英夫利西单抗及维得利珠单抗治疗中重度溃疡性结肠炎的回顾性队列研究

张瀚予; 罗娟; 董明志; 陈杞殷; 张峰睿; 郭蕊; 童俊英; 缪应雷

英夫利西单抗及维得利珠单抗治疗中重度溃疡性结肠炎的回顾性队列研究

张瀚予^{1, 2},
罗娟^{1, 2},
董明志³,
陈杞殷^{1, 2},
张峰睿^{1, 2},
郭蕊^{1, 2},
童俊英⁴,
缪应雷^{1, 2, ,}

1.
昆明医科大学第一附属医院消化内科，云南昆明　650032
2.
云南省消化系统疾病临床医学研究中心，云南昆明　650032
3.
保山市第二人民医院，云南保山　678000
4.
昆明市五华区人民医院，云南昆明　650032

基金项目: 云南省消化系统疾病临床医学研究中心-云南省疑难危重消化系统疾病研究及推广应用子课题（202002AA100205）；国家自然科学基金资助项目（82170550）；云南省基础研究项目（202301AS070027）；兴滇英才支持计划项目

详细信息

作者简介:
张瀚予（1997～），女，云南保山人，医学学士，住院医师，主要从事消化内科诊治工作

通讯作者:
缪应雷，E-mail：miaoyinglei@yeah.net

中图分类号: R574.1
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- 被引次数: 0
出版历程
- 收稿日期: 2024-05-20

Retrospective cohort study of infliximab and Vederizumab in the treatment of moderate-to-severe ulcerative colitis

Hanyu ZHANG^{1, 2},
Juan LUO^{1, 2},
Mingzhi DONG³,
Qiyin CHEN^{1, 2},
Fengrui ZHANG^{1, 2},
Rui GUO^{1, 2},
Junying TONG⁴,
Yinglei MIAO^{1, 2
, ,}

1.
Dept. of Gastroenterology，The 1st Affiliated Hospital of Kunming Medical University，Kunming Yunnan 650032
2.
Yunnan Provincial Clinical Research Center for Digestive Diseases，Kunming Yunnan 650032
3.
The Second People's Hospital of Baoshan，BaoshanYunnan 678000
4.
The People’ s Hospital of Wuhua District，Kunming Yunnan 650032，China

