伊托必利治疗功能性消化不良的Meta分析

Meta-analysis of itopride therapy in functional dyspepsia

目的根据现有的临床研究评价伊托必利治疗功能性消化不良（FD）的疗效与安全性。方法检索Cochrane图书馆、EMBASE、PubMed、Elsevier、科学引文索引数据库、中国知网、维普、万方等数据库中有关伊托必利治疗FD的随机对照试验（RCT）文献，并提取纳入研究的特征信息，计数资料采用相对危险度（RR）值，计量资料采用加权均数差（WMD），根据异质性检验结果选择相应的效应模型，绘制漏斗图评定有无发表偏倚。结果共有9项RCT符合纳入研究标准，2620例FD中有1372例接受伊托必利治疗，1248例接受安慰剂或其他药物对照治疗。伊托必利对FD患者的总体症状疗效、餐后饱胀疗效、早饱疗效的RR值分别为1．1l（95％CI为1．01～1．21，P=0．02）、1．18（95％CI为1．04～1.33，P〈0．01）、1．24（95％CI为1．01～1．53，P=0．04），均优于对照组，但在上腹不适疗效方面差异无统计学意义。Leeds消化不良问卷（LDQ）积分疗效的WMD值为-1．38（95％CI为-1．75～-1．01，P〈0．01）伊托必利伏于对照组。在安全性方面，伊托必利与对照组不良反应发生率相似。各观察指标的漏斗图均基本呈现下宽上窄左右对称的图形，提示无发表偏倚。结论伊托必利对于FD患者的总体症状、餐后饱胀、早饱、LDQ积分有较好的疗效，且不良反应发生率较低。

Objective To evaluate the efficacy and safety of itopride in the treatment of functional dyspepsia （FD） according to the data of published clinical studies. Methods The papers about randomized controlled trials （RCT） of itopride in treatment of FD were searched from Cochrane library, EMBASE , PubMed, Elsevier, web of science （ISI）, China national knonledge internet （CNKI）, VIP Chinese Scientific and Technologic Periodical Database and Wanfang data, and the feature information in the studies were extracted. The relative risk （RR） value was used for count data and the weighted mean difference （WMD） was used for measurement data. The proper effect model was selected according to the results of heterogeneity test and the publication bias was investigated through visual inspection of funnel plots. Results A total of nine RCT met the inclusion standard. Of 2620 FD cases, 1372 received itopride treatment and 1248 cases received placebo or other medicine as control treatment. The RR value of total effective rates, postprandial fullness and early satiety effective rates in itopride treated FD patients was 1.11 （95%CI： 1.01, 1.21; P=0.02）, 1.18 （95% CI： 1.04, 1.33; P=0.009）, 1.24 （95%CI： 1.01, 1.53; P=0.04）, which showed the curative effects of itropride group were all better than those of control group. However there was no statistical significance in epigastric discomfort. The WMD of effective rates evaluated with the leeds dyspepsia questionnaire （LDQ） score was -1.38 （95%CI ：-1. 75, -1. 01; P〈0.01）, which showed the curative effect of itropride group was better than that of control group. For safety, the adverse effects rates of itopride groups were similar with control groups. The funnel plots of each inspection index presented wide bottom, narrow up and symmetrical graphics, which indicated that there was no publication bias. Conclusion Itopride has better efficacy in general symptoms, postprandial fullness, early satiety and LDQ score in FD patients, and few effects are detected.