Stroehmann I, Fedder M, Zeidler H
Rheumatology Clinic, Bonn-Bad Godesberg, Federal Republic of Germany.
Drugs. 1990;40 Suppl 5:38-42. doi: 10.2165/00003495-199000405-00009.
Although randomised controlled comparative trials concerning the efficacy of the drug tested can produce reliable results in a limited number of selected patient groups, drug monitoring studies involving 10,000 patients or more are the methods of choice to detect rare adverse events. The aim of this drug monitoring study was to evaluate the efficacy and safety of dispersible nabumetone tablets. 8865 patients (46.2% male, 53.5% female, mean age 55 years, range 14.95) were involved in the investigation carried out by 1172 general practitioners. The disease indications comprised osteoarthritis (69.8%), soft-tissue rheumatism (11.3%), rheumatoid arthritis (9.9%) and soft tissue injuries (7.7%). Most of the patients (67.3%) received a daily dose of nabumetone 1 g for up to 6 weeks. Efficacy was evaluated at baseline, and after 1 week, 3 weeks and 6 weeks of treatment. With regard to global efficacy, overall improvement (symptoms resolved or markedly improved) was assessed in 82% of the patients. Elimination or at least significant improvement of pain on movement occurred in 95%, pain on pressure in 90% and pain at rest in 89% of the patients with symptoms. In relation to swelling, morning stiffness and joint mobility, elimination or at least significant improvement occurred in 79%, 80% and 82% of patients, respectively. 1846 patients (20.8%) had frequent periods of NSAID-related symptoms before treatment with nabumetone. A total of 1174 adverse events occurred in 850 patients (9.6%), most comprising minor gastrointestinal complaints. Considering that at least 25,000 patients have been documented in 2 German drug monitoring studies, it is therefore unlikely that any unexpected side effects will occur in the future. Consequently, nabumetone can be classified as an effective and safe NSAID.
尽管有关受试药物疗效的随机对照比较试验能够在少数选定的患者群体中产生可靠结果，但涉及10000名或更多患者的药物监测研究才是检测罕见不良事件的首选方法。这项药物监测研究的目的是评估萘丁美酮分散片的疗效和安全性。1172名全科医生参与了该项调查，共有8865名患者（男性占46.2%，女性占53.5%，平均年龄55岁，年龄范围为14.95岁）。疾病适应症包括骨关节炎（69.8%）、软组织风湿病（11.3%）、类风湿性关节炎（9.9%）和软组织损伤（7.7%）。大多数患者（67.3%）接受每日1克萘丁美酮的剂量，持续用药长达6周。在基线以及治疗1周、3周和6周后对疗效进行评估。就整体疗效而言，82%的患者评估为整体改善（症状消失或明显改善）。有症状的患者中，95%的患者运动时疼痛消除或至少明显改善，90%的患者压痛时疼痛改善，89%的患者静息时疼痛改善。在肿胀、晨僵和关节活动度方面，分别有79%、80%和82%的患者症状消除或至少明显改善。1846名患者（20.8%）在使用萘丁美酮治疗前经常出现非甾体抗炎药相关症状。850名患者（9.6%）共发生1174起不良事件，大多数为轻微胃肠道不适。鉴于在两项德国药物监测研究中记录的患者至少有25000名，因此未来不太可能出现任何意外的副作用。因此，萘丁美酮可归类为一种有效且安全的非甾体抗炎药。
