Löfberg R, Rutgeerts P, Malchow H, Lamers C, Danielsson A, Olaison G, Jewell D, Ostergaard Thomsen O, Lorenz-Meyer H, Goebell H, Hodgson H, Persson T, Seidegård C
Unit of Gastroenterology, Karolinska Institute, Huddinge, Sweden.
Gut. 1996 Jul;39(1):82-6. doi: 10.1136/gut.39.1.82.
To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD).
Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment.
Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups.
6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.
评估口服控释制剂布地奈德对回肠和回盲部克罗恩病（CD）患者维持缓解的有效性和安全性。
176例活动性CD患者在接受布地奈德或泼尼松龙治疗10周后达到缓解（CD活动指数评分≤150），其中90例患者被随机分配至双盲、多中心试验中，接受每日1次6mg布地奈德、3mg布地奈德或安慰剂治疗，最长治疗12个月。使用Kaplan-Meier估计法计算症状复发时间。在门诊就诊时测量晨血浆皮质醇，并在治疗3个月后进行促肾上腺皮质激素刺激试验。
32例患者被分配至6mg布地奈德组，31例至3mg组，27例至安慰剂组。3个月后，6mg组19%的患者复发，3mg组为45%，安慰剂组为44%（p=0.047）。12个月后的相应结果为，6mg布地奈德组为59%，3mg组为74%，安慰剂组为63%（p=0.44）。6mg组复发或停药的中位时间为258天，3mg组为139天，安慰剂组为92天（p=0.021）。所有三组患者的平均晨血浆皮质醇值从入组时开始升高，在12个月时无统计学显著差异。3个月后，安慰剂组剩余的13例患者促肾上腺皮质激素刺激反应均正常，6mg布地奈德组23例患者中有18例正常，3mg布地奈德组21例患者中有19例正常（p=0.14）。痤疮和满月脸在布地奈德组中略为常见。
每日1次6mg布地奈德在延长CD患者复发时间方面显著优于安慰剂，且仅引起轻微的全身副作用。
