 1 2008Vivencio Barrios The TOLERANCE study was aimed to compare the tolerability of high doses of lercanidipine (20 mg) with that of other frequently used dihydropyridines (amlodipine 10 mg/nifedipine GITS 60 mg) in the treatment of essential hypertension in daily clinical practice. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 evaluable patients with essential hypertension and age , 18 years were included. They had been treated with high doses of lercanidipine (n= 446) or amlodipine/nifedipine GITS (n= 204) during at least 1 month and previously with low doses (10 mg, 5 mg, and 30 mg, respectively) of the same drugs. The main objective was to compare the rates of vasodilation-related adverse events between both groups. Rates of signs and symptoms related to vasodilation were significantly higher (P < 0.001) in the amlodipine/nifedipine GITS group (76.8%, CI 95%[70.7; 82.9]) than in lercanidipine group (60.8%, [56.1;65.5]). Blood pressure control (< 140/90 mmHg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (around 93%) and fairly comparable in both groups. Most adverse events with lercanidipine were mild (74.5% vs. 64% in amlodipine/nifedipine GITS group, P= 0.035) whereas severe adverse event rates did not differ significantly between groups (2.8% vs. 3.6%). In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of adverse events related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice. [source] Inhomogeneous volumetric Laplacian deformation for rhinoplasty planning and simulation systemCOMPUTER ANIMATION AND VIRTUAL WORLDS (PREV: JNL OF VISUALISATION & COMPUTER ANIMATION), Issue 3-4 2010Sheng-hui Liao Abstract This paper presents an intuitive rhinoplasty planning and simulation system, to provide high quality prediction of postoperative appearance, and design patient specific nose prosthesis automatically. The key component is a novel volumetric Laplacian deformation tool inspired by the state-of-the-art differential surface deformation techniques. Working on the volumetric domain and incorporating inhomogeneous material from CT data make the new approach suitable for soft tissue simulation. In particular, the system employs a special sketch contour driving deformation interface, which can provide realistic 3D rhinoplasty simulation with intuitive and straightforward 2D manipulation. When satisfied with the appearance, the change of soft tissue before and after simulation is utilized to generate the individual prosthesis model automatically. Clinical validation using post-operative CT data demonstrated that the system can provide prediction results of high quality. And the surgeons who used the system confirmed that this planning system is attractive and has potential for daily clinical practice. Copyright © 2010 John Wiley & Sons, Ltd. [source] ASC-US and high-risk HPV testing: Performance in daily clinical practiceDIAGNOSTIC CYTOPATHOLOGY, Issue 11 2006Suzanne M. Selvaggi M.D.Article first published online: 13 OCT 200 Abstract Data are beginning to accrue on high-risk HPV DNA testing in patients with ASC-US on cervical cytology. We report on our experience at the University of Wisconsin Hospital and Clinics. From February 2002 through December 31, 2005 (3 yr, 11 mo), the cytopathology laboratory processed 49,599 Pap Tests, of which 1,792 (3.6%) were diagnosed as ASC-US. Six hundred and seventy two (37.5%) of these cases were processed for high-risk HPV genotypes using the Digene Hybrid® Capture II method. Of these cases, 266 (39.6%) were positive for high-risk HPV genotypes, 11 (1.6%) were equivocal, and 395 (58.8%) were negative. Biopsy follow-up was available for 127 (47.7%) of the 266 cases, of which 66 (52%) were negative, 46 (36.2%) showed CIN I, 9 (7.1%) were CIN II, and 6 (4.7%) were CIN III. Of the remaining 139 (52.3%) cases, 86 (62%) had follow-up Pap Tests, of which 57 (66.3%) were negative, 15 (17.4%) were ASC-US, 12 (15%) were low-grade squamous intraepithelial lesions, and 2 (2.3%) were high-grade squamous intraepithelial lesions; 53 (38.1%) were lost to follow-up. In combination, 90 (42.25%) of the 213 cases with follow-up showed atypia or above after a diagnosis of ASC-US; of which 58 (64%) were low-grade lesions and 17 (19%) were high-grade lesions. Our laboratory's reported high-risk HPV positivity is comparable to recent reports in the literature on its use in daily clinical practice. In addition, cervical abnormalities were found in a significant proportion of the cases. Diagn. Cytopathol. 