滋肾育胎丸联合孕激素治疗先兆流产的Meta分析和间接比较  

Meta-analysis and Indirect Treatment Comparison of Clinical Efficacy and Safety of Zishen Yutai Pills Combined with Progestogen in Treating Threatened Abortion

作　　者：马丹丽[1] 习元堂 蒋凯林 郑丹如 赵颖[1] MA Dan-Li;XI Yuan-Tang;JIANG Kai-Lin;ZHENG Dan-Ru;ZHAO Ying(The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405 Guangdong, China;The First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou 510405 Guangdong, China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]广州中医药大学第一临床医学院,广东广州510405

出　　处：《广州中医药大学学报》2018年第4期751-757,共7页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省科技计划项目(编号:2016A020215180)

摘　　要：【目的】系统评价滋肾育胎丸联合不同孕激素治疗先兆流产的临床疗效和安全性。【方法】通过检索英文数据库(Medline、Pub Med、EMBase、the Cochrane Library)及中文数据库(CNKI、VIP、CBM、万方数据库),筛选滋肾育胎丸联合孕激素治疗先兆流产的随机对照试验(RCTs)和临床对照试验(CCTs)。采用系统评价的方法对符合纳入标准的研究进行风险评估和质量评价;用Rev Man5.3软件对研究结局指标进行Meta分析,并利用间接比较法(ITC)软件对滋肾育胎丸联合孕激素方案治疗先兆流产的临床疗效进行间接比较。【结果】共纳入18项研究,涉及1 790名患者。Meta分析结果显示:滋肾育胎丸联合孕激素治疗先兆流产的临床疗效高于单用孕激素组,可提高14%的临床总有效率[RR=1.14,95%CI(1.07,1.20),Z=4.45,P<0.01,13篇文献]和提高11%的保胎成功率[RR=1.11,95%CI(1.05,1.17),Z=3.56,P<0.01,6篇文献];滋肾育胎丸单用治疗先兆流产的临床疗效高于单用孕激素组,可提高16%的临床有效率,但差异无统计学意义[RR=1.16,95%CI(1.07,1.20),Z=1.41,P=0.16,5篇文献]。间接比较结果显示:滋肾育胎丸联合黄体酮抑或地屈孕酮方案治疗先兆流产的临床有效率和保胎成功率之间差异无统计学意义(P>0.05)。所有研究均未出现明显不良反应。【结论】滋肾育胎丸单用或联用孕激素治疗先兆流产可提高其临床有效率和保胎成功率,且未见明显不良反应;但其单用或联合不同孕激素方案治疗先兆流产的确切疗效、安全性等需更多高质量的临床试验的验证。Objective To make a systematic evaluation of the clinical effect and safety of Zishen Yutai Pills（ZYP）combined with various kinds of progestogen in treating threatened abortion. Methods The randomized controlledtrials（RCTs）and controlled trials（CCTs）for the treatment of threatened abortion with ZYP or the combination ofZYP plus various kinds of progestogen were collected by searching databases of Medline,Pub Med,EMBase,theCochrane Library,and CNKI,VIP,CBM,Wanfang databases. Risk assessment and quality evaluation of theincluded studies were performed by using Cochrane systematic review. Meta-analysis was performed by Rev Man5.3 software and indirect comparison was performed by Indirect Treatment Comparison（ITC）software. Results Eventually 18 clinical studies involving 1790 cases of patients were included. Meta-analysis results showed that,compared with the treatment of progestogen alone,ZYP plus progestogen therapy showed better curative effect,which could increase the total clinical efficiency by 14%[RR = 1.14,95% CI（1.07,1.20）,Z = 4.45,P〈0.01,13 articles],and increase the fetus-protection rate by 11%[RR = 1.11,95% CI（1.05,1.17）,Z = 3.56,P〈0.01,6 articles]. ZYP used alone also showed better curative effect than progestogen alone,which could increase the total clinical efficiency by 16%[RR = 1.16,95% CI（1.07,1.20）,Z = 1.41,P = 0.16,6 articles],but thedifference was insignificant. Indirect comparison results showed that,either in total clinical efficacy or the fetus-protection rate, there was no difference between the two therapies of ZYP plus progesterone or ZYP plusdydrogesterone in the treatment of threatened abortion（P〉0.05）. Besides,no obvious adverse drug reaction wasreported in all of the included studies. Conclusion Compared with the treatment of progestogen alone,ZYP usedalone or combined with various kinds of progesterone could increase clinical effect and the fetus-protection rate inthe treatment of threatened abortion,and no obvious side effects were found. However,

关 键 词：先兆流产 滋肾育胎丸 孕激素 META分析 间接比较 

分 类 号：R271.1[医药卫生—中医妇科学]