早期应用英夫利昔单抗联合硫唑嘌呤治疗合并2个以上预后不良高危因素克罗恩病疗效及安全性研究

发布时间：2018-04-30 17:31

本文选题：克罗恩病 + 英夫利昔单抗　；参考：《中国实用内科杂志》2017年03期

【摘要】：目的探讨英夫利昔单抗(IFX)联合硫唑嘌呤(AZA)治疗合并2个以上预后不良高危因素克罗恩病(CD)患者的疗效及安全性。方法回顾性分析2013年3月至2015年6月中国医科大学附属盛京医院接受早期IFX联合AZA治疗的18例合并≥2个预后不良高危因素CD患者的临床资料。比较治疗前、治疗后14、30周患者实验室指标、克罗恩病活动指数(Best CDAI)评分、克罗恩病简化内镜评分(SES-CD)、瘘管愈合率及不良反应的情况。结果 18例患者均完成14周的治疗,其中9例完成30周的治疗。与治疗前相比,治疗后第14周患者Best CDAI、SES-CD评分、红细胞沉降率(ESR)及C反应蛋白(CRP)明显下降(P0.05);红细胞比容(HCT)、白蛋白(ALB)及体重指数(BMI)明显升高(P0.05)。与治疗后第14周相比,治疗后第30周患者Best CDAI、SES-CD评分进一步显著下降(P0.05);BMI进一步上升(P0.05)。第14、30周临床缓解率分别为83.3%(15/18)、88.9%(8/9);内镜下黏膜愈合率分别为11.1%(2/18)、55.6%(5/9)。6例合并有肛瘘的CD患者中2例完成第30周的治疗。治疗后第14周,6例瘘管部分愈合;2例患者完成了30周的治疗,瘘管均完全愈合。2例在第2周出现一过性肝功能异常,3例患者在第6周时出现WBC计数下降,经相应治疗短期内恢复正常,均未影响继续治疗。所有患者随访至2016年10月11日未观察到药物相关感染及恶性肿瘤等不良事件发生。结论 IFX早期联合AZA治疗合并≥2个预后不良高危因素的CD患者,可有效改善临床症状,控制全身炎症状态;持续治疗能够有效诱导并维持疾病缓解,促进内镜下肠黏膜愈合,促进瘘管愈合;且并未明显增加不良反应的发生。
[Abstract]:Objective to evaluate the efficacy and safety of infliximab IFX combined with azathioprine (AZA) in the treatment of patients with more than 2 risk factors for poor prognosis: Crohn's disease. Methods from March 2013 to June 2015, clinical data of 18 patients with CD complicated with more than 2 risk factors for poor prognosis in Shengjing Hospital affiliated to China Medical University who received early IFX combined with AZA therapy were retrospectively analyzed. The laboratory indexes, activity index of Crohn's disease and best CDAIscore, the simplified endoscopic score of Crohn's disease, the fistula healing rate and the adverse reactions were compared before and 14 weeks after treatment. Results all 18 patients completed 14 weeks of treatment, 9 of them completed 30 weeks of treatment. Compared with before treatment, the scores of Best CDAISES-CD, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were significantly decreased in the patients at the 14th week after treatment, and the RBC specific volume of HCT, Alb) and body mass index (BMI) were significantly increased (P 0.05). Compared with the 14th week after treatment, the scores of Best CDAISES-CD in the patients at the 30th week after treatment were significantly lower than those at the 14th week after treatment. At 1430 weeks, the clinical remission rate was 83.3 / 1888. 9%, respectively, and the rate of mucosal healing under endoscope was 11. 1 / 18 / 55.6 / 9.6 patients with anal fistula. 2 of the patients with anal fistula completed the treatment at 30 weeks. At the 14th week after treatment, 6 patients with partial fistula healing and 2 patients with partial fistula healing completed the treatment for 30 weeks. The fistula was completely healed in 2 patients with transient hepatic dysfunction at week 2. The WBC count decreased in 3 patients at the 6th week. After the corresponding treatment within a short period of time to return to normal, did not affect the continuation of treatment. No adverse events such as drug-related infection and malignant tumor were observed in all patients until Oct 11, 2016. Conclusion early IFX combined with AZA can effectively improve clinical symptoms and control systemic inflammation in CD patients with more than 2 risk factors for poor prognosis, and continuous treatment can effectively induce and maintain remission of the disease and promote endoscopic intestinal mucosal healing. Promote fistula healing, and did not significantly increase the incidence of adverse reactions.
【作者单位】：中国医科大学附属盛京医院消化内科;
【基金】：沈阳市科技创新专项资金(F13-220-9-50)
【分类号】：R574.62

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