新疆医科大学学报

目的系统、全面分析评价半夏泻心汤及其加减方治疗慢性萎缩性胃炎的临床疗效和安全性。方法计算机检索CNKI、万方数据库、VIP、CBM、Pubmed、EMbase等数据库,并手工检索相关领域杂志,时间从建库至2014年10月。搜集关于半夏泻心汤及其加减方治疗慢性萎缩性胃炎的随机对照研究,并由2名评价员严格按照纳入和排除标准进行文献筛查,独立选择试验、提取资料和质量评估,并采用Review Manager 5软件进行Meta分析。结果最终纳入7项随机对照试验,共683例患者。Meta分析结果显示,未发现双盲试验。在临床有效性方面,中医半夏泻心汤及其加减组优于西医治疗组[RR=1.33,95%CI(1.21,1.46),P<0.000 01],差异具有统计学意义;半夏泻心汤及其加减联合西医治疗组优于单纯西医治疗组[RR=1.26,95%CI(1.00,1.60),P=0.05],差异具有统计学意义。结论半夏泻心汤及其加减方或联合西医治疗慢性萎缩性胃炎的临床疗效和安全性优于西医治疗组,但由于研究文献均为小样本和高偏倚风险的原始研究,建议今后开展样本量充足、设计合理、执行严格的临床试验进一步评价。

Objective To evaluate the clinical efficacy and safety of Banxia xiexin decoction for treating chronic atrophic gastritis with Meta-analysis. Methods We reviewed studies and data about the randomized controlled trials of Banxia xiexin decoction in treating chronic gastritis from The CNKI database,Wang fang database,VIP database,CBM database,Pubmed database and EMbase database and related Chinese journals since the date of database establishment to 2014. The data were reviewed and analyzed independently by two evaluators with Meta analysis method. Results Seven randomized controlled trials involving 683 patients were included in the Meta-analysis.The Meta-analysis showed the Banxia xiexin decoction was better than the west medicine [RR = 1. 15,95% CI( 1.08,1. 24),P <0. 0001]. There was a statistical significance in total effective rate; Banxia xiexin decoction combined with the west medicine was better than the west medicine [RR = 1. 26,95% CI( 1. 00,1. 60),P = 0. 05].Conclusion Existing evidence suggests that the clinical efficacy and safety of Banxia xiexin decoction or combined with western medicine treatment is superior to western medicine treatment group. However,since the findings from all the reviewed studies were based on small sample,and on high risk clinical trials,it is too early to draw a convincing conclusion about the definite clinical efficacy and safety of Banxia xiexin decoction in treating chronic gastritis. We suggest that further clinical trials with adequate samples,rational design and strict execution be carried out to provide more reliable evidence.