益气活血方联合肝素钠注射液治疗急性下肢深静脉血栓临床观察

Clinical efficacy of Yiqi Huoxue Formula with heparin sodium injection for acute deep venous thrombosis of lower extremities

目的观察益气活血方联合肝素钠注射液治疗急性下肢深静脉血栓的临床疗效。方法将70例急性下肢深静脉血栓气虚血瘀证患者随机分为治疗组35例、治疗组35例,剔除脱落病例后,对照组33例、治疗组33例。对照组给予肝素钠注射液治疗,治疗组在对照组治疗的基础上加用益气活血方治疗。观察临床疗效,皮肤温度、皮肤色泽、疼痛、患肢肿胀、Homans征、超声改变等患肢疗效指标量化评分,D-二聚体(D-D)、纤维蛋白原(FIB)和抗凝血酶Ⅲ(AT-Ⅲ)等凝血指标,超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6)、肿瘤坏死因子-a(TNF-α)等炎性指标,并进行安全性评估。结果治疗组33例中痊愈10例,显效11例,有效10例,无效2例,总有效率为93.94%;对照组33例中,痊愈7例,显效7例,有效9例,无效10例,总有效率为69.70%。经秩和检验,Z=-2.150,P=0.032,P<0.05,说明治疗组临床疗效优于对照组。2组治疗后皮肤温度、皮肤色泽、疼痛、患肢肿胀、Homans征、超声改变评分较本组治疗前均降低(P<0.05)。治疗后皮肤温度、皮肤色泽、疼痛、患肢肿胀、Homans征、超声改变评分治疗组较对照组均降低明显(P<0.05),治疗组优于对照组。2组治疗后D-D、FIB较本组治疗前均降低,AT-Ⅲ较本组治疗前升高,差异均有统计学意义(P<0.05)。治疗后D-D、FIB治疗组较对照组降低明显,AT-Ⅲ治疗组较对照组升高明显,差异均有统计学意义(P<0.05),治疗组优于对照组。2组治疗后hs-CRP、IL-6、TNF-α较本组治疗前均降低(P<0.05)。治疗后hs-CRP、IL-6、TNF-α治疗组均较对照组降低明显(P<0.05),治疗组优于对照组。结论益气活血方联合肝素钠注射液治疗急性下肢深静脉血栓具有较好的临床疗效。

Objective To observe the clinical efficacy of Yiqi Huoxue Formula combined with heparin sodium injection in the treatment of the acute deep venous thrombosis in the lower limbs.Methods Seventy patients with acute lower extremity deep venous thrombosis and with the Qi deficiency and blood stasis pattern were randomly assigned to the control group(n=35)and treatment group(n=35).After the drops-out and withdrawals excluded,there were 33 cases in the control group and 33 cases in the treatment group.The control group was treated with heparin sodium injection,and the treatment group received additional Yiqi Huoxue Formula on the basis of the treatment of the control group.Clinical efficacy,skin temperature,skin color,pain,swelling of affected limbs,Homans sign,ultrasonic changes and other quantitative scores of affected limbs,coagulation indexes such as D-Dimer(D-D),fibrinogen(FIB)and antithrombinⅢ(AT-Ⅲ),high-sensitivity C-reactive protein(hs-CRP),interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)and other inflammatory indexes were observed,and the safety was assessed.Results In the treatment group,10 cases were cured,11 cases were markedly effective,10 cases were effective and 2 cases were ineffective.The total effective rate was 93.94%;In the control group,7 cases were cured,7 cases were markedly effective,9 cases were effective and 10 cases were ineffective.The total effective rate was 69.70%.Nonparametric test showed that the clinical effect was better in the treatment group than in the control group(Z=-2.150,P=0.032,P<0.05).After treatment,the skin temperature,skin color,pain,swelling of affected limbs,Homans sign and ultrasonic change scores in the two groups were lower than those before treatment(P<0.05).After treatment,the skin temperature,skin color,pain,swelling of affected limbs,Homans sign and ultrasonic change scores in the treatment group were significantly lower than those in the control group(P<0.05).After treatment,D-D and FIB in the two groups were lower than those before treatment,and AT-Ⅲwas higher than those before treatment(P<0.05).After treatment,D-D and FIB were significantly lower in the treatment group than in the control group,and AT-Ⅲwas significantly higher in the treatment group than in the control group(P<0.05),better in the treatment group than in the control group.After treatment,the hs-CRP,IL-6,TNF-αin the two groups were lower than those before treatment(P<0.05).After treatment,hs-CRP,IL-6,TNF-αwere significantly lower in the treatment group than in the control group(P<0.05),better in the treatment group than in the control group.Conclusions Yiqi Huoxue Formula combined with heparin sodium injection has a good clinical effect in the treatment of acute deep venous thrombosis of the lower extremities.