胃食管反流病中安慰剂反应率的Meta分析

Meta-analysis of Placebo Response Rate in the Treatment of Gastroesophageai Reflux Disease

【目的】对胃食管反流病（GERD）随机对照试验中的安慰剂反应率进行Meta分析，并研究影响该反应率的因素。【方法】检索Medline，CochraneControlledTrialRegister和EMBASE数据库中公开发表的关于随机、双盲、安慰剂对照治疗GERD的英文文献，所有文献均包括质子泵抑制剂／H2受体阻滞剂，治疗时间至少为2周。对文献试验数据进行Meta分析，绘制森林图，同时绘制漏斗图检查发表偏倚。【结果】纳入24个研究，共包括9989名患者。有效治疗的反应率与安慰剂反应率相比的0R为3．71[95％CI：2．78～4．96]。所有的安慰剂反应率为18．85％[2．94％～47．06％]。运用质子泵抑制剂治疗的患者与Hz受体阻滞剂治疗者相比，安慰剂反应率明显降低（14．51％VS．24．69％，P＝0．05）。糜烂性食管炎患者的安慰剂反应率与非糜烂性食管炎者相比略低，两者差异无显著性（P〉0．05）。【结论】在GERD随机对照试验中，安慰剂反应率确实存在。该反应率降低与质子泵抑制剂的运用相关，而与腐蚀性食管炎的存在与否无关。

[Objective]To perform a meta-analysis of placebo response rate in randomized controlled trials of gastroesophageal reflux disease（GERD） and to investigate the influential factors of placebo response rate. [Methods]The published English documents about randomized, double-blind and placebo controlled trials of the treatment of GERD in Medline, Cochrane, Controlled Trial Register and EMBASE databases were searched. All these documents included proton-pump inhibitors or Hz-receptor antagonists. The treatment du- ration was at least 2 weeks. Meta analysis was performed for the trial data in documents. The forest plot was drawn. Meanwhile, the funnel plot was drawn to determine the publication bias. [Results]Twenty four stud- ies with 9989 patients were enrolled. The odds ratio（OR） of the response rate of effective treatment to placebo response rate was 3. 71 （95% CI： 2. 78-4. 96）. The overall placebo response rate was 18. 85% （2. 94% 47.06%）. Compared with the patients treated by H2-receptor antagonists, the placebo response rate of pa- tients treated by proton-pump inhibitors significantly decreased（14.51% vs. 24.69%, P =0.05）. There was no significant difference in placebo response rate between patients with erosive esophagitis and patients with non-erosive esophagitis. [Conclusion]The placebo response rate certainly exists in randomized controlled trials of GERD. The decreasing of the placebo response is related to the application of proton-pump inhibitors, but has no association with erosive esophagitis.