中国临床药理学杂志

维得利珠单抗联合美沙拉嗪治疗溃疡性结肠炎患者的临床研究

PDF下载

侯静 ^1a , 张欣欣 ² , 孟凡来 ^1b , 袁永胜 ^1c , 叶敬新 ^1a

中国临床药理学杂志 | 临床与基础桥接研究 2026,42(8): 1090-1094

收起

中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (8) : 1090 -1094

维得利珠单抗联合美沙拉嗪治疗溃疡性结肠炎患者的临床研究

全屏

侯静^1a, 张欣欣², 孟凡来^1b, 袁永胜^1c, 叶敬新^1a

作者信息

^1a.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院消化内科，江苏宿迁 223800

^1b.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院病理科，江苏宿迁 223800

^1c.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院影像科，江苏宿迁 223800

^2.宿迁市妇幼保健院消化内科，江苏宿迁 223800

通讯作者:

张欣欣，副主任医师 MP: 13056116667 E-mail: 531816572@qq.com

作者简介:

侯静（1985-），女，副主任医师，主要从事炎症性肠病基础与临床方面的工作和研究

The clinical efficacy of vedolizumab in combination with mesalazine in the treatment of patients with ulcerative colitis

Jing HOU^1a, Xin-xin ZHANG², Fan-lai MENG^1b, Yong-sheng YUAN^1c, Jing-xin YE^1a

Affiliations

^1a.Department of Gastroenterology, Suqian Hospital Affiliated to Xuzhou Medical University/Suqian Hospital of Nanjing Gulou Hospital Group, Suqian 223800, Jiangsu Province, China

^1b.Department of Pathology, Suqian Hospital Affiliated to Xuzhou Medical University/Suqian Hospital of Nanjing Gulou Hospital Group, Suqian 223800, Jiangsu Province, China

^1c.Department of Imaging, Suqian Hospital Affiliated to Xuzhou Medical University/Suqian Hospital of Nanjing Gulou Hospital Group, Suqian 223800, Jiangsu Province, China

^2.Department of Gastroenterology, Suqian Maternal and Child Health Hospital, Suqian 223800, Jiangsu Province, China

出版时间: 2026-04-28 doi: 10.13699/j.cnki.1001-6821.2026.08.007

文章导航

摘要

收起

目的

观察维得利珠单抗注射液与美沙拉嗪肠溶片联合应用在溃疡性结肠炎（UC）中的临床疗效和安全性。

方法

将UC患者通过随机数表法分为对照组和试验组。对照组给予美沙拉嗪肠溶片，诱导期（0~14周）每次1g，每天4次，维持期（14周后至研究结束）调整为每次1g，每天2~3次；试验组在对照组基础上，联合给予维得利珠单抗注射液治疗，分别在治疗的第0、2、6、14周给药，静脉滴注每次300 mg。比较2组治疗6个月后的临床疗效、炎性因子水平[C-反应蛋白（CRP）、粪便钙卫蛋白]、免疫微环境[辅助性T细胞（Th）17、调节性T细胞（Treg）]、肠道屏障功能（D-乳酸、内毒素）、白蛋白水平，并进行安全性评价。

结果

共入组108例患者，2组各入组54例，其中对照组脱落5例，最终有49例纳入统计分析，试验组脱落3例，最终有51例纳入统计分析。治疗6个月后，试验组和对照组的治疗总有效率分别为94.12%（48例/51例）和77.55%（38例/49例），试验组显著高于对照组（P<0.05）；CRP水平分别为（6.75±1.86）和（11.71±2.12）mg·L^-1，粪便钙卫蛋白水平分别为（36.93±4.54）和（60.15±7.04）μg·g^-1，白蛋白水平分别为（44.29±5.31）和（37.41±4.62）g·L^-1，Th17比例分别为（2.07±0.26）%和（2.54±0.36）%，Treg比例分别为（4.20±0.61）%和（3.58±0.49）%，D-乳酸水平分别为（4.62±0.98）和（6.99±1.42）μg·L^-1，内毒素水平分别为（2.97±0.39）和（4.03±0.94）U·mL^-1，上述指标2组间比较，在统计学上差异均有统计学意义（均P<0.05）。试验组的药物不良反应有恶心2例，腹泻1例，肝功能异常（谷丙转氨酶升高）2例，皮疹2例，合计7例；对照组有恶心1例，腹痛1例，肾功能异常（血肌酐轻度升高）1例，皮疹2例，合计5例。试验组和对照组的药物不良反应总发生率分别为13.73%（7例/51例）和10.20%（5例/49例），在统计学上差异无统计学意义（P>0.05）。

结论

维得利珠单抗注射液联合美沙拉嗪肠溶片可提高溃疡性结肠炎患者的临床疗效，且不会增加药物不良反应发生率。

关键词

维得利珠单抗注射液 / 美沙拉嗪肠溶片 / 溃疡性结肠炎 / 临床疗效 / 安全性评价

Abstract

收起

Objective

To investigate the clinical efficacy of vedolizumab injection combined with mesalazine enteric-coated tablets in the treatment of patients with ulcerative colitis(UC).