摘要

摘要: 目的比较英夫利西单抗（infliximab，IFX）及维得利珠单抗（vedolizumab，VDZ）在中重度溃疡性结肠炎（ulcerative Colitis，UC）治疗中的疗效及安全性差异。方法回顾性收集自2020年01月至2023年12月于昆明医科大学第一附属医院确诊为中重度UC并使用IFX/VDZ治疗的患者129例，其中IFX治疗组65例，VDZ治疗组64例，剔除资料严重缺失及非疗效原因导致疗程不足14周患者19例，最终共纳入110例患者进行分析，其中IFX治疗组55例，VDZ治疗组55例。记录患者在治疗前（0周）及治疗14周、30周、54周的临床症状、疾病活动相关指标、内镜表现以及治疗过程中发生的不良反应，分析两种药物对于中重度UC治疗的疗效及安全性是否存在差异。结果 2组患者在各项基线指标之间无显著差异（P > 0.05）；IFX治疗组的炎症指标（WBC、PLT、ESR、CRP）水平在第14周高于VDZ治疗组，营养指标ALB水平在第30周低于VDZ治疗组，其差异具有统计学意义（P < 0.05）；其余实验室指标在各随访节点之间的差异无统计学意义（P > 0.05）。IFX治疗组及VDZ治疗组的临床应答率在治疗第14周（81.8% vs 85.5%）、第30周（80.8% vs 92.5%）及第54周（91.3% vs 90.0%）无显著差异（P > 0.05）；临床缓解率在治疗第14周（41.8% vs 49.1%）、第30周（50.0% vs 67.5%）及第54周（65.2% vs 63.3%）无显著差异（P > 0.05）；内镜应答率在治疗第14周（54.3% vs 72.2%）、第30周（41.3% vs 73.3%）及第54周（60.0% vs 75.0%）无显著差异（P > 0.05）；内镜缓解率在治疗第14周（34.3% vs 55.6%）及第54周（53.3% vs 54.2%）无显著差异（P > 0.05），IFX治疗组的内镜缓解率在治疗第30周（23.5% vs 73.3%）低于VDZ治疗组，其差异具有统计学意义（P = 0.005）。IFX治疗组与VDZ治疗组的失应答率在治疗14周至30周期间（7.3% vs 1.8%）无显著差异（P > 0.05），IFX治疗组的失应答率在治疗第30周至54周期间（16.4% vs 0）高于VDZ治疗组，其差异具有统计学意义（P = 0.005）；IFX治疗组及VDZ治疗组不良反应发生率（10.9% vs 5.5%）之间差异无统计学意义（P > 0.05）。结论在中重度UC的治疗中，IFX治疗组与VDZ治疗组在第14周、54周的临床应答率及临床缓解率、内镜应答率、内镜缓解率之间未观察到显著差异，在第30周IFX治疗组的内镜缓解率低于VDZ治疗组；维持治疗过程中IFX治疗组的失应答率高于VDZ治疗组，提示IFX治疗组可能存在更高的远期耐药率；两药物治疗过程中的不良反应发生率之间无显著差异。
- 溃疡性结肠炎 /
- 回顾性队列研究 /
- 生物制剂 /
- 英夫利西单抗 /
- 维得利珠单抗
Abstract: Objective To compare the efficacy and safety of Infliximab （IFX） and Vedolizumab （VDZ） in the treatment of moderate-to-severe Ulcerative Colitis （UC）. Methods A total of 129 patients diagnosed with moderate-to-severe ulcerative colitis and treated with IFX/VDZ in the First Affiliated Hospital of Kunming Medical University from January 2020 to December 2023 were retrospectively collected, including 65 patients in the IFX treatment group and 64 patients in the VDZ treatment group, and 19 patients whose treatment course was less than 14 weeks due to serious data missing or non-therapeutic reasons were excluded. A total of 110 patients were included for analysis, including 55 in the IFX treatment group and 55 in the VDZ treatment group. Clinical symptoms, indicators related to disease activity, endoscopic manifestations and adverse reactions occurred during treatment were recorded before treatment （0 weeks） and 14, 30, and 54 weeks of treatment, and whether there were differences in the efficacy and safety of the two drugs in the treatment of moderate to severe UC was analyzed. Results There were no significant differences in baseline indexes between the two groups （P > 0.05）. The levels of inflammatory indicators （WBC, PLT, ESR, CRP） in IFX treatment group were higher than those in VDZ treatment group at week 14, and the level of nutrition indicator ALB was lower than those in VDZ treatment group at week 30, with statistical significance （P < 0.05）. There was no significant difference in other laboratory indexes among follow-up time points （P > 0.05）. The clinical response rate of IFX treatment group and VDZ treatment group was not significantly different at week 14 （81.8% vs 85.5%）, week 30 （80.8% vs 92.5%） and week 54 （91.3% vs 90.0%）（P > 0.05）. There was no significant difference in clinical response rate at week 14 （41.8% vs 49.1%）, week 30 （50.0% vs 67.5%） and week 54 （65.2% vs 63.3%）（P > 0.05）. There was no significant difference in endoscopic response rate at week 14 （54.3% vs 72.2%）, week 30 （41.3% vs 73.3%） and week 54 （60.0% vs 75.0%）（P > 0.05）. There was no significant difference in the endoscopic remission rate at week 14 （34.3% vs 55.6%） and week 54 （53.3% vs 54.2%）（P > 0.05）. The endoscopic remission rate at week 30 （23.5% vs 73.3%） in IFX treatment group was lower than that in VDZ treatment group, the difference was statistically significant （P = 0.005）. There was no significant difference between IFX group and VDZ group （7.3% vs 1.8%） during 14 to 30 weeks of treatment （P > 0.05）, and IFX group had higher non-response rate during 30 to 54 weeks of treatment （16.4% vs 0） than VDZ group. The difference was statistically significant （P = 0.005）. There was no significant difference in the incidence of adverse reactions between IFX treatment group and VDZ treatment group （10.9% vs 5.5%）（P > 0.05）. Conclusion During the treatment of moderate to severe UC, no significant difference was observed in the clinical response rate, clinical remission rate, endoscopic response rate and endoscopic remission rate between the IFX treatment group and the VDZ treatment group at week 14 and week 54, and the endoscopic remission rate in the IFX treatment group was lower than that in the VDZ treatment group at week 30. The non-response rateof IFX treatment group was higher than that of VDZ treatment group during maintenance treatment, suggesting that IFX treatment group may have a higher long-term drug resistance rate. There was no significant difference in the incidence of adverse reactions between the two drugs.
- Ulcerative colitis /
- Retrospective cohort study /
- Biological agent /
- Infliximab /
- Vedelizumab