2006;34: 731,733. © 2006 Wiley-Liss, Inc. [source] Electrical optimization of cardiac resynchronization in chronic heart failure is associated with improved clinical long-term outcomeEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 8 2010Christopher Adlbrecht Eur J Clin Invest 2010; 40 (8): 678,684 Abstract Background, Cardiac resynchronization therapy (CRT) is an established treatment option for symptomatic chronic heart failure (CHF) patients with pharmacological baseline therapy, but not all patients benefit from device therapy. One reason for this may be inadequate device settings. In real-world practice, echocardiographic evaluation of atrioventricular (AV) delay is not performed in a high proportion of patients, as the effect of electrical optimization of CRT is an issue open for investigation. Materials and methods, We performed a retrospective observational study analysing the effect of AV-interval evaluation with echocardiography on long-term [32 (23?43) months] clinical outcome in 205 CHF patients. A stepwise Cox regression model including a co-morbidity score, failed AV-interval evaluation, satisfactory device function after the first implantation attempt, failure to reach 100% of the recommended renin-angiotensin system inhibitor and beta-blocker dose at follow-up and CRT device implantation compared with CRT in combination with an implanted cardioverter defibrillator (ICD) was applied. Results, In the total study cohort, 124 (60·5%) patients had reached the primary combined endpoint death or cardiac hospitalization and 59 (28·8%) had died. Cox regression analysis revealed that failed AV-interval evaluation [HR = 1·72 (1·19,2·49), P = 0·004] non-optimized CHF pharmacotherapy dosages [HR = 2·12 (1·32,3·42), P = 0·002], the presence of a CRT/ICD combination device [HR = 1·87 (1·28,2·71), P = 0·001] and satisfactory device function after the first implantation attempt [HR = 0·44 (0·25,0·77), P = 0·004] were associated with the primary endpoint. Conclusion, Echocardiographic evaluation of the AV-interval in patients with CRT was independently associated with improved clinical outcome, impacting on daily clinical practice of HF patient care. [source] Prediction of survival in patients with head and neck cancerHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 9 2001Robert Jan Baatenburg de Jong PhD Abstract Background In patients with head and neck squamous cell carcinoma (HNSCC) the estimated prognosis is usually based on the TNM classification. The relative weight of the three contributing parameters is often not completely clear. Moreover, the impact of other important clinical variables such as age, gender, prior malignancies, etc is very difficult to substantiate in daily clinical practice. The Cox-regression model allows us to estimate the effect of different variables simultaneously. The purpose of this study was to design a model for application in new HNSCC patients. In our historical data-base of patients with HNSCC, patient, treatment, and follow-up data are stored by trained oncological data managers. With these hospital-based data, we developed a statistical model for risk assessment and prediction of overall survival. This model serves in clinical decision making and appropriate counseling of patients with HNSCC. Patients and Methods All patients with HNSCC of the oral cavity, the pharynx, and the larynx diagnosed in our hospital between 1981 and 1998 were included. In these 1396 patients, the prognostic value of site of the primary tumor, age at diagnosis, gender, T-, N-, and M-stage, and prior malignancies were studied univariately by Kaplan-Meier curves and the log-rank test. The Cox-regression model was used to investigate the effect of these variables simultaneously on overall survival and to develop a prediction model for individual patients. Results In the univariate analyses, all variables except gender contributed significantly to overall survival. Their contribution remained significant in the multivariate Cox model. Based on the relative risks and the baseline survival curve, the expected survival for a new HNSCC patient can be calculated. Conclusions It is possible to predict survival probabilities in a new patient with HNSCC based on historical results from a data-set analyzed with the Cox-regression model. The model is supplied with hospital-based data. Our model can be extended by other prognostic factors such as co-morbidity, histological data, molecular biology markers, etc. The results of the Cox-regression may be used in patient counseling, clinical decision making, and quality maintenance. © 2001 John Wiley & Sons, Inc. Head Neck 23: 718,724, 2001. [source] Response Evaluation Criteria in Cancer of the Liver (RECICL) proposed by the Liver Cancer Study Group of Japan (2009 Revised Version)HEPATOLOGY RESEARCH, Issue 7 2010Masatoshi Kudo The World Health Organization (WHO) criteria and Response Evaluation Criteria in Solid Tumors (RECIST) are inappropriate to assess the direct effects of treatment on the