Tacrolimus is safe and effective in patients with severe steroid-refractory or steroid-dependent inflammatory bowel disease - A long-term follow-up
Tacrolimus is safe and effective in patients with severe steroid-refractory or steroid-dependent inflammatory bowel disease - A long-term follow-up
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DOI：
10.1111/j.1572-0241.2006.00524.x
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发表时间：
2006-05-01
影响因子：
9.8
通讯作者：
Dignass, Axel U.
中科院分区：
文献类型：
--
作者：
Baumgart, Daniel C.;Pintoffl, Jan P.;Dignass, Axel U.
目的：我们和其他人已经报道了他克莫司在难治性炎症性肠病（IBD）中的应用。鲜为人知的是，其长期efficacy and safety.METHODS：在这项回顾性，观察性单中心研究的图表53例成人患者类固醇依赖性（n = 18）或类固醇难治性（n = 35）IBD，克罗恩病（CD）（n = 11），溃疡性结肠炎（UC）（n = 40），或结肠袋炎（PC）（n = 2）进行了审查。他克莫司（0.1 mg/kg体重/天）全部经口给药，2例患者最初经静脉给药（0.01 mg/kg体重/天），旨在使血清谷浓度达到4-8 ng/mL。53例患者中的41例（77.1%）接受了硫唑嘌呤合并治疗。平均治疗持续时间为25.2 ± 4.6 SD个月（0.43-164个月）。患者平均随访39 ± 4.1 SD个月（5-164个月）。结果：31例UC患者（78%）、10例CD患者（90.1%）和2例PC患者（100%）在30天内立即出现临床反应或缓解。UC和CD患者的M-CAI记录了统计学显著性下降。9例UC患者（22.5%）在治疗开始后1.6 - 41.3个月接受结肠切除术。平均无结肠切除术生存期为104.8 ± 15.5（95% CI 74.4-135.2）个月（限于164.4个月）。43.8个月时累积无结肠切除术生存率估计为56.5%。45例UC和CD患者中有40例（90%）减少或停用类固醇。副作用包括肌酐暂时升高4例（7.6%）、震颤或感觉异常5例（9.4%）、高钾血症1例（1.9%）、高血压1例（1.9%）和机会性感染2例（3.8%）。
OBJECTIVE: We and others have reported the use of tacrolimus in refractory inflammatory bowel disease (IBD). Little is known about its long-term efficacy and safety.METHODS: In this retrospective, observational single center study the charts of 53 adult patients with steroid-dependent (n = 18) or steroid-refractory (n = 35) IBD, Crohn's disease (CD) (n = 11), ulcerative colitis (UC) (n = 40), or pouchitis (PC) (n = 2) were reviewed. Tacrolimus (0.1 mg/kg body weight per day) was administered orally in all and initially intravenously in 2 patients (0.01 mg/kg body weight per day), aiming for serum trough levels of 4-8 ng/mL. Forty-one of 53 (77.1%) patients were receiving concomitant azathioprine. The mean treatment duration was 25.2 +/- 4.6 SD months (0.43-164 months). Patients were followed for a mean of 39 +/- 4.1 SD months (5-164 months). Response was evaluated using a modified clinical activity index (M-CAI).RESULTS: Thirty-one UC (78%), 10 CD (90.1%), and both PC (100%) patients experienced an immediate clinical response or went into remission at 30 days. A statistically significant drop on the M-CAI was documented for UC and CD patients. Nine UC patients (22.5%) underwent colectomy between 1.6 and 41.3 months following initiation. Mean colectomy-free survival was 104.8 +/- 15.5 (95% CI 74.4-135.2) months (limited to 164.4 months). Cumulative colectomy-free survival was estimated 56.5% at 43.8 months. Steroids were reduced or discontinued in 40 of 45 UC and CD patients (90%) taking steroids. Side effects included a temporary rise of creatinine (n = 4, 7.6%), tremor or paresthesias (n = 5, 9.4%), hyperkalemia (n = 1, 1.9%), hypertension (n = 1, 1.9%), and opportunistic infections (n = 2, 3.8%).CONCLUSION: Long-term tacrolimus therapy appears safe and effective in refractory IBD.