Zheng Jia-Ju, Wang Yu-Ming, Zhu Fan, Gu Wei, Xing Ye-Chen, Zhou Chun-Li, Shen Bi-Wu
Department of Gastroenterology, Affiliated Suzhou Hospital of Nanjing Medical University/Suzhou Municipal Hospital, Suzhou Institute for Digestive Disease and Natrition, Suzhou 215008, China. Email:
Zhonghua Nei Ke Za Zhi. 2009 Nov;48(11):922-5.
To investigated the potential and safety of the monoclonal antibody to TNFalpha infliximab (IFX) in the treatment of active Crohn's disease (CD).
Patients who were confirmed diagnosis of CD and were unresponsive to the conventional treatments, or recurred after surgeries, or discontinued treatment due to drug intolerance, were treated with IFX intravenously in a dose of 5 mg/kg at week 0, 2, 6 (IFX infusion continued at an interval of every 8 weeks if respond to initial dosing). Clinical assessments, including disease activity, blood biological markers and colonoscopic findings, were performed at baseline (week 0) and each week (4 weeks or later for colonoscopy) after IFX infusion were conducted until the week before 4(th) infusion from initiated.
Ten patients (8 male, 2 female) with mean age of 31.4 years (ranged from 15 to 65 years old) were included in the analysis. The mean subjective score from baseline to week 14 was decreased from 2.2 +/- 0.6 to 1.2 +/- 0.4 (P < 0.05). The mean Harvey-Bradshaw index was 6.6 +/- 1.6 at baseline and 2.1 +/- 1.0 at week 14. The levels of ESR, CRP, serum total protein (TP) and albumin (Alb) were significantly improved during the 14-week period. Colonoscopy showed a remarkable improvement of Crohn's Disease Endoscopic Index of Severity (CDEIS). No infusion-related reaction was observed in all patients during the treatment. Mild or transient skin itching and headache were respectively reported in two patients. Transient elevation of serum ALT and AST after 3(rd) infusion in one patient, and severe anemia including leucopenia and thrombocytopenia at week 35 after 1(st) infusion in one male patient were observed.
Treatment with three infusions of IFX in a dose of 5 mg/kg was effective for induction of remission for active and complex CD patients who failed to respond to conventional treatment. Long-term safety of the therapy effect was warranted in further investigations.
探讨抗TNFα单克隆抗体英夫利昔单抗（IFX）治疗活动期克罗恩病（CD）的有效性和安全性。
确诊为CD且对传统治疗无反应、手术后复发或因药物不耐受而停药的患者，于第0、2、6周静脉注射IFX，剂量为5mg/kg（若对初始剂量有反应，则每8周继续输注IFX）。在基线（第0周）及IFX输注后的每周（结肠镜检查在4周或更晚进行）进行临床评估，包括疾病活动度、血液生物学标志物和结肠镜检查结果，直至第4次输注前一周。
纳入分析的10例患者（8例男性，2例女性），平均年龄31.4岁（15至65岁）。从基线到第14周，主观评分均值从2.2±0.6降至1.2±0.4（P<0.05）。Harvey-Bradshaw指数在基线时为6.6±1.6，第14周时为2.1±1.0。在14周期间，血沉、CRP、血清总蛋白（TP）和白蛋白（Alb）水平显著改善。结肠镜检查显示克罗恩病内镜严重程度指数（CDEIS）有显著改善。治疗期间所有患者均未观察到输注相关反应。分别有2例患者报告了轻度或短暂的皮肤瘙痒和头痛。1例患者在第3次输注后血清ALT和AST短暂升高，1例男性患者在第1次输注后第35周出现包括白细胞减少和血小板减少的严重贫血。
5mg/kg剂量的IFX三次输注治疗对传统治疗无效的活动期和复杂性CD患者诱导缓解有效。该治疗效果的长期安全性有待进一步研究证实。