hepatocellular carcinoma (HCC) by locoreginal therapies such as radiofrequency ablation (RFA) and transcatheter arterial chemoembolization (TACE). Therefore, establishment of response evaluation criteria solely devoted for HCC is needed urgently in the clinical practice as well as in the clinical trials of HCC treatment, such as molecular targeted therapies, which cause necrosis of the tumor. Response Evaluation Criteria in Cancer of the Liver (RECICL) was revised in 2009 by Liver Cancer Study Group of Japan based on the 2004 version of RECICL, which was commonly used in Japan. Major revised points of the RECICL 2009 is to provide TE4a (Complete response with enough ablative margin) and TE4b (complete response without enough ablative margin) for local ablation therapy. Second revised point is that setting the timing at which the overall treatment effects are assessed. Third point is that emergence of new lesion in the liver is regarded as progressive disease, different from 2004 version. Finally, 3 tumor markers including alpha-fetoprotein (AFP) and AFP-L3 and des-gamma-carboxy protein (DCP) were also added for the overall treatment response. We hope this new treatment response criteria, RECICL, proposed by Liver Cancer Study Group of Japan will benefit the HCC treatment response evaluation in the setting of the daily clinical practice and clinical trials as well not only in Japan, but also internationally. [source] Vacuum-assisted closure home care training: a process to link education to improved patient outcomesINTERNATIONAL WOUND JOURNAL, Issue 2008Kevin Y Woo Negative pressure wound therapy (NPWT) applies subatmospheric pressure across the wound bed inducing cellular and molecular changes that are beneficial to wound healing. This healing modality may facilitate tissue debridement, infection/inflammation control, and moisture balance; the key components of the wound bed preparation paradigm. To ensure that scientific evidence is diffused into daily clinical practice, we are proposing a knowledge transfer model that articulates an educational plan for the various levels of professional development. The discussion highlights the challenges and potential solutions to integrate NPWT into a seamless continuum of care including a community-based patient care model. [source] Sources of knowledge in clinical practice in postgraduate medical students and faculty members: a conceptual mapJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2007Reza Yousefi-Nooraie MD Abstract Objectives, To determine the most important knowledge sources that can influence clinical practice and to cluster them in conceptual groups based on their relative importance. Methods, Faculty members, fellows and residents of a large teaching tertiary care hospital were asked to rate the importance of different resources in their daily clinical practice and their understanding of some common terms from evidence-based medicine. The knowledge sources were distributed in a two-dimensional map using multidimensional scaling and hierarchical cluster analysis. Results, A total of 250 of 320 recruited hospital staff returned the questionnaires. The most important resources in daily practice were English journals, text books and literature searching for faculty members, experience, text books and English journals for fellows and text books, experience and peers for residents. Regional journals were the least important resources for all study groups. About 62.7% of residents did not know the meaning of ,number needed to treat', 36.8%,confidence interval', 54.9%,confounding factor' and 44.6%,meta-analysis'. The percentages for faculty members were 41.3%, 37%, 42.2% and 39.1%. The knowledge sources were placed in four clusters in a point map derived from the multidimensional scaling process. Conclusion, The dominance of the traditional information resources and experience-based medicine debate which is the consequence of traditional approaches to medical education may be one of the considerable barriers to the dissemination of evidence-based medicine in developing countries. The evidence-based clinical practice guidelines could be used as a useful passive-predigested source for busy clinicians to make informed decisions. A considerable Western bias may undermine the local research in developing world. [source] Treatment of scalp psoriasis with clobetasol-17 propionate 0.05% shampoo: a study on daily clinical practiceJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2010HJ Bovenschen Abstract Background, Safety and clinical effectiveness of clobetasol-17 propionate 0.05% shampoo have been shown in patients with scalp psoriasis. Aim, First, to evaluate treatment satisfaction, user convenience safety and effectiveness of clobetasol-17 