Incidence Of Minor Adverse Effects Research Articles

Different doses of methimazole treatment of children and adolescents with graves’ disease: a clinical study based on 161 cases of outpatients

ObjectiveThis study aimed to evaluate the association between the initial dose of MMI and the clinical course, as well as adverse effects on young people with GD.MethodsOne hundred and sixty-one children and adolescents with newly diagnosed GD were enrolled for this study and categorized into four groups based on initial serum-free T3 and T4 levels and daily MMI doses: Group A (mild, 0.3–0.5 mg/kg/day, n = 78), Group B (moderate, 0.6–0.8 mg/kg/day, n = 37), Group C (severe, 0.6–0.8 mg/kg/day, n = 24), and Group D (severe, 0.8-1.0 mg/kg/day, n = 22). The thyroid function, blood cell analysis and liver function were examined before treatment and at 4, 8 and 12 weeks after treatment. Outcome of long-term follow-up were also observed.ResultsAfter 12 weeks of treatment, 91.0% of the patients in group A and 90.9% of the patients in group D recovered to normalization of FT3, which was slightly higher than the other two groups; 70.8% of the patients in group C recovered to normalization of FT4, which was slightly lower than that in the other three groups. The incidence of minor adverse effects was 12.8% in group A, 13.5% in group B, 16.7% in group C and 40.9% in group D (P < 0.01). Remission was achieved in 38 patients (23.6%).ConclusionsLower doses of MMI (0.3–0.5 mg/kg/day) are suitable for mild GD, and higher doses of MMI (0.6–0.8 mg/kg/day) are advisable for moderate or severe GD. Much higher doses of MMI (0.8-1.0 mg/kg/day) are harmful for initial use in children and adolescents with GD patients.

P002: Prehospital analgesia with intra-nasal ketamine: a randomized double-blind pilot study

Introduction: Primary care paramedics (PCPs) have limited options to provide analgesia during transport thus timely pain relief is often significantly delayed. Inhaled nitrous oxide is considered usual care for PCPs, but is limited in effectiveness. Intranasal (IN) ketamine has been shown to provide effective analgesia with no deleterious effects on cardiorespiratory function thus may provide rapid, easily-administered and well-tolerated analgesia in prehospital transports. Methods: This was a randomized double-blind pilot series. Patients with an acute painful condition reporting a pain score of 5 or more on an 11-point verbal numeric rating scale (VNRS) were included. Exclusion criteria were age under 18 years, known intolerance to ketamine, non-traumatic chest pain, altered mental status, pregnancy and nasal occlusion. Patients were randomized to 0.75 mg/kg of IN ketamine or IN saline. All patents received inhaled nitrous oxide. The primary outcome was the proportion of patients experiencing a reduction in VNRS pain score of two points or more (clinically significant pain reduction) at 30 minutes. Secondary outcomes were patient-reported comfort, patient and provider satisfaction, and incidence of adverse events. Results: 40 patients were enrolled, 20 in each group. 80% of IN ketamine patients compared to 60% of placebo patients reported a 2-point reduction in VNRS pain score by 30 minutes. 50% of ketamine vs 25% of placebo patients reported feeling moderately or much better. 85% of ketamine vs 75% of placebo patients reported any improvement in subjective comfort. 80% of ketamine patients reported minor adverse effects compared to 52% of placebo patients. No serious adverse effects were reported. Conclusion: The addition of IN ketamine to usual care with nitrous oxide appears to result in a greater proportion of patients reporting a clinically significant reduction in VNRS pain score and improved subjective comfort, with a greater incidence of minor adverse effects. These findings will be used to power a definitive randomized double-blind trial.

