柴胡疏肝散加减治疗慢性胆囊炎的Meta分析和试验序贯分析
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国家自然科学基金项目(81973753);湖南省自然科学基金项目(2018JJ2291)


Meta-analysis and Trial Sequential Analysis of Modified Chaihu Shugan Powder in the Treatment of Chronic Cholecystitis
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    摘要:

    目的:系统评价柴胡疏肝散加减较常规西药治疗慢性胆囊炎的临床疗效和安全性,为柴胡疏肝散的临床应用提供循证依据。方法:检索PubMed、Embase、The Cochrane Library、国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、中国生物医学文献数据库(CBM)等数据库,检索国内外发表的关于柴胡疏肝散加减治疗慢性胆囊炎的随机对照试验,时限从建库至2020年8月。由2位研究员按筛选标准独立甄选文献,提取资料及评价偏倚风险,运用Revman5.3软件开展Meta分析,Stata15.0软件评估发表偏倚评估,TSA0.9软件开展试验序贯分析(TSA),GRADE3.6软件评价证据质量。结果:纳入11项临床研究,共计样本量1 772例,涵盖观察组1 034例,对照组738例。1)Meta分析:相对于常规西药,柴胡疏肝散能提高慢性胆囊炎的临床治愈率(RR=1.35,95%CI为1.21~1.50,P<0.000 01)、临床总有效率(RR=1.17,95%CI为1.13~1.22,P<0.000 01),降低复发率(RR=0.07,95%CI为0.01~0.34,P=0.001)和不良反应发生率(RR=0.06,95%CI为0.01~0.33,P=0.000 9)。2)TSA分析:TSA报告临床总有效率累计Z值在第3项研究达到传统界值和TSA界值,表明该结果具有确切结论性。3)发表偏倚:Harbord回归示不存在发表偏倚(P=0.23)。4)证据质量评价:GRADE示临床治愈率及临床总有效率证据质量均为低,复发率和不良反应率证据质量均为极低,且推荐强度均为弱推荐。结论:柴胡疏肝散治疗慢性胆囊炎的临床疗效和安全性均优于常规西药,拥有辨治应用的价值。

    Abstract:

    To systematically evaluate the clinical efficacy and safety of modified Chaihu Shugan powder compared with conventional western medicine in the treatment of chronic cholecystitis,so as to provide an evidence-based basis for the clinical application of Chaihu Shugan powder.Methods:We searched PubMed,Embase,the Cochrane Library,China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),and China Biology Medicine disc(CBMdisc) for randomized controlled trials involving the treatment of chronic cholecystitis with modified Chaihu Shugan powder from inception to August 2020.Two researchers independently selected the papers according to the screening criteria,extracted data,and evaluated the risk of bias.We employed Revman5.3 to carry out meta-analysis,Stata15.0 to evaluate publication bias,TSA0.9 to perform trial sequential analysis(TSA),and GRADE3.6 to evaluate the quality of evidence.Results:Eleven clinical studies involving 1 772 cases(1 034 cases in the observation group and 738 cases in the control group) were included in this study.1) Meta-analysis:Compared with conventional western medicine,Chaihu Shugan powder can improve the clinical cure rate of chronic cholecystitis(RR=1.35,95%CI 1.21 to 1.50,P<0.000 01) and the clinical total effective rate(RR=1.17,95%CI 1.13 to 1.22,P<0.000 01),and it can reduce the recurrence rate(RR=0.07,95%CI 0.01 to 0.34,P=0.001) and the incidence of adverse reactions(RR=0.06,95%CI 0.01 to 0.33,P=0.000 9).2) TSA:The cumulative Z value of TSA reported clinical total effective rate reached the traditional and TSA cut-off values in the third study,indicating that the results were conclusive.3) Publication bias:The Harbord test showed no existence of publication bias(P=0.23).4) Evaluation of evidence quality:The grading of recommendations,assessment,development,and evaluation(GRADE) showed low quality of the evidence for clinical cure rate and clinical total effective rate,extremely low quality of the evidence for recurrence rate and incidence of adverse reactions,and weak recommendation.Conclusion:Chaihu Shugan powder demonstrates the clinical efficacy and safety superior to conventional western medicine in the treatment of chronic cholecystitis and has the potential to be applied in the treatment after syndrome differentiation.

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俞赟丰,张家齐,徐思琦,韦方敏,陈玉莹,简维雄.柴胡疏肝散加减治疗慢性胆囊炎的Meta分析和试验序贯分析[J].世界中医药,2022,(21).

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  • 收稿日期:2020-12-28
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  • 在线发布日期: 2022-12-12
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