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Significant Side Effects (significant + side_effects)
Selected AbstractsAnaesthesiological considerations on tocolytic and uterotonic therapy in obstetricsACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 6 2009M. VERCAUTEREN Aim: Significant side effects of tocolytic and uterotonic substances may be of concern to the anaesthesiologist. Recently, new drugs have been introduced having less side effects for both the mother and the neonate. Methods: A literature search was undertaken mainly focusing on meta-analyses, to review the possible side effects that might affect the course of anaesthesia and to suggest which precautions should be considered to prevent the occurrence of significant interactions with anaesthetic manipulations and drugs. Results: Magnesium sulphate has a proven benefit in lowering systolic blood pressure and preventing the occurrence of eclampsia, but not as a tocolytic. ,-adrenergic agonists are being abandoned due to the availability of tocolytic agents causing less side effects. Calcium channel blockers (CCB) are frequently used but can cause major maternal cardiovascular complications. Nitroglycerin seems to be appreciated as an acute tocolytic rather than a routine substance during pre-term labour. Cyclo-oxygenase-2 inhibitors are still under investigation but their tocolytic benefit is questionable mainly due to foetal side effects. Atosiban is considered the first-choice tocolytic. With respect to oxytocic drugs, oxytocine, prostaglandines and methylergometrine may all cause serious side effects especially when combined. The cardiovascular side effects of prostaglandins and methylergometrine can be life-threatening. Both oxytocin and carbetocin have a rather low risk for maternal complications. Conclusion: Atosiban and CCB are at least as effective tocolytic agents as ,-mimetics but have significantly less side effects. Magnesium sulphate can cause neuromuscular blockade, especially when combined with CCB. Concerning oxytocic agents, short-acting oxyctocin and long-acting carbetocin have the least side effects as compared with prostaglandins and methylergometrine. [source] Budesonide delivered by dosimetric jet nebulization to preterm very low birthweight infants at high risk for development of chronic lung diseaseACTA PAEDIATRICA, Issue 12 2000B Jónsson We investigated the effect of an aerosolized corticosteroid (budesonide) on the oxygen requirement of infants at high risk for developing chronic lung disease (CLD) in a randomized, double-blind study. The study objective was to attain a 30% decrease in FiO2 levels in the budesonide treatment group after 14 d of therapy. Thirty very low birthweight (VLBW) infants (median (range)) gestational age 26 wk (23,29) and birthweight 805 g (525,1227) were randomized. Inclusion criteria were mechanical ventilation on day 6 of life, or if extubated on nasal continuous positive airway pressure with FiO2± 0.3. The budesonide (PulmicortÔ dose was 500 ,g bid, or placebo. The aerosol was delivered with a dosimetric jet nebulizer, with variable inspiratory time and breath sensitivity. Inhalations were started on day 7 of life. Twenty-seven patients completed the study. A significant lowering of the FiO2 levels at 21 d of life was not detected. Infants who received budesonide were more often extubated during the study period (7/8 vs 2/9) and had a greater relative change from baseline in their oxygenation index (budesonide decreased 26% vs placebo increased 60%). Subsequent use of intravenous dexamethasone or inhaled budesonide in the treatment group was significantly less. All patients required O2 supplementation on day 28 of life. At 36 wk postconceptual age, 61% of infants in the budesonide group needed supplemental O2 as opposed to 79% in the placebo group. No side effects on growth or adrenal function were observed Conclusion: We conclude that inhaled budesonide aerosol via dosimetric jet nebulizer started on day 7 of life for infants at high risk for developing CLD decreases the need for mechanical ventilation similar to intravenous dexamethasone, but without significant side effects. [source] The therapeutic potential of NO-NSAIDsFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 1 2003John L. Wallace Abstract NSAIDs, including those that are selective for cyclooxygenase-2, are among the most widely used drugs. However, these drugs produce significant side effects in the gastrointestinal and cardiorenal systems, which greatly limit their utility. In recent years, a new type of anti-inflammatory agent has been developed that appears to offer significant advantages over conventional and Cox-2-selective NSAIDs. No-NSAIDs are derivatives of conventional NSAIDs, which are able to release nitric oxide over prolonged periods of time. The combination of balanced inhibition of the two main isoforms of COX with controlled release of nitric oxide yields a series of drugs that exert anti-inflammatory and analgesic activities in a wide range of settings, and have markedly reduced gastrointestinal and cardiorenal toxicity. Recent clinical trials of NO-NSAIDs have provided