塞来昔布安全性与耐受性评价

目的:评价COX-2抑制药塞来昔布的安全性和耐受性.方法:采用随机双盲阳性对照方法,将430例RA和OA病人分成3组,塞来昔布100 mg bid组、塞来昔布200mg bid组和双氯芬酸钠75 mg bid组,比较3组在安全性和耐受性的差异.结果:内窥镜下塞来昔布两组病人胃十二指肠溃疡的发生率比双氯芬酸钠组低4倍,具有统计学差异(P＜0.01).塞来昔布对血小板聚集和出血时间无影响,而双氯芬酸钠可减少血小板聚集,延长出血时间.结论:塞来昔布通过选择性抑制COX-2有效减少了胃肠道的毒性作用,避免了与COX-1抑制相关的生理效应,具有良好的安全性和耐受性.

Evaluation of Safety and Tolerability of Celecoxib

Objective: To evaluate the safety and tolerability of the selective COX-2 inhibitor Celecoxib . Method: The randomized positively controlled study was conducted in 430 patients who were randomly divided into three groups; Celecoxib 100 mg bid group, Celecoxib 200 mg bid group and Diclofenac Sedium 75 mg bid group, to compare the difference of them. Result: The rate of gastroduodenal ulcer in two celecoxib groups was four times lower than diclofenac sedium group(P< 0.01).And Celecoxib had no effects on the platelet aggregation and blooding time in comtrast that diclofenac sedium can inhibit the platelet aggregation and prolong the blooding time. Conclusion: Because of selective COX-2 inhibition , celecoxib can effectively reduce the gastroenteric toxicity and avoid the physiologic effection in related to COX-1 inhibition, which have good safety and tolerability.