醋氯芬酸缓释片治疗骨关节炎的临床研究

Clinical Study on the Treatment of Osteoarthritis with Sustained-released Tablet of Aceclofenac

目的:比较醋氯芬酸缓释片和阳性对照药醋氯芬酸片治疗骨关节炎的疗效和安全性。方法:共有42例骨关节炎患者参加本实验。试验组21例,口服醋氯芬酸缓释片200mg,每日1次;对照组21例,口服醋氯芬酸片100mg,每日2次。疗程4周,采用随机、双盲、双模拟、平行对照的试验方法。结果:治疗2周后:试验组总有效率52.38%,对照组总有效率42.86%(P>0.05)。治疗4周后:试验组总有效率80.95%,对照组总有效率61.90%(P>0.05)。4周疗程后,两药均能显著改善骨关节炎患者的症状和体征(P<0.05)。试验组不良反应发生率为14.29%,对照组为9.52%,统计学分析显示两组间不良反应发生率无明显差异(P>0.05)。不良反应均以轻度消化道症状为主,无需特殊处理。结论:醋氯芬酸缓释片治疗骨关节炎的疗效和安全性与普通片相近,但服用更方便。

Objective： To assess the efficacy and safety of sustained-released tablet of aceclofenac versus aceclofenac tablet in the treatment of osteoarthritis（OA）. Methods： Randomized, double-blind, double-simulated, paralleled, and controlled clinical trial was performed. 42 patients were divided into sustained-released tablet of aceclofenac group（ n = 21） and aceclofenac tablet group（ n = 21）. They were given sustained-released tablet of aceclofcnac 200 mg daily or aceclofenac tablets I00 mg twice a day for 4 weeks, respectively. Results： Mter the treatment of 2 and 4 weeks, the total efficacy rates of sustalned-released tablet of aceclofenac group were 52.38% and 80.95%, while those of aceclofenac tablet group were 42.86% and 61.90%, respectively （P 〉0.05）. Both drugs could improve the symptoms and signs of OA（P 〈0.05）. The incidence of adverse effects of sustained-released tablet of aceclofenac was 14.29% ; and that of aceclofenac tablet was 9.52% （ P 〉 0.05 ）, The main adverse events of sustalned-released tablet of aceclofenac were slight gastrointestinal symptoms. 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 OA.