The use of infliximab in the prevention of postsurgical recurrence in polysurgery Crohn's disease patients: a pilot open-labeled prospective study.
The use of infliximab in the prevention of postsurgical recurrence in polysurgery Crohn's disease patients: a pilot open-labeled prospective study.
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使用英夫利昔单抗预防多手术克罗恩病患者的术后复发：一项开放标记的试点前瞻性研究。
DOI：
10.1007/s00384-011-1398-y
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
Hibi T.
中科院分区：
文献类型：
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作者：
Sakuraba A;Sato T;Matsukawa H;Okamoto S;Takaishi H;Ogata H;Iwao Y;Hibi T.
目的：罗恩病（CD）术后经常复发，许多患者需要反复手术治疗，尤其是吸烟者和多次手术或有穿透性疾病的患者。英夫利昔单抗是否能预防高危CD术后复发尚不清楚。在目前的试点开放标签研究中，我们调查了术后早期开始使用预定的英夫利昔单抗维持因穿透性疾病而多次手术的CD患者缓解的安全性和有效性。方法选取6例因穿透性疾病多次手术的患者（中位4例，范围2 ~ 5例），其中男9例，女2例，年龄26 ~ 48岁。术后2 ~ 4周，患者开始静脉注射英夫利昔单抗（5 mg/kg），间隔8周。主要终点是研究结束时临床缓解的患者比例，24个月时内镜/放射学缓解率，以及不良反应发生率。结果1例患者因不符合而退出，10例患者符合分析条件。在研究结束时，10名患者中有6名（60.0%）维持临床缓解。24个月时，10例患者中有4例内镜或放射学缓解（40.0%）。2例患者出现不良反应（18.2%），其中1例选择退出研究。结论本研究结果无重大安全性问题和可能的临床获益，表明英夫利昔单抗作为预防高危CD术后复发的治疗方法值得进一步研究。
PurposeCrohn's disease (CD) commonly recurs after surgery, and a number of patients need repeated surgery, especially smokers and those with repeated surgeries or penetrating disease. Whether infliximab prevents postsurgical recurrence in high-risk CD remains unknown. In the present pilot open-labeled study, we investigated the safety and efficacy of scheduled infliximab, which was started early after surgery, in maintaining remission of CD patients who have undergone multiple surgeries due to penetrating disease.MethodsEleven patients (nine male, two female; age range, 26–48 years) who had undergone repeated surgeries (median, 4; range, 2–5) for penetrating disease were enrolled. Two to 4 weeks after surgery, the patients were started on intravenous infliximab (5 mg/kg) at an 8-week interval. The primary end points were the proportion of patients in clinical remission at the end of the study, the rate of endoscopic/radiologic remission at 24 months, and the rate of adverse effects.ResultsOne patient dropped out due to non-compliance, and ten patients were eligible for analysis. Clinical remission was maintained in six of ten patients (60.0%) at the end of the study. At 24 months, four out of ten patients were in endoscopic or radiological remission (40.0%). Two patients experienced adverse effects (18.2%), one of whom elected to withdraw from the study.ConclusionThe findings of no major safety concern and possible clinical benefit in our study suggest that further investigation of infliximab as a treatment for prevention of postsurgical recurrence in high-risk CD is warranted.