Nguyen M, Dougados M, Berdah L, Amor B
Hôpital Cochin, Paris, France.
Arthritis Rheum. 1994 Apr;37(4):529-36. doi: 10.1002/art.1780370413.
To determine the efficacy and safety of diacerhein, a potential new therapeutic agent with properties differing from those of existing nonsteroidal anti-inflammatory drugs (NSAIDs), and of a combination of diacerhein and an NSAID (tenoxicam) in the treatment of osteoarthritis (OA) of the hip.
Two hundred eighty-eight patients with painful OA of the hip were enrolled in an 8-week randomized, double-blind, placebo-controlled, 2 x 2 factorial design study. Four treatment groups were defined: 1) diacerhein placebo and tenoxicam placebo, 2) tenoxicam and diacerhein placebo, 3) diacerhein and tenoxicam placebo, and 4) diacerhein and tenoxicam. The daily dosages of diacerhein and tenoxicam were 100 mg and 20 mg, respectively.
Analyses of efficacy showed no interaction between diacerhein and tenoxicam in terms of efficacy, a clinically significant rapid (< or = 2 weeks) and persisting effect of tenoxicam during the 8 weeks of the study, and a slow-acting (6 weeks) effect of diacerhein. Moderate, transient diarrhea was the most frequent side effect observed in the diacerhein group (37%) compared with the placebo group (4%).
Both tenoxicam and diacerhein appear to be superior to placebo, and neither agent appears to significantly enhance or detract from the efficacy of the other when they are administered concomitantly. The onset of action of diacerhein appears to be delayed (> or = 4 weeks).
确定双醋瑞因（一种特性与现有非甾体抗炎药不同的潜在新型治疗药物）以及双醋瑞因与一种非甾体抗炎药（替诺昔康）联合用药治疗髋骨关节炎（OA）的疗效和安全性。
288例髋部疼痛性OA患者参加了一项为期8周的随机、双盲、安慰剂对照的2×2析因设计研究。定义了四个治疗组：1）双醋瑞因安慰剂和替诺昔康安慰剂，2）替诺昔康和双醋瑞因安慰剂，3）双醋瑞因和替诺昔康安慰剂，4）双醋瑞因和替诺昔康。双醋瑞因和替诺昔康的日剂量分别为100毫克和20毫克。
疗效分析显示，双醋瑞因和替诺昔康在疗效方面无相互作用；在研究的8周期间，替诺昔康有临床上显著的快速（≤2周）且持续的效果，双醋瑞因有缓慢起效（6周）的效果。与安慰剂组（4%）相比，双醋瑞因组观察到的最常见副作用是中度、短暂性腹泻（37%）。
替诺昔康和双醋瑞因似乎均优于安慰剂，二者同时给药时，似乎均未显著增强或降低对方的疗效。双醋瑞因的起效似乎延迟（≥4周）。
