外科治疗联合英夫利昔单抗与乌司奴单抗克对罗恩肛瘘的临床疗效观察

doi:10.3969/j.issn.1006-5725.2025.06.015

摘要/Abstract

摘要：

目的研究克罗恩肛瘘（perianal fistulizing Crohn's disease，pfCD）外科治疗联合生物制剂的临床疗效观察。方法采用回顾性病例对照研究，选取医院2021年5月至2023年12月收治的pfCD患者60例，随机分为治疗组A（n = 30）和治疗组B（n = 30），治疗组A患者采用外科治疗+英夫利昔单抗（IFX） + 硫唑嘌呤（AZA），治疗组B患者采用外科治疗 + 乌司奴单抗（UST） + AZA，观察两组患者克罗恩病活动指数（CDAI）、肛周疾病活动指数（PDAI）及Assche评分，术后MRI检查，观察pfCD愈合状况。结果治疗组A与B的治疗前与治疗后比较，CDAI、PDAI、Assche评分差异有统计学意义（P < 0.05）且各时间点的CDAI、PDAI、Assche评分变化量间均有差异。治疗组A与B，8、16、24、32周的CDAI、PDAI、Assche评分及40周的PDAI评分比较差异无统计学意义（P > 0.05），而40周的CDAI及Assche评分比较差异有统计学意义（P < 0.05）。结论外科治疗联合IFX/UST治疗pfCD安全有效，但外科治疗联合UST远期疗效更好。

关键词: 克罗恩肛瘘, 外科治疗, 英夫利昔单抗, 乌司奴单抗

Abstract:

Objective To evaluate the efficacy of combining surgical treatment with biological agents for perianal fistulizing Crohn′s disease （pfCD）. Methods Sixty patients with perianal fistulizing Crohn′s disease （pfCD） admitted to our hospital from May 2021 to December 2023 were randomly allocated into two groups： Treatment Group A （n = 30） and Treatment Group B （n = 30）. Treatment Group A received pfCD surgery combined with infliximab （IFX） and azathioprine （AZA）， while Treatment Group B underwent pfCD surgery along with ustekinumab （UST） and AZA. The CDAI score， PDAI score， and Assche score were monitored for both groups， and postoperative MRI examinations were conducted to evaluate the healing of pfCD. Results There were statistically significant differences in CDAI， PDAI， and Assche scores between pre?treatment and post?treatment comparisons within treatment groups A and B （P < 0.05）， as well as in the magnitude of change at each time point. Comparisons of CDAI， PDAI， and Assche scores at 8， 16， 24， and 32 weeks， and PDAI scores at 40 weeks between groups A and B using independent samples t?tests did not yield statistically significant results （P > 0.05）. However， significant differences were observed for CDAI and Assche scores at 40 weeks （P < 0.05）. Significant changes in CDAI， PDAI， and Assche scores were noted at 8， 16， 24， 32， and 40 weeks post?treatment within both groups A and B （P < 0.05）. Multiple comparisons using the LSD method revealed that the changes in these scores at each time point were statistically significant （P < 0.05）. The data indicate a temporal trend in the changes of CDAI， PDAI， and Assche scores， with group B showing a more rapid decline compared to group A. In terms of fistula response rates， both groups A and B achieved 100% （30/30）. However， the clinical healing rate of fistulas was higher in group B at 86.7% （26/30） compared to 76.7% （23/30） in group A. Conclusion The combination of surgical treatment with IFX/UST plus AZA is safe and effective for treating pfCD. However， the long?term efficacy of combining surgical treatment with UST appears to be superior.

Key words: pfCD, surgical treatment, infliximab, ustekinumab

中图分类号:

R574

袁和学,田丰,李卉,罗芳,赵亮,刘宗剑,潘春来,刘利军,朱娜. 外科治疗联合英夫利昔单抗与乌司奴单抗克对罗恩肛瘘的临床疗效观察[J]. 实用医学杂志, 2025, 41(6): 872-876.

Hexue YUAN,Feng TIAN,Hui LI,Fang LUO,Liang ZHAO,Zongjian LIU,Chunlai PAN,Lijun LIU,Na. ZHU. Clinical efficacy of surgical treatment combined with IFX and UST on Crohn′s anal fistulae[J]. The Journal of Practical Medicine, 2025, 41(6): 872-876.

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参考文献 20

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分组	CDAI	PDAI	Assche
治疗组A	288.13 ± 98.57	8.63 ± 3.03	11.50 ± 2.61
治疗组B	288.33 ± 98.61	8.33 ± 2.95	11.37 ± 2.77
t值	-0.008	0.388	0.192
P值	> 0.05	> 0.05	> 0.05

时间	治疗组A			治疗组B
时间	CDAI	PDAI	Assche	CDAI	PDAI	Assche
0周	288.13 ± 98.57	8.633 ± 3.03	11.5 ± 2.60	288.33 ± 98.61	8.33 ± 2.95	11.37 ± 2.77
8周	252.9 ± 96.06	7.567 ± 3.11	9.9 ± 2.28	266.63 ± 96.96	7.5 ± 3.03	9.77 ± 2.37
16周	242.93 ± 95.95	5.533 ± 2.53	7.43 ± 1.92	254.2 ± 99.71	4.6 ± 2.36	6.57 ± 2.01
24周	162.8 ± 68.01	3.433 ± 1.79	4.27 ± 1.23	154.6 ± 57.45	3.27 ± 2.35	3.93 ± 1.08
32周	144.73 ± 48.72	2.533 ± 1.59	2.27 ± 1.44	123.13 ± 40.25	1.7 ± 1.84	1.53 ± 1.41
40周	134.77 ± 40.80	2.033 ± 1.69	1.07 ± 1.17	106.5 ± 31.07	0.97 ± 1.19	0.53 ± 0.73
F值	1 941.658	124.25	192.351	274.008	105.965	153.458
P值	< 0.001	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01

分组	CDAI
分组	8周	16周	24周	32周	40周
治疗组A	252.9 ± 96.06	242.93 ± 95.95	162.8 ± 68.01	144.73 ± 48.72	134.77 ± 40.80
治疗组B	266.63 ± 96.96	254.2 ± 99.71	154.6 ± 57.45	123.13 ± 40.25	106.5 ± 31.07
t值	-0.551	-0.446	0.504	1.872	3.019
P值	> 0.05	> 0.05	> 0.05	> 0.05	< 0.05

分组	PDAI
分组	8周	16周	24周	32周	40周
治疗组A	7.5 ± 3.11	5.53 ± 2.53	3.43 ± 1.79	2.53 ± 1.59	2.03 ± 1.69
治疗组B	7.5 ± 3.03	4.6 ± 2.36	3.27 ± 2.35	1.7 ± 1.84	0.97 ± 1.19
t值	0.084	1.479	0.309	1.875	2.826
P值	> 0.05	> 0.05	> 0.05	> 0.05	> 0.05

分组	Assche
分组	8周	16周	24周	32周	40周
治疗组A	9.9 ± 2.28	7.43 ± 1.92	4.27 ± 1.23	2.27 ± 1.44	1.07 ± 1.17
治疗组B	9.77 ± 2.37	6.57 ± 2.01	3.93 ± 1.08	1.53 ± 1.41	0.53 ± 0.73
t值	0.222	1.705	1.115	1.997	2.115
P值	> 0.05	> 0.05	> 0.05	> 0.05	< 0.05