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目的评价塞来昔布治疗类风湿关节炎(RA)和骨关节炎(OA)的有效性和安全性。方法采用随机、双盲、双模拟和对照研究的方法,将48例患者分为治疗组24例,其中RA14例,OA10例,每天早、晚各服塞来昔布100mg和安慰剂1片;对照组24例,其中RA13例,OA11例,每天早、晚各服双氯芬酸50mg和安慰剂1片,治疗12周以评价药物的安全性和有效性。结果譹两组患者对关节炎疼痛的评估(VAS)均有明显改变;两组差值为3.0,其95%可信区间(CI)为-14.4~20.4;②患者对疾病的总体评价,两组差值为0.1,其95%CI为-0.39~0.59;譻研究者对疾病的总体评价,两组差值为0.05,其95%CI为-0.59~0.49;譼对照组发生胃肠道不良事件3起,治疗组未报告胃肠道不良事件(Fisher精确概率检验,P=0.233)。结论塞来昔布、双氯酚酸均能显著降低患者对关节炎疼痛的评估,改善患者及研究者对疾病状况的总体评价,塞来昔布具有良好耐受性。
Objective To evaluate the efficacy and safety of celecoxib in the treatment of rheumatoid arthritis (RA) and osteoarthritis (OA). Methods A total of 48 patients were divided into treatment group (24 cases), including 14 cases of RA and 10 cases of OA. Each group received 100 mg celecoxib daily and 1 placebo daily morning and evening. Control group of 24 cases, including RA13 cases, OA11 cases, daily morning and evening diclofenac 50mg and placebo tablets for 12 weeks to evaluate the safety and efficacy of the drug. Results 评 The assessment of arthritis pain (VAS) was significantly changed in both groups. The difference between the two groups was 3.0 with a 95% confidence interval (CI) of -14.4 to 20.4. (2) Overall evaluation of patients with disease, Group difference of 0.1, 95% CI -0.39 ~ 0.59; 譻 researchers overall evaluation of the disease, the difference between the two groups was 0.05, the 95% CI was -0.59 ~ 0.49; 譼 control group gastrointestinal dysfunction From Event 3, the treatment group did not report any gastrointestinal adverse events (Fisher’s exact test, P = 0.233). Conclusion Both celecoxib and diclofenac significantly reduce the assessment of arthritis pain in patients and improve the overall evaluation of patients and researchers on the disease status. Celecoxib has good tolerability.