天丹通络胶囊治疗脑梗死恢复期风痰瘀血痹阻脉络证临床疗效观察  

Clinical Efficacy of Tiandan Tongluo Capsule Against Cerebral Infarction in Convalescence Corresponding to Stoke Due to Wind-Phlegm-Static Blood Obstructing Vessels

作　　者：金泽[1] 陈静[1] 侯鑫磊 安微 李兆贤[1] 姜珊珊[1] 魏宁 JIN Ze;CHEN Jing;HOU Xin-lei;AN Wei;LI Zhao-xian;JIANG Shan-shan;WEI Ning(Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Haerbin 150000,China)

机构地区：[1]黑龙江中医药大学附属第二医院,哈尔滨150000

出　　处：《中国实验方剂学杂志》2021年第13期58-64,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划项目(2017YFC1702700)。

摘　　要：目的:以脑栓通胶囊为对照,评价天丹通络胶囊用于脑梗死恢复期(中风中经络风痰瘀血痹阻脉络证)的安全性和有效性。方法:采用随机、双盲单模拟、阳性药、多中心临床研究,研究周期为2016年12月28日至2019年4月12日。计划纳入352例脑梗死恢复期,中医辨证属中风中经络风痰瘀血痹阻脉络证的患者,按3∶1的比例随机分为试验组与对照组。试验组给予天丹通络胶囊口服,5粒/次,3次/日;对照组同时服用脑栓通胶囊模拟剂与脑栓通胶囊,脑栓通胶囊3粒/次,3次/日,脑栓通胶囊模拟剂2粒/次,3次/d。连续服药12周,随访至发病后180 d。以日常生活活动(ADL)能力量表(Barthel指数)评分为主要疗效指标;次要疗效指标神经功能缺损评分[国立卫生研究院卒中量表(NIHSS)],改良Rankin量表(mRS),中医证候疗效,新发血管性事件患者的比例。并观察治疗过程中实验室指标变化及不良反应发生率。结果:实际入组389例患者,脱落30例,脱落率7.71%;纳入全分析数据集374例,纳入安全集分析377例。与对照组比较,试验组主要疗效指标Barthel指数评分总分,Barthel指数评分≥75分的百分率均有所升高,但差异无统计学意义;与对照组比较,试验组次要疗效指标发病后180 d mRS评分≤2分的百分率明显升高(P<0.05);中医证候疗效与对照组比较,试验组愈显率高于对照组(P<0.05);研究期间,试验组未出现新发血管事件,发生率0.00%;对照组发生1例,发生率1.09%,与对照组比较,试验组新发血管事件比例差异无统计学意义。结论:天丹通络胶囊与脑栓通胶囊治疗脑梗死恢复期(中风中经络风痰瘀血痹阻脉络证)疗效确切,与脑栓通胶囊比较,天丹通络胶囊在改善神经功能缺损、促进神经功能恢复及中医证候疗效更显著,试验期间新发血管事件比例及不良事件发生率两组差异无统计学意义,且试验组无严重不良事件发生。Objective:To evaluate the safety and effectiveness of Tiandan Tongluo capsule in the treatment of cerebral infarction(CI)in convalescence(stoke involving meridians and collaterals due to windphlegm-static blood obstructing vessels),with Naoshuantong capsule as a control.Method:A total of 352 convalescent patients with CI differentiated into stoke involving meridians and collaterals due to wind-phlegmstatic blood obstructing vessels in traditional Chinese medicine(TCM)were included in this multi-center,randomized,double-blind,single-simulated,Naoshuantong capsule-controlled clinical trial,which lasted from28 December,2016 to 12 April,2019.After being randomized into an experimental group and a control group at a ratio of 3∶1,patients in the experimental group were provided with oral Tiandan Tongluo capsule,five capsules per time,three times per day,whereas those in the control group received both Naoshuantong capsule simulator,two capsules per time,three times per day,and Naoshuantong capsule,three capsules per time,three times per day,for 12 successive weeks.The patients were followed up until 180 days after onset.The Barthel activities of daily living(ADL)index(BI)score was used as the primary outcome,and the secondary outcomes included neurological deficit score[assessed with National Institutes of Health Stroke Scale(NIHSS)],modified Rankin scale(mRS),TCM syndrome score,and proportion of patients with new vascular events.The changes in laboratory indexes and the incidence of adverse reactions during treatment were observed.Result:Among the 389 cases enrolled,30 dropped out,with the drop-out rate being 7.71%.There were 374 cases included in the full analysis set and 377 in the safety set.The comparison with the control group revealed that the total BI score and the percentage of BI score≥75 in the experimental group were increased,but the difference was not statistically significant.The percentage of mRS score≤2 within 180 days after onset in the experimental group obviously elevated in contrast to that o

关 键 词：天丹通络胶囊 脑梗死恢复期 中风中经络 风痰瘀血痹阻脉络证 脑卒中 

分 类 号：R22[医药卫生—中医基础理论] R242[医药卫生—中医学]