补肾活血方联合低分子肝素治疗产科非典型抗磷脂综合征

Bushen Huoxue Recipe with Low Molecular Weight Heparin in Treatment of Non-criteria Obstetric Antiphospholipid Syndrome

目的:观察补肾活血方联合低分子肝素治疗产科非典型抗磷脂综合征肾虚血瘀证的临床疗效。方法:60例患者随机分为对照组和观察组,各30例。对照组给予低分子肝素,观察组给予补肾活血方+低分子肝素。两组均自妊娠用药至宫内孕12周。观察两组临床疗效、治疗前后中医证候评分、抗磷脂抗体[抗心磷脂抗体(antiphospholipid antibody,ACA)-IgA,ACA-IgG,ACA-IgM],抗β2-糖蛋白Ⅰ抗体[(anti-β2-glycoprotein-Ⅰantibody,β2GPⅠ)-IgA、β2GPⅠ-IgM)]、狼疮抗凝物(lupus anticoagulant,LA)[狼疮抗凝物归一化率(TR),狼疮抗凝物筛选比率(dRWTS),狼疮抗凝物确证比率(dRWTC)]、血栓弹力图[凝血因子(blood coagulation factor,R),血小板功能(platelet function,MA)]以及随访妊娠期间不良反应发生率。结果:观察组有效率为93.33%(28/30),高于对照组的73.33%(22/30)(χ^(2)=4.32,P=0.038)。与对照组治疗后比较,观察组中医证候评分、抗磷脂抗体(ACA-IgA、ACA-IgG、β2GPⅠ-gA、β2GPⅠ-IgM、TR、dRVVTS)明显降低(P<0.05),血栓弹力图明显升高(P<0.05)。研究期间观察组不良反应发生率为6.7%(2/30),对照组为6.7%(2/30),两组比较,差异无统计学意义(P>0.05)。结论:补肾活血方联合低分子肝素可明显提高产科非典型抗磷脂综合征肾虚血瘀证患者的临床疗效,降低中医证候评分、抗磷脂抗体水平,改善高凝状态。

Objective:To observe the clinical effect of Bushen Huoxue Recipe with low molecular weight heparin(LMWH)in treating Kidney deficiency and Blood stasis of non-criteria obstetric antiphospholipid antibody syndrome(APS).Methods:70 patients were randomized into the control group and observation group,with 35 cases in each group.The patients in the control group were given LMWH,and those in the observation group received the Bushen Huoxue recipe and LMWH.Both groups were prescribed medication from pregnancy to 12 weeks of intrauterine pregnancy.The clinical effect,TCM symptoms before and after treatment,antiphospholipid antibody(ACA-IgA,ACA-IgG,ACA-IgM),anti-β2-glycoprotein-1 Antibody(β2 GPⅠAb-IgA,β2 GPⅠAb-IgM),lupus anticoagulant(LA)(TR,dRWTS,dRWTC),thrombelastogram(TEG)(R,MA)were observed.And the incidence of adverse reactions during pregnancy was followed up.Results:5 cases lost to follow-up in each of the groups.The total effective rate of the observation group was 93.33%(28/30),higher than that in the control group 73.33%(22/30)(χ^(2)=4.32,P=0.038).The TCM symptom scores and levels of anti-phospholipid antibody(ACA-IgA,ACA-IgG,β2 GPⅠ-IgA,β2 GPⅠ-IgM,TR,dRVVTS)in the observation group were significantly lower than those of the control group(P<0.05),and R-value according to the thrombelastogram was significantly elevated(P<0.05).The incidence of adverse reactions was 6.7%(2/30)in the observation group and 6.7%(2/30)in the control group,whichout statistically significant difference(P>0.05).Conclusion:Bushen Huoxue Recipe combined with LMWH can significantly improve the clinical efficacy of Kidney deficiency and Blood stasis from APS,reduce TCM syndrome scores and antiphospholipid antibody levels,and improve the hypercoagulable stata.