Evaluation of tenoxicam in rheumatology--clinical trial results in Argentina and Brazil.

C A Barclay, C A Traballi
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Abstract

The therapeutic activity of tenoxicam, a thienothiazine derivative with analgesic and anti-inflammatory properties, has been studied by 15 investigators in Argentina and Brazil. Twenty-nine clinical trials were performed in a total of 747 patients suffering from rheumatoid arthritis (270), cox- and gonarthrosis (190), extra-articular inflammation (250) and acute gout (37). Out of the patients studied, 507 received tenoxicam and 240 were given comparative preparations. In 76% of the patients 20 mg tenoxicam was given as a single daily dose. In most patients duration of treatment was either six weeks or six months. Therapeutic results were evaluated according to the evolution of pain in various conditions as well as that of the articular, clinical and functional status. Once treatment was concluded a global evaluation of efficacy and tolerance was performed. The statistical analysis showed a significant improvement, in comparison to baseline, in all parameters considered under the different conditions. Double-blind studies showed no significant statistical differences between tenoxicam and the comparative preparations. Tolerance to tenoxicam was considered excellent, granting that some patients referred to adverse effects of the gastrointestinal type, such as epigastric discomfort, pyrosis and flatulence of moderate intensity. Tenoxicam is a new non-steroidal anti-inflammatory compound which is well tolerated and has excellent activity in the treatment of diverse rheumatoid conditions.

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替诺昔康在风湿病学中的评价——阿根廷和巴西的临床试验结果。
替诺昔康是一种具有镇痛和抗炎特性的噻吩噻嗪衍生物,阿根廷和巴西的15名研究人员对其治疗活性进行了研究。29项临床试验共纳入747例患者,这些患者分别患有类风湿关节炎(270例)、膝关节炎和膝关节炎(190例)、关节外炎症(250例)和急性痛风(37例)。在研究的患者中,507人接受替诺昔康治疗,240人接受比较制剂治疗。76%的患者每日给药20mg替诺昔康。大多数患者的治疗时间为6周或6个月。根据不同情况下疼痛的演变以及关节、临床和功能状态评估治疗效果。一旦治疗结束,对疗效和耐受性进行全面评估。统计分析显示,与基线相比,在不同条件下考虑的所有参数都有显着改善。双盲研究显示替诺昔康与比较制剂之间无显著统计学差异。对替诺昔康的耐受性被认为是优秀的,考虑到一些患者提到胃肠道类型的不良反应,如胃脘不适、中度的灼热和胀气。替诺昔康是一种新的非甾体抗炎化合物,耐受性好,在治疗多种类风湿疾病中具有良好的活性。
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