目的 评价中药联合阿司匹林治疗复发性流产的疗效及安全性。方法 检索中国知网(CNKI)、万方数据库(WF)、维普期刊数据库(VIP)、中国生物医学文献数据库、PubMed、Web of Science从建库至2023年3月发表的关于复发性流产患者服用中药和阿司匹林的随机对照试验(RCT),干预方案为临床常规处理(对照组)和临床常规处理基础上的中药联合阿司匹林治疗(治疗组)。由两位研究者分别独立检索文献、收集数据及评估偏移风险;应用RevMan 5。4。1软件完成统计分析,并进行了安全性分析及敏感分析,用漏斗图评估可能存在的发表偏倚。结果 19篇文献纳入分析,共有1 265例复发性流产病例。Meta分析结果显示:中药联合阿司匹林治疗复发性流产可以显著提高妊娠率、抗心磷脂抗体(ACA)转阴率(P<0。05),提高活化部分凝血活酶时间(APTT)、血清激素(HCG、孕酮、雌二醇)水平(P<0。05),降低纤维蛋白原(FIB)、D-二聚体(D-D)水平(P<0。05),而对凝血酶原时间(PT)、凝血酶时间(TT)的改善可能不具有明显的疗效优势(P>0。05)。结论 采用中医药联合阿司匹林治疗复发性流产,可改善孕妇高凝状态、提高孕期激素水平及ACA转阴率,从而改善患者的妊娠率。但需更进一步的作用机制研究,同样也需要纳入更多大样本、高质量的随机对照试验来加以验证。
Meta-analysis of efficacy and safety of Chinese medicine combined with aspirin in treatment of recurrent abortion
Objective:To evaluate the efficacy and safety of Chinese medicine combined with aspirin in the treatment of recurrent abortion.Methods:The randomized controlled clinical trials(RCT)about Chinese medicine combined therapy with aspirin in patients with recurrent abortion were searched from China National Knowledge Network(CNKI),Wanfang Database(WF),VIP Journal Database,China Biomedical Literature Database,PubMed,Web of science from establishment of database to March 2023.The patients in the control group received conventional treatment,and the patients in experimental group were treated with traditional Chinese medicine combined with aspirin based on clinical routine treatment.Two researchers independently searched literature,collected data and assessed the bias risk.Statistical analysis was performed using RevMan5.4.1 software.The safety analysis and sensitivity analysis were conducted,and funnel plot was used to evaluate potential publication bias.Results:Nineteen randomized controlled studies were included,with a total of 1 265 patients.Meta-analysis results showed that Chinese medicine combined with aspirin significantly improved the pregnancy rate,the negative conversion rate of anti-cardiolipin antibody(ACA)(P<0.05).It also significantly increased the levels of activated partial thromboplastin time(APTT),the levels of HCG,progesterone(P),estradiol(E2),and reduced the levels of fibrinogen(FIB)and D-dimer(D-D).However,the improvement of prothrombin time(PT)and thrombin time(TT)may not had a significant therapeutic advantage(P>0.05).Conclusions:The use of traditional Chinese medicine combined with aspirin in the treatment of recurrent abortion can improve the high coagulation of pregnancy women,increase the hormones levels and the negative conversion rate of ACA,so as to improve the pregnancy rate of patients.However,further research on the mechanism of action is needed,and larger sample,high-quality randomized controlled trials also need to be included for validation.
Traditional Chinese medicineAspirinRandomized controlled trialMeta-analysisRecurrent spontaneous abortion