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

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：FA S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%。FA S分析与P P S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.