乌司奴单克隆抗体治疗克罗恩病的短期临床疗效及影响因素

doi:10.3969/j.issn.1006-5725.2024.07.019

Abstract

Abstract:

Objective To analyze the short?term clinical efficacy and influencing factors of ustekinumab monoclonal antibody （UST） in the treatment of Crohn's disease （CD）. Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People's Hospital affiliated to Tongji University from December 2020 to October 2022. The main analysis is the short?term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16， And analyze the endoscopic response rate of some patients. Results A total of 91 CD patients who first used UST were included. The 8?week clinical response rate of UST treatment for CD was 61.5%， and the clinical response rate was 45%； The clinical response rate at 16 weeks was 71.4%， and the clinical response rate was 54.9%. 56 cases underwent endoscopic re?examination in our hospital， and the endoscopic response rate at 16 weeks was 41.1%. Univariate analysis showed that fistula （including anal fistula， personal history of anal fistula， and intestinal skin fistula） is associated with clinical remission in Crohn's disease patients at 8/16 weeks. Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks （HR = 0.04，95% CI： 0.00 ~ 0.38； P = 0.005） and 16 weeks （HR = 0.04，95% CI： 0.01 ~ 0.34； P = 0.003） compared to those without fistula； Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non?narrow and non?penetrating lesions （HR = 1.75， 95% CI： 1.08 ~ 2.84； P = 0.023）. No patients were found to have stopped medication due to serious adverse reactions. Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks， and has good short?term clinical efficacy. CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies， while patients with stenotic lesions should be cautious in using UST monoclonal antibodies. Whether the patient has undergone surgical treatment in the past， as well as whether UST has been used on the first or non?first line， has no significant impact on clinical remission.

Key words: ustekinumab monoclonal antibody, Crohn's disease, clinical remission, clinical response

CLC Number:

R574

Rui WANG,Changqin LIU,Cui ZHANG,Qinglu YANG,Jiaolan YANG,Pengyun YIN,Xiaohui LI,Yongshun SUN,Zhanju LIU,Xiaomin. SUN. Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn′s disease[J]. The Journal of Practical Medicine, 2024, 40(7): 989-995.

Figures/Tables 4

Fig.1

Tab.1

Tab.2

Fig.2

References 25

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因素	单因素COX分析			多因素COX分析
因素	P值	HR	95%CI	P值	HR	95%CI
性别	0.377	1.29	0.74 ~ 2.24	0.448	1.29	0.67 ~ 2.49
手术	0.472	0.80	0.44 ~ 1.46	0.250	0.66	0.33 ~ 1.34
发病年龄	0.054	1.02	1.00 ~ 1.04	0.592	1.01	0.96 ~ 1.05
病程	0.259	0.98	0.94 ~ 1.02	0.490	0.99	0.94 ~ 1.03
CDAI评分	0.498	1.00	0.99 ~ 1.01	0.519	1.01	0.96 ~ 1.06
发病部位	0.857			0.530
L2 vs. L1	0.977	1.01	0.47 ~ 2.19	0.480	1.17	0.76 ~ 1.79
L3 vs. L1	0.590	0.82	0.39 ~ 1.70	0.519	0.56	1.04 ~ 4.36
L4 vs. L1
疾病行为	0.039			0.093
B2 vs. B1	0.512	0.73	0.29 ~ 1.86	0.074	1.60	0.96 ~ 2.67
B3 vs. B1	0.301	0.83	0.66 ~ 3.86	0.132	0.56	0.96 ~ 1.54
发病年龄	0.257			0.527
A2 vs. A1	0.104	0.43	0.16 ~ 1.19	0.472	1.41	0.55 ~ 3.59
A3 vs. A1	0.526	0.80	0.39 ~ 1.61	0.861	1.29	0.73 ~ 1.56
UST非一线 vs. 一线	0.757	1.10	0.60 ~ 2.00	0.539	0.49	0.05 ~ 4.81
既往抗TNF?α vs. 无	0.727	1.12	0.61 ~ 1.10	0.352	2.84	0.32 ~ 25.68
既往VDZ vs. 无	0.608	1.22	0.57 ~ 2.60	0.097	2.23	0.86 ~ 5.75
合用激素 vs. 无	0.470	1.44	0.53 ~ 3.89	0.898	1.08	0.32 ~ 3.62
合用免疫抑制剂 vs. 无	0.201	1.91	0.71 ~ 5.13	0.132	2.49	0.76 ~ 8.15
瘘	0.010			0.044
肛瘘 vs. 无瘘	0.002	0.08	0.02 ~ 0.40	0.112	0.22	0.04 ~ 1.42
肛瘘手术史 vs. 无瘘	0.002	0.03	0.00 ~ 0.28	0.005	0.04	0.00 ~ 0.38
肠瘘 vs. 无瘘	0.003	0.08	0.02 ~ 0.42	0.108	0.22	0.03 ~ 1.40

因素	单因素COX分析			多因素COX分析
因素	P值	HR	95%CI	P值	HR	95%CI
性别	0.259	1.35	0.80 ~ 2.25	0.257	1.43	0.77 ~ 2.66
手术	0.774	0.92	0.54 ~ 1.59	0.337	0.72	0.37 ~ 1.47
发病年龄	0.127	1.02	0.99 ~ 1.04	0.667	1.01	0.97 ~ 0.52
病程	0.514	0.99	0.96 ~ 1.02	0.711	0.99	0.96 ~ 1.03
CDAI评分	0.881	1.00	0.99 ~ 1.01	0.955	1.00	0.99 ~ 1.00
发病部位	0.978			0.341
L2 vs. L1	0.924	1.05	0.43 ~ 2.56	0.369	1.21	0.80 ~ 1.83
L3 vs. L1	0.840	1.08	0.50 ~ 2.33	0.287	1.63	0.95 ~ 1.57
L4 vs. L1
疾病行为	0.170			0.092
B2 vs. B1	0.524	0.78	0.32 ~ 1.79	0.023	1.75	1.08 ~ 2.84
B3 vs. B1	0.206	1.71	0.75 ~ 3.89	0.219	1.55	0.74 ~ 2.96
发病年龄	0.468			0.441
A2 vs. A1	0.223	0.58	0.24 ~ 1.40	0.663	1.21	0.51 ~ 2.86
A3 vs. A1	0.559	0.82	0.42 ~ 1.60	0.237	1.68	0.77 ~ 2.14
UST非一线 vs. 一线	0.832	1.06	0.61 ~ 1.85	0.414	0.39	0.04 ~ 3.69
既往抗TNF?α vs. 无	0.797	1.07	0.62 ~ 1.85	0.302	3.12	0.36 ~ 7.01
既往VDZ vs. 无	0.356	1.38	0.70 ~ 2.74	0.054	2.36	0.98 ~ 5.65
合用激素 vs. 无	0.295	1.70	0.63 ~ 4.16	0.330	1.91	0.52 ~ 7.01
合用免疫抑制剂 vs. 无	0.258	1.51	0.74 ~ 3.06	0.368	1.51	0.61 ~ 3.73
瘘	0.110			0.260
肛瘘 vs. 无瘘	0.001	0.81	0.16 ~ 0.40	0.780	0.20	0.03 ~ 1.19
肛瘘手术史 vs. 无瘘	0.001	0.04	0.01 ~ 0.30	0.003	0.04	0.01 ~ 0.34
肠瘘 vs. 无瘘	0.002	0.08	0.02 ~ 0.42	0.097	0.22	0.04 ~ 1.32

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Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn′s disease

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