Pasero G, Marcolongo R, Serni U, Parnham M J, Ferrer F
Department of Rheumatology, St. Chiara Hospital, Pisa, Italy.
Curr Med Res Opin. 1995;13(6):305-15. doi: 10.1185/03007999509110491.
A long term multi-centre, double-blind, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (170 patients, 100 mg b.i.d. and placebo once daily) in comparison to diclofenac (173 patients, 50 mg t.i.d.) given for 6 months to patients of both sexes with active rheumatoid arthritis. Efficacy was evaluated in 131 aceclofenac and 130 diclofenac patients at 15 days, 1, 2, 4 and 6 months. Although both treatment groups showed significant improvement in all evaluations of pain and inflammation (assessed by a Visual Analogue Scale and the Ritchie Index) and a progressive reduction in morning stiffness, there were no significant differences between the groups. There was, however, a trend towards greater improvement in hand grip strength with aceclofenac (22% improvement) than diclofenac (17% improvement). Adverse events in both groups were minor, predominantly gastro-intestinal, and fewer patients tended to experience gastro-intestinal events on aceclofenac (13%) than on diclofenac (17%). The overall assessment of tolerance, however, did not differ significantly between groups. In summary, this study supports a therapeutic role for aceclofenac in the treatment of rheumatoid arthritis, and suggests it is an effective and safe NSAID for the treatment of this disease.
开展了一项长期多中心、双盲、平行组研究，以调查醋氯芬酸（170例患者，每日两次，每次100毫克，与每日一次的安慰剂对照）与双氯芬酸（173例患者，每日三次，每次50毫克）相比，对患有活动性类风湿性关节炎的男女患者进行6个月治疗的疗效和安全性。在15天、1、2、4和6个月时，对131例醋氯芬酸患者和130例双氯芬酸患者的疗效进行了评估。尽管两个治疗组在所有疼痛和炎症评估（通过视觉模拟量表和里奇指数评估）中均显示出显著改善，且晨僵逐渐减轻，但两组之间无显著差异。然而，醋氯芬酸组的握力改善趋势（改善22%）大于双氯芬酸组（改善17%）。两组的不良事件均较轻微，主要为胃肠道事件，服用醋氯芬酸的患者发生胃肠道事件的比例（13%）低于服用双氯芬酸的患者（17%）。然而，两组之间的总体耐受性评估无显著差异。总之，本研究支持醋氯芬酸在类风湿性关节炎治疗中的治疗作用，并表明它是治疗该疾病的一种有效且安全的非甾体抗炎药。