propionate 0.05% shampoo treatment in daily clinical practice. Second, to identify subgroup variables that may predict treatment success or failure. Methods, A total of 56 patients with scalp psoriasis were treated with short-contact clobetasol-17 propionate 0.05% shampoo once daily for 4 weeks. Data on treatment satisfaction, user convenience, safety and effectiveness were assessed on a 7-point Likert scale using postal questionnaires. Subgroup analyses were performed to identify variables that may predict treatment outcome. Results, A total of 41 patients returned both questionnaires (73%). Positive treatment satisfaction and user convenience were reported by 66% and 79% of patients respectively. Patient-rated indicators for disease severity improved by 39,46% (P < 0.05%). No major side-effects were reported. Subgroup analyses did not reveal any statistically significant patient variable that may predict treatment outcome. However, a tendency towards improved treatment satisfaction was observed in patients who had received fewer topical antipsoriatic treatments previously (P > 0.05). Conclusions, Short-contact treatment with clobetasol-17 propionate 0.05% shampoo has high user convenience and patient satisfaction rates. Moreover, the treatment is well-tolerated and efficacious from patients' perspective. Subgroup analyses did not reveal factors predicting treatment outcome, although treatment success tended to be more evident in patients who had received fewer treatments previously. [source] Reliability of the assessment of preventable adverse drug events in daily clinical practice,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2008Jasperien E. van Doormaal PharmD Abstract Purpose To determine the reliability of the assessment of preventable adverse drug events (ADEs) in daily practice and to explore the impact of the assessors' professional background and the case characteristics on reliability. Methods We used a combination of the simplified Yale algorithm and the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) scheme to assess on the one hand the causal relationship between medication errors (MEs) and adverse events in hospitalised patients and on the other hand the severity of the clinical consequence of MEs. Five pharmacists and five physicians applied this algorithm to 30 potential MEs. After individual assessment, the pharmacists reached consensus and so did the physicians. Outcome was both MEs' severity (ordinal scale, NCC MERP categories A,I) and the occurrence of preventable harm (binary outcome, NCC MERP categories A,D vs. E,I). Kappa statistics was used to assess agreement. Results The overall agreement on MEs' severity was fair for the pharmacists (,,=,0.34) as well as for the physicians (,,=,0.25). Overall agreement for the 10 raters was fair (,,=,0.25) as well as the agreement between both consensus outcomes (,,=,0.30). Agreement on the occurrence of preventable harm was higher, ranging from ,,=,0.36 for the physicians through ,,=,0.49 for the pharmacists. Overall agreement for the 10 raters was fair (,,=,0.36). The agreement between both consensus outcomes was moderate (,,=,0.47). None of the included case characteristics had a significant impact on agreement. Conclusions Individual assessment of preventable ADEs in real patients is difficult, possibly because of the difficult assessment of contextual information. Best approach seems to be a consensus method including both pharmacists and physicians. Copyright © 2008 John Wiley & Sons, Ltd. [source] 5-Aminolevulinic Acid Derivatives in Photomedicine: Characteristics, Application and PerspectivesPHOTOCHEMISTRY & PHOTOBIOLOGY, Issue 4 2006Nicolas Fotinos ABSTRACT The introduction of lipophilic derivatives of the naturally occurring heme precursor 5-aminolevulinic acid (5-ALA) into photomedicine has led to a true revival of this research area. 5-ALA-mediated photodynamic therapy (PDT) and fluorescence photodetection (FD) of neoplastic disease is probably one of the most selective cancer treatments currently known in oncology. To date, this method has been assessed experimentally for the treatment of various medical indications. However, the limited local bioavailability of 5-ALA has widely prevented its use in daily clinical practice. Although researchers were already aware of this drawback early during the development of 5-ALA-mediated PDT, only recently have well-established concepts in pharmaceutical science been adapted to investigate ways to overcome this drawback. Recently, two derivatives of 5-ALA, methylaminolevulinate (MAL) and hexylaminolevulinate (HAL), gained marketing authorization from the regulatory offices in Europe and Australia. MAL is marketed under the trade name Metvix for the treatment of