Department of TCM Gynecology, Tongxiang Maternal and Child Health-Care Center, Tongxiang, Zhejiang 314500, China.
Department of Anesthesiology, Affiliated Hospital of Jiaxing University, The First Hospital of Jiaxing, Jiaxing, Zhejiang 314000, China.
Biomed Res Int. 2020 Aug 8;2020:7495161. doi: 10.1155/2020/7495161. eCollection 2020.
Shoutai Pill (STP), a famous classic herbal formula documented in traditional Chinese medicine (TCM), is widely available in China for treating unexplained recurrent spontaneous abortion (URSA). This systematic review and meta-analysis aims at evaluating the efficacy and safety of STP in the first trimester of pregnancy in women with a history of unexplained recurrent spontaneous abortion.
The following eight databases were searched from their establishment to Dec 31, 2019, for randomized controlled trials (RCTs): PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), the Chinese BioMedical database (CBM), Chinese Scientific Journal Database (VIP), and the Wanfang database. The quality of evidence was estimated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).
A total of 12 studies (916 patients) with URSA were contained in this meta-analysis. The forest plot showed that patients treated with Shoutai Pill and western medicine had a significantly lower incidence of early pregnancy loss (RR: 0.42; 95% CI: 0.34-0.52; < 0.01, = 0%). Subgroup analysis revealed that different types of TCM syndrome differentiation had the similar results. Also, in the combined group, patients had a lower TCM syndromes and symptoms and serum D-dimer level, while higher incidence of live birth.
Our findings suggest that cotreatment with STP and western medicine might be superior to western medicine alone in the first trimester of pregnancy to prevent miscarriage in women with unexplained recurrent spontaneous abortion, and there was no adverse event in the experimental group reported. However, the methodological quality of included RCTs was unsatisfactory; it is necessary to verify its effectiveness with further more standardized researches of rigorous design.
寿胎丸（STP）是一种著名的经典中药方剂，在中医中广泛应用于治疗不明原因复发性自然流产（URSA）。本系统评价和荟萃分析旨在评估寿胎丸在有不明原因复发性自然流产史的孕妇妊娠早期的疗效和安全性。
从建库到 2019 年 12 月 31 日，我们在以下 8 个数据库中搜索了随机对照试验（RCT）：PubMed、Embase、Cochrane 图书馆、Web of Science、中国国家知识基础设施（CNKI）、中国生物医学文献数据库（CBM）、中国科技期刊数据库（VIP）和万方数据库。证据质量采用推荐评估、制定和评估（GRADE）进行评估。
本荟萃分析共纳入 12 项 URSA 研究（916 例患者）。森林图显示，寿胎丸联合西药治疗组早期妊娠丢失发生率明显降低（RR：0.42；95%CI：0.34-0.52；<0.01， = 0%）。亚组分析显示，不同中医证型辨证结果相似。此外，联合组患者的中医证候和症状及血清 D-二聚体水平较低，活产率较高。
我们的研究结果表明，寿胎丸联合西药治疗可能优于西药单独治疗不明原因复发性自然流产患者的妊娠早期，实验组未报告不良事件。然而，纳入 RCT 的方法学质量并不令人满意；有必要通过进一步更规范的严谨设计研究来验证其有效性。