Clinical, Immunological and Virological Profile of Patients with HIV Infection on Second Line Antiretroviral Therapy

Background and Objectives: The goal of antiretroviral therapy is to maximally and durably inhibit viral replication. Objectives of this study were –  To study the various clinical features of patients on second line anti retroviral therapy.  To study the immunological and virological profile of these patients.  To study various factors determining the initiation of second line ART Material and Methodology: Retrospective analysis of 30 HIV patients on second line Antiretroviral Therapy was done. Clinical examination and various immunological profiles like CD4 count, CD8 count and virological profiles like viral load and viral resistance testing were noted if done. Details of therapy in terms of drugs, schedule, adverse effects etc. were noted. Results: Majority of patients had BMI in the normal range. Mean CD4 cell count increased from 114/mm3 at start of first line therapy to 168/mm3 at start of second line therapy. Immunological failure was the reason to switch to second line therapy in 63.33% patients. The most common second line regimen followed was Tenofovir + Abacavir + Lopinavir + Ritonavir, in 73.33% of patients, but it showed a high incidence of minor adverse effects. Viral load was estimated in 50% patients of which 36.67% patients had >20,000 HIV virus copies/ml. Tuberculosis was the main opportunistic infection encountered. Analysis and Discussion: Second line antiretroviral therapy has changed the prognosis of HIV infected patients who have first line regimen failure. The switch to second line treatment was relatively slow, due to CD4 cell count being used as the main criteria to switch therapy. This study highlights the importance of assessing viral load to monitor any early virological failure of first line ART to switch early to second line therapy. The

Tratamiento médico del aborto espontáneo del primer trimestre

ObjectivesTo evaluate the efficacy of medical treatment with misoprostol in spontaneous abortion in the first trimester; to determine the incidence of adverse effects and complications and identify causes that may lead to the failure of medical treatment; to identify the acceptability of the treatment, patient acceptance and patient satisfaction; and to perform a cost-effectiveness analysis. Subjects and methodsA longitudinal, observational, prospective, descriptive and analytic study was performed in 680 patients diagnosed with spontaneous abortion in the first trimester between June 2009 and December 2011 at the Hospital Clínico San Carlos. A protocol was developed for medical treatment with misoprostol administration for patients who accepted to undergo this treatment rather than classical surgery. ResultsThe success of medical treatment was 81.85%. The treatment was effective in 89.21% of incomplete abortions, in 79.52% of missed abortions, and in 78.46% of anembrionic pregnancies. Minor adverse effects occurred in 33.59% of the patients, and 84.99% of the patients reported they were satisfied. Medical treatment produced a cost saving of € 960.54 per patient. ConclusionsThe success of medical treatment in our study was high, with misoprostol administration being effective in approximately 8 out of 10 patients. Misoprostol is highly accepted by patients and most reported that they were satisfied. The incidence of minor adverse effects was low, and these effects were well tolerated; consequently, their presence does not seem to restrict the application of this treatment. Misoprostol use helps to reduce healthcare costs.

Comparison of Isoproterenol Infusion and Nitrate Spray during Provocative Head-Up Tilt Test

Background and Objectives:The head-up tilt test (HUT) is widely used for the diagnosis of vasovagal syncope. To improve the sensitivity of the test, provocation with isoproterenol is frequently used. The aim of this study was to evaluate the values of isosorbide dinitrate spray as a provocation drug in the HUT. Subjects and Methods: Two hundred patients, undergoing baseline HUT (60°for 20 minutes) for suspected vasovagal syncope or presyncope and unexplained dizziness, were enrolled. If the baseline HUT was negative, isosorbide dinitrate (2.5 mg) spray was applied sublingually (group I, n=93), or isoproterenol (3 μg/min) infused (group II, n=93), in a randomized fashion. The values of isosorbide dinitrate and isoproterenol were compared in those patients that developed a positive vasovagal response or who completed the drug-provocative HUT. Results:Syncope was similarly reproduced in both groups (47.7 vs. 41.9%, p>0.05). Type I responses were most common in both groups, and types I and II responses were more common in group I than group II (78.0 vs. 55.6% and 12.2 vs. 5.6%, p<0.05, respectively). The average time to a positive response was longer in group I than group II (8.5±3.4 vs. 6.1±3.6 minutes, p<0.01). The sensitivity and specificity of the drug-provocative HUT were significantly higher in group I than group II (73.5 and 87.5% vs. 58.5 and 71.1%; respectively, p<0.01). The incidence of minor adverse effects were similar in both groups, but serious cardiac side effects were significantly more common in group II than group I (4.3 vs. 0%, p<0.05). Conclusion:Sublingual isosorbide dinitrate spray may be used as a simple, effective and well tolerated provocative drug during HUT. (Korean Circulation J 2005;35:690-695)