actinic keratosis and difficult-to-treat basal cell carcinoma. HAL has recently been launched under the trade name Hexvix to improve the detection of superficial bladder cancer in Europe. This review will first present the fundamental concepts underlying the use of 5-ALA derivatives in PDT and FD from a chemical, biochemical and pharmaceutical point of view. Experimental evidences from preclinical data on the improvements and limits observed with 5-ALA derivatives will then be introduced. The state-of-the-art from clinical studies with 5-ALA esters will be discussed, with special emphasis placed on the process that led to the development of MAL in dermatology and to HAL in urology. Finally, we will discuss promising medical fields in which use of 5-ALA derivatives might potentially lead to further use of this methodology in photomedicine. [source] Development of 2-hour suicide intervention program among medical residents: First pilot trialPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 5 2010Takahiro A. Kato MD Aim:, Suicide is associated not only with primary psychiatric disorders but also with physical disorders. Physicians' education on suicide prevention contributes to reducing suicide. Therefore, medical residents, who contact patients daily and who eventually become primary physicians in each specialty, might be the most appropriate candidates for intervention. In this article, we introduce our newly developed suicide intervention program among medical residents. Methods:, We developed a 2-hour suicide intervention program among medical residents, based on the Mental Health First Aid (MHFA), which had originally been developed for the public. The program contains a 1-hour lecture and a 1-hour role-play session. As the first pilot trial, we conducted the program among 44 first-year medical residents at a university hospital and evaluated its effectiveness. Changes in confidence, attitudes and behavior toward suicidal people were evaluated using self-reported questionnaires before, immediately after, and 6 months after the program. Results:, Participants' confidence and attitudes significantly improved after the program. The total mean score (standard deviation) of the Suicide Intervention Response Inventory improved from 18.4 (2.0) before the intervention to 19.4 (2.0) immediately after the intervention. However, the effectiveness was limited after 6 months. In the course of 6 months, the participants learned to apply the MHFA principles in their daily clinical practice. Conclusion:, Our newly developed brief suicide intervention program demonstrating its effectiveness among medical residents should be modified in order to be more effective in the long term. The next trial with a control group ought to be conducted to evaluate our developed program. [source] Elbow flexion response as another primitive reflexPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 2 2002Kazumasa Sudo MD Abstract In daily clinical practice we noticed that patients with intellectual impairment spontaneously flex the elbow within a few seconds of the forearm being manipulated during routine examination of spasticity of the muscles in the upper extremities. We termed this phenomenon elbow flexion response (EFR), and prospectively studied it in 229 patients who underwent in-hospital rehabilitation following brain damage. Evaluation of each patient included EFR, patient profile, ability to communicate, scores on three parameters from various intelligence tests, scores on seven parameters testing primitive reflexes, and scores on three parameters describing personality. We investigated for relationships among these parameters. Consequently, although EFR rarely have a statistical association with the varied profiles of patients, patients with bilateral lesion or bilateral paresis demonstrated significantly more marked EFR than those with unilateral lesion or unilateral paresis. Patients with involvement of the frontal lobe showed significantly more marked EFR than those without damage in this area. Elbow flexion responses occurred significantly more frequently in relation with lower scores on intelligence and occurred with significantly higher frequency in conjunction with the more marked appearance of conventional primitive reflexes. Therefore, we conclude that EFR have a strong association with intelligence and with the existence of frontal lobe lesion, and their mode of clinical presentation parallels that of primitive reflexes particularly that of the grasp reflex. We propose that EFR could be referred as a variation of the grasp reflex occurring in the more proximal or axial part of the body. [source] Resident Training in Emergency Ultrasound: Consensus Recommendations from the 2008 Council of Emergency