镇眩通络胶囊治疗后循环缺血120例：一项随机双盲安慰剂对照临床观察  

Zhenxuantongluo capsule for treatment of 120 patients with posterior circulatory ischemia： a randomized, double-blinded, placebo-controlled clinical study

作　　者：王凌 李玲 王静怡 李静 张选国 陈伟铭 Wang Ling;Li Ling;Wang Jingyi;Li Jing;Zhang Xuanguo;Chen Weiming(Department of Geriatrics,Shaanxi Provincial Hospital of Traditional Chinese Medicine,Xi＇ an 710003,Shaanxi,China)

机构地区：[1]陕西省中医医院老年病科,陕西西安710003

出　　处：《中国中西医结合急救杂志》2018年第4期403-407,共5页Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care

基　　金：国家级名中医工作室建设项目（2016-279）;国家发明专利（ZL200610043035.9）

摘　　要：目的观察镇眩通络胶囊治疗后循环缺血（PCI）的临床疗效及安全性。方法选择2013年7月至2016年3月陕西省中医医院老年病科门诊及住院的PCI患者。入选条件：年龄40-75岁，性别不限；具有西医体征、中医证候、视频眼震电图（VEG）、头颅磁共振弥散加权成像（DWI）、至少1种血管病史或危险因素。将同意参与本研究的人选患者分为治疗组（口服镇眩通络胶囊，每粒0．33g，每次5粒，每日3次，连用14d）和对照组，两组基础用药相同。治疗14d时，根据西医体征、中医证候和VEG进行疗效判定，采用全分析集（FAS）、符合方案集（PPS）、安全数据集（ss）方法分析数据，并记录不良事件发生情况。结果实际人组120例PCI患者，治疗组80例，对照组40例。治疗组除年龄、心率低于对照组外，两组病例来源、性别、身高、体质量、药物过敏史、人院时合并症及用药情况、针对本次PCI的治疗药物、体温、呼吸、血压、西医体征量表总积分及单项评分、病灶类型、中医证候量表总积分及单项评分、VEG总积分及单项评分比较差异均无统计学意义。用PPS方法分析数据（治疗组75例，安慰剂对照组31例）显示，与对照组比较，治疗组临床疗效愈显率和总有效率明显升高（57．3％比16．1％，82．7％比41．9％，均P〈0．01），中医证候愈显率和总有效率明显升高（41．3％比6．5％，88．0％比25．8％，均P〈0．01），VEG痊愈率、愈显率和总有效率均明显升高（24．0％比3．2％，33．3％比6．5％，88．0％比32．3％，均JP〈0．01）。对于不同类型病灶（陈旧性病灶、DWI正常）的患者，镇眩通络胶囊具有同样的疗效。试验期间，治疗组不良事件发生率与对照组一致[2．5％（2／80）比2．5％（1／40）]，均因感冒而停止用药；两组均无不良反应及严重不良事件发生。结论镇眩通络�Objective To observe the efficacy and safety of Zhenxuantongluo capsule in the treatment of posterior circulation ischemia （PCI）. Methods PCI out- and in-patients admitted to the Department of Geriatrics of Shaanxi Provincial Hospital of Traditional Chinese Medicine（TCM） from July 2013 to March 2016 were enrolled. Recruitment criteria： age 40 - 75 years old, no gender restriction, patients with western medicine physical symptoms and signs scale, TCM syndrome scale, video-nystagmography （VEG）, diffusion-weighted imaging （DWI） of skull, at least one kind of vascular disease history or risk factor. The patients who had agreed to enter this study were divided into a treatment group （Zhenxuantongluo capsule, 5 capsules each time, 3 times a day for consecutive 14 days） and a placebo control group, and the basic medicine in two groups was the same. After treatment, on the 14th day, according to western medicine physical symptoms and signs scale, TCM syndromes scale and VEG findings, the curative effect was judged, the full analysis set （FAS）, per protocol set （PPS） and security data set （SS） methods were applied to analyze the data and the incidence of adverse events was recorded. Results There were actually 80 patients in the treatment group and 40 patients in the control group. Except in the treatment group, the age and heart rate were lower than those in the control group, there were no statistical significant differences between the two groups in patients＇ resources, sex, body height and weight, history of drug allergy, complication and medication on admission, drug treatment directing at this time PCI, the body temperature, respiration, blood pressure, the total score of western medical signs scale and the score of single item, the type of lesion focus, the total score of the TCM syndromes scale and single item score, VEG total score and single item score. When per protocol set （PPS） method was used to analyze the data, it was shown that there were 75 cases in treatment group

关 键 词：镇眩通络胶囊 后循环缺血 西医体征 中医证候 视频眼震电图 

分 类 号：R277.772[医药卫生—中医学]