Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial
Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial
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DOI：
10.1016/s0140-6736(08)60799-0
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发表时间：
2008-05-01
期刊：
影响因子：
168.9
通讯作者：
van Weel, Chris
中科院分区：
文献类型：
--
作者：
Janssens, Hein J. E. M.;Janssen, Matthijs;van Weel, Chris
背景用于治疗痛风性关节炎的非甾体抗炎药和秋水仙碱具有胃肠道、肾脏和心血管不良反应。全身性皮质类固醇可能是一个有益的替代方案。我们研究了萘普生和泼尼松龙在初级保健中的等效性。方法我们进行了一项随机临床试验，以测试泼尼松龙和萘普生在治疗单关节痛风方面的等效性。经尿酸盐晶体证实的痛风初级保健患者符合条件。120例患者随机分配，计算机生成的随机接受泼尼松龙（35毫克，每天一次; n=60）或萘普生（500毫克，每天两次; n=60），5天。对患者和医生的治疗均设盲。主要结局是在100 mm视觉模拟量表上测量的疼痛，等效性的先验界值设定为10%。本研究注册为国际标准随机对照试验，编号ISRCTN 14648181。结果每个治疗组中有1例患者的数据不完整，因此符合方案分析包括每组59例患者。90小时后，泼尼松龙和萘普生的疼痛评分分别降低44.7 mm和46.0 mm（差异1.3 mm; 95% CI-9.8至7.1），表明等效。疼痛变化的大小差异为1.57 mm（95% CI -8.65至11.78）。两组之间的不良反应相似，轻微，并解决了3周follow.Interpretation口服泼尼松龙和萘普生是同样有效的痛风关节炎的初始治疗超过4天。基金流变学研究基金阿纳姆，荷兰。
Background Non-steroidal anti-inflammatory drugs and colchicine used to treat gout arthritis have gastrointestinal, renal, and cardiovascular adverse effects. Systemic corticosteroids might be a beneficial alternative. We investigated equivalence of naproxen and prednisolone in primary care.Methods We did a randomised clinical trial to test equivalence of prednisolone and naproxen for the treatment of monoarticular gout. Primary-care patients with gout confirmed by presence of monosodium urate crystals were eligible. 120 patients were randomly assigned with computer-generated randomisation to receive either prednisolone (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. Treatment was masked for both patients and physicians. The primary outcome was pain measured on a 100 mm visual analogue scale and the a priori margin for equivalence set at 10%. Analyses ware done per protocol and by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN14648181.Findings Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients in each group. After 90 h the reduction in the pain score was 44.7 mm and 46.0 mm for prednisolone and naproxen, respectively (difference 1.3 mm; 95% CI-9.8 to 7.1), suggesting equivalence. The difference in the size of change in pain was 1.57 mm (95% CI -8.65 to 11.78). Adverse effects were similar between groups, minor, and resolved by 3 week follow-up.Interpretation Oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days.Funding Rheumatology Research Fund Arnhem, Netherlands.