a ,proof of concept' that is completely consistent with pre-clinical characterization of these compounds. [source] A pilot study evaluating the safety and microbiologic efficacy of an economically viable antimicrobial lozenge in patients with head and neck cancer receiving radiation therapyHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 1 2002FRCPC, Samy El-Sayed MD Abstract Background Mucositis occurs in almost all radiotherapy-treated head and neck cancer patients, in approximately 75% of patients receiving hematopoietic marrow transplantation, and in approximately 40% of all patients who receive chemotherapy. Mucositis is painful, may affect all oral functions, and is a dose- and rate-limiting toxicity of therapy for cancer. Radiation-associated mucositis (onset, intensity, and duration) has been shown in recent clinical trials to be modified by the use of antibacterial/antifungal lozenges. Purpose The aim of this collaborative two-center phase II study was to assess the toxicity and microbiologic efficacy of an economically viable antimicrobial lozenge in the management of patients receiving radiation therapy for head and neck cancer. Materials and Methods Seventeen patients scheduled to receive radical or postoperative radiotherapy were provided with bacitracin, clotrimazole, and gentamicin (BCoG) lozenges (one lozenge dissolved in the mouth qid from day 1 of radiotherapy until completion). Ease of use and palatability of the lozenges, patients' symptoms (swallowing and pain), and quantitative and qualitative microbiologic evaluation of an oral rinse collection was conducted at least once weekly during radiation therapy. Results No significant side effects were reported from the use of the lozenges. The lozenges were well tolerated at the beginning of treatment by all patients, with some minor difficulty associated with oral discomfort toward the end of the treatment. Microbiologic evaluation showed consistent elimination of yeast organisms in all patients. In four patients there was no growth of gram-negative bacilli on culture, whereas in two patients, fluctuating counts were seen, and one patient had increased counts. The remaining patients had significant reduction in the gram-negative bacilli counts. Conclusions This study demonstrated that the BCoG lozenge is tolerable and microbiologically efficacious, achieving elimination of Candida in all patients and reduction in gram-negative flora in most patients. A phase III study is underway to evaluate the clinical efficacy of this lozenge. © 2002 John Wiley & Sons, Inc. Head Neck 24: 6,15, 2002. [source] Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infectionHEPATOLOGY, Issue 3 2001Ph.D., Robert A. de Man M.D. Entecavir is an oral antiviral drug with selective activity against hepatitis B virus (HBV). We conducted a randomized, placebo-controlled, dose-escalating study in patients with chronic hepatitis B infection in which we evaluated the efficacy and safety of entecavir given for 28 days. Follow-up was 24 weeks. All doses of entecavir (0.05 mg, 0.1 mg, 0.5 mg, and 1.0 mg) showed a pronounced suppression of replication of the HBV with a 2.21, 2.29, 2.81, and 2.55 mean log10 reduction of viral load, respectively. Approximately 25% of patients on entecavir showed a decline of HBV DNA below the limit of detection of the Chiron HBV-DNA assay (<0.7 MEq/mL). In the postdosing follow-up period patients who were treated with 0.5 and 1.0 mg of entecavir showed a considerably slower return in their HBV DNA levels to baseline compared with those patients treated with lower dosages (P < .05). All doses of entecavir were well tolerated with no significant difference between treated patients and those receiving placebo. No significant changes in alanine transaminase (ALT) levels within the dose groups and the placebo group between baseline and the end of treatment were observed. Three patients (9%) (1 each in the 0.05-, 0.1-, and 0.5-mg groups) experienced asymptomatic hepatitis flares 16 weeks (2 patients) and 24 weeks (1 patient) after withdrawal of entecavir. In conclusion, in this 28-day study of entecavir a pronounced decrease of HBV DNA was observed and there were no significant side effects in entecavir patients in comparison with placebo-treated patients. (HEPATOLOGY 2001;34:578-582.) [source] Prevention of relapse of Crohn's diseaseINFLAMMATORY BOWEL DISEASES, Issue 4 2000Dr. Lloyd R. Sutherland Abstract Until a cure for Crohn's disease(s) is found, strategies that prolong the time spent in remission offer the greatest hope for reducing the morbidity and significant social costs associated with the disease. Medical therapy to date has been disappointing, and the search for a safe, effective therapy that could be offered at low cost continues. The aminosalicylates, so effective in ulcerative colitis, have shown, at best, minimal efficacy in maintaining remission in Crohn's disease. Conventional corticosteroids are not effective, and any reduction in time to relapse for budesonide-treated patients is measured in weeks not months. Azathioprine, 6-mercaptopurine, and methotrexate are effective in maintaining remission, but