半夏泻心汤加减治疗胃食管反流病的Meta分析和试验序贯分析  

Meta-analysis and Trial Sequential Analysis of Modified Banxia Xiexin Decoction in the Treatment of Gastroesophageal Reflux Disease

作　　者：俞赟丰 兰晓栋 金梦雨 徐思琦 梁妍 简维雄[1] YU Yunfeng;LAN Xiaodong;JIN Mengyu;XU Siqi;LIANG Yan;JIAN Weixiong(Hunan University of Chinese Medicine,Changsha 410208,China)

机构地区：[1]湖南中医药大学,湖南长沙410208

出　　处：《云南中医学院学报》2020年第5期28-35,共8页Journal of Yunnan University of Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(81973753)。

摘　　要：目的系统评价半夏泻心汤治疗胃食管反流病(GERD)的有效性,为辨治处方提供临床证据。方法检索CNKI、VIP、WanFang、PubMed、Embase、The Cochrane Library数据库,查找国内外公开发表的关于半夏泻心汤治疗胃食管反流病的临床研究,由2位研究人员按照纳入与排除标准独立筛选文献,提取资料并评价纳入研究的质量,采用Revman5.3软件进行Meta分析,TSA0.9软件进行试验序贯分析,Stata15.0软件进行发表偏倚评估,GRADE3.6软件进行证据质量评价。结果共纳入13项研究,共计患者1089例,其中试验组576例,对照组513例。(1)Meta分析结果显示:同常规西药相比半夏泻心汤能有效提高临床治愈率[RR=1.55,95%CI=(1.17,2.05),P=0.002]、胃镜治愈率[RR=1.45,95%CI=(1.07,1.98),P=0.02]、临床总有效率[RR=1.15,95%CI=(1.10,1.21),P<0.00001]和胃镜总有效率[RR=1.21,95%CI=(1.09,1.35),P=0.0003],降低复发率[RR=0.25,95%CI=(0.09,0.72),P=0.01]。(2)试验序贯分析:临床总有效率的累计Z值在第5项研究穿过传统界值和TSA界值,校正后结果一致,可作为确切证据。(3)发表偏倚:Harbord检验显示不存在显著发表偏倚(P=0.12)。(4)证据质量评价:临床治愈率、胃镜治愈率、临床总有效率、胃镜总有效率、复发率的证据质量均为中,推荐强度均为弱推荐。结论半夏泻心汤应用于胃食管反流病的临床疗效优于优选西药组合,具有在GERD的临床辨治中推广应用的价值。Objective To systematically evaluate the effectiveness of Banxia Xiexin Decoction in the treatment of gastroesophageal reflux disease(GERD),and to provide clinical evidence for the diagnosis and treatment of prescriptions.Methods Search the databases of CNKI,VIP,WanFang,PubMed,Embase,The Cochrane Library,and search for the treatment of Banxia Xiexin Decoction published at home and abroad.Two researchers independently screened the literature according to the inclusion and exclusion criteria,extracted the data and evaluated the inclusion for the quality of the study,Revman5.3 software was used for Meta-analysis,TSA0.9 software was used for trial sequential analysis,Stata15.0 software was used for publication bias evaluation,and GRADE3.6 software was used for evidence quality evaluation.Results A total of 13 studies were included,with a total of 1089 patients.In fact,there were 576 cases in the test group and 513 cases in the control group.(1)The results of Meta-analysis show that Banxia Xiexin Decoction can effectively improve the clinical cure rate[RR=1.55,95%CI=(1.17,2.05),P=0.002]and the cure rate of gastroscopy[RR=1.45,95%CI=(1.07,1.98),P=0.02],total clinical effective rate[RR=1.15,95%CI=(1.10,1.21),P<0.00001]and total effective rate of gastroscopy[RR=1.21,95%CI=(1.09,1.35),P=0.0003],reduce the recurrence rate[RR=0.25,95%CI=(0.09,0.72),P=0.01].(2)Trial sequential analysis:The cumulative Z value of the clinical total effective rate crossed the traditional boundary value and the TSA boundary value in the fifth study,and the corrected results are consistent,which can be used as definite evidence.(3)Publication bias:Harbord test showed that there was no significant publication bias(P=0.12).(4)Evidence quality evaluation:The quality of evidence for clinical cure rate,gastroscopy cure rate,clinical total effective rate,total gastroscopy effective rate,and recurrence rate are all medium,and the recommendation strength is weak recommendation.Conclusion The clinical efficacy of Banxia Xiexin Decoction applied to gastroe

关 键 词：半夏泻心汤 质子泵抑制剂 促动力药 胃食管反流病 Meta分析 试验序贯分析 

分 类 号：R259[医药卫生—中西医结合]