Leatham P A, Bird H A, Wright V, Fowler P D
Agents Actions. 1982 Apr;12(1-2):221-4. doi: 10.1007/BF01965150.
Psoriatic arthropathy is a relatively uncommon arthritis that exists in a wide variety of clinical forms. These two features of the disease cause problems in the design of clinical trials. In a comparison of two non-steroidal anti-inflammatory agents in this condition we attempted to overcome the difficulties by using a run-in period during which the dosage of one of the trial drugs was adjusted to suit the individual patient. After two weeks on indomethacin (75 mg or 150 mg/day) patients were allocated to four-week periods of indomethacin in the chosen dosage or diclofenac (75 mg or 150 mg/day) in a double-blind randomized crossover trial that used double dummy packaging. Of the 35 patients that entered the study, 19 completed both study groups. No significant differences were observed between the clinical improvements due to both drugs during the course of the study. In general more side-effects were seen during indomethacin treatment, though the study design precluded exact comparison. In a study biased against diclofenac, patient preference was 9/19 for indomethacin, 4/19 for diclofenac and 7/19 expressing no choice. Advantages and disadvantages of the study design are discussed.
银屑病关节炎是一种相对罕见的关节炎，有多种临床形式。该疾病的这两个特征给临床试验的设计带来了问题。在比较两种非甾体抗炎药治疗这种疾病时，我们试图通过一个导入期来克服困难，在此期间调整其中一种试验药物的剂量以适应个体患者。在服用吲哚美辛（75毫克或150毫克/天）两周后，患者被分配到为期四周的选定剂量吲哚美辛组或双氯芬酸（75毫克或150毫克/天）组，这是一项采用双盲随机交叉试验且使用双模拟包装的研究。在进入研究的35名患者中，19名完成了两个研究组的治疗。在研究过程中，两种药物在临床改善方面未观察到显著差异。总体而言，在吲哚美辛治疗期间观察到更多的副作用，尽管研究设计排除了精确比较。在一项对双氯芬酸不利的研究中，患者对吲哚美辛的偏好为9/19，对双氯芬酸的偏好为4/19，7/19表示无选择。讨论了该研究设计的优缺点。
