Laws D, Saul S, Fehilly B
Herrington House, Houghton-le-Spring, Tyne and Wear, United Kingdom.
Drugs. 1990;40 Suppl 5:29-33. doi: 10.2165/00003495-199000405-00007.
20 UK general-practice centres entered 243 patients into a 6-week double-blind, double-dummy, randomised, parallel-group trial designed to compare nabumetone 1 g at night with slow release diclofenac 100mg at night in the treatment of osteoarthritis. Seven efficacy parameters were measured, adverse events were recorded and laboratory monitoring was performed. The study monitor entered trial data into a portable laptop microcomputer at the participating centres. Both treatment groups showed highly significant clinical improvements at the end of the 6-week study period and there were no significant inter-group differences. Overall, the incidence of adverse events was similar in the 2 groups, but significantly fewer patients in the nabumetone group (n = 21) than in the diclofenac group (n = 35) complained of gastrointestinal adverse events (p = 0.03). On-site use of the microcomputer contributed to increased monitoring efficiency and trialist motivation, resulting in rapid recruitment of patients, collection of high quality data and speedy analysis at the end of the study.
20家英国全科医疗中心将243名患者纳入一项为期6周的双盲、双模拟、随机、平行组试验，该试验旨在比较每晚服用1克萘丁美酮与每晚服用100毫克缓释双氯芬酸治疗骨关节炎的效果。测量了7项疗效参数，记录了不良事件并进行了实验室监测。研究监测人员在参与中心将试验数据录入便携式笔记本微型计算机。在为期6周的研究期结束时，两个治疗组均显示出高度显著的临床改善，且组间无显著差异。总体而言，两组不良事件的发生率相似，但萘丁美酮组（n = 21）抱怨胃肠道不良事件的患者明显少于双氯芬酸组（n = 35）（p = 0.03）。在现场使用微型计算机有助于提高监测效率和试验人员的积极性，从而实现患者的快速招募、高质量数据的收集以及研究结束时的快速分析。
