关节克痹丸的有效性和安全性临床研究

Clinical study of effectivity and safety of guanjiekebiwan

目的:探讨关节克痹丸的临床有效性和安全性。方法:按江苏省卫生厅医政规范五对"骨关节病、大骨关节病、神经病性关节病、绒毛结节状滑膜炎"的临床诊断和疗效标准,结合临床辨证分型,纳入符合条件的患者400例,随机选择治疗组患者300例,对照组100例,治疗组予以关节克痹丸治疗,对照组予以安慰剂,观察患者服用关节克痹丸3个月后临床症状、体征的变化及不良反应,明确关节克痹丸的临床有效性和安全性。结果:治疗组300例患者经关节克痹丸治疗后临床症状、体征明显改善,不良反应极少且比较轻,处理较简单。对照组100例予以安慰剂后临床症状、体征无改善。结论:关节克痹丸临床使用有效、安全,不良反应极少且比较轻,处理较简单。

Objective ：To evaluate the clinical effectivity and safety of guanjiekcbiwan by clinical observation. Methods： According to the sdandard of diagnosis and therapeutic effect made by the health department of Jiangsu province on ＂osteoarthropathia, KaschinBeck disease,neuropathic arthropathy, villonodular synovitis＂, 400 patients were randomly divided into treatment group （300 patients） and control group （100 patients）. Patients of treatment group were administrated with guanjiekebiwan,while patients of control group took placebo. Clinical symptoms, physical signs and side reactions were observed after 3 months of treatment. Results：300 patients of treatment group gained improved clinical symptoms, physical signs,with very little side effect, 100 patients of control group had no improvement in clinical symptoms, physical signs. Conclusion：Guanjiekebiwan is clinically effective and safe with very little side effect.