卿仙止痛膏治疗腰肌劳损的Ⅲ期临床疗效观察

PhaseⅢ Clinical Trial of Qingxian Zhitong Plaster in Treating Strain of Lumbar Muscles

目的:评价卿仙止痛膏治疗腰肌劳损(风湿痹阻兼瘀血阻络)临床症状的有效性及安全性。方法:采用随机、双盲、安慰剂平行对照的方法将64例腰肌劳损患者随机分为卿仙止痛膏治疗组(治疗组)和安慰剂对照组(对照组),将膏药贴于患处,24h换药1次,每次2贴,7d后观察患者治疗前后的临床症状、体征的变化,检测安全性指标:生命体征、血尿便常规、肝肾功能、心电图、不良反应。结果:治疗组总有效率为76.60%,对照组总有效率37.5%,治疗组疗效明显优于对照组(P<0.05);并且治疗组治疗后的疼痛、重着积分较对照组治疗后明显下降(P<0.001),而治疗后腰膝酸软、转侧不利积分较对照组治疗后也明显下降(P<0.05)。结论:卿仙止痛膏治疗腰肌劳损疗效确切、安全。

Objective：To evaluate the effectiveness and safety of Qingxian Zhitong Plaster in treating strain of lumbar mus cles （syndrome of wind-damp and blood stasis）. Methods：A randomized, double-blinded, placebo-controlled design was used. Sixty-four patients with strain of lumbar muscles were randomly divided into the treatment group （treated with Qingxian Zhitong Plaster） and the control group （treated with placebo）. All the patients were treated with 2 plasters once and changed the dressing every 24h. The treatment for both groups continued for 7 days. All patients＇ clinical symptoms and signs, index of safety,including vital sign, routine test for blood, urine, and stool, ALT, AST, BUN, Cr, ECG, and adverse events were observed. Results：The result showed that the effective rate was 76.60% in the treatment group while 37.50% in the placebo group, and there was statistical difference between the two groups （P〈0.05）. In the treatment group, the scores of pain and heavy feeling were decreased obviously （P〈 0. 001）. The scores of soreness and weakness of waist and knees, and the difficulty in turning were also decreased obviously compared with control group after treatment （P〈 0.05）. Conclusion： Qingxian Zhitong Plaster is effective and safe for the treatment of strain of lumbar muscles.