Comparison of safety and efficacy of the early injection of atropine during dobutamine stress echocardiography with the conventional protocol

Although dobutamine-atropine stress echocardiography (DASE) is an established method for evaluating patients who have coronary artery disease (CAD), it can increase test duration and a patient's exposure to large doses of dobutamine. New protocols, including the early injection of atropine during dobutamine stress echocardiography (EA-DSE), have been proposed to decrease test duration. This study compared the safety, efficacy, and accuracy of EA-DSE with those of DASE. We retrospectively evaluated 3,163 patients who underwent DASE and 1,664 patients who underwent EA-DSE over a period of 12 years. In EA-DSE, atropine at a dose </=2 mg was started with 20 microg/kg/min of dobutamine if heart rate was <100 beats/min. Diagnostic accuracy for detecting CAD (>50% stenosis) was assessed in patients who underwent quantitative angiography </=3 months of stress testing. The dobutamine dose used in EA-DSE was smaller than that used in DASE (31 +/- 6 vs 36 +/- 6 microg/kg/min, p <0.0001), although the atropine dose was larger (0.8 +/- 0.5 vs 0.5 +/- 0.25 mg, p <0.0001). EA-DSE resulted in a significantly shorter duration of dobutamine infusion (12.4 +/- 2.0 vs 14.6 +/- 2.5 minutes, p <0.0001), more diagnostic studies (88% vs 81%, p <0.0001), and a lower incidence of minor adverse effects than did DASE. The rate of major adverse effects was similar in the 2 protocols. Sensitivities, specificities, positive predictive values, negative predictive values, and accuracies for detecting CAD were 84%, 90%, 93%, 76%, and 86% for EA-DSE and 86%, 78%, 84%, 79%, and 82% for DASE, respectively (p = NS). Therefore, EA-DSE is a safe and effective alternative to DASE and had a similar accuracy for the detection of CAD.

Respective potencies of Botox and Dysport: a double blind, randomised, crossover study in cervical dystonia

Objectives: Botulinum toxin type A is a potent neuromuscular paralyzing agent used in various disorders including cervical dystonia. Two preparations of botulinum toxin are now commercially available ( Dysport and...

WITHDRAWN: Eletriptan for acute migraine.

