孕康颗粒联合阿司匹林和低分子肝素钠治疗复发性流产的临床研究

Clinical study on Yunkang Granules combined with aspirin and low molecular weight heparin sodium in treatment of recurrent abortion

目的探讨孕康颗粒联合阿司匹林及低分子肝素钠治疗复发性流产的临床疗效。方法选取2019年1月—2020年6月于河南省生殖妇产医院就诊的108例复发性流产患者为研究对象,随机分为对照组和治疗组,每组各54例。对照组口服阿司匹林肠溶片,100 mg/次,1次/d,同时皮下注射低分子肝素钠注射液,3200 IU/次,1次/d。治疗组在对照组基础上口服孕康颗粒,1袋/次,3次/d。两组患者均连续治疗10周。观察两组患者临床疗效,比较治疗前后两组患者激素雌二醇(E_(2))、孕酮(P)和人绒毛膜促性腺激素(HCG)水平,凝血-纤溶系统指标凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)、血清纤溶酶原激活抑制剂1(PAI-1)水平和组织型纤溶酶原激活剂(t-PA),细胞因子白细胞介素-17(IL-17)、白细胞介素-23(IL-23)、转化生长因子-β(TGF-β)和白细胞介素-10(IL-10)水平。结果治疗后,与对照组相比,治疗组临床有效率显著升高,差异具有统计学意义(P<0.05)。治疗后,两组E_(2)、P及HCG、PT、APTT及TGF-β和IL-10水平均显著升高(P<0.05),而IL-17、PAI-1和IL-23水平显著降低(P<0.05),且治疗组这些指标水平明显好于对照组(P<0.05)。结论孕康颗粒联合阿司匹林及低分子肝素钠治疗复发性流产的临床疗效显著且安全性高,其中机制可能与改善复发性流产患者的激素水平、凝血-纤溶系统及调节Th17/Treg细胞失衡有关。

Objective To investigate the clinical efficacy of Yunkang Granules combined with aspirin and low molecular weight heparin sodium in treatment of recurrent abortion.Methods Patients(108 cases)with recurrent abortion in Henan Obstetrics and Gynecology Hospital from January 2019 to June 2021 were randomly divided into control and treatment group,and each had 54 cases.Patients in the control group were po administered with Aspirin Enteric-coated Tablets,100 mg/time,once daily,and they were subcutaneous injected with Low Molecular Weight Heparin Sodium Injection,3200 IU/time,once daily.Patients in the treatment group were po administered with Yunkang Granules on the basis of the control group,1 bag/time,three times daily.Patients in two groups were treated for 10 weeks.After treatment,the clinical evaluation was evaluated,the levels of hormone E_(2),P,and HCG,the levels of coagulation-fibrinolysis system indexes PT,APTT and PAI-1,the levels of serum IL-17,IL-23,TGF-αand IL-10 in two groups before and after treatment were compared.Results After treatment,the clinical effective rate of the treatment group was significantly higher than that of the control group,and the difference was statistically significant(P<0.05).After treatment,the levels of E_(2),P,HCG,PT,APTT,TGF-βand IL-10 in two groups were significantly increased,while the levels of IL-17 and IL-23 were significantly decreased in the treatment group(P<0.05),and the level of these indexes in the treatment group was significantly better than that in the control group(P<0.05).Conclusion Yunkang Granules combined with aspirin and low molecular weight heparin sodium had a significant clinical efficacy and high safety in treatment of recurrent abortion.The therapeutic mechanism may be related to improve the hormone levels,coagulation-fibrinolysis system and regulate the imbalance of Th17/Treg cells in patients with recurrent abortion.