{"title":"[维多珠单抗治疗溃疡性结肠炎的临床疗效及其影响因素]。","authors":"J H Lu, L Y Fang, S G Cao, G L Ma, Y Xu, Y Jiang","doi":"10.3760/cma.j.cn112137-20240422-00945","DOIUrl":null,"url":null,"abstract":"<p><p><b>Objective:</b> To analyze the clinical efficacy and its influencing factors of vedolizumab (VDZ) in the treatment of ulcerative colitis (UC). <b>Methods:</b> The patients with moderately-to-severely active UC, who underwent VDZ treatment at the Second Affiliated Hospital of Wenzhou Medical University from November 2020 to November 2023 were retrospectively included. Based on whether 5-aminosalicylic acid (5-ASA) was used in combination with VDZ treatment, the patients were divided into combination group (received combination therapy of VDZ and 5-ASA) and monotherapy group (received monotherapy of VDZ). The clinical response rate and biological remission rate were analyzed at week 14. The clinical remission rate and mucosal healing rate were analyzed at week 38. The differences in efficacy of VDZ between the two groups were compared at week 14 and week 38, respectively. Multivariate logistic regression model was applied to analyze the influencing factors of clinical remission rate and mucosal healing rate in UC patients. <b>Results:</b> A total of 137 patients were included, including 74 males and 63 females, aged 18-76 (44±14) years old; Seventy-six cases in combination group and 61 cases in monotherapy group. At week 14 of VDZ treatment, the clinical response rate and biological remission rate were 79.6% (109/137) and 80.5% (33/41), respectively. At week 38, the clinical remission rate and mucosal healing rate were 78.8% (108/137) and 47.9% (57/119), respectively. There was no significant difference in clinical response rate and biological remission rate between combination group and monotherapy group at week 14 (both <i>P</i>>0.05). The clinical remission rate [85.5% (65/76) vs 70.5% (43/61), <i>P</i>=0.032] and mucosal healing rate [56.5% (39/69) vs 36.0% (18/50), <i>P</i>=0.027] were higher in combination group than those in monotherapy group at week 38. Multivariate logistic regression analysis showed that the combination therapy of VDZ and 5-ASA (<i>OR</i>=2.48, 95%<i>CI</i>: 1.02-6.03) and the clinical response at week 14 (<i>OR</i>=5.05, 95%<i>CI</i>: 1.98-12.85) were influencing factors of clinical remission rate of UC patients at week 38. Moreover, the baseline serum albumin (Alb) level ≥42.5 g/L was the influencing factor for the mucosal healing rate of UC patients at week 38 (<i>OR</i>=4.60, 95%<i>CI</i>: 2.06-10.24). <b>Conclusions:</b> VDZ is effective in treating UC patients. Both the combination of 5-ASA and the clinical response at week 14 are the influencing factors of the clinical remission rate at week 38. In addition, the baseline serum Alb level ≥42.5 g/L is the influencing factor of the mucosal healing rate at week 38.</p>","PeriodicalId":24023,"journal":{"name":"Zhonghua yi xue za zhi","volume":"104 39","pages":"3669-3675"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Clinical efficacy and its influencing factors of vedolizumab in the treatment of ulcerative colitis].\",\"authors\":\"J H Lu, L Y Fang, S G Cao, G L Ma, Y Xu, Y Jiang\",\"doi\":\"10.3760/cma.j.cn112137-20240422-00945\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Objective:</b> To analyze the clinical efficacy and its influencing factors of vedolizumab (VDZ) in the treatment of ulcerative colitis (UC). <b>Methods:</b> The patients with moderately-to-severely active UC, who underwent VDZ treatment at the Second Affiliated Hospital of Wenzhou Medical University from November 2020 to November 2023 were retrospectively included. Based on whether 5-aminosalicylic acid (5-ASA) was used in combination with VDZ treatment, the patients were divided into combination group (received combination therapy of VDZ and 5-ASA) and monotherapy group (received monotherapy of VDZ). The clinical response rate and biological remission rate were analyzed at week 14. The clinical remission rate and mucosal healing rate were analyzed at week 38. The differences in efficacy of VDZ between the two groups were compared at week 14 and week 38, respectively. Multivariate logistic regression model was applied to analyze the influencing factors of clinical remission rate and mucosal healing rate in UC patients. <b>Results:</b> A total of 137 patients were included, including 74 males and 63 females, aged 18-76 (44±14) years old; Seventy-six cases in combination group and 61 cases in monotherapy group. At week 14 of VDZ treatment, the clinical response rate and biological remission rate were 79.6% (109/137) and 80.5% (33/41), respectively. At week 38, the clinical remission rate and mucosal healing rate were 78.8% (108/137) and 47.9% (57/119), respectively. There was no significant difference in clinical response rate and biological remission rate between combination group and monotherapy group at week 14 (both <i>P</i>>0.05). The clinical remission rate [85.5% (65/76) vs 70.5% (43/61), <i>P</i>=0.032] and mucosal