Kornasoff D, Maisenbacher J, Bowdler J, Raber A
Pharmakopius (Services) Ltd., Goring-on-Thames, UK.
Rheumatol Int. 1996;15(6):225-30. doi: 10.1007/BF00290375.
The efficacy and tolerability of aceclofenac (100 mg bid; n = 109), a new non-steroidal anti-inflammatory agent, was compared to that of indomethacin (50 mg bid; n = 110) in a multi-centre, 12-week, randomized, double-blind clinical trial in patients with rheumatoid arthritis. The efficacy of aceclofenac, on the basis of several clinical features characteristic for rheumatoid arthritis, was comparable to that of indomethacin. Patients in both treatment groups showed a notable and significant improvement during the study. Under aceclofenac treatment, the number of painful and swollen joints decreased by a median of six and nine, respectively, morning stiffness was shortened by 1 h, and the grip strength of both hands increased by a median of 8 mmHg. Pain at rest was relieved in 65.3% of aceclofenac-treated patients and in 67.1% of those treated with indomethacin (n.s.). With regard to safety, aceclofenac tended to be better tolerated than indomethacin. Among the 109 aceclofenac-treated patients, 26 incidents of adverse effects due to the drug were noted in 20 patients (18.4%). Sixty-four incidents of adverse events were documented in 32 (29.1%) of the 110 patients treated with indomethacin. The most common adverse events reported during treatment with aceclofenac were heartburn (four patients) and vertigo (three patients).
在一项针对类风湿性关节炎患者的多中心、为期12周的随机双盲临床试验中，将新型非甾体抗炎药醋氯芬酸（100毫克，每日两次；n = 109）的疗效和耐受性与吲哚美辛（50毫克，每日两次；n = 110）进行了比较。基于类风湿性关节炎的几个临床特征，醋氯芬酸的疗效与吲哚美辛相当。两个治疗组的患者在研究期间均显示出显著且明显的改善。在醋氯芬酸治疗下，疼痛和肿胀关节的数量分别中位数减少了6个和9个，晨僵缩短了1小时，双手握力中位数增加了8毫米汞柱。65.3%接受醋氯芬酸治疗的患者静息时疼痛得到缓解，接受吲哚美辛治疗的患者中这一比例为67.1%（无显著差异）。在安全性方面，醋氯芬酸的耐受性往往优于吲哚美辛。在109例接受醋氯芬酸治疗的患者中，20例患者（18.4%）出现了26起药物不良反应事件。在110例接受吲哚美辛治疗的患者中，32例（29.1%）记录了64起不良事件。醋氯芬酸治疗期间报告的最常见不良事件是烧心（4例患者）和眩晕（3例患者）。