Medicine Residency Directors ConferenceACADEMIC EMERGENCY MEDICINE, Issue 2009Saadia Akhtar MD Abstract Over the past 25 years, research performed by emergency physicians (EPs) demonstrates that bedside ultrasound (US) can improve the care of emergency department (ED) patients. At the request of the Council of Emergency Medicine Residency Directors (CORD), leaders in the field of emergency medicine (EM) US met to delineate in consensus fashion the model "US curriculum" for EM residency training programs. The goal of this article is to provide a framework for providing US education to EM residents. These guidelines should serve as a foundation for the growth of resident education in EM US. The intent of these guidelines is to provide minimum education standards for all EM residency programs to refer to when establishing an EUS training program. The document focuses on US curriculum, US education, and competency assessment. The use of US in the management of critically ill patients will improve patient care and thus should be viewed as a required skill set for all future graduating EM residents. The authors consider EUS skills critical to the development of an emergency physician, and a minimum skill set should be mandatory for all graduating EM residents. The US education provided to EM residents should be structured to allow residents to incorporate US into daily clinical practice. Image acquisition and interpretation alone are insufficient. The ability to integrate findings with patient care and apply them in a busy clinical environment should be stressed. [source] Current trends in paediatric regional anaesthesiaANAESTHESIA, Issue 2010H. Willschke Summary Regional anaesthesia is a cornerstone in paediatric anaesthesia today. Many paediatric anaesthetists include regional anaesthetic techniques in their daily clinical practice to provide superior and long-lasting analgesia without the risk of respiratory depression. The first part this article reviews new scientific findings in the field of paediatric regional anaesthesia. The second part focuses on safety aspects and on the impact of ultrasound on paediatric regional anaesthesia. [source] Three-year registry data on biological treatment for psoriasis: the influence of patient characteristics on treatment outcomeBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2009R.J.B. Driessen Summary Background, The course of biological treatment in clinical practice may be highly different from treatment schedules in clinical trials. Treatment modifications and patient characteristics may influence treatment safety and efficacy. So far, long-term results from the use of biological treatment in clinical practice are lacking. Objectives, To report short- and long-term efficacy and safety data on biologics, especially etanercept, used in daily clinical practice. Special attention has been paid to patient characteristics that may have influenced the response to therapy. Methods, Prospectively collected registry data of all patients with psoriasis treated with biologics in the Radboud University Nijmegen Medical Centre outpatient clinic were used for analysis. Patient and treatment characteristics were surveyed. Efficacy and safety of etanercept for up to 3 years were analysed. Moreover, the influence of patient characteristics on etanercept treatment response was studied. Results, The analysed cohort, consisting of 118 patients, went through 142 treatment episodes in total. Patients treated with biologics had an extensive medical history. Optimization of biological treatment was established in various ways, including treatment switches and introduction of concomitant therapies. Short-term etanercept efficacy analysis showed a mean Psoriasis Area and Severity Index (PASI) improvement at week 24 of 59·7%. No significant influence of gender, age, baseline PASI, body mass index, number of previous systemic therapies or duration of psoriasis was found on week 24 efficacy results, although trends were discernible. The efficacy of etanercept remained stable for up to 156 weeks. Long-term daily practice treatment with etanercept was only occasionally accompanied by major safety concerns. Conclusions, The current study demonstrates that etanercept is able to improve psoriasis symptoms for a considerable time, and that serious side-effects are infrequent. The influence of patient characteristics on treatment response is limited. [source] Tolerability of High Doses of Lercanidipine versus High Doses of Other Dihydropyridines in Daily Clinical Practice: The TOLERANCE StudyCARDIOVASCULAR THERAPEUTICS, Issue 1 2008Vivencio Barrios The TOLERANCE study was aimed to compare the tolerability of high doses of lercanidipine (20 mg) with that of other frequently used dihydropyridines (amlodipine 10 mg/nifedipine GITS 60 mg) in the treatment of essential hypertension in daily clinical practice. