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托法替布暴露并不会增加溃疡性结肠炎患者全结肠切除术后的并发症:一项回顾性病例对照研究。

Tofacitinib Exposure Does Not Increase Postoperative Complications Among Patients With Ulcerative Colitis Undergoing Total Colectomy: A Retrospective Case-Control Study.

机构信息

Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota.

Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota.

出版信息

Dis Colon Rectum. 2024 Nov 1;67(11):1443-1449. doi: 10.1097/DCR.0000000000003440. Epub 2024 Aug 1.

DOI:10.1097/DCR.0000000000003440
PMID:39087684
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11477851/
Abstract

BACKGROUND

Ulcerative colitis, total colectomy, and tofacitinib have all been associated with an increased risk of venous thromboembolism.

OBJECTIVE

To determine whether preoperative tofacitinib exposure increases venous thromboembolism or other postoperative complications among patients with ulcerative colitis undergoing subtotal colectomy, total colectomy, or total proctocolectomy.

DESIGN

Retrospective, case-controlled study at a single institution.

SETTINGS

A tertiary referral center.

PATIENTS

Adult patients with ulcerative colitis undergoing subtotal colectomy, total colectomy, or total proctocolectomy after 2018 who were taking tofacitinib within 30 days of surgery (n = 56) were compared to age- and sex-matched patients with ulcerative colitis undergoing the same surgeries but who were not exposed to tofacitinib (n = 56).

MAIN OUTCOME MEASURE

The primary outcome was differences in the incidence of venous thromboembolism within 90 days of surgery based on tofacitinib exposure. Secondary outcomes were 90-day postoperative complications.

RESULTS

Groups were well matched for age (non-tofacitinib: mean 35.2 years [SD 12.0], tofacitinib: 35.9 [SD 12.1], p = 0.36) and sex (41% women in each group, p = 1.00). Medical characteristics were similar between groups except for biological medication exposure 30 days before surgery (non-tofacitinib: 66%, tofacitinib: 36%, p = 0.004). Surgical characteristics did not differ between groups. Most patients were discharged on extended venous thromboembolism prophylaxis (non-tofacitinib: 80% and tofacitinib: 77%). Adjusted for biological exposure, there were no statistically significant differences in venous thromboembolism (non-tofacitinib exposed: 14%, tofacitinib exposed: 4%, p = 0.09) or other postoperative outcomes.

LIMITATION

Retrospective, single institutional study.

CONCLUSIONS

Among patients with ulcerative colitis undergoing total colectomy or proctocolectomy, exposure to tofacitinib was not associated with an increased risk of venous thromboembolism or other postoperative complications. See Video Abstract .

LA EXPOSICIN A TOFACITINIB NO AUMENTA LAS COMPLICACIONES POSOPERATORIAS ENTRE PACIENTES CON COLITIS ULCEROSA SOMETIDOS A COLECTOMA TOTAL UN ESTUDIO RETROSPECTIVO DE CASOS Y CONTROLES

ANTECEDENTES:La colitis ulcerosa, la colectomía total y el tofacitinib han sido asociados con un mayor riesgo de tromboembolismo venoso.OBJETIVO:Determinar si la exposición preoperatoria a tofacitinib aumenta la tromboembolia venosa u otras complicaciones posoperatorias entre pacientes con colitis ulcerosa sometidos a colectomía subtotal, colectomía total o proctocolectomía total.DISEÑO:Estudio retrospectivo de casos y controles en una sola institución.AJUSTES:Un centro de referencia terciario.PACIENTES:Los pacientes adultos con colitis ulcerosa sometidos a colectomía subtotal, colectomía total o proctocolectomía total después del año 2018 que se encontraron consumiendo tofacitinib dentro de los 30 días posteriores a la cirugía (n = 56) fueron comparados con pacientes con colitis ulcerosa de la misma edad y sexo sometidos a las mismas cirugías pero que no estuvieron expuestos a tofacitinib (n = 56).MEDIDA DE RESULTADO PRINCIPAL:El resultado primario fueron las diferencias en las incidencias de tromboembolismo venoso dentro de los 90 días posteriores a la cirugía según la exposición a tofacitinib. Los resultados secundarios fueron las complicaciones posoperatorias a los 90 días.RESULTADOS:Los grupos se encontraban bien emparejados por edad (sin tofacitinib: media 35,2 años [DE 12,0], tofacitinib: 35,9 [DE 12,1], p = 0,36) y sexo (41% mujeres en cada grupo, p = 1,00). Las características médicas fueron similares entre los grupos, excepto por la exposición a medicamentos biológicos 30 días antes de la cirugía (sin tofacitinib: 66 %, tofacitinib: 36 %, p = 0,004). Las características quirúrgicas no difirieron entre los grupos. La mayoría de los pacientes fueron dados de alta con profilaxis extendida para tromboembolismo venoso (sin tofacitinib: 80% y tofacitinib: 77%). Ajustado a la exposición biológica, no hubo diferencias estadísticamente significativas en el tromboembolismo venoso (no expuestos a tofacitinib: 14%, expuestos a tofacitinib: 4%, p = 0,09) u otros resultados posoperatorios.LIMITACIÓN:Estudio institucional único, retrospectivo.CONCLUSIÓN:Entre los pacientes con colitis ulcerosa sometidos a colectomía total o proctocolectomía, la exposición a tofacitinib no se asoció con un mayor riesgo de tromboembolismo venoso u otras complicaciones posoperatorias. (Traducción-Dr Osvaldo Gauto ).

摘要

背景

溃疡性结肠炎、全结肠切除术和托法替尼均与静脉血栓栓塞风险增加有关。

目的

确定溃疡性结肠炎患者在接受全结肠切除术、全结肠直肠切除术或全直肠结肠切除术之前接受托法替尼治疗是否会增加静脉血栓栓塞或其他术后并发症。

设计

单机构回顾性病例对照研究。

地点

三级转诊中心。

患者

2018 年后接受全结肠切除术、全结肠切除术或全直肠结肠切除术且手术前 30 天内接受托法替尼治疗的溃疡性结肠炎成年患者(n = 56)与未接受托法替尼治疗但接受相同手术的溃疡性结肠炎患者(n = 56)进行年龄和性别匹配。

主要观察指标

根据托法替尼暴露情况,术后 90 天内静脉血栓栓塞的发生率差异为主要结局。次要结局为 90 天术后并发症。

结果

两组患者的年龄(非托法替尼组:平均 35.2 岁[SD 12.0],托法替尼组:35.9 [SD 12.1],p = 0.36)和性别(每组 41%为女性,p = 1.00)均匹配良好。两组的医疗特征相似,除手术前 30 天接受生物药物治疗的比例不同(非托法替尼组:66%,托法替尼组:36%,p = 0.004)外。手术特征两组之间没有差异。大多数患者接受了延长静脉血栓栓塞预防治疗(非托法替尼组:80%,托法替尼组:77%)。在调整生物暴露因素后,静脉血栓栓塞(非托法替尼暴露:14%,托法替尼暴露:4%,p = 0.09)或其他术后结局无统计学差异。

局限性

回顾性、单机构研究。

结论

在接受全结肠切除术或全直肠结肠切除术的溃疡性结肠炎患者中,托法替尼暴露与静脉血栓栓塞或其他术后并发症的风险增加无关。

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