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机构地区:[1]中国医学科学院中国协和医科大学北京协和医院风湿免疫科,北京100730 [2]浙江医科大学第一附属医院内科,杭州310003
出 处:《中国新药杂志》2001年第7期524-527,共4页Chinese Journal of New Drugs
摘 要:目的 :评价塞来昔布 (西乐葆 )治疗类风湿关节炎 (RA)和骨关节炎 (OA)的疗效和安全性。方法 :采用随机、双盲和双模拟的方法 ,将 85例患者分为治疗组 43例 ,其中RA 15例 ,OA 2 8例 ,每天早晚各服塞来昔布10 0mg和安慰剂 1片。对照组 42例 ,包括RA 15例 ,OA 2 7例 ,每天早晚各服双氯芬酸 5 0mg和安慰剂 1粒。疗程12周。结果 :患者自我评估 :2组均有 88%的患者关节炎得到改善 (P =0 .688) ;医生的总体评估为 :治疗组 88%、对照组 80 %得到改善 (P =0 .182 )。在不良反应中 ,治疗组较对照组胃肠道症状发生率低 ,分别为 37%和 60 % ,统计学有显著性差异 (P =0 .0 0 41) ,其余不良反应 2组无显著差异。结论 :塞来昔布保留了传统的非甾体类药物治疗RA和OA的疗效 ,降低了胃肠道的不良反应 。Objective:To evaluate the efficacy and safety of celecoxib in treatment of RA and OA.Methods:The randomized,double blind,and double dummy study were conducted in 85 patients.They were divided into active arm (15 RA and 28 OA) and control arm (15 RA and 27 OA).Patients in the active arm were treated with celecoxib in twice daily dose of 100 mg for 12 weeks,and patients in the control arm were treated with diclofenac in twice daily dose of 50 mg for 12 weeks.Results:The effective rate obtained by patients self evaluation was 88% for both arms ( P =0.688).The effective rate obtained by doctor's evalution was 88% for active arm and 80% for control arm ( P = 0.182). The incidence of GI side effect was 37% for active arm and 60% for control arm ( P =0.0041).No difference in incidence of other side effects were observed between arms.Conclusion:Celecoxib is an effective agent for treatment of RA and OA but with fewer GI side effect in comparison with traditional NSAIDs. [
分 类 号:R593.220.5[医药卫生—内科学] R971.1[医药卫生—临床医学]
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