尼美舒利和萘普生治疗骨关节炎的临床试验

Nimesulide vs naproxen in therapy of osteoarthritis

目的：比较尼美舒利和萘普生治疗骨关节炎的疗效和安全性。方法：采用随机、双盲或单盲、多中心、对照研究方法。尼美舒利１００例（男性４１例，女性５９例，年龄５４±ｓ１０ａ），萘普生６８例（男性２９例，女性３９例，年龄５３±１２ａ）。尼美舒利口服１００ｍｇ，ｂｉｄ；萘普生口服２５０ｍｇ，ｂｉｄ，疗程２ｗｋ。结果：尼美舒利的总有效率为８３％，萘普生的总有效率为７５％（Ｐ＜０．０５）。不良反应发生率分别为２３％和３２％（Ｐ＞０．０５），以胃肠反应为主。结论：尼美舒利对骨关节炎治疗作用优于萘普生，不良反应发生率与萘普生相近。

AIM: To compare the therapeutic effects and safety of nimesulide and naproxen in the treatment of osteoarthritis. METHODS: In the randomized, double or single_blind, paralleled and multi_center studies, 100 patients (M 41, F 59, age 54±s 10 a) were given nimesulide 100 mg po, bid for 2 wk and 68 patients (M 29, F 39, age 53±12 a) were given naproxen 250 mg po, bid for 2 wk. RESULTS: Both nimesulide and naproxen improved the inflammatory signs and symptoms of patients with to_ tal effective rates 83% and 75% respectively (P< 0.05) and adverse reaction rates of 23% and 32% respectively (P>0.05). CONCLUSION: Nimesulide is more effective than naproxen in the treatment of osteoarthritis with similar adverse reaction.