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 evaluable patients with essential hypertension and age , 18 years were included. They had been treated with high doses of lercanidipine (n= 446) or amlodipine/nifedipine GITS (n= 204) during at least 1 month and previously with low doses (10 mg, 5 mg, and 30 mg, respectively) of the same drugs. The main objective was to compare the rates of vasodilation-related adverse events between both groups. Rates of signs and symptoms related to vasodilation were significantly higher (P < 0.001) in the amlodipine/nifedipine GITS group (76.8%, CI 95%[70.7; 82.9]) than in lercanidipine group (60.8%, [56.1;65.5]). Blood pressure control (< 140/90 mmHg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (around 93%) and fairly comparable in both groups. Most adverse events with lercanidipine were mild (74.5% vs. 64% in amlodipine/nifedipine GITS group, P= 0.035) whereas severe adverse event rates did not differ significantly between groups (2.8% vs. 3.6%). In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of adverse events related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice. [source] Drug allergy claims in children: from self-reporting to confirmed diagnosisCLINICAL & EXPERIMENTAL ALLERGY, Issue 1 2008E. Rebelo Gomes Summary Background Poorly documented self-reported drug allergy (DAll) is a frequent problem in daily clinical practice and has a considerable impact on prescription choices. The diagnostic work-up of drug hypersensitivity (DHs) allows a better classification of the reactions and provides patients with more reliable information and recommendations for future treatments. Objective To assess the prevalence of self-reported adverse drug reactions (ADRs) and DAll in a paediatric population and to investigate children reporting suspected DAll in order to achieve a firm diagnosis. Design The first phase was based on a cross-sectional survey assessing the life occurrence of ADRs and self-reported DAll carried out at the outpatient clinic of a paediatric hospital. The second phase was based on the diagnostic work-up in children with parent-reported DAll, including detailed anamnesis and in vitro and in vivo investigations (skin and provocation tests). Participants One thousand four hundred and twenty-six parents responded to the initial survey. Sixty of the 67 patients with reported DAll were evaluated at the allergy clinic. Results The prevalences of self-reported ADRs and DAll were 10.2% and 6.0%, respectively. Most of the suspected allergic reactions were non-immediate cutaneous events attributable to ,-lactam antibiotics and occurred in very young children. Thirty-nine of the 60 patients consulting for evaluation had a plausible clinical history and were recommended further investigation. DHs was diagnosed in three children only, based on positive responses in skin (n=1) and oral provocation (n=2) tests. Conclusion ADRs are frequently reported in children, and many children are classified as having a DAll. After complete evaluation, only a few of these reactions can be attributed to DHs and DAll. Most of the patients (94% in this study) could actually tolerate the initially suspected drug. [source] Simultaneous radio- and chemotherapy for squamous cell carcinoma of the head and neck in daily clinical practice: 5 years experience in a University HospitalCLINICAL OTOLARYNGOLOGY, Issue 6 2004M. Langenberg Several randomized studies and meta-analyses have shown that simultaneous radio- and chemotherapy prolongs survival in patients with unresectable squamous cell carcinoma of the head and neck as compared with conventional radiotherapy. We assessed the feasibility and effectiveness of simultaneous radiotherapy (35 × 2 Gy) and chemotherapy [cisplatinum 100 mg/m2 or carboplatin (AUC 6) on days 1, 22 and 43] in daily clinical practice in a cohort of 87 patients treated at our institute between 1998 and 2002. Eighty patients completed radiotherapy according to schedule. Eighty patients received two courses of chemotherapy and 50 patients three courses. Nephrotoxity, bone marrow suppression and ototoxicity were the most frequent side-effects. Median weight loss was 8.5%. Median survival was 15 months and 44% of the patients were alive at 2 years. Patients receiving three courses of chemotherapy had a better survival than patients receiving two or less courses. Treatment with simultaneous radio- and chemotherapy for advanced head and neck cancer is a demanding, but feasible treatment in daily clinical practice. Survival seems to be comparable with the results achieved in patients selected for clinical trials. [source] |