非普拉宗治疗关节病变II期临床试验1000例

Phase III clinical trial of feprazone in treatment of arthral lesion in 1000 patients

目的：分析非普拉宗治疗４种关节病变的疗效及不良反应。方法：１６家医院，按国际公认的诊断标准和疗效判断标准随机观察１０００例，其中类风湿关节炎５０５例，骨关节炎３１６例，风湿热１４７例，痛风关节炎３２例。非普拉宗用量０．２ｇ／次，ｐｏ，ｂｉｄ，４ｗｋ为一个疗程，开放式观察。结果：骨关节炎、类风湿关节炎、风湿热、痛风关节炎的总有效率分别为８２．０％，８４．０％，９６．６％，１００％。胃肠道不良反应率１２．６％，其余均较低。结论：国产非普拉宗的疗效可靠。

AIM: To evaluated the curative effects and adverse reaction of feprazone. METHODS: According to the international standards of diagnosis and efficacies standards of treatment, 16 hospitals took part the open study. 1000 patients and 4 kinds of arthritis were studied. There were osteoarthritis 316 patients, rheumatoid arthritis 505 patients, rheumatic fever 147 patients and gouty arthritis 32 patients. Feprazone, 200 mg, po, bid, for 4 wk. RESULTS: The effective rates of osteroarthitis, rheumatoid arthritis, rheumatic fever, and gouty arthritis were 82.0%, 84.0%, 96.6% and 100%, respectively. The rate of gastrointestinal adverse reaction was 12.6%. CONCLUSION: It is evident on curative effects of domestic feprazone. The rate of adverse reaction is low.