半夏泻心汤加减治疗反流性食管炎疗效的Meta分析

目的:系统评价半夏泻心汤加减治疗反流性食管炎(reflux esophagitis,RE)的临床效果以及安全性。方法:计算机检索Pubmed,The Cochrane Library,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,检索时间限定为建库至2015年6月20日,检索所有半夏泻心汤加减治疗反流性食管炎的随机对照试验(randomized controlled trials,RCTs),并追索纳入研究的参考文献。由两位评价者根据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12个研究,共914例患者。Meta分析结果显示:与常规西医治疗相比,半夏泻心汤加减治疗反流性食管炎可显著提高临床综合疗效OR=3.41,95%CI(2.22,5.23),P0.000 01],提高胃镜下疗效OR=1.58,95%CI(1.04,2.41),P=0.03]以及降低复发率OR=0.23,95%CI(0.14,0.40),P0.000 01],两组差异均具有统计学意义。不良反应方面,1项研究跟踪报道:治疗组未见明显不良反应发生,对照组有14例出现不同程度的不良反应,其中恶心4例、头痛7例、腹痛2例、腰酸1例,但均能坚持服药至疗程结束,且继续服药后上述不良反应有所减轻。敏感性分析结果显示,疗效评价结果较稳定;"漏斗图"分析结果显示不对称,可能有潜在发表偏倚存在。结论:半夏泻心汤加减治疗反流性食管炎疗效优于常规西医组,且未发现严重不良反应。鉴于纳入研究方法学和报告质量较低、样本量较少,故半夏泻心汤加减治疗反流性食管炎的疗效以及安全性仍需要多中心、大样本、高质量的随机双盲试验加以验证。

Meta-analysis of Reflux Esophagitis Treated by Modified Banxia Xiexin Tang

Objective: To study the safety and efficacy of modified Banxia Xiexin Tang in treating reflux esophagitis(RE). Method: We searched Pubmed, The Cochrane Library, Embase, CNKI, CBM, VIP and Wanfang Data through computer for data June 20,2015.All of Randomized Controlled Trials(RCTs) of modified Banxia Xiexin Tang in treating reflux esophagitis were 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 12 RCTs involving 914 patients were included into the study. The Meta-analysis results showed that compared with the pure application of western medicine, modified Banxia Xiexin Tang in treating reflux esophagitis can significantly improve the comprehensive clinical efficacyOR=3.41, 95%CI(2.22,5.23), P<0.00001], improve the efficacy under gastroscopeOR=1.58, 95%CI(1.04,2.41), P=0.03] and reduce the recurrence rateOR=0.23, 95%CI(0.14, 0.40), P<0.00001], with statistical significant differences. In the Adverse reactions, one study showed follow-up reports that the treatment group showed no obvious adverse reaction, whereas the control group showed 14 different degree of adverse reactions, including 4 cases of nausea, 7 cases of headache, 2 cases of abdominal pain, 1 case of soreness of waist, but all of them were tolerant to the drug until the end of the treatment, and the above adverse reactions were relieved with the continuous medication.Sensitivity analysis results showed a stable efficacy evaluation, asymmetric 'Funnel Plot' analysis, with the potential publication bias. Conclusion: Banxia Xiexin Tang in treating reflux esophagitis shows a superior comprehensive clinical efficacy to conventional western medicine, without any severe adverse effect. Therefore, more multicenter, randomized, double-blind trials with a large sample size are required to further verifythe efficacy and safety of Banxia Xiexin Tang in treating reflux esophagitis.