阿达木单抗在伊朗西南地区治疗炎症性肠病的疗效

P. Alavinejad, S. Delavari, A. Parsi, A. Shayesteh
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引用次数: 0

摘要

背景:近年来,包括抗肿瘤坏死因子在内的生物药物已经彻底改变了炎症性肠病(IBD)的治疗;然而,阿达木单抗优于英夫利昔单抗尚无共识。目的:本研究旨在评估阿达木单抗在伊朗西南地区治疗IBD的疗效。方法:在这项前瞻性观察性研究中,纳入了在IBD诊所就诊的活动性IBD患者和既往治疗无反应的患者。此外,本研究还评估和比较了治疗后0、12、24和52周阿达木单抗注射的临床缓解率、疾病活动指数(溃疡性结肠炎(UC)患者的Mayo评分和克罗恩病(CD)患者的克罗恩病活动指数(CDAI))、临床反应和副作用。结果:共纳入71例患者,其中男性42例,女性29例,平均年龄29岁。本研究中,37例和34例患者分别被诊断为UC(52.1%,男性20例,女性17例)和CD(47.8%,男性22例,女性12例)。UC组缓解时间明显长于CD组(10.05个月和1.71个月;P < 0.0001)。阿达木单抗治疗后第12周UC患者的临床缓解率(Mayo评分降低≥2分)为67.5%,在治疗后第24周和第52周提高到100%(所有UC患者)。所有UC患者均无疾病复发。在CD患者中,CDAI在治疗期间显著降低(P < 0.0001);然而,所有CD患者(100%)在平均2.59±0.55个月(2 - 4个月)后出现疾病复发(P < 0.0001)。94.1%的CD患者治疗失败(n = 32);然而,没有UC患者出现治疗失败(P < 0.0001)。在研究期间,没有发生与阿达木单抗相关的并发症,没有患者需要结肠切除术。结论:阿达木单抗在改善中重度UC患者临床症状、降低疾病活动度、预防疾病复发、减少结肠切除术需要方面具有积极作用。然而,阿达木单抗在改善CD患者方面没有疗效,在大多数患者中观察到治疗失败。阿达木单抗可作为治疗既往治疗失败的UC的治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran
Background: In recent years, biological drugs, including antitumor necrosis factors, have revolutionized the treatment of inflammatory bowel disease (IBD); however, there is no consensus about the superiority of adalimumab over infliximab. Objectives: This study was designed to evaluate the efficacy of adalimumab for the management of IBD in the southwest region of Iran. Methods: During this prospective observational study, the patients with active IBD and a history of no response to previous treatments that referred to an IBD clinic were included. Moreover, this study evaluated and compared the effectiveness of treatment, including clinical remission rate, disease activity index (the Mayo score in ulcerative colitis (UC) patients and the Crohn’s Disease Activity Index (CDAI) in Crohn’s disease (CD) patients), clinical response, and side effects related to adalimumab injection in 0, 12th, 24th, and 52nd weeks after treatment. Results: A total of 71 patients, including 42 male and 29 female, with a mean age of 29 years, were included. In this study, 37 and 34 patients were diagnosed with UC (52.1%, 20 male and 17 female) and CD (47.8%, 22 male and 12 female), respectively. The time to remission in the UC group was significantly longer than in the CD group (10.05 and 1.71 months; P < 0.0001). Clinical remission rate (≥ 2 points reduction in the Mayo score) in the 12th week among UC patients after treatment with adalimumab was 67.5% and raised to 100% (all the UC patients) in the 24th and 52nd weeks after treatment. None of the UC patients experienced disease recurrence. In CD patients, the CDAI significantly decreased during the treatment time (P < 0.0001); however, all CD patients (100%) experienced disease recurrence after a mean time of 2.59 ± 0.55 months (within 2 - 4 months) (P < 0.0001). Failure of treatment was observed in 94.1% of CD patients (n = 32); nevertheless, none of the UC patients had treatment failure (P < 0.0001). There were no complications related to adalimumab, and no patients needed colectomy during the study period. Conclusions: Adalimumab has a positive effect on the improvement of clinical symptoms, reduction of disease activity, prevention of disease recurrence, and need for colectomy in moderate to severe UC patients. However, adalimumab has no efficacy in the improvement of CD patients, and failure of treatment was observed in most of these patients. Adalimumab could be a therapeutic option for the management of UC with prior failure of treatment.
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