Eletriptan (Relpax) is a new triptan soon to be made available by prescription for the treatment of acute migraine. Currently five triptans are available by prescription and more are under development. In light of the many drugs for treating acute migraine, there is a need for evidence-based assessments to help determine the relative efficacy and harm of these treatments. To determine the efficacy of eletriptan for treating a single migraine attack using the outcomes of headache response and pain-free response at 0.5, 1, 2 and 4 hours, and sustained relief over 24 hours. To express efficacy in terms of number-needed-to-treat (NNT). To determine the adverse effects of a single dose of eletriptan and express this in terms of number-needed-to-harm (NNH). To allow for the comparison of the efficacy of eletriptan with other migraine treatments evaluated systematically in the same way. Data from all Phase III randomised placebo-controlled trials were made available by the manufacturer, Pfizer Inc. To date, these trials comprise the only data on eletriptan relevant to this review in a published or unpublished form; thus, searches of electronic databases for further trials of eletriptan were not conducted. Date of last search: January 2000. Trials of eletriptan for acute migraine; randomised allocation to treatment groups, including a placebo group; double-blind design; International Headache Society diagnostic criteria for migraine with or without aura; single migraine attack; single-dose treatment at standard doses; adult population; baseline pain of moderate or severe intensity using a 4-point standardised rating scale (0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain); and dichotomous or percentage data for at least one of the main efficacy outcomes. Trials were scored for quality and data extracted by two independent reviewers. Dichotomous or percentage data were extracted and pooled to calculate the relative benefit (RB) or relative risk (RR) and NNTs or NNHs for a number of outcomes for eletriptan 20 mg, 40 mg and 80 mg. The main outcomes considered were headache response at 1 and 2 hours, pain-free response at 2 hours, sustained relief over 24 hours and adverse effects. Minor outcomes considered were headache response at 0.5 and 4 hours, and pain-free response at 0.5, 1 and 4 hours. Six trials met the inclusion criteria. Significant benefit of eletriptan over placebo was shown for eletriptan 20 mg, 40 mg and 80 mg for the primary efficacy outcomes of headache response and pain-free response at 2 hours. For headache response at 2 hours, the NNTs (with 95% confidence intervals) were 4.4 (3.4 to 6.2), 2.9 (2.6 to 3.3) and 2.6 (2.4 to 3.0) for eletriptan 20 mg, 40 mg and 80 mg, respectively. For pain-free response at 2 hours, the NNTs were 9.9 (6.9 to 18), 4.0 (3.6 to 4.5) and 3.7 (3.4 to 4.2), for eletriptan 20 mg, 40 and 80 mg, respectively. There was no significant difference in the incidence of major adverse effects between any dose of eletriptan and placebo. The incidence of minor adverse effects was significantly higher for all eletriptan doses than for placebo, with NNHs of 11 (95% confidence interval, 6.2 to 39), 7.0 (5.2 to 11) and 3.7 (3.1 to 4.5) for eletriptan 20 mg, 40 mg and 80 mg, respectively. Eletriptan 20 mg, 40 mg and 80 mg are effective for the treatment of an acute migraine attack. Effectiveness is dose-related, with statistically significant differences between doses for pain-free response and 24-hour outcomes. Eletriptan compares well with other triptans available for outcomes measured up to 2 hours and provides meaningful relief for 24 hours. Taken as a single dose, eletriptan was well tolerated and caused no major harm. The incidence of minor harm was dose-dependent, with 80 mg giving significantly more adverse effects than 40 mg.

Antidepressants and Anticonvulsants for Diabetic Neuropathy and Postherpetic Neuralgia: A Quantitative Systematic Review

To determine the relative efficacy and adverse effects of antidepressants and anticonvulsants in the treatment of diabetic neuropathy and postherpetic neuralgia, published reports were identified from a variety of electronic databases, including Medline, EMBASE, the Cochrane Library and the Oxford Pain Relief Database, and from two previously published reviews. Additional studies were identified from the reference lists of retrieved reports. The relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief was calculated from available dichotomous data, as was the relative risk (RR) and number-needed-to-harm (NNH) for minor adverse effects and drug related study withdrawal. In diabetic neuropathy, 16 reports compared antidepressants with placebo (491 patient episodes) and three compared anticonvulsants with placebo (321). The NNT for at least 50% pain relief with antidepressants was 3.4 (95% confidence interval 2.6–4.7) and with anticonvulsants 2.7 (2.2–3.8). In postherpetic neuralgia, three reports compared antidepressants with placebo (145 patient episodes) and one compared anticonvulsants with placebo (225), giving an NNT with antidepressants of 2.1 (1.7–3) and with anticonvulsants 3.2 (2.4–5). There was little difference in the incidence of minor adverse effects with either antidepressants or anticonvulsants compared with placebo, with NNH (minor) values of about 3. For drug-related study withdrawal, antidepressants had an NNH (major) of 17 (11–43) compared with placebo, whereas with anticonvulsants there was no significant difference from placebo. Antidepressants and anticonvulsants had the same efficacy and incidence of minor adverse effects in these two neuropathic pain conditions. There was no evidence that selective serotonin reuptake inhibitors (SSRIs) were better than older antidepressants, and no evidence that gabapentin was better than older anticonvulsants. In these trials patients were more likely to stop taking antidepressants than anticonvulsants because of adverse effects.

Eletriptan for acute migraine.

