OBJECTIVE: To investigate the clinical efficacy of a randomized controlled study of the application of Chinese herbal medicine to Bushen Huoxue method with supplemented Shoutai pill in combination with low-molecular heparin and low-dose aspirin for pregnancy loss associated with Obstetric Antiphospholipid syndrome with Shenxu Xueyu type,to provide more therapeutic options and a basis for clinical use in the diagnosis and treatment of this disease.METHODS: Patients with early pregnancy who met the diagnostic criteria of Obstetric antiphospholipid syndrome and were also identified as Shenxu Xueyu type in Chinese medicine were collected from June 2021 to December 2022 at the gynecology outpatient and inpatient departments of the Affiliated Hospital of Jiangxi University of TCM,and those who met the inclusion criteria were divided into 2 groups according to the principle of randomized control,with a total of 60 cases collected and58 cases finally included.In the control group,28 cases were treated with subcutaneous injection of calcium low molecular heparin combined with oral administration of small dose aspirin;in the observation group,30 cases were treated with oral administration of supplemented Shoutai Pill of traditional Chinese medicine soup combined with small dose aspirin and low molecular heparin;the medication was started from the confirmation of intrauterine pregnancy,and a course of treatment was given for 14 days with luteal support therapy and necessary symptomatic treatment.Observation indexes: levels of antibodies related to phospholipid syndrome,platelet aggregation rate,D-dimer,uterine artery resistance and TCM evidence score before and after treatment in the two groups.Each observation index was recorded at three nodes before treatment,8 weeks of gestation and 12 weeks of gestation in the two groups.We analyzed the success rate of early pregnancy,negative rate of antibodies related to phospholipid syndrome,changes in coagulation function,changes in uterine artery resistance and changes in TCM symptoms scores in the two groups,and discussed the therapeutic effects and advantages of the application of TCM in the treatment of obstetric antiphospholipid syndrome in early pregnancy,so as to provide more optional and feasible treatment options for the clinical treatment of obstetric antiphospholipid syndrome,and thus better improve patients’ early pregnancyResults:1.There were no statistical differences in age,number of adverse pregnancies,D-dimer,platelet aggregation rate,uterine artery resistance and TCM evidence score before treatment between the two groups(P>0.05).2.The early pregnancy success rate after treatment was lower in the control group(67.85%)than in the observation group(90%),which was statistically significant(P<0.05);the conversion rate of antibodies related to phospholipid syndrome was lower in the control group(28.57%)than in the observation group(40%),which was not statistically significant(P>0.05).3.At 8 weeks of gestation,platelet aggregation rate and uterine artery resistance were significantly lower in the observation group compared with the control group,which was statistically significant(P<0.001),and the mean level of D-dimer in the observation group was lower than that in the control group,which was not statistically significant(P>0.05);at 12 weeks of gestation,compared with that before treatment,D-dimer,platelet aggregation rate and uterine artery resistance in the observation group were lower than those in the control group,which was statistically significance(P<0.05).4.After treatment,the TCM symptom scores of both groups decreased compared with those before treatment,and the observation group decreased significantly compared with the control group,and the symptoms improved significantly,and the difference was statistically significant(P<0.001).5.the total effective rate after treatment was 67.85% in the control group and 90% in the observation group,and the difference between the two groups was statistically significant(P<0.05).Conclusion:1.Bushen Huoxue method combined with anticoagulation therapy effectively improves coagulation function,reduces antibody titers,improves uterine microcirculation and reduces the incidence of miscarriage in Shenxu xueyu type OAPS in early pregnancy.2.The method of Bushen Huoxue can significantly alleviate the symptoms of small abdominal cramps,waist and knee soreness in patients with Shenxu xueyu type of early pregnancy,as well as alleviate the impact of patients’ anxiety and other adverse emotions due to the condition on pregnancy outcome.3.The combination of Bushen Huoxue method with anticoagulation therapy can significantly improve the symptoms and signs of early pregnancy in patients with Shenxu xueyu type of OAPS,with obvious efficacy,which can increase the success rate of early pregnancy,reduce the occurrence of side effects and optimize the overall treatment effect. |