Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (4): 361-365.
DOI: 10.19803/j.1672-8629.20240057

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Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence

YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi*, FENG Xin#   

  1. Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing 100026, China
  • Received:2024-01-25 Online:2024-04-15 Published:2024-04-18

Abstract: Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion (RSA) with Chinese patent medicines, so as to provide reference evidence for the rational use of medicines in the clinic, and a basis for the decision-making in the clinical practice and healthcare. Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA. Relevant software was used to manage the literature, extract the basic information of the drugs and studies, and carry out visual comparative analyses in the form of textual descriptions and charts. Results A total of 95 research articles on Chinese patent medicines were screened out, including 2 systematic reviews and 93 clinical studies. 11 types of Chinese patent medicines were involved, including 1 Chinese medicine injection. The drugs with a higher number of clinical studies were Zishenyutai pills, Gushenantai pills, and Baotailing preparation. Since 2005, the number of related studies has been on an overall elevated trend, and has been carried out in 24 regions of China, the largest number of studies with sample sizes of 51~100 cases included 67 (72.04%); the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines, with a total number of studies amounted to 75 (80.65%). At present, there is no uniform clinical treatment protocol and efficacy judgement standard, and some studies (43.01%) recorded the occurrence of adverse reactions during drug administration in patients. Conclusion Chinese patent medicines have good suitability for the treatment of RSA, and their effectiveness in combination with western medicines is clear. However, there are problems such as lack of content in the drug instruction, timing and duration of medication and outcome evaluation indexes are not standardised, insufficient attention to medication safety, insufficient embodiment of Chinese medicine characteristics , which needs to be improved in the future.

Key words: recurrent spontaneous abortion, habitual abortion, Zishenyutai pills, Gushenantai pills, Baotailing preparation, Chinese patent medicine, rational use of drugs

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