间苯三酚与硫酸镁治疗先兆流产疗效与安全性比较的Meta分析

Comparing the Efficacy and Safety of Phloroglucinol and Magnesium Sulfate in the Treatment of Threatened Abortion: A Meta-analysis

目的:采用系统评价的方法比较间苯三酚及硫酸镁在先兆流产中的疗效及安全性。方法:计算机检索the Cochrane Library、PubMed、Embase、SinoMed、CNKI、WanFang Data、VIP数据库,搜集关于间苯三酚与硫酸镁比较治疗先兆流产的随机对照试验(RCTs)。检索时限均为建库至2018年5月。由两位研究者独立地进行文献筛选、数据提取及对纳入研究的偏倚风险评价后,采用Stata 12.0软件进行Meta分析。结果:共纳入21个RCTs,包含1 940例患者,纳入研究的质量均不高。Meta分析结果显示:间苯三酚治疗先兆流产的总有效率[RR=1.12,95%CI(1.08,1.17),P<0.001]、治疗起效时间[SMD=0.25,95%CI(0.09,0.41),P=0.002]均高于硫酸镁,间苯三酚治疗先兆流产的宫缩缓解时间[SMD=-0.22,95%CI(-0.39,-0.05),P<0.001]、潮红发热发生率[RR=0.09,95%CI(0.05,0.16),P<0.001]、头晕头痛发生率[RR=0.15,95%CI(0.08,0.28),P<0.001]、肠胃不适发生率[RR=0.19,95%CI(0.10,0.36),P<0.001]、子宫收缩症状完全消失时间[SMD=-2.08,95%CI(-3.05,-1.12),P<0.001]均低于硫酸镁。结论:间苯三酚治疗先兆流产的疗效优于硫酸镁,且药品不良反应发生率明显降低。但鉴于证据质量不高,仍需要更多大样本、多中心、高质量研究予以验证。

Objective:To compare the efficacy and safety of phloroglucinol and magnesium sulfate in threatened abortion by adopting the method of systematic evaluation.Methods:The Cochrane Library,PubMed,Embase,SinoMed,CNKI,VIP and WanFang Data were electronically searched to collect randomized controlled trials(RCTs)of phloroglucinol and magnesium sulfate in the treatment of threatened abortion from inception to May 2018.Two researchers independently conducted literature screening,data extraction and assessed the risk of bias of included studies evaluation.Stata 12.0 software was used for Meta-analysis.Results:A total of 21 RCTs involving 1 940 patients were included,and the quality of the included studies was not high.The result of Meta-analysis showed that the total effective rate(RR=1.12,95%CI 1.08 to 1.17,P<0.001)and onset time of phloroglucinol(SMD=0.25,95%CI 0.09 to 0.41,P=0.002)in the treatment of threatened abortion were higher than those of magnesium sulfate,and the remission time of uterine contraction(SMD=-0.22,95%CI-0.39 to 0.05,P<0.001),incidence of flush fever(RR=0.09,95%CI 0.05 to 0.16,P<0.001),incidence of dizziness and headache(RR=0.15,95%CI 0.08 to 0.28,P<0.001),incidence of gastrointestinal discomfort(RR=0.19,95%CI 0.10 to 0.36,P<0.001)and the complete disappearance time of uterine contraction symptoms(SMD=-2.08,95%CI-3.05 to-1.12,P<0.001)were lower than those of magnesium sulfate.Conclusion:Phloroglucinol is superior to magnesium sulfate in the treatment of threatened abortion with significant reduced incidence of adverse reactions.However,in consideration of the low quality of evidence,larger sample,multi-center,high-quality studies are still needed to verify.