Clin Gastroenterology H:维多利珠单抗治疗炎症性肠病的安全性回顾性分析

2019-07-14 不详 MedSci原创

关于维多利珠单抗治疗克罗恩病(CD)或溃疡性结肠炎(UC)的安全性研究报道比较少。因此,本项研究旨在量化维多利珠单抗治疗炎症性肠病临床实践中与感染性和非感染性不良事件显着相关的比率和确定的因素。

背景与目的
关于维多利珠单抗治疗克罗恩病(CD)或溃疡性结肠炎(UC)的安全性研究报道比较少。因此,本项研究旨在量化维多利珠单抗治疗炎症性肠病临床实践中与感染性和非感染性不良事件显着相关的比率和确定的因素。

方法
研究人员对2014年5月至2017年6月间的数据进行了回顾性分析。传染性和不良事件被定义为需要抗生素,住院,维多珠单抗停药或导致死亡的事件。最后研究人员进行了多变量逻辑回归分析,以确定与事件显着相关的因素。

结果
本项研究共分析1087名患者(650名CD和437名UC; 55%女性;中位年龄37岁),在68名患者中观察到感染(6.3%;每100 PYE 7.9,每100 PYF 7.1); 肠道感染(n = 31,2.4 / 100 PYE,2.2 / 100 PYF)和呼吸道感染(n = 14,1.6 / 100 PYE,1.5 / 100 PYF)是最常见的。Arthralgias是最常见的非感染性不良事件(n = 31,2.9%;每100 PYE 3.6)。两名患者出现恶性肿瘤(鳞状细胞皮肤癌和结肠直肠癌;每100 PYE 0.23,每100 PYF 0.21)。使用的活跃吸烟者状态(OR,3.39)和伴随的免疫抑制剂(皮质类固醇或免疫调节剂; OR,每个药剂1.72)的数量与感染独立相关。

结论
本项研究发现维多珠单抗具有良好的耐受性与安全性,主动吸烟和伴随使用免疫抑制剂与感染独立相关。

原始出处:

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    2019-12-05 许安
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