摘要
目的:评价维得利珠单抗(VDZ)治疗炎症性肠病的疗效和安全性.方法:回顾性收集2021年3月至2023年8月本院肛肠科收治的使用VDZ治疗的炎症性肠病(IBD)患者共25例[溃疡性结肠炎(UC)13例、克罗恩病(CD)12例]的病例资料.给予静脉输注VDZ,在第0、2、6周给药300 mg诱导缓解治疗,随后每8周300 mg静脉给药一次维持缓解治疗,用药30周后进行评价.主要疗效指标包括临床应答率、临床缓解率、内镜缓解率,次要疗效指标包括营养状况指标[体质量(Wt)、血红蛋白(HGB)、白蛋白(ALB)、血细胞比容(HCT)]、炎症程度指标[超敏C反应蛋白(hs-CRP)、红细胞沉降率(ESR)].记录VDZ治疗期间出现的所有不良反应.结果:IBD患者使用VDZ治疗6周和14周的总临床应答率分别为32％和60％,用药14周和30周的总临床缓解率分别为16％和36％,用药30周的总内镜缓解率为16％.VDZ对于治疗UC和CD的临床应答率和临床缓解率无统计学差异.与用药前相比,UC患者用药30周后体质量明显增加,营养指标HCT％、ALB、HGB水平明显好转,炎症指标ESR水平显著下降;CD患者用药30周与用药前相比,体质量明显增加,炎症指标hs-CRP、营养指标HCT％、ALB、HGB水平显著改善.1例患者在第3次输注VDZ后出现白细胞计数升高外,未发生其他不良反应.结论:VDZ作为IBD患者的诱导和维持治疗用药,能够显著减轻IBD患者肠道炎症反应、缓解患者临床症状、改善患者营养状况、提高患者生活质量,且安全性良好.
Abstract
AIM:To evaluate the efficacy and safe-ty of vedolizumab in the treatment of inflammato-ry bowel disease.METHODS:The clinical data of 25 patients with inflammatory bowel disease(IBD)(13 ulcerative colitis(UC)and 12 Crohn's disease(CD))treated with vedolizumab(VDZ)in the Anorectal department of our hospital from July 2020 to Au-gust 2023 were retrospectively collected.VDZ 300 mg was given intravenously at weeks 0,2 and 6 to induce remission,and 300 mg was given intrave-nously every 8 weeks to maintain remission.The evaluation was carried out after 30 weeks of treat-ment.The primary efficacy indicators included clini-cal response rate,clinical remission rate,and endo-scopic remission rate.The secondary efficacy indi-cators included nutritional status indicators(body weight(Wt),hemoglobin(HGB),albumin(ALB),he-matocrit(HCT)),inflammation degree indicators(high-sensitivity C-reactive protein(hs-CRP),eryth-rocyte sedimentation rate(ESR)).All adverse reac-tions that occurred during VDZ treatment were re-corded.RESULTS:The total clinical response rate of IBD patients treated with VDZ for 6 weeks and 14 weeks was 32％and 60％,respectively.The total clinical remission rate of IBD patients treated with VDZ for 14 weeks and 30 weeks was 16％and 36％,respectively.There was no significant difference in clinical response rate and clinical remission rate be-tween UC and CD treated with VDZ(P＞0.05).After 30 weeks of treatment,the body weight of UC pa-tients was significantly increased,the levels of HCT％,ALB and HGB were significantly improved,and the level of ESR was significantly decreased.Af-ter 30 weeks of treatment,the body weight of CD patients increased significantly,and the inflamma-tory index hs-CRP,nutritional index HCT％,ALB and HGB levels were significantly improved.One pa-tient had an increase in white blood cell count af-ter the third infusion of VDZ,and no other adverse reactions occurred.CONCLUSION:As an induction and maintenance therapy for IBD patients,VDZ can alleviate intestinal inflammation,relieve clinical symptoms,improve nutritional status and improve quality of life of patients,with high safety.
基金项目
国家自然科学基金面上项目(82373878)
安徽省自然科学基金(2308085MH312)
安徽省新时代育人质量工程项目(2022cxcysj082)
研究生科研与实践创新项目(YJS20230009)
维普
万方数据