宫外孕Ⅱ号方联合 甲氨蝶呤与米非司酮治疗未破裂型输卵管妊娠疗效和安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Ectopic Pregnancy Ⅱ Prescription Combined with Methotrexate and Mifepristone in the Treatment of Unruptured Tubal Ectopic Pregnancy

作　　者：杜贞苹 征征 万宇 邢玉[1] 刘艳霞[1] DU Zhen-ping;ZHENG Zheng;WAN Yu;XING Yu;LIU Yan-xia(Department of Gynecdogy,Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078)

机构地区：[1]北京中医药大学东方医院妇科,北京100078

出　　处：《世界中西医结合杂志》2023年第1期16-27,共12页World Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金项目(81904241)。

摘　　要：目的 系统评价宫外孕Ⅱ号方联合甲氨蝶呤(Methotrexate, MTX)与米非司酮治疗未破裂型输卵管妊娠(Tubal ectopic pregnancy, TEP)的疗效和安全性。方法 计算机检索中国知网、万方Databases、维普、中国生物医学文献数据库,Pub Med、Embase、Web of Science,检索时限均从建库至2022年5月31日,筛选出宫外孕Ⅱ号方联合MTX和米非司酮治疗TEP的随机对照试验(Randomized controlled trials, RCTs),由两位研究者独立筛选文献、提取资料并评价偏倚风险后,应用Rev Man 5.3评价软件进行最终纳入的研究进行Meta分析。结果 共纳入27项研究,包括2731例TEP患者,涉及疗效指标7个、安全性指标7个。Meta分析结果显示:(1)试验组的总有效率[RR=0.50,95%CI(0.42,0.59),P<0.000 01]、治愈率[OR=2.55,95%CI(2.02,3.23),P<0.000 01]、血β-HCG转阴所需时间[MD=-6.43,95%CI(-8.55,-4.31),P<0.000 01]、盆腔包块消失所需时间[MD=-8.71,95%CI(-10.64,-6.77),P<0.000 01]、腹痛消失所需时间[MD=-6.46,95%CI(-9.40,-3.51),P<0.0001]、盆腔积液恢复所需时间[MD=-5.75,95%CI(-8.80,-2.70),P=0.0002]、血β-HCG治疗前后差值[SMD=2.13,95%CI(0.76,3.50),P=0.002]等疗效指标方面均优于对照组,其差异有统计学意义;(2)试验组的总不良反应发生率[RR=0.48,95%CI(0.36,0.66),P<0.000 01]、其他不良反应率[RR=0.40,95%CI(0.29,0.54),P<0.000 01]、胃肠道不适[RR=0.75,95%CI(0.57,0.97),P=0.03]、肝功能异常[RR=0.31,95%CI(0.18,0.54),P<0.000 01]、骨髓抑制[RR=0.30,95%CI(0.14,0.67),P=0.003]、口腔溃疡[RR=0.46,95%CI(0.29,0.74),P=0.001]等安全性指标的改善方面均优于对照组,其差异有统计学意义;两组患者白细胞减少发生率比较,差异无统计学意义(P>0.05);(3)敏感性分析提示结果较为稳健。结论 宫外孕Ⅱ号方联合MTX和米非司酮治疗TEP可提高疗效、缩短临床症状消失时间,且不良反应发生率相对较低。受纳入研究质量和数量限制,上述结论尚待更多高质量、大样本、设计�Objective To systematically evaluate the efficacy and safety of ectopic pregnancy Ⅱ prescription combined with methotrexate(MTX)and mifepristone in the treatment of unruptured tubal ectopic pregnancy(TEP).Methods CNKI,Wanfang Data, VIP,CBM,PubMed, Embase, and Web of Science were searched for randomized controlled trials(RCTs)of ectopic pregnancy Ⅱ prescription combined with MTX and mifepristone in the treatment of TEP from database inception to May 2022.Two investigators screened the literature, extracted data, and evaluated the risk of bias independently, and RevMan 5.3 software was used for Meta-analysis of the included studies.Results Twenty-seven studies were included, involving 2 731 TEP patients, seven efficacy indicators, and seven safety indicators.Meta-analysis results showed that(1) the treatment group was superior to the control group in terms of overall effective rate [RR=0.50,95% CI(0.42,0.59),P<0.000 01],the recovery rate [OR=2.55,95% CI(2.02,3.23),P<0.000 01],serum β-HCG clearance time[MD=-6.43,95% CI(-8.55,-4.31),P<0.00 001],disappearance time of pelvic masses[MD=-8.71,95% CI(-10.64,-6.77),P<0.000 01],abdominal pain relief time [MD=-6.46,95% CI(-9.40,-3.51),P<0.000 1],recovery time for pelvic effusion [MD=-5.75,95% CI(-8.80,-2.70),P=0.000 2],and difference in serum β-HCG before and after treatment [SMD=2.13,95% CI(0.76,3.50),P=0.002].(2) The treatment group was superior to the control group in improving the safety indicators, such as total incidence of adverse reactions [RR=0.48,95% CI(0.36,0.66),P<0.000 01],incidence of other adverse reactions [RR=0.40,95% CI(0.29,0.54),P<0.000 01],gastrointestinal discomfort [RR=0.75,95% CI(0.57,0.97),P=0.03],abnormal liver function [RR=0.31,95% CI(0.18,0.54),P<0.000 01],bone marrow suppression [RR=0.30,95% CI(0.14,0.67),P=0.003],and oral ulcer [RR=0.46,95% CI(0.29,0.74),P=0.001].There was no significant difference in leukopenia incidence between the two groups(P>0.05).(3) The sensitivity analysis suggested that the results were reliable.Conclusion Ectopic

关 键 词：宫外孕Ⅱ号方 甲氨蝶呤 米非司酮 输卵管妊娠 META分析 

分 类 号：R714.2[医药卫生—妇产科学]