摘要
背景:慢性抗生素难治性储袋炎(CARP)是回肠储袋-肛管吻合术(IPAA)的一个并发症,治疗上存在巨大挑战。维多珠单抗是一种肠道选择性的抗α4β7整合素单克隆抗体,现已应用于CARP患者,但其疗效数据报道不多。本研究旨在评估维多珠单抗作为诱导治疗,应用于CARP患者的有效性和安全性。方法:从一个单中心的历史队列中,筛选出2015年1月至2017年6月间接受维多珠单抗治疗的CARP患者。病例纳入标准:改良储袋疾病严重指数(mPDAI)评分≥5的急性储袋炎;但如果没有mPDAI评分则以临床医生作出急性储袋炎的诊断为准。于治疗前及治疗后3个月,通过储袋镜和门诊检查来进行mPDAI评分。结果:19例患者纳入研究,平均年龄(26.7612.8)岁,其中男性10例(53%)。9例(47%)在结肠切除术前曾接受抗肿瘤坏死因子(TNF)药物治疗,10例(53%)患者在IPAA术后接受过抗TNF药物治疗。维多珠单抗治疗后,6例(32%)患者mPDAI症状评分显著改善(P=0.031);14例(74%)患者mPDAI内镜评分和总评分均显著改善,中位下降均为2分(P=0.031)。仅2例(11%)患者出现药物不良反应,另有4例(21%)患者需针对CARP行再次手术治疗。结论:本研究显示,维多珠单抗治疗CARP患者安全有效。而这些结果尚需更大样本量的研究证实。
Background:Chronic antibiotic-refractory pouchitis(CARP)is a complication of ileal pouch-anal anastomosis(IPAA),which poses a therapeutic challenge.Vedolizumab,a gut-selective monoclonal antibody to the a4b7 of integrin,has been used in such patients,but data on its efficacy are limited.Our aim was to assess the efficacy and safety of vedolizumab as induction therapy in CARP patients.Methods:In this single-center,historic cohort,patients with CARP who received vedolizumab between January 2015 to June 2017 were identified and analysed.Patients were included if they had active pouchitis with a total of modified pouch disease activity index(mPDAI)score5 or if unavailable clinician diagnosis of active pouchitis.Pre-treatment and at 3-month posttherapy pouchoscopy and clinical visits were used to calculate mPDAI.Results:A total of 19 patients were included in the study.The mean age was 26.7612.8 years,with 10(53%)males.Nine(47%)patients had been treated with anti-tumor necrosis factor(TNF)agents before colectomy and 10(53%)had anti-TNFs after colectomy and IPAA.Six(32%)patients had improvement in the mPDAI symptom subscores(P=0.031)and 14(74%)had improvement in both endoscopic and total mPDAI scores with a median change of-2 units(both P=0.031).Adverse events were noted only in two(11%)patients and four(21%)required surgery for CARP.Conclusions:Our study suggests that vedolizumab has efficacy and can be safely used for CARP patients.Larger studies with a higher number of patients are required to confirm these findings.
