真实世界中通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证的疗效与安全性评价  

Evaluation of Efficacy and Safety of Tongluo Huatan Capsules(通络化痰胶囊) in the Treatment of Cerebral Infarction Recovery Phase with Phlegm-Stasis Obstructing Collaterals Syndrome: a Real World Study

作　　者：张丹丹[1] 富苏[2] 马雪颜 林景峰 王一浩[1] 刘甘露 常泽 王育纯 范吉平 韩振蕴 ZHANG Dandan;FU Su;MA Xueyan;LIN Jingfeng';WANG Yihao;LIU Ganlu;CHANG Ze;WANGYuchun;FAN Jiping;HAN Zhenyu(Beijing University of Chinese Medicine,Beijing,100029;Eye Hospital,China Academy of Chinese Medical Sciences;China Press of Traditional Chinese Medicine;Dongfang Hospital,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学,北京市朝阳区100029 [2]中国中医科学院眼科医院 [3]中国中医药出版社 [4]北京中医药大学东方医院

出　　处：《中医杂志》2020年第1期42-47,共6页Journal of Traditional Chinese Medicine

摘　　要：目的基于真实世界数据评价通络化痰胶囊治疗脑梗死恢复期痰瘀阻络证的有效性和安全性。方法本研究为多中心、前瞻性、单臂、真实世界IV期临床研究,纳入34家医院符合西医脑梗死恢复期及中医中风病中经络痰瘀阻络证诊断标准的病例,予通络化痰胶囊每日3次、每次30mg口服,共治疗4周。以美国国立卫生研究院卒中量表(NIHSS)评定神经功能缺损,中医证候评分及改良Rankin评分量表为疗效评价指标;以血常规、肝功能、肾功能为安全性评价指标。结果共纳入受试者2169例,治疗后NIHSS综合疗效、中医证候疗效总有效率分别为84.09%、81.01%;改良Rankin评分治疗前平均(2.19±0.86)分,治疗后平均(1.55±0.85)分,差异具有统计学意义(P<0.01);治疗过程中发生轻度不良反应13例。结论通络化痰胶囊在脑梗死恢复期痰瘀阻络证的治疗中单用或联用其他西医基础治疗对于改善患者神经功能缺损程度、减轻残障及症状均有较好的疗效及安全性。Objective Based on the real world data,to elevate the efficacy and safety of Tongluo Huatan Capsules(通络化痰胶囊)in the treatment of cerebral infarction patients of phlegm-stasis obstructing collaterals syndrome in the recovery phase.Methods This was a phase IV,multicenter,prospective,one-armed,real world study.Cases met the western medicine diagnostic criteria of atherosclerotic thrombotic cerebral infarction in the recovery phase and Chinese medicine diagnostic criteria of stroke in the meridians(phlegm-stasis obstructing collaterals syndromes)in 34 hospitals were included.All of the patients were given Tongluo Huatan Capsules for 4 weeks,3 times per day,30 mg each time for oral administration.Neurological function deficit was assessed with National Institute of Health Stroke Scale(NIHSS),traditional Chinese medicine(TCM)syndrome scores and modified Rankin scores were used as efficacy evaluation indicators;blood routine,liver and kidney function were used as safety evaluation in・dicators.Results A total of 2169 cases were included.After treatment,the total effective rate of NIHSS and TCM syndrome scores was 84.09%and 81.01%,respectively.The modified Rankin score was 2.19±0.86 before treatment and 1.55±0.85 after treatment,and the difference was statistically significant(P<0.01).Thirteen cases showed mild adverse events.Conclusion Tongluo Huatan Capsules is effective and safe for improving the degree of neurological deficit,reducing disability and TCM symptoms in the treatment of cerebral infarction in the recovery phase,no matter using it alone or together with other basic treatment.

关 键 词：脑梗死 中风 中经络 通络化痰胶囊 痰瘀阻络证 真实世界研究 

分 类 号：R277.7[医药卫生—中医学]