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图 1 2治疗组不同随访点临床及内镜疗效比较

A：临床应答；B：内镜应答；C：临床缓解；D：内镜缓解；^**P < 0.01，NS：P > 0.05。

Figure 1. Comparison of clinical and endoscopic effects at different follow-up time points between the two treatment groups

下载: 全尺寸图片幻灯片

图 2 2治疗组失应答率比较

^**P < 0.01，NS：P > 0.05。

Figure 2. Comparison of non-response rate between the two treatment groups

下载: 全尺寸图片幻灯片

图 3 2治疗组不良反应发生率对比

NS：P > 0.05

Figure 3. Comparison of the incidence of adverse reactions between the two treatment groups

下载: 全尺寸图片幻灯片

表 1 2治疗组患者基线特征比较[n（%）/$ \bar x \pm s $/ M（P25，P75）]

Table 1. Comparison of baseline characteristics between the two treatment groups[n（%）/$ \bar x \pm s $/ M（P25，P75）]

特征	IFX（n=55）	VDZ（n=55）	t/Z/χ²	P
性别
男	31（56.4）	28（50.9）	0.329	0.566
女	24（43.6）	27（49.1）
民族
汉族	49（89.1）	51（92.7）	0.440	0.507
少数民族	6（10.9）	4（7.3）
年龄（岁）	46.0±15.1	48.2±16.9	0.732	0.466
发病年龄（岁）	40（28，50）	39（27，53）	0.260	0.795
病程/年	5（3，7）	6（3，11）	1.413	0.158
病变范围
直肠型（E1）	0	2（3.6）	−	0.177
左半结肠型（E2）	4（7.3）	8（14.5）
全结肠型（E3）	51（92.7）	45（81.8）
疾病活动度
中度活动	23（41.8）	18（32.7）	0.972	0.324
重度活动	32（58.2）	37（67.3）
Mayo（0周）/分	11（10.0，12.0）	11（9.0，11.0）	−1.812	0.07
营养指标
BMI（0周）/（kg·m⁻²）	20.08（18.0，22.0）	20.70（18.3，22.8）	0.577	0.564
HB（0周）/（g/L）	118.6±25.5	112.4±34.4	1.065	0.289
ALB（0周）/（g/L）	34.4±6.3	35.7±7.5	−1.029	0.306
炎症指标
WBC（0周）/（10⁹/L）	7.8±2.6	7.64±2.2	0.249	0.804
PLT（0周）/（10⁹/L）	358.5±106.7	351.2±112.5	0.348	0.729
ESR（0周）/（mm/h）	30（19.0，46.0）	30（14.0，53.0）	−0.185	0.853
CRP（0周）/（mg/L）	18.60（6.4，58.1）	12.40（3.1，45.7）	−1.166	0.244

下载: 导出CSV

表 2 2治疗组各随访点营养指标比较[ M（P25，P75）/$ \bar x \pm s $]

