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莫沙必利治疗功能性消化不良的荟萃分析。

Mosapride treatment for functional dyspepsia: a meta-analysis.

作者信息

Bang Chang Seok, Kim Jong Hyeok, Baik Gwang Ho, Kim Hyo Sun, Park Sang Hyun, Kim Eun Jin, Kim Jin Bong, Suk Ki Tae, Yoon Jai Hoon, Kim Yeon Soo, Kim Dong Joon

机构信息

Department of Internal Medicine, Hallym University College of Medicine, Chuncheon.

出版信息

J Gastroenterol Hepatol. 2015 Jan;30(1):28-42. doi: 10.1111/jgh.12662.

Abstract

BACKGROUND AND AIM

The aim of this study was to assess the therapeutic effect of mosapride in patients with functional dyspepsia (FD).

METHODS

Randomized controlled trials (RCTs) of mosapride for the treatment of FD performed between 2002 and 2013 were identified from databases. Symptom response rates were extracted and analyzed using risk ratios (RRs). A random effect model was applied based on Higgins I(2) tests. Publication bias was evaluated using a funnel plot, Egger's test, trim and fill, and the rank correlation test.

RESULTS

In total, 13 RCTs, which included 1091 mosapride-treated patients and 1129 control patients (on placebo or other drugs), were identified and analyzed. Overall, mosapride showed an RR of 0.999 (95% confidence interval [CI]: 0.869-1.150, P = 0.992) for improving global efficacy or symptom-based scores. In a sensitivity analysis of the high-quality RCTs, mosapride showed an RR of 1.114 (95% CI: 1.011-1.227, P = 0.029). However, in the studies using the Rome III criteria for the diagnosis of FD, mosapride showed an RR of 0.906 (95% CI: 0.807-1.016, P = 0.092). In the studies having funding source, mosapride showed an RR of 1.131 (95% CI: 1.028-1.244, P = 0.012), whereas an RR of 0.966 (95% CI: 0.896-1.042, P = 0.367) was observed in the studies without funding source. Publication bias was not detected.

CONCLUSION

In this analysis, we could not find a significant effect of mosapride on FD. Inconsistent diagnostic criteria for FD and different assessment outcomes are causes of heterogeneity. Further studies using common validated outcomes or questionnaires and high-quality RCTs will elucidate the real effect of this medication on FD.

摘要

背景与目的

本研究旨在评估莫沙必利对功能性消化不良(FD)患者的治疗效果。

方法

从数据库中检索2002年至2013年间进行的关于莫沙必利治疗FD的随机对照试验(RCT)。提取症状缓解率并使用风险比(RRs)进行分析。基于希金斯I²检验应用随机效应模型。使用漏斗图、埃格检验、修剪和填充以及秩相关检验评估发表偏倚。

结果

共识别并分析了13项RCT,其中包括1091例接受莫沙必利治疗的患者和1129例对照患者(接受安慰剂或其他药物治疗)。总体而言,莫沙必利在改善总体疗效或基于症状的评分方面的RR为0.999(95%置信区间[CI]:0.869 - 1.150,P = 0.992)。在高质量RCT的敏感性分析中,莫沙必利的RR为1.114(95%CI:1.011 - 1.227,P = 0.029)。然而,在使用罗马III标准诊断FD的研究中,莫沙必利的RR为0.906(95%CI:0.807 - 1.016,P = 0.092)。在有资金来源的研究中,莫沙必利的RR为1.131(95%CI:1.028 - 1.244,P = 0.012),而在无资金来源的研究中观察到的RR为0.966(95%CI:0.896 - 1.042,P = 0.367)。未检测到发表偏倚。

结论

在本分析中,我们未发现莫沙必利对FD有显著疗效。FD诊断标准不一致和评估结果不同是异质性的原因。使用通用的有效结局或问卷以及高质量RCT进行的进一步研究将阐明这种药物对FD的实际效果。

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