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首页> 外文期刊>Inflammatory bowel diseases >Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label phase I-II study of tolerance.
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Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label phase I-II study of tolerance.

机译：口服尼古丁治疗炎性肠病的初步观察：I-II期开放性耐受研究。

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BACKGROUND: Transdermal nicotine provides benefit in active ulcerative colitis but is often associated with adverse events (AEs). An oral formulation has been developed to minimize AEs. This study was undertaken to make initial observations on the safety and tolerance of oral nicotine therapy in inflammatory bowel disease; the effect on disease activity was also noted. METHODS: Twenty-six patients with ulcerative colitis, 11 with active disease, and 5 patients with Crohn's colitis (2 with active disease) were given oral nicotine in 3-mg capsules, gradually increasing the dose to the maximum tolerated. AEs were recorded, concomitant prednisolone and/or azathioprine were reduced where possible, and disease activity was reassessed at the end of nicotine treatment. RESULTS: Patients were followed for up to 12 months. Twenty-nine of 31 could tolerate at least 6 mg of nicotine each day, and 5 patients tolerated at least 18 mg daily. Twenty-four patients had nicotine-related nonserious AEs; over one half occurred during the period of dose escalation, but 7 discontinued treatment because of them. Six of the 13 patients with active disease became asymptomatic, whereas 3 patients in remission developed active symptoms; 11 patients reduced their concomitant medication. CONCLUSIONS: Oral nicotine is a safe potential treatment of inflammatory bowel disease, but there is considerable variation in tolerance.
机译：背景：尼古丁经皮可在活动性溃疡性结肠炎中发挥作用，但通常与不良事件（AE）相关。已经开发了口服制剂以最小化AE。进行这项研究是为了对炎症性肠病中口服尼古丁治疗的安全性和耐受性进行初步观察。还注意到了对疾病活动的影响。方法：对26例溃疡性结肠炎患者，11例活动性疾病患者和5例克罗恩氏结肠炎患者（2例活动性疾病）给予尼古丁口服3 mg胶囊，逐渐将其剂量增加至最大耐受量。记录不良事件，并在可能的情况下减少泼尼松龙和/或硫唑嘌呤的使用，并在尼古丁治疗结束时重新评估疾病活动。结果：对患者进行了长达12个月的随访。 31名患者中有29名每天可耐受至少6 mg尼古丁，而5名患者每天可耐受至少18 mg。 24例患者发生了尼古丁相关的非严重不良事件;超过一半的时间发生在剂量递增期间，但有7位患者因此中断治疗。 13例活动性疾病患者中有6例无症状，而缓解的3例患者出现活动性症状。 11例患者减少了用药。结论：口服尼古丁是治疗炎症性肠病的一种安全的潜在方法，但耐受性差异很大。

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