Oral budesonide is as effective as oral prednisolone in active Crohn's disease
Oral budesonide is as effective as oral prednisolone in active Crohn's disease
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DOI：
10.1136/gut.41.2.209
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发表时间：
1997-08-01
期刊：
影响因子：
24.5
通讯作者：
Weir, DG
中科院分区：
文献类型：
--
作者：
Campieri, M;Ferguson, A;Weir, DG
背景-糖皮质激素在活动期克罗恩病中的应用常常受到副作用的限制。布地奈德是一种有效的皮质类固醇激素，由于广泛的首过肝脏代谢，其全身生物利用度较低。目的：比较布地奈德和强的松龙两种剂量方案对影响回肠和/或上行结肠的活动期克罗恩病患者的疗效和安全性。患者和方法：178名患者随机分为布地奈德回肠控制释放胶囊9 mg/d或4.5 mg/d/d，或强的松龙片40 mg/d/d。疗程均为12周。主要疗效变量为临床缓解，定义为克隆氏病活动指数小于或等于150。结果：经过8周的治疗后，接受布地奈德每日一次或强的松龙治疗的患者中有60%出现缓解，接受布地奈德每日两次治疗的患者中有42%出现缓解(p=0.062)。糖皮质激素相关副作用的出现在所有组中都是相似的，但强的松龙组中月亮脸更常见(p=0.0005)。短促肾上腺皮质激素试验显示，强的松龙组肾上腺功能受损的发生率最高(p=0.0023)。结论：布地奈德CIR每日1次9 mg或每日2次，在诱导活动期克罗恩病缓解方面与强的松龙相当。单剂量给药与强的松龙一样迅速有效，代表了一种更简单、更安全的治疗方法，副作用显著减少。
Background-The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism.Aims-To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon.Patients and methods-One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks. The primary efficacy variable was clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of 150 or less.Results-After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p=0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p=0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p=0.0023).Conclusions-Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn's disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.