艾瑞昔布治疗膝骨关节炎的Ⅳ期多中心开放临床试验

A multicenter open＇labeled phase IV trial of imrecoxib in the treatment of knee Osteoarthritis

目的评价艾瑞昔布治疗膝OA的疗效和安全性。方法采用多中心、开放、单臂的研究方法。口服艾瑞昔布100mg每日2次，疗程8周。比较基线和治疗后8周西安大略和麦克马斯特大学OA指数（WOMAC）VA3．0总评分，并记录治疗过程中的不良事件。计量资料采用协方差分析。结果共入组2413例患者。治疗后8周WOMACVA3．0总评分较基线降低了（15±10）分，差异有统计学意义（t=68．29，P〈0．01）。药物相关不良事件的发生率为9．08％（217例）。其中胃肠道出血占0．13％（3例）。共发生45例心血管不良事件、无心肌梗死、脑卒中、血管栓塞等严重心脑血管事件。结论艾瑞昔布可有效、安全地治疗膝OA，不良事件发生率低，胃肠道不良事件少，无严重心血管不良事件，值得推广用于OA的治疗。

Objective To evaluate the efficacy and safety of imrecoxib tablets in the treatment of osteoarthritis （OA）. Methods In this multi-centered, open-labeled study, 100 mg imrecoxib tablets were given twice a day for 8 weeks in patients：with OA. At baseline and 8 week after treatment, the Western Ontario and McMaster Universities ArthritisIndex （WOMAC） VA 3.0 scores were compared to assess efficacy while any complaints and laboratory abnormalities were included to assess for adverse, effects. Covariance analysis was Used to analyze the collected data. Results Two thousand four hundred and thirteen patients were enrolled. After 8 weekS＂ treatment, the WOMAC VA 3.0 score decreased to （15±10） from baseline （t=68.29, P〈0.01） and the difference was statistically significant. Three hundreds and eighty-four （16.07%） of the patients reported to have adverse effects, in which 217 cases （9.08%） had treatment related. The rate of gastrointestinal bleeding was 0.13%. Forty-five cases （1.88%） were cardiovascular adverse effects. No case of coronary artery infarction, stroke or thromhoembolism was reported. Conclusion lmrecoxib is an efficacious drug in the treatment of OA with a low adverse effect profile.