通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证353例临床研究

目的 评价通络化痰胶囊治疗脑梗死恢复期(痰瘀阻络证)的安全性及有效性.方法 采用多中心随机双盲对照方法,在7个临床试验中心筛选479例受试者,随机分为对照组121例与试验组358例,分别给予血栓心脉宁胶囊和通络化痰胶囊治疗,以神经功能缺损程度评分、中风病证候评分及血脂和血液流变学检查为疗效评价指标,以一般生命体征、血、尿、便常规检查、心电图、肝功能(丙氨酸氨基转移酶)、肾功能(血尿素氮、血肌酐)为安全性评价指标.结果 472例完成了试验,其中对照组119例,试验组353例.对照组临床神经功能缺损程度综合疗效愈显率和总有效率分别为22.69％、71.43％,试验组为37.96％、84.70％,试验组优于对照组(P＜0.01)；对照组中医证候疗效愈显率和总有效率分别为30.25％、68.91％,试验组为50.99％、83.85％,试验组优于对照组(P＜0.01).治疗前后组内及治疗后组间比较,血脂及血液流变学指标差异均无统计学意义(P＞0.05).结论 通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证可以较好地减少神经功能缺损症状及改善中医证候,但对血脂及血液流变学指标无明显改善作用；该药安全性较好,无明显不良反应.

Clinical Study on Tongluo Huatan Capsule for Cerebral Infarction Patients with Syndrome of Phlegm-Stasis Obstructing the Network Vessels in the Recovery Phase

Objective To evaluate the safety and effect of Tongluo Huatan Capsule(c apsule for freeing the network vessels and transforming phlegm) for cerebral inf arction patients of phlegm-stasis obstructing the network vessels syndrome in t h e recovery phase.Methods Multi-centered,randomized,parallel controlled and do uble-blind design was carried out.The selected 479 subjects from seven clinical trial centers were randomized into control group of 121 cases and test group of 358 cases.Tongluo Hu atan Capsule and Xueshuan Xinmaining Capsule(capsule for cerebral thrombosis) w ere given to the test group and control group respectively.The indicators of ef ficacy evaluation included neurological function deficit(NFD) scores,stroke syndrome scores,blood lipid and hemorheology.The indicators of safety evaluation included norma l vital signs,routine examinations of blood,urine,stool,electrocardiogram,l iver function and renal function.Results There were 47 9 subjects enrolled,but 472 subjects finished the trial,with 119 in the control group and 353 in the te st group.Both capsules could significantly improve neurological function and re lieve Chinese medical symptoms.The comprehesive effective rate of NFD and the total effective rate were 22.69% and 71.43% respectively,in the control group,and those in the test group were 37.96% and 84.70% respectively,with significant difference between groups(P<0.01).The total effective rates of r elieving Chinese medical symptoms were 68.91% and 83.85% respectively in the con trol group and test group respectively,with significant difference between grou ps(P<0.01).There was no significant difference in blood lipid and hemorh eology between groups and in group(P>0.05).Conclusion Tongluo Huatan Capsul e could significantly improve neurological function and relieve Chinese medical symptoms for cerebral infarction patients of phlegm-stasis obstructing the netw o rk vessels syndrome in the recovery phase.However,it has not significant effec t in improving blood lipid and hemorheology.In addition,it has a good safety w ithout obvious adverse reactions.