醋氯芬酸缓释片治疗类风湿关节炎有效性和安全性评价

目的: 比较醋氯芬酸缓释片和阳性对照药醋氯芬酸片治疗活动期类风湿关节炎(RA) 疗效和安全性。方法: 采用随机、双盲双模拟、平行对照方法, 选择疾病活动期RA 患者45 例(试验组22 例, 对照组23 例) ;试验药醋氯芬酸缓释片200 mg, 每天一次;对照药醋氯芬酸片100 mg, 每天2 次;4 周为一疗程。结果: 治疗4 周后, 试验组总有效率为63.6 %, 对照组总有效率69.6 %(P >0.05) 。两药均能显著改善RA 患者的症状和体征(P <0.05) 。不良反应发生率试验组为13.0 %, 对照组为12.0 %, 两组间不良反应发生率差异无统计学意义(P >0.05) 。结论: 醋氯芬酸缓释片治疗RA 的疗效和安全性与醋氯芬酸片类似, 但用药方便。

Efficacy and safety of sustained-released tablet of aceclofenac in the treatment of patients with rheumatoid arthritis

AIM: To compare the efficacy and safety of sustained-released tablet of aceclofenac versus aceclofenac in patients with active rheumatoid arthritis (RA). METHODS: Randomized, double-blind, double-simulated, paralleled, and controlled clinical trial was performed. 45 RA patients randomly assigned to two groups (treatment group n =22, controlled group n =23). The treatment group was given sustained- released tablet of aceclofenac 200mg once a day and the controlled group was given aceclofenac 100 mg twice a day. The total course lasted for 4 weeks. RESULTS: The total effective rates of the treatment group and the control group were 63.6 %(n =22) and 69.6 % (n =23), respectively after treatment for 4 weeks. Both drugs could improve the symptoms and signs of RA. The adverse reaction rate was 13.0 %, 12.0 % in the treatment group and control group, there was no statistical significance between the two groups (P > 0.05). CONCLUSION: Sustained-released tablet of aceclofenac is a safe and effective drug, as same as aceclofenac tablet, and also a more convenient drug in treating RA.