血可舒浸膏辅助治疗恶性血液病血瘀证患者22例临床观察

Clinical Observation on Xuekeshu Extract(血可舒浸膏) in Treating Malignant Hematopathy Patients with Blood Stasis Syndrome

目的评价血可舒浸膏治疗恶性血液病血瘀证的临床疗效,并从血栓形成机制方面探讨其作用途径。方法将44例恶性血液病血瘀证患者按随机数字表分为治疗组与对照组各22例。对照组予常规治疗,治疗组在对照组治疗基础上加用血可舒浸膏口服,每次5 g,每日3次。比较两组治疗前后血瘀证候积分并判断临床疗效,观察血栓事件,检测血液流变学指标、凝血功能指标及血小板、血栓弹力图、血栓相关指标[血栓调节蛋白(TM)、血浆内皮素1 (ET-1)、蛋白C (PC)、组织纤溶酶原激活物(t-PA)、组织纤溶酶原激活物抑制剂(PAI)],并观察安全性。结果治疗后治疗组中医证候疗效、中医证候总积分均明显优于对照组(P <0. 05);两组血栓发生率、缓解率、新发血栓率差异无统计学意义(P> 0. 05)。与对照组比较,治疗组治疗后血液流变学检查示全血高切黏度、全血中切黏度、红细胞聚集指数、全血还原黏度(低切)、血沉方程K值均下降(P <0. 05);血栓弹力图示凝血反应时间(R时间)延长、最大振幅(MA值)降低(P <0. 05);TM、ET-1、PC、t-PA、PAI差异无统计学意义(P> 0. 05),但与治疗前比较,ET-1降低、PC升高(P <0. 05)。两组凝血功能指标及血小板计数比较差异无统计学意义(P> 0. 05)。两组均未发生明显不良事件。结论血可舒浸膏能明显改善恶性血液病血瘀证候,对血栓栓塞的预防及治疗有一定作用,可能通过降低血液黏稠度、减少血浆内皮素,提高蛋白C含量,从血流及血管内皮多途径发挥抗血栓作用。

Objective To evaluate the clinical effects of Xuekeshu Extract(血可舒浸膏) in the treatment of malignant hematopathy with blood stasis syndrome and study on its antithrombotic pathway from the aspect of thrombosis mechanism. Methods A total of 44 patients with malignant hematopathy and blood stasis syndrome were divided into a treatment group and a control group according to random number table,with 22 cases in each group. The control group was treated with routine therapy,and the treatment group was treated with oral administration of Xuekeshu Extract on the basis of the control group,5 g per time,three times per day. The clinical efficacy was evaluated by comparing the scores of blood stasis syndrome before and after treatment. The thrombotic events were observed. The hemodynamic indexes,coagulation function indicators,thrombelastogram( TEG) and thrombosis related indexes( thrombomodulin( TM),plasma endothelin 1( ET-1),protein C( PC),tissue plasminogen activator( t-PA),tissue plasminogen activator inhibitor( PAI)) were detected,and the safety was observed. Results After treatment,in comparison of the 2 groups:( 1) the curative effect and scores of traditional Chinese medicine syndromes of the treatment group were significantly better than those of the control group( P < 0. 05).( 2) The incidence of thrombosis,remission rate and new thrombosis rate were significantly improved,but there were no statistical difference( P >0. 05).( 3) The hemodynamic indexes showed that the whole blood high and medium shear rate viscosity,the red blood cell aggregation index,the reduced viscosity( low shear rate) and the K value of the ESR equation all decreased( P < 0. 05).( 4) TEG showed coagulation reaction time( R time) was prolonged and maximum amplitude( MA) value was decreased( P < 0. 05).( 5) There was no significant difference in TM,ET-1,PC,t-PA,PAI( P > 0. 05). However,compared with those before treatment,ET-1 decreased and PC increased( P < 0. 05).( 6)There was no significant difference in coagulation term and platelet count( P > 0. 05). No obvious adverse events occurred. Conclusion Xuekeshu Extract can obviously improve the symptoms of blood stasis in malignant hematopathy,and has certain effects on the prevention and treatment of thromboembolism. Xuekeshu Extract can reduce blood viscosity,and plasma endothelin,improve protein C content. It may play a role of antithrombus through the pathway of blood flow and vascular endothelium.