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维得利珠单抗与英夫利西单抗在Bio-naive溃疡性结肠炎患者中的疗效和安全性比较
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| 篇名： | 维得利珠单抗与英夫利西单抗在Bio-naive溃疡性结肠炎患者中的疗效和安全性比较 |
| TITLE： | Comparison of the efficacy and safety of vedolizumab versus infliximab in Bio-naive patients with ulcerative colitis |
| 摘要： | 目的 比较维得利珠单抗（VDZ）与英夫利西单抗（IFX）在初次使用生物制剂（Bio-naive）中重度活动期溃疡性结肠炎（UC）患者中的疗效和安全性，并分析其疗效影响因素。方法回顾性收集2023年6月－2024年6月在山西省人民医院消化内科接受治疗的Bio-naive中重度活动期UC患者的临床资料。根据其所用生物制剂的种类，分为IFX组（41例）和VDZ组（30例）。两组患者均接受IFX（5mg/kg）或VDZ（300mg）进行诱导缓解和维持缓解治疗。比较两组患者治疗后的改良Mayo评分、血清学指标（血红蛋白、白蛋白、血小板计数、红细胞沉降率、C反应蛋白）、联合用药情况、疗效相关指标（临床反应率/缓解率、内镜反应率/缓解率）和不良反应发生情况；基于Logistic回归模型进行单因素、多因素分析，挖掘影响治疗第14周时临床缓解和治疗第38周时内镜缓解的潜在因素。结果两组患者治疗第14、38周时的临床反应率/缓解率、内镜反应率/缓解率比较，差异均无统计学意义（P＞0.05）；而VDZ组治疗第14周时联用激素的患者比例为26.67%，显著高于IFX组的7.50%（P＜0.05）。两组患者总不良反应发生率比较的差异虽无统计学差异（P＞0.05），但IFX组均为导致治疗中止的3级不良反应（6例），而VDZ组则为未中断治疗的2级不良反应（1例）。单因素、多因素回归分析结果显示，疾病类型（复发）与患者治疗第14周时临床缓解、有吸烟史与患者治疗第38周时内镜缓解分别显著相关（比值比均为0.08，95%置信区间分别为0.01～0.77、0.01～0.91，P＜0.05）。结论对于Bio-naive中重度活动期UC患者，VDZ和IFX在诱导和维持临床缓解、促进黏膜愈合方面的效果及总体安全性相当；尽管IFX可在疾病早期更快实现炎症控制，但其所致不良反应更为严重。临床类型（复发）和有吸烟史分别是影响短期临床缓解和长期内镜缓解的独立负面预测因素。 |
| ABSTRACT： | OBJECTIVE To compare the efficacy and safety of vedolizumab （VDZ） versus infliximab （IFX） in biologic-naive（Bio-naive） patients with moderate-to-severe active ulcerative colitis （UC）， and to analyze the factors influencing efficacy. METHODS Clinical data were retrospectively collected from Bio-naive patients with moderate-to-severe active UC who received treatment in the Department of Gastroenterology at Shanxi Provincial People’s Hospital from June 2023 to June 2024. Based on the type of biologic agent administered， the patients were divided into the IFX group （41 cases） and the VDZ group （30 cases）. Patients in the two groups received IFX （5 mg/kg） or VDZ （300 mg） for induction and maintenance of remission therapy. The two groups were compared regarding modified Mayo score， serological indicators （hemoglobin， albumin， platelet count， erythrocyte sedimentation rate， C-reactive protein）， combined medication， efficacy-related indexes （clinical response rate/remission rate， and endoscopic response rate/remission rate）， and the occurrence of adverse drug reactions （ADR）. Based on Logistic regression model， univariate and multivariate analyses were conducted to identify potential factors influencing clinical remission at week 14 and endoscopic remission at week 38. RESULTS There were no statistically significant differences in clinical response rate/remission rate， or endoscopic response rate/remission rate between the two groups at weeks 14 and 38 （ P ＞0.05）. However， at week 14 of treatment， the proportion of patients using concomitant corticosteroids in VDZ group was 26.67%， significantly higher than the 7.50% in IFX group （ P ＜0.05）. There was no statistical significance in the overall incidence of ADR between the two groups （ P ＞0.05）； all ADRs in the IFX group were grade 3 and led to treatment discontinuation （6 cases）， whereas ADR in the VDZ group was grade 2 and did not interrupt therapy （1 case）. Univariate and multivariate regression analyses revealed that disease type （relapsing） was significantly associated with clinical remission at week 14 of treatment， and a history of smoking was significantly associated with endoscopic remission at week 38 of treatment （the odds ratios were 0.08 for both， with 95% confidence intervals of 0.01-0.77 and 0.01-0.91 respectively， P ＜0.05）. CONCLUSIONS For Bio-naive patients with moderate-to-severe active UC， VDZ and IFX demonstrate comparable efficacy in inducing and maintaining clinical remission and promoting mucosal healing， as well as overall safety. Although IFX can achieve faster control of inflammation in the early stage of the disease， it causes more severe ADR. Disease type （relapsing） and smoking history are identified as independent negative predictors for short-term clinical remission and long-term endoscopic remission， respectively. |
| 期刊： | 2026年第37卷第10期 |
| 作者： | 姚堆堆；栗菲雪；武佳琪；刘晓兵；温红萍 |
| AUTHORS： | YAO Duidui，LI Feixue，WU Jiaqi，LIU Xiaobing，WEN Hongping |
| 关键字： | 维得利珠单抗；英夫利西单抗；溃疡性结肠炎；初次使用生物制剂；中重度；疗效；安全；影响因素 |
| KEYWORDS： | vedolizumab； infliximab； ulcerative colitis； biologic-naive； moderate-to-severe； efficacy； safety； influencing |
| 阅读数： | 1 次 |
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