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目的:评价罗氏滋肾育胎丸联合西药治疗先兆流产的疗效和安全性。方法:计算机检索Pubmed、Embase、Cochrane library、中国生物医学文摘数据库(CBM)、中国期刊全文数据库(CNKI)、维普数据库(VIP)和万方数据库中关于罗氏滋肾育胎丸联合西药治疗先兆流产的随机对照试验(Randomized Clinical Trials,RCT),数据库建立至2015年12月2日,纳入研究的质量评价和资料提取由两名研究者独立严格进行,采用Rev Man 5.3软件进行Meta分析。结果:最终纳入10项RCT,共1047例患者,Meta分析结果显示:滋肾育胎丸联合西药治疗先兆流产在总有效率、治疗后孕酮水平、治疗后症状消失时间、治疗后腹痛消失例数、不良反应等方面具有统计学意义(P<0.05),在治疗后阴道流血消失例数方面不具有统计学意义(P=0.05)。结论:滋肾育胎丸联合西药治疗先兆流产具有一定疗效,滋肾育胎丸临床使用易引发不良反应,临床无需特殊处理。
Objective: To evaluate the curative effect and safety of Roche’s Zishen Yu fetal pill combined with Western medicine in the treatment of threatened abortion. Methods: The clinical data of Pubmed, Embase, Cochrane library, CBM, CNKI, VIP database and Wanfang database were collected and analyzed for the treatment of threatened abortion Randomized Clinical Trials (RCTs). The database was established as of December 2, 2015. The quality evaluation and data extraction of the included studies were independently and rigorously performed by two investigators and Meta-analysis was performed using Rev Man 5.3 software. Results: 10 RCTs were enrolled in the study. A total of 1047 patients were enrolled in the study. The results of Meta analysis showed that the total effective rate, the progesterone level after treatment, the disappearance time after treatment, the disappearance of abdominal pain after treatment (P <0.05), and no statistical significance in the number of vaginal bleeding disappeared after treatment (P = 0.05). Conclusion: Zishenyicheng pills combined with Western medicine treatment of threatened abortion have a certain effect, Ziyin Yuk fetal pills easily lead to adverse clinical reactions, clinical treatment without special treatment.