all three have significant side effects. Antibiotics may have a role to play. Biological therapy may be considered, but the issues of cost and long-term safety require evaluation. Future studies should segregate patients into two groups, those with a medically induced remission and patients whose concern is the prevention of postoperative recurrence. [source] Botulinum toxin injection therapy in the management of lower urinary tract dysfunctionINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2006A. K. PATEL Summary We have great pleasure in introducing this supplement containing a collection of articles reviewing the contemporary clinical management of functional disorders of the lower urinary tract (LUT) with particular emphasis on the potential role of botulinum toxin injection therapy. Detrusor sphincter dyssynergia (DSD), detrusor overactivity (DO), painful bladder syndrome (PBS) and LUT symptoms consequent on bladder outflow obstruction (LUTS/BPH) have all been treated by the injection of botulinum toxin. This treatment can be administered as a minimally invasive, outpatient procedure which on the initial trials for DO (particularly of neurogenic aetiology) shows a remarkable efficacy with effects lasting up to a year after a single treatment with few significant side effects. Success has been reported with the management of detrusor sphincter dyssynergia and preliminary series report positive outcomes in the management of PBS and LUTS/BPH. However, most of the studies to date include small numbers and have a recruitment bias with few randomised controlled trials having been reported. The answers to some of the key questions are addressed with reference to our contemporary knowledge. It is clear that considerable work both clinical and basic science still needs to be performed to answer the many remaining questions with regard to this treatment modality but undoubtedly it will be a major future treatment option in those with intractable symptoms or those unable to tolerate medications. Currently, all botulinum toxin use for urological conditions is off-label and unlicensed, therefore caution should be exercised until future large randomised studies are reported. [source] Medical rhinoplasty with hyaluronic acid and botulinum toxin A: a very simple and quite effective techniqueJOURNAL OF COSMETIC DERMATOLOGY, Issue 3 2008Alessio Redaelli MD Summary Objective, The management of nasal deformities, and in particular those with "plunging" tip, has always been a typical area of interest in surgery. In the author's experience many of these problems can be successfully approached with a new medical technique, which consists of using only hyaluronic acid for the correction of nasal angles and botulinum toxin for patients with hyperactivity of the depressor septi nasi muscle. The present study aims to illustrate this new technique and evaluates safety and results. Materials and methods, Ninety-five patients were treated between January 2006 and July 2007. The average age of the patients was 42.7 years. In 45% of the cases, botulinum toxin was employed. In all of the cases, the treatment was conducted with hyaluronic acid (24 mg/mL), the same substance used for face rejuvenation. The amount varied from 0.6 to 1.4 mL. Results Results were evaluated using a definitive graduated score calculated by patient's and doctor's satisfaction score (range, 1,10) and by photographs' score at time 0, after 30 days, and after 180 days. It ranged from 8 to 10 (average of 9.1). No significant side effects were reported. Conclusion, The medical rhinoplasty for a "plunging" nose is a simple and very effective technique with immediate results. It can be used in those cases where patients are reluctant to undergo surgery, or as primary indication in the correction of minor nose defects. Results are satisfactory and no side effects have been reported so far. Results will last for a long time. [source] Persistent cough in children and the overuse of medicationsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 6 2002F Thomson Objective: Children referred for persistent cough were evaluated for the referring and final diagnosis, and the extent of the use of medications prior to referral and the side effects encountered. Methods: Data on children seen by respiratory paediatricians for persistent cough (,4 weeks) in a tertiary respiratory setting were collected prospectively over 12 months. Results: Of the 49 children, 61.2% were diagnosed with asthma at referral, with similar referral rates from general practitioners and paediatricians. Children with isolated cough were just as likely to have been diagnosed with asthma as children with cough and wheeze. Medication use (asthma, gastro-oesophageal reflux and antibiotics) prior to referral was high, asthma medications were most common, and of these 12.9% had significant steroid side effects. The most common abnormality found (46.9%) was a bronchoscopically defined airway lesion, and in 56.5% of these children, another diagnosis (aspiration, achalasia, gastro-oesophageal reflux) existed. No children had a sole final diagnosis of asthma and pre-referral medications