加味寿胎丸联合低分子肝素钙注射液治疗多囊卵巢综合征合并复发性流产患者血栓前状态临床研究
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R711.75;R714.21

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浙江省“十三五”中医药重点专科建设项目[浙卫办〔2019〕1号];宁波市科技计划项目(2019A610358)


Clinical Study on Modified Shoutai Pills Combined with Low Molecular Weight Heparin Calcium Injection for Prethrombotic State in Patients with Polycystic Ovary Syndrome Complicated with Recurrent Spontaneous Abortion
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    摘要:

    目的:观察加味寿胎丸联合低分子肝素钙注射液治疗多囊卵巢综合征(PCOS) 合并复发性流产患者血栓前状态的临床疗效。方法:选取150 例肾虚血瘀证PCOS 合并复发性流产患者,按随机数字表法分为西药组、中药组及联合组,各50 例。西药组给予低分子肝素钙注射液,中药组给予加味寿胎丸,联合组给予低分子肝素钙注射液联合加味寿胎丸。7 d 为1 个疗程,共治疗4 个疗程。比较3 组临床疗效,比较3 组治疗前后血清β-人绒毛膜促性腺激素(β-HCG)、雌二醇(E2)、孕激素(P)、凝血-纤溶指标[血浆凝血酶原时间(PT)、凝血酶时间(TT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)、D-二聚体(D-D)、纤溶酶原激活物抑制因子-1(PAI-1)、抗凝血酶Ⅲ(AT-Ⅲ)]、子宫动脉血流参数[双侧收缩期峰值流速/舒张期流速(S/D)、搏动指数(PI)、阻力指数(RI)] 的变化。结果:治疗后(孕10-11 周),3 组β-HCG、E2、P 水平均较治疗前上升,差异均有统计学意义;治疗后(孕10-11 周),联合组β-HCG、E2、P 水平均高于西药组、中药组,差异均有统计学意义(P<0.05)。治疗后(孕10-11 周),3 组PT、TT、APTT、ATIII 指标值均较治疗前升高,D-D、FIB、PAI-1 指标值均较治疗前下降,差异均有统计学意义(P<0.05);治疗后(孕10-11 周),联合组TT、APTT、ATIII 指标值均高于西药组、中药组,D-D、FIB、PAI-1 指标值均低于西药组、中药组,差异均有统计学意义(P<0.05)。治疗后(孕10-11 周),3 组双侧子宫动脉S/D、PI、RI 指标值均较治疗前下降,差异均有统计学意义(P<0.05);治疗后(孕10-11 周),联合组双侧子宫动脉S/D、PI、RI指标值均低于西药组、中药组,差异均有统计学意义(P<0.05)。治疗后,西药组临床疗效总有效率为70%,中药组为72%,联合组为90%。联合组总有效率高于西药组及中药组,差异均有统计学意义(P<0.05)。结论:加味寿胎丸联合低分子肝素钙注射液治疗PCOS 合并复发性流产患者血栓前状态可有效改善血浆黏度,降低异常的子宫动脉血流阻力,改善子宫内膜容受性,恢复绒毛间隙血流量,保证胎儿的正常发育,提高保胎成功率。

    Abstract:

    Abstract: Objective: To observe the clinical effect of the therapy of modified Shoutai pills combined with low molecular weight heparin calcium injection on prethrombotic state in patients with polycystic ovary syndrome(PCOS) complicated with recurrent spontaneous abortion. Methods:A total of 150 PCOS patients with kidney deficiency and blood stasis syndrome and complicated with recurrent spontaneous abortion were selected and randomly divided into the western medicine group,the Chinese medicine group and the combination group, with 50 cases in each group. The western medicine group was given low molecular weight heparin calcium injection, the Chinese medicine group was given modified Shoutai pills, and the combination group was given low molecular weight heparin calcium injection combined with Shoutai pills. All groups were treated for four courses, with seven days being a course. The clinical effects in the three groups were compared. Before and after treatment, the changes of serum β- human chorionic gonadotropin(β-HCG),estradiol(E2),progesterone(P),coagulation-fibrinolysis indexes,including plasma prothrombin time(PT),thrombin time(TT),activated partial thromboplastin time(APTT),plasma fibrinogen (FIB), D- dimer(D- D), plasminogen activator inhibitor- 1(PAI- 1), and antithrombin Ⅲ (AT- Ⅲ), and uterine artery blood flow parameters, including bilateral peak systolic velocity/diastolic velocity(S/D), pulsatility index(PI) and resistance index(RI), were compared between the three groups. Results: After treatment,during the 10th to 11th weeks of pregnancy,the levels of β-HCG,E2 and P in the three groups were increased when compared with those before treatment, differences being significant; after treatment,during the 10th to 11th weeks of pregnancy,the above three levels in the combination group were higher than those in the western medicine group and the Chinese medicine group,differences being significant(P<0.05). After treatment, during the 10th to 11th weeks of pregnancy, the values of PT, TT, APTT and ATIII in the three groups were increased when compared with those before treatment,and the values of D-D,FIB and PAI- 1 were decreased,differences being significant(P<0.05);after treatment, during the 10th to 11th weeks of pregnancy,the values of TT,APTT and ATIII in the combination group were higher than those in the western medicine group and the Chinese medicine group,and the values of D-D, FIB and PAI-1 were lower,differences being significant(P<0.05). After treatment,during the 10th to 11th weeks of pregnancy, the values of S/D, PI and RI of bilateral uterine arteries in the three groups were decreased when compared with those before treatment, differences being significant(P<0.05); after treatment,during the 10th to 11th weeks of pregnancy,the above three values in the combination group were lower than those in the western medicine group and the Chinese medicine group,differences being significant(P<0.05). After treatment, the total effective rate was 70% in the western medicine group, 72% in the Chinese medicine group and 90% in the combination group. The total effective rate in the combination group was higher than that in the western medicine group and the Chinese medicine group, differences being significant(P<0.05). Conclusion:The therapy of modified Shoutai pills combined with low molecular weight heparin calcium injection for prethrombotic state in PCOS patients complicated with recurrent spontaneous abortion can effectively improve the plasma viscosity, reduce the abnormal resistance of uterine artery blood flow,improve the endometrial receptivity,restore the intervillous blood flow,ensure the normal development of the fetus,and increase the success rate of fetal protection.

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沈颖,叶利群.加味寿胎丸联合低分子肝素钙注射液治疗多囊卵巢综合征合并复发性流产患者血栓前状态临床研究[J].新中医,2022,54(13):6-11

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  • 在线发布日期: 2022-07-07
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