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-《中国中医骨伤科杂志》

文章信息/Info

Title:: 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

作者:: 王文岳¹ 谢利民¹ 张跃¹ 胡镜清¹ 吕发明² 李洪久³ 昝强⁴ 孙庆⁵ 谷福顺⁶ 沈霖⁷ 姜宏⁸; ¹中国中医科学院广安门医院(北京,100053) ²新疆维吾尔自治区中医医院 ³辽宁中医药大学附属医院 ⁴陕西中医学院附属医院 ⁵天津中医药大学第一附属医院 ⁶天津中医药大学第二附属医院 ⁷华中科技大学同济医学院协和医院 ⁸苏州市中医医院

Author(s):: WANG Wenyue¹ XIE Limin¹ ZHANG Yue¹ HU Jingqing¹ LV Kaiming² LI Hongjiu³ ZAN Qiang⁴ SUN Qing⁵ GU Fushun⁶ SHEN Lin⁷ JIANG Hong⁸

摘要:: 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。

Abstract:: 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 randomized 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 plaster(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±3.97), while the placebo group from(12.94±4.78)to(9.86±4.29)(P<0.05); VAS scores of Shaoling plaster group decreased 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.