Eletriptan (Relpax) is a new triptan soon to be made available by prescription for the treatment of acute migraine. Currently five triptans are available by prescription and more are under development. In light of the many drugs for treating acute migraine, there is a need for evidence-based assessments to help determine the relative efficacy and harm of these treatments. To determine the efficacy of eletriptan for treating a single migraine attack using the outcomes of headache response and pain-free response at 0.5, 1, 2 and 4 hours, and sustained relief over 24 hours. To express efficacy in terms of number-needed-to-treat (NNT). To determine the adverse effects of a single dose of eletriptan and express this in terms of number-needed-to-harm (NNH). To allow for the comparison of the efficacy of eletriptan with other migraine treatments evaluated systematically in the same way. Data from all Phase III randomised placebo-controlled trials were made available by the manufacturer, Pfizer Inc. To date, these trials comprise the only data on eletriptan relevant to this review in a published or unpublished form; thus, searches of electronic databases for further trials of eletriptan were not conducted. Trials of eletriptan for acute migraine; randomised allocation to treatment groups, including a placebo group; double-blind design; International Headache Society diagnostic criteria for migraine with or without aura; single migraine attack; single-dose treatment at standard doses; adult population; baseline pain of moderate or severe intensity using a 4-point standardised rating scale (0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain); and dichotomous or percentage data for at least one of the main efficacy outcomes. Trials were scored for quality and data extracted by two independent reviewers. Dichotomous or percentage data were extracted and pooled to calculate the relative benefit (RB) or relative risk (RR) and NNTs or NNHs for a number of outcomes for eletriptan 20 mg, 40 mg and 80 mg. The main outcomes considered were headache response at 1 and 2 hours, pain-free response at 2 hours, sustained relief over 24 hours and adverse effects. Minor outcomes considered were headache response at 0.5 and 4 hours, and pain-free response at 0.5, 1 and 4 hours. Six trials met the inclusion criteria. Significant benefit of eletriptan over placebo was shown for eletriptan 20 mg, 40 mg and 80 mg for the primary efficacy outcomes of headache response and pain-free response at 2 hours. For headache response at 2 hours, the NNTs (with 95% confidence intervals) were 4.4 (3.4 to 6.2), 2.9 (2.6 to 3.3) and 2.6 (2.4 to 3.0) for eletriptan 20 mg, 40 mg and 80 mg, respectively. For pain-free response at 2 hours, the NNTs were 9.9 (6.9 to 18), 4.5 (4.0 to 5.1) and 3.7 (3.4 to 4.2), for eletriptan 20 mg, 40 and 80 mg, respectively. There was no significant difference in the incidence of major adverse effects between any dose of eletriptan and placebo. The incidence of minor adverse effects was significantly higher for all eletriptan doses than for placebo, with NNHs of 11 (95% confidence interval, 6.2 to 39), 7.0 (5.2 to 11) and 3.7 (3.1 to 4.5) for eletriptan 20 mg, 40 mg and 80 mg, respectively. Eletriptan 20 mg, 40 mg and 80 mg are effective for the treatment of an acute migraine attack. Effectiveness is dose-related, with statistically significant differences between doses for pain-free response and 24-hour outcomes. Eletriptan compares well with other triptans available for outcomes measured up to 2 hours and provides meaningful relief for 24 hours. Taken as a single dose, eletriptan was well tolerated and caused no major harm. The incidence of minor harm was dose-dependent, with 80 mg giving significantly more adverse effects than 40 mg.

A Comparison of Intrathecal Analgesia with Fentanyl or Sufentanil After Total Hip Replacement

We designed this study to compare the postoperative analgesic effects of intrathecal fentanyl and sufentanil, the end points being onset, quality, and duration of action. A total of 42 geriatric patients, scheduled for elective total hip replacement under continuous spinal anesthesia, were randomized in two double-blinded groups as soon as they experienced a pain score higher than 3 of 10 on the visual analog scale in the recovery room. Either 7.5 μg sufentanil or 40 μg fentanyl in 2 mL normal saline were intrathecally administered. Pain scores, rescue analgesia (ketorolac and morphine), and adverse effects (respiratory depression, postoperative nausea and vomiting, and itching) were recorded for 24 h after surgery. In both groups, comparing sufentanil to fentanyl, the time to a pain score <3 (9 ± 9 vs 11 ± 8 min), the time to the lowest pain score (18 ± 6 vs 20 ± 15 min), and the time to the first systemic analgesic intervention for a pain score >3 (241 ± 102 vs 214 ± 120 min) were comparable as were the analgesic requirements during the first 24 h. We conclude that, after total hip replacement, both lipid soluble opioids produce excellent analgesia with comparable onset, duration of action, and low incidence of minor adverse effects. Implications: We compared the postoperative analgesic properties of 40 μg intrathecal fentanyl and 7.5 μg sufentanil after total hip replacement. Both opioids provided satisfactory analgesia, with comparable onset (11 ± 8 vs 9 ± 9 min) and duration of action (214 ± 120 vs 241 ± 102 min), as well as low incidence of minor side effects.

