腰痛宁胶囊治疗腰椎间盘突出症(寒湿瘀阻证)的有效性和安全性的随机、盲法、多中心临床对照研究

Effectivity and safety of Yaotongning Capsules in treatment of lumbar discherniation with cold dampness and blood stasis syndrome: A randomized blind controlled and multicenter trial

目的评价腰痛宁胶囊治疗腰椎间盘突出症(寒湿瘀阻证)的有效性和安全性。方法采用分层区组随机、盲法(第3方评价)、阳性药对照、多中心临床研究方法。根据SAS 9.1.3生成的随机数字分入试验A组(4粒组)120例,试验B组(6粒组)120例,对照组120例。试验组口服腰痛宁胶囊,对照组口服腰痹通胶囊,疗程4周。期间设立3个访视点进行视觉模拟(VAS)评分、Oswestry功能障碍指数(ODI)评估,并记录患者治疗疼痛的起效时间,于治疗后评价疗效及安全性。结果治疗4周ODI等级疗效显示试验A组(4粒组)的优秀率为85.83%、对照组为73.95%、试验B组(6粒组)为85.00%,试验A组优于试验B组及对照组,且不良反应最少。VAS评分和ODI的下降值试验B组优于试验A组,均优于对照组。结论腰痛宁胶囊治疗腰椎间盘突出症(寒湿瘀阻证)临床疗效确切,且安全性好,能快速缓解疼痛和改善腰椎功能。

Objective To evaluate the efficacy and safety of Yaotongning Capsules in the treatment of lumbar disc herniation （cold dampness and blood stasis syndrome）. Methods This research was carried out using stratified random method, blind, positive drug controlled, and multi-center clinical. And the random number was generated by SAS9.1.3 into two experimental groups （4 grains, 120 cases and 6 grains, 120 cases）, and control group （120 cases）. The experimental group was treated with Yaotongning Capsules for 4 weeks, and the control group was treated with Yaobitong Capsules for 4 weeks. At 0 day, 2, and 4 weeks, the VAS score, Oswestry dysfunction index, and onset time of pain were evaluated, and the efficacy and safety of the treatment were evaluated. Results After 4 weeks of treatment, the efficacy of ODI grade showed that the excellent rates of the experimental group （4 grains）, control group, and experimental group （6 grains） were 85.83%, 73.95%, and 85%, the efficacy of the experimental group （4 grains） was better than other groups, and the adverse reaction was the least. However, in terms of pain relief and improvement in the ODI scale, the experimental group （6 grains） in 2 and 4 weeks after treatment of In VAS and ODI improvement experiment, the decreased value of experimental group （6 grains） 〉 experimental group （4 grains） 〉 control group. Conclusion Yaotongning Capsules in the treatment of lumbar disc herniation （cold dampness and blood stasis syndrome） have obviously curative effect and good safety, and have the advantage of the rapid relief of pain and could improve the function of lumbar spine.