摘要
目的观察寒湿透骨散治疗寒湿痹阻证类风湿关节炎的临床疗效和安全性。方法应用随机平行、双肓和双模拟对照的多中心临床研究方案,试验组入选360例,对照组入选120例,试验组采用寒湿透骨散外敷,对照组采用模拟药物外敷,敷用1次,观察3d。观察两组患者关节疼痛、关节肿胀、关节压痛、关节屈伸不利和晨僵评分,比较其疗效并得出结论。结果两组除关节屈伸不利外,关节疼痛、关节肿胀、关节压痛、晨僵评分比较差异均有显著性(P<0.05)。两组安全性指标、不良事件发生率差异无显著性(P>0.05)。结论①寒湿透骨散能改善寒湿痹阻证类风湿关节炎关节疼痛、关节肿胀、关节压痛、晨僵等症状。②寒湿透骨散未发现存在明显的安全性问题。
[Objective ] To investigate the efficacy and safety of Han-Shi-Tou-Gu-San in the treatment of rheumatoid arthritis （RA） of cold-dampness syndrome. [Methods] 480 cases with RA of cold-dampness syndrome were randomly divided into two groups：a Han-Shi-Tou-Gu-San treatment group and a control group （only placebo treatment）, with 360 cases for group Han-Shi-Tou-Gu-San, 120 for control group. The treatment lasted three days, and the two medicine only used to local application one time. Score on the pain, swelling degree, tenderness degree, flexion-extension degree of joint, morning stiffness degree. Blood routine, urine routine, stool test, AST, ALT, BUN, Cr, ECG were measured before and after treatment as safe indexes. [ Results ] Aside from flexion-extension degree of joint, there was significant difference on the pain, swelling degree, tenderness degree of joint, morning stiffness degree between group Han-Shi-Tou-Gu-San and control group （P 〈0.05）. The two groups show no significant difference （P 〈0.05）. [ Conclusion ] The results indicated Han-Shi-Tou-Gu-San could improve the pain, swelling degree, tenderness degree of joint, morning stiffness degree. And the medicine is safety.
出处
《中国现代医学杂志》
CAS
CSCD
北大核心
2009年第18期2828-2830,2832,共4页
China Journal of Modern Medicine
关键词
寒湿透骨散
类风湿关节炎
寒湿痹阻证
外治法
Han-Shi-Tou-Gu-San
Rheumatoid Arthritis
cold-dampness syndrome
external treatment
