A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis

A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis
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DOI:
10.1097/00004836-200210000-00009
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发表时间:
2002-10-01
影响因子:
2.9
通讯作者:
Awasthi, G
Awasthi, G
中科院分区:
医学3区
文献类型:
--
作者:
Sood, A;Midha, V;Awasthi, G

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背景:严重溃疡性结肠炎的常规治疗方法是注射糖皮质激素后再口服糖皮质激素。经常使用皮质类固醇会产生副作用。本研究尝试了皮质类固醇脉冲治疗,即使用超生理剂量,然后完全停药,副作用可能更少。研究:对14例重度溃疡性结肠炎患者进行地塞米松脉冲治疗,即以5%葡萄糖滴注100 mg/d,连续3天。在第7、15、30和60天评估溃疡性结肠炎疾病活动性。主要终点定义为在第15天达到临床缓解和活动指数低于150的患者数量。第二个终点是在30天和60天仍处于缓解期且活动指数低于150的患者数量。在接受3天大剂量皮质类固醇输注后,没有患者接受后续的口服皮质类固醇治疗。结果:93%的患者(14例患者中的13例)在第15天达到临床缓解。这13例患者中有2例在随访期间复发,因此,79%的患者在30天和60天的临床缓解持续。结论:地塞米松脉冲治疗在溃疡性结肠炎患者诱导缓解方面非常有效,但需要随机对照试验来比较地塞米松脉冲治疗与标准口服皮质类固醇持续治疗方案。
Background: Severe ulcerative colitis is conventionally treated with parenteral corticosteroids followed by oral corticosteroids. Regular use of corticosteroids is associated with side effects. Corticosteroid pulse therapy, i.e., use of supraphysiologic dose followed by complete withdrawal, which is likely to have fewer side effects, was tried in the current study. Study: Dexamethasone pulse therapy, i.e., 100-mg/d infusion in 5% dextrose, was used for 3 consecutive days in 14 patients with severe ulcerative colitis. Ulcerative colitis disease activity was assessed on days 7, 15, 30, and 60. The primary end point was defined as the number of patients who achieved clinical remission and an activity index less than 150 at day 15. The second end point was the number of patients who remained in remission and had an activity index less than 150 at 30 and 60 days. None of the patients enrolled got subsequent oral corticosteroids after their 3 days of megadose corticosteroid infusion. Results: Clinical remission was achieved in 93% patients (13 of 14 patients) by day 15. Two of these 13 patients suffered relapse during follow-up, and hence, the clinical remission was sustained in 79% patients at 30 and 60 days. Conclusions: Dexamethasone pulse therapy is highly effective in inducing remission in patients with ulcerative colitis, but randomized controlled trials are needed to compare dexamethasone pulse therapy with standard oral continuous corticosteroid regimens.