Table 2. Comparison of nutritional indicators at each follow-up between the two treatment groups[ M（P25，P75）/$ \bar x \pm s $]

营养指标	时间	IFX	VDZ	t/Z	P
BMI（kg·m⁻²）	14周	20.20（18.55，22.04）	21.30（19.33，23.44）	1.267	0.205
	30周	20.26（19.11，22.33）	21.96（19.03，23.58）	0.828	0.408
	54周	20.96（19.10，26.35）	21.00（18.59，22.78）	0.503	0.615
HB/（g/L）	14周	132（100，146）	136（111，149）	1.273	0.203
	30周	131（122，151）	133（117，146）	0.425	0.671
	54周	139.78±24.04	131.77±26.54	1.134	0.262
ALB/（g/L）	14周	38.38±5.17	40.06±5.10	1.666	0.099
	30周	39.64±4.95	42.37±4.82	2.399	0.019*
	54周	41.25（37.73，45.55）	44.10（39.60，46.10）	1.332	0.183
^*P < 0.05。

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表 3 2治疗组各随访点炎症指标比较[$ \bar x \pm s $/ M（P₂₅，P₇₅）]

Table 3. Comparison of inflammatory indicators at each follow-up between the two treatment groups[$ \bar x \pm s $/ M（P₂₅，P₇₅）]

炎症指标	时间	IFX	VDZ	t/Z	P
WBC/（10⁹/L）	14周	6.06±1.96	7.00±2.09	2.400	0.018*
	30周	6.28±2.04	6.31±1.63	0.088	0.930
	54周	6.06±2.06	6.20±1.1.43	0.281	0.779
PLT/（10⁹/L）	14周	290（257，379）	251（216，320）	2.021	0.043*
	30周	290（238，388）	268（227，312）	1.409	0.159
	54周	270（220，342）	265（228，338）	0.099	0.921
ESR/（mm/h）	14周	30（10，42）	10（5，21）	3.106	0.002*
	30周	22（9，31）	9（5，20）	1.537	0.124
	54周	13.21±10.50	13.50±11.65	0.076	0.940
CRP/（mg/L）	14周	4.00（1.03，12.87）	1.40（0.68，3.29）	2.882	0.004*
	30周	3.58（1.10，12.73）	3.20（0.60，7.94）	1.435	0.151
	54周	1.77（0.72，8.80）	1.42（0.59，7.04）	0.557	0.578
^*P < 0.05。

下载: 导出CSV

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英夫利西单抗及维得利珠单抗治疗中重度溃疡性结肠炎的回顾性队列研究

作者简介:
张瀚予（1997～），女，云南保山人，医学学士，住院医师，主要从事消化内科诊治工作

通讯作者:
缪应雷，E-mail：miaoyinglei@yeah.net

计量

Retrospective cohort study of infliximab and Vederizumab in the treatment of moderate-to-severe ulcerative colitis

