血塞通软胶囊治疗高粘血症临床研究

A Plot Double-blind Randomized Aspirin-controlled Study of Xuesaitong Soft Capsule in Patients Suffering from Hyperviscosity Blood Syndrome

目的与肠溶阿司匹林作对照,观察血塞通软胶囊治疗高粘血症的有效性和安全性。方法120例高粘血症患者,依据随机双盲双模拟的原则随机分为血塞通组和肠溶阿司匹林组各60例,治疗28d后进行中医证候疗效评定,并观察治疗前后血液流变学、内皮素、前列环素、血栓素及血脂变化。结果两组全血粘度(高切、低切)、红细胞聚集率、血小板聚集率、血小板粘附率治疗前后有显著性差异(P<0.01,P<0.05),而血浆粘度、红细胞压积、红细胞变形指数治疗前后无显著性差异。两组治疗后血液流变学各项指标无显著性差异。两组内皮素、前列环素、血栓素治疗后均有显著性差异。两组血脂变化均无显著性差异。改善中医证候方面亦明显优于阿司匹林(P<0.05)。结论血塞通能显著抑制血小板粘附和聚集、抗血栓形成、降低血粘度、改善微循环等,疗效明显优于阿司匹林组。

Objective To observe the safety and teffect of Xuesaitong soft capsule （XST） contrast to Aspirin, on endothelial function, adhesion, aggregation and activation of platelet of Hyperviscosity Blood Syndrome （HBS）, so as to comprehensively analysis the mechanism of XST. Methods 120 HBS patients were randomly divided into 2 groups. ）（ST group （60 patients） was treated with XST, and the Aspirin group （60 patients） was given Aspirin. The course of treatment for both groups was 28 days. The changes of effective rate, score of HBS and the traditional Chinese syndrome, bloodrheology, endothelin （ET）, PGI2 and TXB2, and blood-lipid were all observed. Results The total effective rate of traditional Chinese syndrome of XST group was 86.66%, that of Aspirin group was 56,66%, there was significant difference between the two groups （P〈0.05）. After the therapy, the total blood-viscosity, aggregation rate of red cell （AGREE）, platelet adhesion rate （PADT）, platelet aggregation rate （PAGT）, fibrinogen, ET and TXA2 of both groups were obviously decreased （P〈0.01, P〈0.05）, while PGI2 was increased obviously, there was insignificant difference between the 2 groups after treatment （P〉0,05）. Plasma viscosity, hematocrit and red cell distortion index （EI） had no significantly change {P〉0.05）, The blood-lipid of the both groups were only insignificantly difference （P〉0.05）. Conclusion XST could be safety and effective to HBS, the mechanism of which is obviously decreasing platelet face activation, inhibiting platelet adhesion and aggregation, decreasing blood viscosity, improving mierocirculation and inhibiting thrombosis. XST is much better than Aspirin in improving traditional Chinese syndrom.