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中国临床研究:2025,38(11):1726-1730
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维得利珠单抗治疗溃疡性结肠炎的疗效及安全性评价
(徐州医科大学附属淮安医院药学部, 江苏 淮安 223001)
Efficacy and safety of vedolizumab in the treatment of ulcerative colitis
(Department of Pharmacy,The Affiliated Huai'an Hospital of Xuzhou Medical University,Huai'an,Jiangsu 223001,China)
摘要
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投稿时间:2025-07-22   网络发布日期:2025-11-26
中文摘要: 目的 评价维得利珠单抗(VDZ)用于溃疡性结肠炎(UC)治疗时的疗效并探讨其安全性。方法 回顾性分析 2020 年 12 月至 2024 年 12 月徐州医科大学附属淮安医院使用 VDZ 治疗 UC 患者的临床资料;通过改良Mayo评分(MMS)评估UC疾病活动程度、溃疡性结肠炎内镜下严重程度指数(UCEIS)评估UC内镜严重程度;对比治疗前后炎症指标[白细胞(WBC)、淋巴细胞(LYM)、C反应蛋白(CRP)、红细胞沉降率(ESR)、粪便钙卫蛋白(Fc)等]及营养指标[身体质量指数(BMI)、白蛋白(ALB)];根据既往UC治疗中是否使用生物制剂,分为VDZ一线治疗组及二线治疗组,评估两组VDZ疗效差异;记录治疗过程中的不良反应发生情况。结果 最终纳入研究的UC患者共 54 例,男性占 40.74%,年龄(48.85±16.75)岁,病程 46.00(25.50,70.25)个月;VDZ 治疗后第 14 周临床应答率为 51.85%、临床缓解率为 20.37%,第 30 周临床应答率、临床缓解率及内镜缓解率分别为 66.67%、46.30%、27.78%。第 30 周时,与二线治疗组(n=26)比较,VDZ 一线治疗组(n=28)临床应答率(82.14 % vs50.00%,χ2=6.268,P=0.012)及临床缓解率(71.43% vs 19.23%,χ2=14.774,P=0.001)均更高;与基线值相比,第30周营养指标显著升高、炎症指标显著降低(P<0.01)。VDZ 不良反应发生率为 3.70%(2/54)。结论 VDZ 在 UC诱导缓解及维持治疗中效果较好,可显著改善患者营养状况、抑制炎症反应,安全性高。生物制剂初治患者中,选择VDZ效果更优。
Abstract:Objective To evaluate the efficacy of vedolizumab(VDZ)in the treatment of ulcerative colitis(UC)and explore its safety. Methods A retrospective analysis was performed on the clinical data of UC patients treated with VDZ in the Affiliated Huai'an Hospital of Xuzhou Medical University from December 2020 to December 2024. The activity degree and endoscopic severity of UC disease were evaluated using the Modified Mayo Score(MMS)and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS),respectively. Inflammatory markers [white blood cell(WBC),lymphocyte(LYM),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),fecal calprotectin(Fc)]and nutritional indicators[body mass index(BMI),albumin(ALB)]were compared between pre-and post-treatment.The patients were divided into the VDZ first-line treatment group and the VDZ second-line treatment group based on whether biological agents were used in their previous treatment of UC,to evaluate the differences in the efficacy of VDZ between the two groups,and the adverse events were recorded. Results A total of 54 UC patients were finally included,with males accounting for 40.74%,the age being(48.85 ± 16.75)years,and the disease duration being 46.00(25.50,70.25)months. At 14th week,the clinical response rate was 51.85% and clinical remission rate was 20.37%. At 30th week,the clinical response rate,clinical remission rate,and endoscopic remission rate reached 66.67%,46.30%,and 27.78%,respectively. At 30th week,compared with the second-line group(n=26), the first-line VDZ treatment group (n=28)exhibited significantly higher clinical response(82.14% vs 50.00%,χ2=6.268,P=0.012)and clinical remission rate(71.43% vs 19.23%,χ2=14.774,P=0.001). Compared with baseline values,nutritional indicators significantly increased and inflammatory markers significantly decreased at 30th week(P<0.01). The incidence of adverse events was 3.70%(2/54). Conclusion VDZ demonstrates favorable efficacy in both induction and maintenance therapy for UC,significantly improving nutritional status,suppressing inflammation,and exhibiting a high safety profile. Among patients receiving biological agents for the first time,choosing VDZ may yield better effects.
文章编号:     中图分类号:R969.4 R574.1    文献标志码:A
基金项目:江苏省新药研究与临床药学重点实验室开放课题(KFKT-2313)
附件
引用文本:
李影,杨姯,张国桃.维得利珠单抗治疗溃疡性结肠炎的疗效及安全性评价[J].中国临床研究,2025,38(11):1726-1730.

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