骨痛宁膏治疗膝骨性关节炎(风寒湿阻、气血瘀滞证)临床观察

The Clinical Research of Gu Tong Ning Gao’s Therapeutic Effects on Knee Osteoarthritis

目的:评价骨痛宁膏治疗膝骨性关节炎(风寒湿阻、气血瘀滞证)的临床疗效及安全性。方法:随机将4个临床试验中心的448例患者分为治疗组336例(骨痛宁膏组)和对照组112例(骨通贴膏组),疗程1周,观察治疗后两组患者的膝骨性关节炎临床疗效和中医证候疗效,及治疗前后膝骨性关节炎症状分级量化积分,膝关节疼痛指数,中医症候积分的变化,同时作安全性评价指标的检测。结果:(1)与治疗前相比,两组患者的膝骨性关节炎临床疗效和中医证候疗效都较明显(P<0.05),膝骨性关节炎症状分级量化积分,膝关节疼痛指数,中医症候积分都明显下降(P<0.01)。(2)治疗后两组间比较,膝骨性关节炎临床疗效和中医证候疗效有显著差异(P<0.05),中医症候积分亦有显著差异(P<0.05),余无显著差异(P>0.05)。结论:骨痛宁膏治疗膝骨性关节炎(风寒湿阻、气血瘀滞证)疗效确切,安全,无毒副作用,不良反应少,值得临床大力推广使用。

Objective：To study the therapeutic effects and reliable safety of Gu Tong Ning Gao （GTLG） on knee osteoarthritis （KOA）. Methods：Cases of KOA were randomly divided into two groups, coming from 4 clinical research centres. The therapeutic group was treated with GTLG including 336 patients and the comparative group was treated with Gu Tong Tie Gao （GTTG） including 112 patients. The course was 1 week. The following indexes were observed and measured, including the validity of clinical therapeutic effects and the therapeutic effects of traditional chinese medicine, the integral of symptoms and signs, the integral of knee joints~ ache, the integral of symptoms and signs of traditional chinese medicine. They were analyzed after statistical calculation. Results ：（1）We compared with the states before treatment, the following indexes of the 2 groups, the validity of clinical therapeutic effects and the therapeutic effects of traditional chinese medicine （P〈0.05）, and the integral of symptoms and signs, the integral of knee joints＇ ache, the integral of symptoms and signs of traditional chinese medicine has significant statistical difference （P〈0.01）. （2）After treatment, the validity of clinical therapeutic effects, the therapeutic effects of traditional chinese medicine and the integral of symptoms and signs of traditional chinese medicine had significant statistical differences between the 2 groups （P〈0.05）, but other indexes had no significant statistical differences （P〉0.05）. Conelusion：GTLG has conspicuous therapeutic effects in treating KOA and it has reliable safety, no toxicity, rare adverse reaction. It deserves wider＇ applications in clinical therapy.