Crowley B, Hamill J J, Lyndon S, McKellican J F, Williams P, Miller A J
Royal Gwent Hospital, Newport, England.
Curr Med Res Opin. 1990;12(3):143-50. doi: 10.1185/03007999009111495.
The efficacy and tolerability of a new, controlled-release indomethacin (75 mg) tablet was compared to that of a sustained-release diclofenac sodium (100 mg) tablet in 84 patients with rheumatoid arthritis. The study was designed as a double-blind, double-dummy crossover trial, patients being allocated at random to receive 1 active tablet and 1 placebo tablet of the alternative medication at night for 4 weeks before being crossed over to the alternative treatment for a further 4 weeks. Patient and clinical assessments on entry and at the end of each treatment period showed that pain scores for day and night, duration of morning stiffness, requirement for escape analgesia (paracetamol) and treatment preference were similar for both treatments. Both preparations also significantly improved the degree of joint tenderness compared to baseline (p less than 0.001), as measured by a modified Ritchie Articular Index. Incidence and severity of side-effects were comparable, with a significant improvement in degree of constipation reported for both treatments compared to baseline (p less than 0.05). The incidence and severity of headache was statistically significantly worse (p less than 0.05) for controlled-release indomethacin; however, there was no difference in any other parameter of tolerability. It was concluded that controlled-release indomethacin tablets (75 mg) given as a single night-time dose were as efficacious and well tolerated as sustained-release diclofenac sodium (100 mg).
在84例类风湿性关节炎患者中，对一种新型控释吲哚美辛（75毫克）片剂与缓释双氯芬酸钠（100毫克）片剂的疗效和耐受性进行了比较。该研究设计为双盲、双模拟交叉试验，患者被随机分配，在夜间服用1片活性片剂和1片替代药物的安慰剂片剂，持续4周，然后交叉接受另一种治疗，再持续4周。在每个治疗期开始和结束时对患者进行的临床评估显示，两种治疗的日夜疼痛评分、晨僵持续时间、解救镇痛（扑热息痛）需求和治疗偏好相似。与基线相比，两种制剂还显著改善了关节压痛程度（p<0.001），采用改良的里奇关节指数进行测量。副作用的发生率和严重程度相当，与基线相比，两种治疗的便秘程度均有显著改善（p<0.05）。控释吲哚美辛的头痛发生率和严重程度在统计学上显著更差（p<0.05）；然而，在耐受性的任何其他参数方面没有差异。得出的结论是，夜间单次服用控释吲哚美辛片剂（75毫克）与缓释双氯芬酸钠（100毫克）具有相同的疗效和耐受性。
