芍灵消增贴治疗骨性关节炎(肝肾不足、瘀血阻络证)的疗效及安全性评价

Efficacy and Safety of Shaoling Plaster in the Treatment of Osteoarthritis with the Insufficiency of Liver and Kidney, the Syndrome of Static Blood Blocking Collaterals:A Double-blind,Placebo-controlled,and Randomized Study

目的:评价芍灵消增贴治疗骨性关节炎(肝肾不足、瘀血阻络证)疗效及安全性。方法:采用随机双盲多中心安慰剂平行对照的研究方法。共入组患者480例,芍灵消增贴组360例,安慰剂组120例,疗程1周。以Lequesne MG指数和疼痛评分(Visual Analog Scales,VAS)作为疗效评价指标。结果:基于Lequesne MG指数评估,芍灵消增贴组总有效率67.5%,安慰剂组28%(P<0.05);芍灵消增贴组及安慰剂组Lequesne MG指数总评分由疗前13.28±4.44和12.94±4.78分别下降至疗后7.90±3.97和9.86±4.29(P<0.05);芍灵消增贴组及安慰剂组VAS疼痛评分由疗前6.48±1.40 6.15±1.60分别下降至疗后4.09±1.70和4.71±1.70(P<0.05);不良反应发生率芍灵消增贴组5%,安慰剂组4.2%,差异无统计学意义。结论:芍灵消增贴治疗骨性关节炎安全有效。

Objective：To evaluate the curative effect and safety of Shaoling plaster in osteoarthritis with the insufficiency of liver and kidney, the syndrome of static blood blocking collaterals. Methods：A double-blind, placebo-controlled, and ran- domized study were used, and a total of 480 osteoarthritis cases enrolled in the treatment for 1 week. The subjects were treated by Shaoling plaster （n=360） or placebo piaster （n= 120）, and the efficacy was evaluated by Lequesne MG Index and Visual Analog Scales （VAS）. Results：The total effective rate of Shaoling plaster group was higher than placebo group （67. 5% vs. 28%, P〈0.05）. Lequesne MG scores of Shaoling plaster group decreased from （13. 28±4.44） to （7.90=1= 3.97）, while the placebo group from （12.94±4.78） to （9.86±4.29） （P〈0.05） ; VAS scores of Shaoling plaster groupdecreased from （6.48±1.40） to （4.09±1.70）, while the placebo group from （6.15±1.60） to （4.71±1.70） （P〈0. 05）. The adverse-event rate was not different significantly between Shaoling plaster group and placebo group （5% vs. 4.2%）. Conclusion： Shaoling plaster is effective and safe in the treatment of osteoarthritis with the insufficiency of liver and kidney, the syndrome of static blood blocking collaterals.