Hart C B, Tempero K F, Sromovsky J A, Rhymer A R
Curr Med Res Opin. 1983;8 Suppl 2:72-82. doi: 10.1185/03007998309109826.
A 12-week, double-blind, multi-centre trial was carried out in 402 out-patients with osteoarthritis to compare the efficacy and tolerability of the osmotic-release formulation of indomethacin ('Osmosin') with that of indomethacin capsules. Data from a sub-set of 178 patients aged 60 years or over were analyzed separately. The results indicated that 'Osmosin', releasing the equivalent of 7 mg indomethacin per hour over approximately 10 hours, provided efficacy comparable to or better than that of indomethacin capsules (25 mg 3-times daily) and had a better tolerance profile. Fewer patients treated with 'Osmosin' developed adverse experiences (p less than 0.05), especially central nervous system symptoms (p less than 0.05), and fewer were withdrawn from treatment because of adverse experiences (p less than 0.05). A reduction in the number of patients having gastro-intestinal symptoms was also identified. The majority of the patients maintained on one daily dose of 'Osmosin' had a good or excellent therapeutic response.
对402例骨关节炎门诊患者进行了一项为期12周的双盲多中心试验，以比较吲哚美辛渗透释放制剂（“Osmosin”）与吲哚美辛胶囊的疗效和耐受性。对178例60岁及以上患者的子集数据进行了单独分析。结果表明，“Osmosin”在约10小时内每小时释放相当于7mg吲哚美辛，其疗效与吲哚美辛胶囊（每日3次，每次25mg）相当或更佳，且耐受性更好。接受“Osmosin”治疗的患者出现不良事件的较少（p<0.05），尤其是中枢神经系统症状（p<0.05），因不良事件退出治疗的也较少（p<0.05）。还发现胃肠道症状患者数量有所减少。大多数每日服用一剂“Osmosin”的患者有良好或极佳的治疗反应。
