益母草注射液用于阴道分娩后胎膜残留的多中心临床研究  

Multi-center clinical study of motherwort injection for retained fetal membrane after vaginal delivery

作　　者：陈璐[1] 贺晶[1] 刘兴会 吴琳琳[3] 尹维[4] 李娜[5] 于亚莉 刘正飞[7] CHEN Lu;HE Jing;LIU Xing-hui;WU Lin-lin;YIN Wei;LI Na;YU Ya-li;LU Zheng-fei(Department of Obstetrics,Women Hospital,School of Medicine,Zhejiang University,Hangzhou 310006,China)

机构地区：[1]浙江大学医学院附属妇产科医院产科,浙江杭州310006 [2]四川大学华西第二医院产科,四川成都610000 [3]深圳市妇幼保健院产科,广东深圳518028 [4]绵阳市人民医院产科,四川绵阳621000 [5]广安市人民医院产科,四川广安638001 [6]南充市中心医院产科,四川南充637000 [7]宜宾市第一人民医院产科,四川宜宾644000

出　　处：《中国实用妇科与产科杂志》2019年第5期564-568,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：四川省科技支撑计划项目(2014SZ0139);四川省科技成果转化示范项目(2018CC0108)

摘　　要：目的探讨应用益母草注射液治疗阴道分娩后胎膜残留的有效性和安全性。方法采用多中心、开放、随机、对照的前瞻性研究方法,于2017年12月至2018年10月收集符合纳入、排除标准的全国7所三级医院244例足月阴道分娩产妇作为研究对象。随机分为基础治疗组(对照组)和观察组,分别采用全分析集(FAS)和符合方案分析集(PPS)进行统计分析,失访16例(观察组7例,对照组9例)。主要有效性指标分析结果两者相同,故仅详细报告PPS集分析结果。PPS集中纳入对照组109例,于产后第1天开始给予缩宫素20U每天静脉滴注及二代头孢静脉滴注,连续3d;观察组114例,观察组在产后基础治疗组基础上加用益母草注射液2mL/次,2次/d,连续5d。两组患者出院后均给予口服产复康颗粒或产妇安颗粒,连续7d。以产妇恶露情况、子宫体积变化、残留胎膜排出情况等为主要有效性指标;以产妇感染相关因子及感染情况、晚期产后出血发生率、产后体温变化、合并使用其他止血类药物情况等为次要有效性指标;以实验室检查(血常规、心电图)、不良反应/事件为安全性指标,评价益母草注射液治疗阴道分娩后胎膜残留的有效性和安全性。结果 (1)恶露情况:产妇血性恶露持续时间观察组显著短于对照组[(5.12±1.83)d vs.(6.27±2.07)d,P=0.000];血性恶露5d内终止率观察组显著高于对照组(64.91%vs. 35.78%,P=0.000)。(2)子宫体积比较:观察组子宫体积缩小程度明显优于对照组(Z=-2.27,P<0.05)。(3)残留胎膜情况:观察组治疗5d后及产后42～47d残留胎膜排出率明显高于对照组(62.28%vs. 35.78%,100.00%vs.95.41%,P=0.002);观察组因残留胎膜持续存在所致的清宫率显著低于对照组(1.75%vs. 14.68%,P=0.000)。(4)感染相关因子及感染情况:治疗5d后观察组C-反应蛋白(CRP)值显著小于对照组(P<0.01);将CRP>8.0mg/L或降钙素原(PCT)>0.5ng/L定义为感染,治疗5d后观察组感�Objective To evaluate the efficacy and safety of motherwort(herba leonuri)injection in the treatment of fetal membrane retention after vaginal delivery.Methods The prospective study was designed as a multicenter,open,randomized,controlled research from December 2017 to October 2018.A total of 244 women who achieved fullterm vaginal delivery were enrolled from 7 tertiary hospitals in China.Sixteen people were lost to follow-up(7 in the experimental group and 9 in the control group).All cases were randomly divided into group of motherwort(experimental group)and group of basic treatment(control group).Full Analysis Set(FAS)and Per ProtocolSet(PPS)were used for statistical analysis.The results of main validity indicators were the same.Therefore,only the results of PPS set analysis were reported in detail.PPS set included 109 cases in control group and 114 cases in experimental group.Control group were administered by oxytocin 20 U and cephalosporinⅡintravenous injection daily for3 days after birth;experimental group were administered by motherwort 20 mg intramuscular injection per 12 hours for 5 consecutive days on the basis of basic treatment.Both groups of patients were given oral herb medicine Chan-fu-kang or Chan-fu-an Granules after discharge for 7 consecutive days.The following clinical parameters were collected and analyzed for evaluation of the efficacy and safety of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.The main effectiveness indicators were maternal lochia,uterine volume change,and discharge of retained fetal membrane;the secondary effectiveness indicators were the maternal infection-related factors and infections,the incidence of secondary postpartum hemorrhage,postpartum body temperature changes,and the use of other hemostatic drugs.Safety indicators were laboratory tests(blood routine,electrocardiogram),adverse reactions/events,which were used to evaluate the safety and efficacy of motherwort injection in the treatment of retained fetal membrane after v

关 键 词：益母草注射液 胎膜残留 随机对照 多中心临床研究 

分 类 号：R714.63[医药卫生—妇产科学]