维得利珠单抗治疗炎症性肠病的临床疗效分析  

Clinical efficacy of vedolizumab for inflammatory bowel disease

作　　者：刘思雪[1] 钟娃[1] 林 夏忠胜[1] 钟英强[1] Liu Sixue;Zhong Wa;Lin Ying;Xia Zhongsheng;Zhong Yingqiang(Department of Gastroenterology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,China)

机构地区：[1]中山大学孙逸仙纪念医院消化内科,广州510120

出　　处：《新医学》2022年第10期767-773,共7页Journal of New Medicine

摘　　要：目的分析维得利珠单抗(VDZ)对炎症性肠病(IBD)的临床疗效,了解VDZ联合免疫抑制剂和(或糖皮质激素是否具有更好的治疗效果。方法统计使用VDZ治疗的活动期IBD患者共29例[溃疡性结肠炎(UC)21例、克罗恩病(CD)8例],诱导缓解期为第0、2、6周各用药一次(300 mg静脉滴注),维持缓解期每8周或每4周给药一次。分别在VDZ治疗第14/22周、第54(每8周一次维持治疗)/30周(每4周一次维持治疗)评估治疗效果。根据患者联合用药的类别,将患者分为VDZ单药治疗组及VDZ联合免疫抑制剂和(或)糖皮质激素治疗组,对比2组治疗效果。结果VDZ治疗UC患者第14/22周临床应答率81%(13/16),内镜改善率63%(10/16);第54周临床缓解率80%(4/5),黏膜愈合率40%(2/5)。VDZ治疗CD患者第14/22周治疗有效率75%(6/8),随访至第30周的CD患者仅1例,仍保持疾病缓解。VDZ单药治疗与联合免疫抑制剂和(或)糖皮质激素治疗相比,第14/22周的临床应答率比较差异无统计学意义。结论VDZ治疗UC和CD,诱导缓解和维持缓解均有明显疗效。未发现VDZ联合免疫抑制剂和(或)糖皮质激素能明显增加诱导缓解率,故临床实践中VDZ单药治疗方案可能更好。Objective To assess clinical efficacy of vedolizumab(VDZ) in the treatment of inflammatory bowel disease(IBD) and analyze whether VDZ combined with immunomodulator and/or corticosteroids can achieve better outcomes.Methods Twenty-nine patients with active IBD including 21 cases of ulcerative colitis(UC) and 8 cases of Crohn’s disease(CD) were recruited.They were assigned to receive VDZ(at a dose of 300 mg) intravenously at 0,2,6 weeks as induction therapy and every 8 or 4 weeks as maintenance therapy.The primary endpoint was clinical response at week 14/22,while the secondary endpoints were clinical remission and mucosal healing at week 54(VDZ administration every 8 weeks) or week 30(VDZ administration every 4 weeks).Based on the concomitant medications,all patients were divided into the VDZ monotherapy and combination groups(VDZ combined with immunomodulator and/or corticosteroids).The therapeutic effect was compared between two groups.Results Among UC patients,clinical response and endoscopic remission rates at week 14/22 were 81%(13/16) and 63%(10/16),respectively.At week 54,clinical remission rate was 80%(4/5)and mucosal healing rate was 40%(2/5).Among CD patients,clinical response rates at week 14/22 and week 30 were 75%(6/8) and 100%(1/1),respectively.There was no significant difference in clinical response rate at week 14/22 between the VDZ monotherapy and combination groups.Conclusions VDZ is an effective biologic agent as induction and maintenance therapy for UC and CD.VDZ combined with immunomodulator and/or corticosteroids brings no additional benefit in the induction therapy.Therefore,VDZ monotherapy may be a better choice in clinical practice.

关 键 词：维得利珠单抗 炎症性肠病 临床缓解 联合用药 黏膜愈合 

分 类 号：R574[医药卫生—消化系统]