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目的:观察益气化瘀中药对伴有高凝状态自身免疫型复发性自然流产的疗效及安全性。方法:将64例患者随机分成2组,中药组32例口服益气化瘀中药,肝素组32例注射低分子肝素钙。比较2组患者的妊娠成功率,血清β2-糖蛋白Ⅰ(β2GP-Ⅰ)抗体和D-二聚体(D-Dime)r水平,以及出血倾向、皮疹、血小板减少等不良反应。结果:妊娠成功率中药组为87.5%,肝素组为71.0%,2组比较,差异无显著性意义(P>0.05);与治疗前比较,2组血清β2GP-Ⅰ抗体水平均有不同程度下降,差异有显著性或非常显著性意义(P<0.05,P<0.01);治疗后各时段中药组下降较肝素组更显著,差异均有显著性意义(P<0.05);治疗后2组D-Dimer均较治疗前下降,差异均有非常显著性意义(P<0.01);中药组未见不良反应发生,肝素组1例因皮疹退出。结论:益气化瘀中药治疗伴有高凝状态的自身免疫型复发性自然流产安全有效,疗效优于低分子肝素治疗。
Objective: To observe the efficacy and safety of Yiqi Huayu Herbs on spontaneous recurrent spontaneous abortion with hypercoagulation. Methods: Sixty-four patients were randomly divided into two groups. 32 cases in the traditional Chinese medicine group were given Yiqi Huayu Chinese medicine, while 32 cases in the heparin group were injected with low molecular weight heparin. The pregnancy success rate, serum β2GP-Ⅰ antibody and D-dimer level, as well as adverse reactions such as bleeding tendency, rash and thrombocytopenia were compared between the two groups. Results: The success rate of pregnancy was 87.5% in the traditional Chinese medicine group and 71.0% in the heparin group. There was no significant difference between the two groups (P> 0.05). Compared with before treatment, the level of serum β2GP-Ⅰ antibody in both groups decreased to some extent (P <0.05, P <0.01). After treatment, the decline of the Chinese medicine group was more significant than that of the heparin group (P <0.05), and the difference between the two groups after treatment was statistically significant -Dimer decreased compared with before treatment, the differences were significant (P <0.01); no adverse reactions occurred in the Chinese medicine group, and 1 patient in the heparin group was withdrawn due to a rash. Conclusion: The therapy of Yiqi Huayu is safe and effective in the treatment of autoimmune recurrent spontaneous abortion with hypercoagulable state, and its curative effect is better than that of low molecular weight heparin.