Levenstein J H
S Afr Med J. 1985 Apr 27;67(17):676-9.
A study was conducted in general practice to assess the efficacy and safety of isoxicam 200 mg once daily compared with indomethacin 25 mg 3 times a day in the treatment of acute exacerbations of osteo-arthritis. The trial was conducted as a multicentre, double-blind, randomized parallel-group study with 'dummy loading' of the medications. Thirty-one general practitioners entered 309 patients in the study. Of these, 139 patients on isoxicam and 137 on indomethacin completed the treatment. The most common sites of osteo-arthritis were the knee (100 patients) and the hip (79 patients). On examination at 7 days and 14 days there was a significant improvement in both treatment groups. After 7 days the reduction of pain and clinical symptoms of osteo-arthritis of the hip and knee was significant for both drugs at the P less than 0,001 level. There thus appeared to be no difference in clinical efficacy between the drugs. Eight patients in the isoxicam group experienced definite drug-related adverse reactions as against 19 in the indomethacin group. A total of 38 patients (18 on isoxicam and 20 on indomethacin) suffered probably drug-related effects. Isoxicam therefore appeared to be better tolerated than indomethacin.
在普通医疗实践中进行了一项研究,以评估每日一次服用200毫克异恶丙嗪与每日三次服用25毫克吲哚美辛相比,在治疗骨关节炎急性加重期时的疗效和安全性。该试验作为一项多中心、双盲、随机平行组研究进行,药物采用“虚拟负荷”。31名全科医生让309名患者参与了该研究。其中,139名服用异恶丙嗪的患者和137名服用吲哚美辛的患者完成了治疗。骨关节炎最常见的发病部位是膝盖(100名患者)和臀部(79名患者)。在第7天和第14天检查时,两个治疗组均有显著改善。7天后,两种药物对髋部和膝部骨关节炎疼痛和临床症状的减轻在P值小于0.001水平时均具有显著性。因此,两种药物在临床疗效上似乎没有差异。异恶丙嗪组有8名患者出现明确的药物相关不良反应,而吲哚美辛组有19名。共有38名患者(18名服用异恶丙嗪,20名服用吲哚美辛)可能出现了药物相关反应。因此,异恶丙嗪的耐受性似乎比吲哚美辛更好。