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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100mgbid组、塞来昔布200mgbid组和双氯芬酸钠75mgbid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。
Objective: To evaluate the safety and tolerability of COX-2 inhibitor celecoxib. Methods: A total of 430 patients with RA and OA were divided into three groups by randomized double-blind positive control method: celecoxib 100mgbid group, celecoxib 200mgbid group and diclofenac sodium 75mgbid group. The safety and tolerability The difference. Results: The incidence of gastroduodenal ulcer in patients with celecoxib under endoscopy was 4 times lower than that in diclofenac sodium group, with statistical significance (P <0.01). Celecoxib had no effect on platelet aggregation and bleeding time, while diclofenac sodium reduced platelet aggregation and prolonged bleeding time. CONCLUSION: Celecoxib effectively reduces the toxic effects of gastrointestinal tract by selectively inhibiting COX-2, avoids the physiological effects associated with COX-1 inhibition, and has good safety and tolerability.