四君子汤加减治疗慢性萎缩性胃炎的Meta分析

目的:系统评价四君子汤加减治疗慢性萎缩性胃炎(chronic atrophic gastritis,CAG)的临床效果以及安全性。方法:电子计算机检索The Cochrane Library,Pubmed,Embase,中国期刊全文数据库(CNKI),中国生物医学文献数据库(CBM),中国科技期刊全文数据库(VIP)和万方数据库等,检索时间限定为建库至2015年6月14日,检索所有四君子汤加减治疗慢性萎缩性胃炎的随机对照试验(randomized controlled trials,RCTs),并辅以手工检索相关核心期刊,追索纳入研究的参考文献。由2位评价者根据Cochrane系统评价员手册5.1独立对纳入研究的质量进行严格评价和有效资料提取后,采用Rev Man 5.3软件进行Meta分析。结果:最终纳入7项研究,共577例患者。Meta分析结果显示:与对照组的常规西医治疗方案相比,四君子汤加减治疗能有效提高慢性萎缩性胃炎患者临床疗效,总有效率的合并效应量和95%的置信区间为OR=4.10,95%CI(2.57,6.53),P0.000 01],整体效果检验Z=5.94,两组疗效差异具有统计学意义。不良反应方面,仅有1项研究报道了对照组患者出现口干1例,头晕2例,腹泻1例,未经治疗处理均可自行好转;观察组无不良反应发生,两组不良反应发生率具有显著性差异(P0.05)。结论:基于纳入7项研究的Meta分析结果,四君子汤加减治疗慢性萎缩性胃炎疗效优于常规西医治疗。鉴于纳入研究数量和质量有限,且样本量均较低,四君子汤加减治疗慢性萎缩性胃炎疗效和安全性仍需要今后开展多中心、双盲、大样本量的随机对照试验进一步验证。

Meta-analysis of Modified Sijunzi Tang for Treating Chronic Atrophic Gastritis

Objective: To systematically evaluate the safety and efficacy of modified Sijunzi Tang in treating chronic atrophic gastritis. Method: We searched Cochrane Library, Pubmed, Embase, CNKI, CBM, VIP and Wanfang Data through computer for data as at June 14, 2015.All of randomized controlled trials(RCTs) of modified Sijunzi Tang in treating chronic atrophic gastritis were searched, relevant core journals were manually searched, and research literatures included in the RCTs were also traced. Two researchers independently conducted the strict quality evaluation and data extraction for the included studies on the basis of the Cochrane system assessor handbook 5.1, and made a Meta-analysis by using RevMan 5.3 software. Result: Totally 7 RCTs involving 577 patients were included into the study. The Meta-analysis results showed that compared with western medicine, modified Sijunzi Tang can significantly improve the clinical efficacy in treating patients with chronic atrophic gastritis, with the effect size and 95% confidence interval ofOR=4.10, 95%CI(2.57, 6.53), P<0.00001], merge test analysis result of Z=5.94, and statistically significant differences in both groups. In adverse reaction, only one study showed dry mouth in 1 case, dizziness in 2 cases, 1 case of diarrhea in the control group were recovered with no need of treatment. Observation group showed no adverse reactions, with a significant difference in the incidence of adverse reactions between the two groups(P<0.05). Conclusion: According to the Meta-analysis on the seven included CRTs, modified Sijunzi Tang in treating chronic atrophic gastritis can effectively improve the clinical effective rate. However, due to the low quality and small sample size of included RCTs in this study, more multicenter, double-blind RCTs with a large sample size are required to further verify the efficacy and safety of modified Sijunzi Tang in treating chronic atrophic gastritis.