桂枝茯苓胶囊/丸治疗慢性盆腔炎性疾病临床随机对照试验的系统评价  

Guizhi Fuling capsule/pill treatment for chronic pelvic inflammaory disease: a systematic review of randomized clinical trials

作　　者：张立双[1] 杨丰文[1] 张俊华[1] 郑文科[1] 张明妍[1] 李越[1] 赵宏杰[1] 

机构地区：[1]天津中医药大学循证医学中心,天津300193

出　　处：《中国中药杂志》2017年第8期1500-1509,共10页China Journal of Chinese Materia Medica

基　　金：教育部新世纪优秀人才项目(NCET-13-0936);天津市青年拔尖人才项目

摘　　要：该研究系统评价桂枝茯苓胶囊/丸,治疗慢性盆腔炎性疾病的有效性和安全性。计算机检索中文全文期刊数据库、万方数据库、中国生物医学文献数据库及Pub Med,Embase,The Cochrane Library数据库,检索桂枝茯苓胶囊/丸治疗慢性盆腔炎的随机对照试验(RCT),检索时限均为建库至2017年2月。由2位评价员独立筛选文献、提取资料并评价纳入文献的偏倚风险,风险评估参照Cochran Handbook5.3推荐的偏倚风险评估工具。本研究共纳入30个RCT,涉及3 586例患者,30个研究均报告了临床有效率,提示桂枝茯苓(胶囊、丸)联合西药的临床疗效优于单纯西药[RR=1.20,95%CI(1.16,1.23)];3个研究报告了复发率,提示桂枝茯苓(胶囊、丸)联合西药的复发率低于单纯西药[RR=0.33,95%CI(0.18,0.62)];3个研究采用了hs-CRP、血浆粘度比,2个研究采用了肿瘤坏死因子、纤维蛋白为次要指标,提示桂枝茯苓(胶囊、丸)联合西药在抗炎、改善血循环方面优于单纯西药组。17个研究报告了不良反应,主要为胃肠道的刺激症状,桂枝茯苓(胶囊、丸)联合西药组的不良反应发生率低于单纯西药组,加用桂枝茯苓(胶囊、丸)未增加不良反应。现有证据表明,桂枝茯苓(胶囊、丸)联合西药临床疗效优于单纯西药组,在改善临床症状、降低复发率、抗炎、降低血浆粘度方面的疗效均优于单纯西药组,受纳入研究数量及质量的限制,该结论仍需开展高质量RCT研究进行验证。This systematic review aims to systematically evaluate the efficacy and safety of Guizhi Fuling Capsule/Pill on the treatment of chronic pelvic inflammatory disease.We searched CNKI datebases,WanFang,SinoMed,PubMed,Embase,The Cochrane Library from the inception to February 2017,to collect randomized controlled trials（RCTs）of Guizhi Fuling Capsule/Pill in treating chronic pelvic inflammation disease.Two reviewers independently screened literature,extracted date and assessed the risk of bias of included studies.Then,the risk assessment of included references was evaluated according to criteria recommended by Cochrane Handbook 5.3.A total of 30 RCTs involving 3 586 patients were finally included.30 studies reported the clinical efficacy,the result of meta-analysis showed that：compared with the western medicine group,Guizhi Fuling （capsule,pill） combined with western medicine could significantly improve the clinical efficacy [RR=1.20,95%CI（1.16,1.23）];3 studies reported recurrence rate,the result of meta-analysis showed that：compared with the western medicine,Guizhi Fuling （capsule,pill） combined with western medicine could decrease the recurrence rate [RR=0.33,95%CI（0.18,0.62）];Their secondary indicators mainly included hs-CRP, plasma viscosity ratio and tumor necrosis factor and fibrin,the result of meta-analysis showed that： Guizhi Fuling （capsule,pill） combined with western medicine was better than western medicine in terms of anti-inflammatory and improving blood circulation.17 studies reported adverse reactions,most of the adverse events were the irritation of gastrointestinal tract.The result showed that： compared with the western medicine group, the incidence of adverse reactions in Guizhi Fuling （capsule,pill） combined with western medicine group is low.Guizhi Fuling（capsule,pill） did not increase the adverse reactions.The available evidence suggests that： Guizhi Fuling（capsule, pill） compared with the western medicine group, Guizhi Fuling （capsule,pill） comb

关 键 词：桂枝茯苓胶囊/丸 慢性盆腔炎 系统评价 Meta分析 随机对照试验 

分 类 号：R271.9[医药卫生—中西医结合]