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- 倪敬年主治医师 博士
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医院:
北京中医药大学东直门医院
科室:
脑病三科
- 瑞波西汀,一个无效的抗抑郁药?
- 作者:倪敬年|发布时间:2012-05-05|浏览量:2258次
Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.FROM:BMJ 2010;341:c4737
瑞波西汀用於重型抑郁的急性治?:已?表和未?表的安慰?、??性5-HR再?取抑制??照??的系???和meta分析北京东直门医院老年病科倪敬年
Objectives To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine.目的:通?瑞波西汀的安慰??照或??性5-HR再?取抑制?SSRIs?照????其重型抑郁急性治?的?效和安全性,???瑞波西汀??的?在?表偏倚。
Design Systematic review and meta-analysis including unpublished data.??:包括了未?表??的系???和meta分析。
Data sources Bibliographic databases (Medline, Embase, PsycINFO, BIOSIS, and Cochrane Library), clinical trial registries, trial results databases, and regulatory authority websites up until February 2009, as well as unpublished data from the manufacturer of reboxetine (Pfizer, Berlin).?料?源:????源(Medline, Embase, PsycINFO, BIOSIS, and Cochrane Library),?床??注?,???果???,管理授??站,??截止至2009年2月。?包括瑞波西汀生?商(Pfizer, Berlin)未?表的??。
Eligibility criteria Double blind, randomised, controlled trials of acute treatment (six weeks or more) with reboxetine versus placebo or SSRIs in adults with major depression.?入?准:?盲,??,?照??(安慰?或SSRI?照),重型抑郁患者,?程大於6周(包括)。
Outcome measures Remission and response rates (benefit outcomes), as well as rates of patients with at least one adverse event and withdrawals owing to adverse events (harm outcomes).?局指?:?解率或反?率(?效?局),以及出?至少1一?不良反?的患者比率(不良反??局)。
Data extraction and data synthesis The procedures for data extraction and assessment of risk of bias were always conducted by one person and checked by another. If feasible, data were pooled by meta-analyses (random effects model). Publication bias was measured by comparing results of published and unpublished trials.?料提取和合成:?料提取和?表偏倚??程序始?由一人完成,再由另一人核查。?足meta分析?件的???行基於??效?模型的?萃分析。通??表和未?表的??比?了解?表偏倚。
Results We analysed 13 acute treatment trials that were placebo controlled, SSRI controlled, or both, which included 4098 patients. Data on 74% (3033/4098) of these patients were unpublished. In the reboxetine versus placebo comparison, no significant differences in remission rates were shown (odds ratio 1.17, 95% confidence interval 0.91 to 1.51; P=0.216). Substantial heterogeneity (I2=67.3%) was shown in the meta-analysis of the eight trials that investigated response rates for reboxetine versus placebo. A sensitivity analysis that excluded a small inpatient trial showed no significant difference in response rates between patients receiving reboxetine and those receiving placebo (OR 1.24, 95% CI 0.98 to 1.56; P=0.071; I2=42.1%). Reboxetine was inferior to SSRIs (fluoxetine, paroxetine, and citalopram) for remission rates (OR 0.80, 95% CI 0.67 to 0.96; P=0.015) and response rates (OR 0.80, 95% CI 0.67 to 0.95; P=0.01). Reboxetine was inferior to placebo for both harm outcomes (P<0.001 for both), and to fluoxetine for withdrawals owing to adverse events (OR 1.79, 95% CI 1.06 to 3.05; P=0.031). Published data overestimated the benefit of reboxetine versus placebo by up to 115% and reboxetine versus SSRIs by up to 23%, and also underestimated harm.?果:我?分析了13?安慰??照或SSRI?照??,包括4098例患者。74%(3033/4098)的???未?表。瑞波西汀?安慰?比??果?示??有?解率的差?(OR 1.17,95%CI 0.91-1.51,P=0.216),?入分析的8?安慰??照??同?性很差(I2=67.3%)。敏感性分析?剔除了一人小的住院患者??,仍未?示?解率的差?。?SSRIs比?分析?示,瑞波西汀?解率和反?率均低於SSRIs(氟西汀,帕?西汀和西酞普?)。反?反??局(出?至少1一?不良反?的患者比率)高於安慰?和氟西汀,因不良反?停?的患者比率高於氟西汀。?表??低估了不良反?,而高估了?安慰?比?的?效(高?115%),也高估了?SSRI比?的?效(?到23%)。
Conclusions Reboxetine is, overall, an ineffective and potentially harmful antidepressant. Published evidence is affected by publication bias, underlining the urgent need for mandatory publication of trial data.??:瑞波西汀??上是??效?有?在不良反?的抗抑郁?。?表文?存在?表偏倚,??制性公布?床????。
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