Page 114 - 《中国药房》2024年20期

维得利珠单抗相关肺毒性1例并文献分析 Δ

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梁 瑜 ，丁雪丽 ，武 军 ，全香花 ，赵 俊 ，张传洲 ，姜 曼 （1. 青岛大学附属医院药学部，山东 青岛
266003；2.青岛大学附属医院消化内科，山东 青岛 266003）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2024）20-2552-07
DOI 10.6039/j.issn.1001-0408.2024.20.19
摘 要 目的 介绍1例维得利珠单抗（VDZ）致间质性肺炎的病例，汇总分析该药相关肺毒性的发生特点，为临床安全用药提供
参考。方法 从临床药师角度出发，回顾性分析1例VDZ致间质性肺炎患者的诊治过程，并进行不良反应相关性分析；检索中国知
网、维普网、PubMed、Web of Science等中英文数据库，对VDZ相关肺毒性的病例报道进行汇总分析。结果 该患者在使用VDZ期
间发生间质性肺炎，予抗菌药物经验性抗感染治疗无改善；停用VDZ并予甲泼尼龙治疗后，患者的症状及影像学检查均有改善但
仍提示间质性肺炎。经Naranjo’s不良反应评估量表评估并根据我国《药品不良反应报告和监测工作手册》判断，VDZ与间质性肺
炎的关联性均为“很可能”。文献分析结果显示，纳入的 29 例患者（含本文报道的患者）中，男性 19 例、女性 10 例，平均年龄
（49.24±17.06）岁；肺毒性主要包括VDZ相关性肺炎、嗜酸性粒细胞肺炎、肺肉芽肿或坏死性结节、间质性肺损伤等，多发生在用
药后24周以内（58.62%），主要临床表现为咳嗽、呼吸困难、发热等；绝大多数患者经停药和/或给予糖皮质激素等治疗后好转或康
复，1例患者因呼吸衰竭死亡。结论 肺毒性为VDZ较罕见的不良反应，起病隐匿且症状无特异性。一旦患者出现咳嗽、呼吸困难
等症状，临床应早期判断、及时停药，并给予糖皮质激素等对症治疗，以保障患者用药安全。
关键词 维得利珠单抗；肺毒性；间质性肺炎；药物不良反应；文献分析

Vedolizumab-associated lung toxicity：a case report and literature analysis
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LIANG Yu ，DING Xueli ，WU Jun ，QUAN Xianghua ，ZHAO Jun ，ZHANG Chuanzhou ，JIANG Man（1. Dept.
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of Pharmacy， the Affiliated Hospital of Qingdao University， Shandong Qingdao 266003， China；2. Dept. of
Gastroenterology， the Affiliated Hospital of Qingdao University， Shandong Qingdao 266003， China）
ABSTRACT OBJECTIVE To introduce a case of interstitial pneumonia induced by vedolizumab （VDZ）， summarize and
analyze the characteristics of the occurrence of VDZ-associated lung toxicity， and provide a reference for the clinically safe use of
drugs. METHODS From the perspective of clinical pharmacists， the diagnosis and treatment of a case of VDZ-induced interstitial
pneumonia were retrospectively analyzed， and the association of adverse drug reactions （ADR） was analyzed. Retrieving from
Chinese and English databases such as CNKI， VIP， PubMed and Web of Science， case reports of VDZ-associated lung toxicity
were summarized and analyzed. RESULTS The patient developed interstitial pneumonia during the use of VDZ and empirical anti-
infective therapy with antibiotics was ineffective. After withdrawal of VDZ and treatment with methylprednisolone， symptoms and
imaging examinations improved， but interstitial pneumonia still existed. According to Naranjo’s ADR evaluation scale and based on
China Adverse Drug Reaction Reporting and Monitoring Manual， the association between VDZ and interstitial pneumonia was
“very likely”. Results of the literature analysis showed that among 29 involved patients （including the patient reported in this
article）， there were 19 males and 10 females， with an average age of （49.24±17.06） years. Lung toxicity mainly included VDZ-
associated pneumonia， eosinophilic pneumonia， pulmonary granulomas or necrobiotic nodules， interstitial lung injury， etc.， which
mostly occurred ≤24 weeks after medication （58.62%）. The main clinical manifestations included cough， dyspnea and fever. The
vast majority of patients improved or recovered after drug withdrawal and/or glucocorticoid treatment， but one patient died of
respiratory failure. CONCLUSIONS Lung toxicity is a rare ADR of VDZ with insidious onset and nonspecific symptoms. Once
patients experience symptoms such as cough and dyspnea， early diagnosis，timely drug withdrawal，and symptomatic treatment
measures such as glucocorticoid should be taken to ensure medication safety.
KEYWORDS vedolizumab； lung toxicity； interstitial pneumonia； adverse drug reaction； literature analysis

Δ 基金项目 山东省自然科学基金项目（No.ZR2023MH097）；山东
维得利珠单抗（vedolizumab，VDZ）是一种治疗炎症
省医药卫生科技发展计划项目（No.202102040497）
＊第一作者 副主任药师，硕士。研究方向：临床药学。电话： 性肠病（inflammatory bowel disease，IBD）的新型单克隆
0532-82912182。E-mail：liangyu2791@163.com
抗体，可用于对传统药物或肿瘤坏死因子 α（tumor
# 通信作者 副主任药师，博士。研究方向：临床药学。电话：
0532-82912182。E-mail：jiangman@qdu.edu.cn necrosis factor-α，TNF-α）抑制剂应答不充分、失应答或不

· 2552 · China Pharmacy 2024 Vol. 35 No. 20 中国药房 2024年第35卷第20期