Abstract:Objective To investigate the expression of miR-423-5p in peripheral blood of recurrent spontaneous abortion (RSA) patients with positive antiphospholipid antibodies and the therapeutic efficacy of Bushen Huoxue Formula in these patients.Methods A total of 92 RSA patients with positive antiphospholipid antibodies admitted to Huaihe Hospital of Henan University from May 2017 to December 2019 were selected and divided into control group and study group, with 46 cases in each group. The control group was given conventional Western medicine treatment, and the study group was additionally given Bushen Huoxue Formula. Both groups were treated for 8 weeks, and followed up for 2 years since the initiation of the treatment. The changes of TCM syndrome scores, angiogenesis factors and decidualization markers before and after the treatment were compared between the two groups. Changes in the expression of miR-423-5p and coagulation before and after the treatment in both groups were analyzed. Drug safety was recorded during the treatment in both groups. Pregnancy and delivery in the two groups were recorded during the follow-up.Results The differences in TCM main and secondary syndrome scores before and after the treatment in the study group were greater than those in the control group (P < 0.05). The differences in the levels of transforming growth factor β1 (TGF-β1), vascular endothelial growth factor (VEGF), insulin-like growth factor binding protein 1 (IGFBP-1), miR-423-5p, and D-dimer (DD) as well as prothrombin time (PT), activated partial thromboplastin time (APTT) and thrombin time (TT) before and after the treatment in the study group were also higher than those in the control group (P < 0.05). There was no significant difference in the overall incidence of adverse reactions between the two groups (P > 0.05). The pregnancy rate was not different between the two groups (P > 0.05), whereas the rate of successful delivery in the study group was higher than that in the control group (P < 0.05).Conclusions Bushen Huoxue Formula may alleviate the condition of antiphospholipid antibodies-positive RSA patients, improve angiogenesis factors, decidualization markers and coagulation, and inhibit the expression of miR-423-5p. Besides, it increases the live birth rate with few safety concerns.