Methods

Patients with ulcerative colitis (UC) were randomly divided into control group and treatment group using a random number table. The control group received mesalazine enteric-coated tablets: 1 g four times daily during the induction phase (weeks 0-14), and 1 g two to three times daily during the maintenance phase (from week 14 until the end of the study). The treatment group received vedolizumab injection in addition to the same mesalazine regimen as the control group. Vedolizumab was administered via intravenous infusion at a dose of 300 mg at weeks 0, 2, 6, and 14 of treatment. Clinical efficacy, levels of inflammatory factors [C-reactive protein(CRP)], fecal calprotectin], immune microenvironment indicators[T helper 17 (Th17) cells, regulatory T (Treg) cells], intestinal barrier function markers (D-lactate, endotoxin), and serum albumin were compared between the two groups at 6 months of treatment. Safety evaluations were also performed.

Results

A total of 108 patients were screened, with 54 enrolled in each group. In the control group, 5 dropped out, leaving 49 for statistical analysis; in the treatment group, 3 dropped out, leaving 51 for statistical analysis. After 6 months of treatment, the total effective rates in the treatment and control groups were 94.12% (48/51) and 77.55% (38/49) respectively, with the treatment group significantly higher (P<0.05). The CRP levels in the treatment and control groups were (6.75±1.86) and (11.71±2.12) mg·L^-1, respectively; fecal calprotectin levels were (36.93±4.54) and (60.15±7.04) μg·g^-1, respectively; albumin levels in the experimental and control groups were (44.29±5.31) and (37.41±4.62) g·L^-1, respectively; the proportions of Th17 were (2.07±0.26)% and (2.54±0.36)%, respectively; the proportions of Treg were (4.20±0.61)% and (3.58±0.49)%, respectively; the levels of D-lactate were (4.62±0.98) and (6.99±1.42)μg·L^-1, respectively; the levels of endotoxin were (2.97±0.39) and(4.03±0.94)U·mL^-1, respectively. The differences of above indexes were all statistically significant (all P<0.05). Adverse drug reactions (ADRs) in the treatment group included nausea (2 cases), diarrhea (1 case), liver dysfunction (elevated alanine aminotransferase, 2 cases), and rash (2 cases), totaling 7 cases. ADRs in the control group included nausea (1 case), abdominal pain (1 case), kidney dysfunction (mildly elevated serum creatinine, 1 case), and rash (2 cases), totaling 5 cases. The total incidence of ADRs was 13.73% (7cases/51cases) in the treatment group and 10.20% (5cases/49cases) in the control group, with no statistically significant difference (P>0.05).

Conclusion

The combination of vedolizumab injection and mesalazine enteric-coated tablet improves clinical outcomes for ulcerative colitis patients without raising the incidence of adverse drug reactions.

Key words

vedolizumab injection / mesalazine enteric-coated tablets / ulcerative colitis / clinical efficacy / safety evaluation

引用本文

侯静, 张欣欣, 孟凡来, 袁永胜, 叶敬新. 维得利珠单抗联合美沙拉嗪治疗溃疡性结肠炎患者的临床研究. 中国临床药理学杂志, 2026 , 42 (8) : 1090 -1094 . DOI: 10.13699/j.cnki.1001-6821.2026.08.007

Jing HOU, Xin-xin ZHANG, Fan-lai MENG, Yong-sheng YUAN, Jing-xin YE. The clinical efficacy of vedolizumab in combination with mesalazine in the treatment of patients with ulcerative colitis[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (8) : 1090 -1094 . DOI: 10.13699/j.cnki.1001-6821.2026.08.007

基金

收起

江苏省自然科学基金资助项目(BK20210134)

参考文献

收起

文献

收起

参考文献引证文献

排序方式：

2026年第42卷第8期

PDF下载

112

引用本文

BibTeX

文章信息

doi: 10.13699/j.cnki.1001-6821.2026.08.007

接收时间：2025-09-28
首发时间：2026-08-06
出版时间：2026-04-28

补充材料

相关文章

文章信息

作者

出版历史

收稿日期：2025-09-28

基金

江苏省自然科学基金资助项目(BK20210134)

作者信息

^1a.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院消化内科，江苏宿迁 223800

^1b.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院病理科，江苏宿迁 223800

^1c.徐州医科大学附属宿迁医院/南京鼓楼医院集团宿迁医院影像科，江苏宿迁 223800

^2.宿迁市妇幼保健院消化内科，江苏宿迁 223800

通讯作者:

张欣欣，副主任医师 MP: 13056116667 E-mail: 531816572@qq.com

参考文献

分享链接

https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.08.007

分享至

全文二维码

扫描看全文

引用本文

BibTeX

本文的引用情况

2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

关闭全屏

BibTeX
EndNote
RefWorks
TxT