were weaned in all children. Conclusion: Over diagnosis of asthma and the overuse of asthma treatments with significant side effects is common in children with persistent cough referred to a tertiary respiratory clinic. Children with persistent cough deserve careful evaluation to minimize the use of unnecessary medications and, if medications are used, assessment of response to treatment is important. [source] Lutein in patients with cataracts and age-related macular degeneration: a long-term supplementation studyJOURNAL OF THE SCIENCE OF FOOD AND AGRICULTURE, Issue 9 2001B Olmedilla Abstract Lutein, a non-provitamin A xanthophyll, is widely distributed in fruits and vegetables frequently consumed. In human serum, lutein is transported by lipoproteins and selectively accumulated in certain tissues (eg the retina). Epidemiological studies suggest that high intake and serum levels of lutein are associated with a lower risk of cataracts and age-related maculopathy. Subjects diagnosed with cataracts (CA; n,,=,5) or age-related macular degeneration (ARMD; n,,=,5) agreed to take three lutein capsules per week. Each capsule potentially provided about 12,mg of all- trans -lutein, 3,mg of 13/15- cis -lutein and 3.3,mg of ,-tocopherol, as revealed by HPLC. Zeaxanthin was not detected. Average supplementation time was 13 months (range 4,20 months) for ARMD subjects and 26 months (range 16,36 months) for CA subjects. Blood samples for carotenoid analysis were collected every 3 months, coinciding with ophthalmological revision. In serum, concentrations of lutein, 13- cis -lutein and two ketocarotenoids increased significantly. Maximum increments were observed at 3,6 months, reaching levels above the 95th percentile of the reference population (>0.44,µmol,l,1). Ophthalmological evaluation showed an average increment in visual acuity of 0.4, and glare sensitivity also improved. No significant side effects such as hypercarotenemia, carotenodermia or changes in biochemical or haematological profile were observed. Thus, lutein supplementation at achievable dietary levels increased and maintained serum lutein levels, which were associated with an improvement in the visual function of the patients. © 2001 Society of Chemical Industry [source] Iatrogenic complications and risks of nerve conduction studies and needle electromyographyMUSCLE AND NERVE, Issue 5 2003Amer Al-Shekhlee MD Abstract Electrodiagnostic procedures are routinely performed in patients with a variety of neuromuscular disorders. These studies are generally well tolerated and rarely thought to be associated with any significant side effects. However, needle electromyography is an invasive procedure and under certain situations has the potential to be associated with iatrogenic complications, including bleeding, infection, nerve injury, pneumothorax, and other local trauma. Similar complications are possible if needles are used for either stimulating or recording. In addition, like all other electrical devices and monitoring equipment connected to patients, electrodiagnostic testing carries the risk of stray leakage currents that under certain circumstances can result in electrical injury, especially in patients in the intensive care setting. Similarly, certain precautions are required during nerve conduction studies (NCS) in patients with pacemakers and other similar cardiac devices. In this review, we address the known and theoretical complications of NCS and needle electrode examination, and the possible methods to avoid such hazards. Muscle Nerve 27: 517,526, 2003 [source] Annotation: The use of psychotropic medications in children: an American viewTHE JOURNAL OF CHILD PSYCHOLOGY AND PSYCHIATRY AND ALLIED DISCIPLINES, Issue 2 2003Mark L. Wolraich Background: Psychotropic medications have become an integral component in the treatment of children with mental illnesses. Methods: Selective reviews of the empirical evidence for the efficacy of psychotropic medications and studies of their use patterns were reviewed. Results: Very strong efficacy for at least the short-term benefits and safety of stimulant medications was found and some good efficacy and safety evidence for the treatment of anxiety and depressive disorders with seratonin reuptake inhibitors (SSRI) was also found. Efficacy for tricyclic antidepressants to treat attention deficit hyperactivity disorder was found but the presence of significant side effects makes them less the drugs of choice. Other medications are presented but with less rigorous evidence. Studies of use found that stimulant medications are extensively prescribed in the US by both psychiatrists and primary care physicians. SSRI are also prescribed extensively but not to the extent of stimulants and are more frequently prescribed by psychiatrists. Conclusions: There is now good evidence for the efficacy of some psychotropic agents and their use is an integral component in the management of childhood mental illnesses. [source] Tramadol for prevention of postanaesthetic shivering: a randomised double-blind comparison with pethidineANAESTHESIA, Issue 2 2009M. Mohta Summary The present study was conducted with the