healing rate [56.5% (39/69) vs 36.0% (18/50), <i>P</i>=0.027] were higher in combination group than those in monotherapy group at week 38. Multivariate logistic regression analysis showed that the combination therapy of VDZ and 5-ASA (<i>OR</i>=2.48, 95%<i>CI</i>: 1.02-6.03) and the clinical response at week 14 (<i>OR</i>=5.05, 95%<i>CI</i>: 1.98-12.85) were influencing factors of clinical remission rate of UC patients at week 38. Moreover, the baseline serum albumin (Alb) level ≥42.5 g/L was the influencing factor for the mucosal healing rate of UC patients at week 38 (<i>OR</i>=4.60, 95%<i>CI</i>: 2.06-10.24). <b>Conclusions:</b> VDZ is effective in treating UC patients. Both the combination of 5-ASA and the clinical response at week 14 are the influencing factors of the clinical remission rate at week 38. In addition, the baseline serum Alb level ≥42.5 g/L is the influencing factor of the mucosal healing rate at week 38.</p>\",\"PeriodicalId\":24023,\"journal\":{\"name\":\"Zhonghua yi xue za zhi\",\"volume\":\"104 39\",\"pages\":\"3669-3675\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-10-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Zhonghua yi xue za zhi\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3760/cma.j.cn112137-20240422-00945\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Zhonghua yi xue za zhi","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3760/cma.j.cn112137-20240422-00945","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
目的分析维度珠单抗(VDZ)治疗溃疡性结肠炎(UC)的临床疗效及其影响因素。方法回顾性纳入2020年11月至2023年11月在温州医科大学附属第二医院接受VDZ治疗的中重度活动性UC患者。根据5-氨基水杨酸(5-ASA)是否与VDZ联合治疗,将患者分为联合治疗组(接受VDZ和5-ASA联合治疗)和单一治疗组(接受VDZ单一治疗)。第14周时分析临床反应率和生物缓解率。第 38 周分析临床缓解率和粘膜愈合率。分别在第14周和第38周比较两组间VDZ疗效的差异。应用多变量逻辑回归模型分析UC患者临床缓解率和黏膜愈合率的影响因素。结果共纳入137例患者,其中男74例,女63例,年龄18-76(44±14)岁;联合治疗组76例,单药治疗组61例。VDZ治疗第14周时,临床应答率和生物学缓解率分别为79.6%(109/137)和80.5%(33/41)。第38周时,临床缓解率和粘膜愈合率分别为78.8%(108/137)和47.9%(57/119)。第 14 周时,联合治疗组与单药治疗组的临床应答率和生物缓解率无明显差异(P>0.05)。第38周时,联合治疗组的临床缓解率[85.5%(65/76) vs 70.5%(43/61),P=0.032]和粘膜愈合率[56.5%(39/69) vs 36.0%(18/50),P=0.027]均高于单一治疗组。多变量逻辑回归分析显示,VDZ和5-ASA联合治疗(OR=2.48,95%CI:1.02-6.03)和第14周时的临床反应(OR=5.05,95%CI:1.98-12.85)是第38周时UC患者临床缓解率的影响因素。此外,基线血清白蛋白(Alb)水平≥42.5 g/L是第38周时UC患者粘膜愈合率的影响因素(OR=4.60,95%CI:2.06-10.24)。结论VDZ对治疗UC患者有效。5-ASA联合用药和第14周时的临床反应是第38周时临床缓解率的影响因素。此外,基线血清Alb水平≥42.5 g/L是第38周时粘膜愈合率的影响因素。
[Clinical efficacy and its influencing factors of vedolizumab in the treatment of ulcerative colitis].
Objective: To analyze the clinical efficacy and its influencing factors of vedolizumab (VDZ) in the treatment of ulcerative colitis (UC). Methods: The patients with moderately-to-severely active UC, who underwent VDZ treatment at the Second Affiliated Hospital of Wenzhou Medical University from November 2020 to November 2023 were retrospectively included. Based on whether 5-aminosalicylic acid (5-ASA) was used in combination with VDZ treatment, the patients were divided into combination group (received combination therapy of VDZ and 5-ASA) and monotherapy group (received monotherapy of VDZ). The clinical response rate and biological remission rate were analyzed at week 14. The clinical remission rate and mucosal healing rate were analyzed at week 38. The differences in efficacy of VDZ between the two groups were compared at week 14 and week 38, respectively. Multivariate logistic regression model was applied to analyze the influencing factors of clinical remission rate and mucosal healing rate in UC patients. Results: A total of 137 patients were included, including 74 males and 63 females, aged 18-76 (44±14) years old; Seventy-six cases in combination group and 61 cases in monotherapy group. At week 14 of VDZ treatment, the clinical response rate and biological remission rate were 79.6% (109/137) and 80.5% (33/41), respectively. At week 38, the clinical remission rate and mucosal healing rate were 78.8% (108/137) and 47.9% (57/119), respectively. There was no significant difference in clinical response rate and biological remission rate between combination group and monotherapy group at week 14 (both P>0.05). The clinical remission rate [85.5% (65/76) vs 70.5% (43/61), P=0.032] and mucosal healing rate [56.5% (39/69) vs 36.0% (18/50), P=0.027] were higher in combination group than those in monotherapy group at week 38. Multivariate logistic regression analysis showed that the combination therapy of VDZ and 5-ASA (OR=2.48, 95%CI: 1.02-6.03) and the clinical response at week 14 (OR=5.05, 95%CI: 1.98-12.85) were influencing factors of clinical remission rate of UC patients at week 38. Moreover, the baseline serum albumin (Alb) level ≥42.5 g/L was the influencing factor for the mucosal healing rate of UC patients at week 38 (OR=4.60, 95%CI: 2.06-10.24). Conclusions: VDZ is effective in treating UC patients. Both the combination of 5-ASA and the clinical response at week 14 are the influencing factors of the clinical remission rate at week 38. In addition, the baseline serum Alb level ≥42.5 g/L is the influencing factor of the mucosal healing rate at week 38.