Efficacy and adverse effects of prophylactic antiemetics during patient-controlled analgesia therapy: a quantitative systematic review.

Nausea and vomiting are frequent adverse effects of patient-controlled analgesia (PCA) with opioids. To identify the optimal prophylactic antiemetic intervention in this setting, we performed a systematic search for randomized trials (MEDLINE, EMBASE, Cochrane library, reference lists, hand-searching, no language restriction) published up to May 1998 that compared prophylactic antiemetic interventions with placebo or no treatment in the postoperative PCA-setting with opioids. Fourteen placebo-controlled trials (1117 patients) with different regimens of droperidol, ondansetron, hyoscine TTS, tropisetron, metoclopramide, propofol, and promethazine were analyzed. One PCA was with tramadol, all others were with morphine. At 24 h, the cumulative incidence of nausea and vomiting without antiemetics was approximately 50%. Droperidol 0.017-0.17 mg/mg of morphine (0.5-11 mg/d droperidol) was statistically significantly more effective than placebo without evidence of dose-responsiveness; the number needed to treat to prevent nausea compared with placebo was 2.7 (95% confidence interval 1.8-5.2), and that to prevent vomiting was 3.1 (2.3-4.8). Compared with placebo, the incidence of minor adverse effects with droperidol was increased with doses >4 mg/d. Of 100 patients treated with droperidol added in a patient-controlled analgesia pump with morphine, 30 who would have vomited or been nauseated had they not received droperidol will not suffer these effects. There is no evidence of dose-responsiveness for efficacy with droperidol, but the risk of adverse effects is dose-dependent. There is a lack of evidence for other antiemetics.

Oral fluorescein angiography: reassessment of its relative safety and evaluation of optimum conditions with use of capsules.

Injection of fluorescein intravenously for fundal angiography is associated with a high incidence of minor adverse effects (21%) but a very low incidence of serious (life threatening) reactions (0.05%). A serious reaction may occur without warning in a patient with no history of atopy. There are no reports of oral fluorescein causing a serious reaction, and minor adverse effects are uncommon. A study was undertaken to determine optimum conditions for oral fluorescein angiography. Capsules proved more convenient than a solution for ingestion of fluorescein. A dose of 25 mg/kg body weight produced good quality angiograms in 75% of the patients. The best pictures were obtained by photographing the fundus after 40 and 60 minutes.

Oral Fluoroquinolone versus Mono- Or Combination Parenteral Therapy in the Management of Bacterial Infections: a Critical Appraisal

There has been a great deal of interest in the use of oral fluoroquinolone monotherapy rather than mono- or combination parenteral therapy in the management of serious bacterial infections. A review of the published comparative studies and abstracts indicates that, overall, oral fluoroquinolones were at least as effective as, and certainly less expensive than, the parenteral agents studied. However, the spectrum of infection types and the number of patients studied in comparative trials have been small. In addition, ofloxacin and enoxacin were underrepresented in the study material. Oral fluoroquinolones were devoid of the serious adverse effects associated with the aminoglycosides, vancomycin, and the methylthiotetrazole-containing cephalosporins. In general, the incidence of minor adverse effects were similar for the oral fluoroquinolones and comparison parenteral regimens. Meta-analysis of the published reports and abstracts revealed that the oral fluoroquinolones are as effective as parenteral mono- or combination regimens for the treatment of serious bacterial infections in selected patient populations.