aims of comparing intravenous tramadol 1, 2 and 3 mg.kg,1 with pethidine 0.5 mg.kg,1 for prophylaxis of postanaesthetic shivering and to find a dose of tramadol that could provide the dual advantage of antishivering and analgesic effect in the postoperative period. The study included 165 patients, randomly allocated to five groups of 33 each. Tramadol in doses of 1, 2 and 3 mg.kg,1, pethidine 0.5 mg.kg,1 or normal saline were administered at the time of wound closure. All three doses of tramadol were effective and comparable to pethidine in preventing postanaesthetic shivering. Tramadol 2 mg.kg,1 had the best combination of antishivering and analgesic efficacy without excessive sedation and thus appeared to be a good choice to be administered at the time of wound closure to provide antishivering effect and analgesia without significant side effects in the postoperative period. [source] Amelioration of collagen-induced arthritis and immune-associated bone loss through signaling via estrogen receptor ,, and not estrogen receptor , or G protein,coupled receptor 30ARTHRITIS & RHEUMATISM, Issue 2 2010Cecilia Engdahl Objective The effects of estrogen may be exerted via the nuclear estrogen receptors (ERs) ER, or ER, or via the recently proposed transmembrane estrogen receptor G protein,coupled receptor 30 (GPR-30). The purpose of this study was to elucidate the ER specificity for the ameliorating effects of estrogen on arthritis and bone loss in a model of postmenopausal rheumatoid arthritis (RA). Methods Female DBA/1 mice underwent ovariectomy or sham operation, and type II collagen,induced arthritis was induced. Mice were treated subcutaneously 5 days/week with the specific agonists propylpyrazoletriol (PPT; for ER,), diarylpropionitrile (DPN; for ER,), G1 (for GPR-30), or with a physiologic dose of estradiol. Clinical arthritis scores were determined continuously. At termination of the study, bone mineral density (BMD) was analyzed, paws were collected for histologic assessment, serum was analyzed for cytokines and markers of bone and cartilage turnover, and bone marrow was subjected to fluorescence-activated cell sorting. Results Treatment with PPT as well as estradiol dramatically decreased the frequency and severity of arthritis. Furthermore, estradiol and PPT treatment resulted in preservation of bone and cartilage, as demonstrated by increased BMD and decreased serum levels of bone resorption markers and cartilage degradation markers, whereas no effect was seen after DPN or G1 treatment. Conclusion In a well-established model of postmenopausal RA, ER,, but not ER, or GPR-30 signaling, was shown to ameliorate the disease and the associated development of osteoporosis. Since long-term treatment with estrogen has been associated with significant side effects, increased knowledge about the mechanisms behind the beneficial effects of estrogen is useful in the search for novel treatments of postmenopausal RA. [source] Immersion in Water in the First Stage of Labor: A Randomized Controlled TrialBIRTH, Issue 2 2001Kerena Eckert RN Background:Current forms of analgesia often have significant side effects for women in labor. Bathing in warm water during labor has been reported to increase a woman's comfort level and cause a reduction in painful contractions. The objective of this trial was to compare immersion in warm water during labor with traditional pain management for a range of clinical and psychological outcomes.Methods:A prospective randomized controlled trial of 274 pregnant women, who were free from medical and obstetric complications and expecting a singleton pregnancy at term, was conducted at the Women's and Children's Hospital, a maternity tertiary referral center in Adelaide, South Australia. Women in labor were randomized to an experimental group who received immersion in a bath or to a nonbath group who received routine care. Pharmacological pain relief was the primary outcome that was measured, and secondary outcomes included maternal and neonatal clinical outcomes, factors relating to maternal and neonatal infectious morbidity, psychological outcomes, and satisfaction with care.Results:The use of pharmacological analgesia was similar for both the experimental and control groups; 85 and 77 percent, respectively, used major analgesia. No statistical differences were observed in the proportion of women requiring induction and augmentation of labor or in rates of perineal trauma, length of labor, mode of delivery, or frequency of cardiotocographic trace abnormalities. Neonatal outcomes (birthweight, Apgar score, nursery care, meconium-stained liquor, cord pH estimations) revealed no statistically significant differences. Infants of bath group women required significantly more resuscitation than routine group women. Routine group women rated their overall experience of childbirth more positively than bath group women. Psychological outcomes, such as satisfaction with care or postnatal distress, were the same for both groups.Conclusion:Bathing in labor confers no clear benefits for the laboring woman but may contribute to adverse effects in the neonate. [source] | |||||||||||||||||||