Brobyn R D
Kitsap Medical Research Foundation, Bainbridge Medical Center, Bainbridge Island, Washington 98110.
Am J Med. 1987 Oct 30;83(4B):50-4. doi: 10.1016/0002-9343(87)90594-8.
One hundred patients were entered in a six-month, double-blind comparison of 1,000 mg nabumetone once daily and 250 mg naproxen twice daily. Forty-two patients in each arm of the study were evaluable for efficacy; all were evaluable for safety. There was a low incidence of adverse experiences during this study, with no patients withdrawing from the study because of side effects from either drug. Efficacy was equal, with both compounds sharing the same degree and rate of improvement. All of the patients completing the double-blind phase were then switched to open-label treatment with nabumetone. The dosage of nabumetone was gradually increased. At the end of one year, 84 patients remained in the study (52 taking 1,000 mg per day, 23 taking 1,500 mg, and nine taking 2,000 mg). This gradual increase has continued, and, at this time, 61 patients remain in the study (seven taking 1,000 mg per day, 24 taking 1,500 mg, and 30 taking 2,000 mg). There have been very few side effects. From this study, it can be concluded that nabumetone is at least as effective as naproxen and, even at higher doses, had an acceptable safety profile for extended use in patients with rheumatoid arthritis.
100名患者参与了一项为期6个月的双盲对比试验，比较每日一次服用1000毫克萘丁美酮与每日两次服用250毫克萘普生的效果。研究的每组中有42名患者可进行疗效评估；所有患者均可进行安全性评估。在这项研究中，不良事件的发生率较低，没有患者因任何一种药物的副作用而退出研究。两种药物疗效相当，改善程度和改善速度相同。所有完成双盲阶段的患者随后都改用萘丁美酮开放标签治疗。萘丁美酮的剂量逐渐增加。在一年结束时，84名患者仍在参与研究（52人每天服用1000毫克，23人服用1500毫克，9人服用2000毫克）。这种逐渐增加的情况一直在持续，目前，仍有61名患者在参与研究（7人每天服用1000毫克，24人服用1500毫克，30人服用2000毫克）。副作用非常少。从这项研究可以得出结论，萘丁美酮至少与萘普生一样有效，并且即使在更高剂量下，对于类风湿性关节炎患者长期使用而言，其安全性也是可以接受的。
