六味祛风活络膏治疗肩关节周围炎(气滞血瘀证)的多中心双盲随机对照Ⅱ期临床试验  

A Multiple Center, Randomized, Controlled, Double-blinded Phase II Trial of Liuweiqufenghuoluo Plaster in the Treatment of Shoulder Periarthritis(Syndrome of Qi Stagnation and Blood Stasis)

作　　者：潘定举[1] 陈久毅[1] 贺祝英[1] 黄锦军[2] 陈家兴[2] 葛继荣[3] 杨连梓[3] 姚共和[4] 杨少锋[4] 吴昊峰 张燕 

机构地区：[1]贵阳中医学院第一附属医院,贵州贵阳550001 [2]广西中医学院第一附属医院,广西南宁530000 [3]福建中医药研究院,福建福州350000 [4]湖南中医药大学第一附属医院,湖南长沙410000 [5]贵州苗药药业有限公司,贵州兴义562400

出　　处：《药品评价》2014年第4期34-39,46,共7页Drug Evaluation

摘　　要：目的：对六味祛风活络膏治疗肩关节周围炎（气滞血瘀证）的安全性及临床疗效作初步评价，为III期临床试验提供依据。方法：采用多中心、随机、双盲、安慰剂平行对照临床试验方法，肩关节周围炎（气滞血瘀证）患者240例随机分为六味祛风活络膏组120例，安慰剂组120例。用法用量均为外贴患处．每次1贴，每日1次。疗程均为4周。结果：纳入患者237例，随机化237例，剔除6例，脱落5例，最终进入全分析集（FAS）分析233例，符合方案集（PPS）分析227例。疾病疗效：FAs分析显示．六味祛风活络膏组愈显率为63．48％．总有效率为90．43％；安慰剂组分别为28．81％、66．10％。六味祛风活络膏组疗效高于安慰剂组（P〈0．05）．两组愈显率之差的95％可信区间为23．96％-45．37％。中医证候疗效：FAS分析显示．六味祛风活络膏组愈显率为55．65％，总有效率为89．57％；安慰剂组分别为27．12％、61．86％。六味祛风活络膏组疗效高于安慰剂组（P〈0．05），两组愈显率之差的95％可信区间为17．96％～39．11％。FAS分析与PPS分析结果基本一致。试验过程中两组均分别发生1例轻度皮疹。结论：六味祛风活络膏治疗肩关节周围炎（气滞血瘀证）的疗效确切，试验过程中1例患者发生了轻度皮疹。Objective： To assess the effectiveness and safety of Liuweiqufenghuoluoplaster in the treatment of shoulder periarthritis （syndrome of qi stagnation and blood stasis）. Methods： The multicenter, randomized, double- blind, placebo-controlled, parallel design was adopted to observe 240 patients who were divided into treatment group （n=120, treated with Liuweiqufenghuoluo plaster） and control group （n=120, treated with placebo）. The plaster was applied on affected area, one plaster each day. The therapeutic duration for the two groups was 4 weeks. Results： Through FAS analysis, the markedly effective rate was 63.48% in the Liuweiqufenghuoluo plaster group and the effective rate was 90.43%, which was 28.81% and 66.10% in the placebo group. The effectiveness of Liuweiqufenghuoluoplaster was significantly better than that of placebo （P〈0.05）. FAS and PPS analysis have basically the same results. One adverse effect （slight erythra） was found in each group. Conclusion： Liuweiqufenghuoluo plaster showed definite effect on shoulder periarthritis （syndrome of qi stagnation and blood stasis） with slight adverse effect.

关 键 词：六味祛风活络膏 肩关节周围炎 气滞血瘀证 随机对照试验 

分 类 号：R274.3[医药卫生—中医骨伤科学]