计量

目录

[1]	罗娅, 余彦廷, 张雪, 王重娟. 托珠单抗治疗COVID-19导致继发感染风险的Meta分析, 昆明医科大学学报. 2024, 45(2): 57-64. doi: 10.12259/j.issn.2095-610X.S20240208
[2]	杨东艳, 林华, 张宇箫, 赵昆颖, 向丽蓉, 杨淑达, 胡炜彦. 贝伐珠单抗联合替莫唑胺用于复发性高级别脑胶质瘤的有效性及安全性分析, 昆明医科大学学报. 2024, 45(4): 67-73. doi: 10.12259/j.issn.2095-610X.S20240410
[3]	李春玲, 李玲华, 韩旭, 杨洁, 张衡. 针刺募穴联合口服美沙拉嗪治疗溃疡性结肠炎的临床观察, 昆明医科大学学报. 2024, 45(3): 72-78. doi: 10.12259/j.issn.2095-610X.S20240311
[4]	饶梅子, 蒋心怡, 缪佳蓉. 溃疡性结肠炎合并EB病毒和巨细胞病毒感染的危险因素分析, 昆明医科大学学报. 2024, 46(): 1-8.
[5]	李章琴, 黄奇, 缪应雷. 生物制剂在炎症性肠病治疗中的矛盾性肠外表现研究进展, 昆明医科大学学报. 2024, 45(2): 160-165. doi: 10.12259/j.issn.2095-610X.S20240223
[6]	聂忠顺, 缪应雷. 生物制剂背景下粪菌移植对炎症性肠病的应用前景, 昆明医科大学学报. 2024, 45(10): 1-8.
[7]	张霞, 聂文莎, 王惠萍, 王左华, 王春霞, 郑宇霞. 利妥昔单抗联合甲强龙治疗自身免疫性脑炎的疗效及对外周血PD-1、PD-L1的影响, 昆明医科大学学报. 2023, 44(4): 123-127. doi: 10.12259/j.issn.2095-610X.S20230428
[8]	宋文娟, 马雪娟, 孙钺, 谷颖, 叶雨佳, 李姝墨, 葛菲, 刘利萍, 赵月, 王钰. 超声心动图三维斑点追踪技术对乳腺癌曲妥珠单抗治疗中心脏毒性评估的应用, 昆明医科大学学报. 2023, 44(2): 108-112. doi: 10.12259/j.issn.2095-610X.S20230217
[9]	刘路琼, 陈通, 张永进, 谢振荣, 何成禄, 黄永坤. 丁酸对TNFα所致肠上皮屏障损伤的保护作用, 昆明医科大学学报. 2023, 44(10): 10-17. doi: 10.12259/j.issn.2095-610X.S20231021
[10]	赵剑, 谢九冰, 赵连凯. 雷珠单抗和傲迪适对黄斑区微血管结构的影响, 昆明医科大学学报. 2022, 43(9): 141-146. doi: 10.12259/j.issn.2095-610X.S20220930
[11]	梁桂丽, 李灿美, 邢成锋, 董运龙, 王娟, 雷梓, 缪应雷, 兰丹凤. GC-C^-/-小鼠在DSS诱导下肠道炎症损伤的变化, 昆明医科大学学报. 2022, 43(7): 1-8. doi: 10.12259/j.issn.2095-610X.S20220712
[12]	刘晓琳, 陈晓翠, 孙杨, 李敏丽, 缪应雷. 不同粪菌移植途径治疗溃疡性结肠炎患者的临床疗效及安全性评价, 昆明医科大学学报. 2022, 43(6): 46-51. doi: 10.12259/j.issn.2095-610X.S20220612
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[15]	孙杨. 英夫利西单抗治疗炎症性肠病的临床分析, 昆明医科大学学报. 2015, 36(02): -1.
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[18]	陈贤玉. 曲妥珠单抗1治疗HER-2过表达乳腺癌的研究进展, 昆明医科大学学报. 2013, 34(12): -1.
[19]	杨丽华. 抗整合素αⅤβ3单抗抑制上皮性卵巢癌血管及肿瘤生成的实验研究, 昆明医科大学学报. 2012, 33(06): -.
[20]	陈朝明. 改良早期预警评分预测急诊患者死亡风险的前瞻性队列研究, 昆明医科大学学报. 2012, 33(11): -.

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英夫利西单抗及维得利珠单抗治疗中重度溃疡性结肠炎的回顾性队列研究

作者简介: 张瀚予（1997～），女，云南保山人，医学学士，住院医师，主要从事消化内科诊治工作

通讯作者: 缪应雷，E-mail：miaoyinglei@yeah.net

计量

出版历程

Retrospective cohort study of infliximab and Vederizumab in the treatment of moderate-to-severe ulcerative colitis

计量

出版历程

目录

作者简介:
张瀚予（1997～），女，云南保山人，医学学士，住院医师，主要从事消化内科诊治工作

通讯作者:
缪应雷，E-mail：miaoyinglei@yeah.net