葛酮通络胶囊治疗脑梗死恢复期瘀血痹阻脉络证的Ⅱ期临床研究

摘要

目的 评价葛酮通络胶囊治疗脑梗死恢复期瘀血痹阻脉络证的安全性及有效性.方 法随机、双盲双模拟、阳性平行对照、多中心研究方法进行葛酮通络胶囊的Ⅱ期临床试验.受试者共210例,A组104例给予葛酮通络胶囊500 mg+安慰剂,2次/d;B组106例给予血塞通片100 mg+安慰剂,2次/d.治疗28 d后,观察并评价其临床疗效和安全性 结果 A组和B组中风病总有效率分别为88％和77％,组间比较有显著性差异(P =0.018)A组和B组中医证候总有效率分别为84％和74％,组间比较无显著性差异(P＞0.05).治疗前2组中风病痛类量化评分比较无显著性差异(P＞0.05),治疗中与治疗后组间比较有显著性差异(P =0.045,P=0.001).2组均能改善全血黏度(低切)、纤维蛋白原、血小板聚集率等指标(P＜0.01或0.05),同时A组对血浆黏度有明显改善作用(P=0.008).2组都没有出现不良事件.结论 葛酮通络胶囊治疗脑梗死恢复期瘀血痹阻脉络证安全有效.%Objective It is to observe the effect and safety of Getong Tongluo Capsule in treatment of cerebral infarction patients with blood stasis blockage context.Methods Phase Ⅱ clinical trial randomized,double-blind,positive parallel control,multicenter study method was executed for Getong Tongluo Capsule.The total 210 cases were divided into Group A (104 cases) and Group B (106 cases),then were given Getong Tongluo Capsule 500mg plus placebo twice a day in Group A and was given Xuesaitong tablets 100mg plus placebo twice a day in Group B.28 days after treatment,the clinical effect and safety were observed and evaluated.Results The clinical total effective rate were 88％ in Group A and 77％ in Group B,there were significant difference between both groups (P =0.018).The total effective rate of TCM syndromes were 84％ in Group A and 74％ in Group B,there was no significance difference between two groups (P ＞ 0.05).There was no significant difference in stroke disease score before treatment between two groups (P ＞ 0.05),and were significant differences in treatment and after treatment (P =0.045,P =0.001).The indexes of blood viscosity (low shear),fibrinogen,platelet aggregation rate were improved in both groups (P ＜0.01 or 0.05),and the improvement effect was markedly in plasma viscosity of Group A (P =0.008).There were no adverse events and adverse reaction in both groups.Conclusion Getong Tongluo Capsule is safe and effective in treatment of cerebral infarction period patients with blood stasis blockage context.