摘要
目的促进临床合理使用戈沙妥珠单抗。方法收集美国食品和药物管理局不良事件报告系统(FAERS)2020年4月至2023年6月戈沙妥珠单抗相关药品不良事件(ADE)报告,采用比例报告比(PRR)法和报告比值比(ROR)法对报告进行检验,根据国际医学用语词典中的系统器官分类(SOC)和首选语(PT)进行分类统计和描述性分析。结果共纳入以戈沙妥珠单抗为首要怀疑药物的ADE报告2369份,患者以女性为主(85.69%),适应证为三阴性乳腺癌最多(49.30%);程度以严重ADE(89.70%)最多;主要上报国家为美国(35.42%)。2种方法同时检测出的PT阳性信号为137个,涉及26个SOC,所挖掘的药物主要ADE与药品说明书基本一致,包括中性粒细胞减少症、发热性中性粒细胞减少症、体质量波动、腹泻、脱发等;药品说明书未记载的ADE包括肝细胞溶解、胆汁淤积、脓毒症、结肠炎和心率加快等,信号数较多,且信号较强。结论戈沙妥珠单抗ADE与药品说明书基本一致,血液系统和胃肠道系统ADE值得临床重视并及时干预。
Objective To promote the rational use of sacituzumab govitecan in clinical practice.Methods The adverse drug event(ADE)reports related to sacituzumab govitecan from April 2020 to June 2023 were collected by the FDA′s Adverse Event Reporting System(FAERS).The ADE signals were detected by the proportional reporting ratio(PRR)and reporting odds ratio(ROR)methods.The system organ classification(SOC)and preferred term(PT)in the Medical Dictionary for Regulatory Activities(MedDRA)were used for classification statistics and descriptive analysis.Results A total of 2369 ADE reports with sacituzumab govitecan as the primary suspected drug were included,with female patients being the majority(85.69%);the main indication was triple-negative breast cancer(49.30%),the severe ADEs were the most(89.70%),and the main reporting country was the United States(35.42%).A total of 137 positive PT signals were detected simultaneously by PRR and ROR methods,involving 26 SOCs.The mined main ADEs induced by sacituzumab govitecan included neutropenia,febrile neutropenia,body mass fluctuations,diarrhea,alopecia,which were generally consistent with those in the drug instruction;however,the ADEs not recorded in the drug instruction included hepatic cytolysis,cholestasis,sepsis,colitis and increased heart rate,with a high signal number and strong signal intensity.Conclusion The ADEs induced by sacituzumab govitecan were generally consistent with those in the drug instruction,the hematological and gastrointestinal systems-related ADEs require clinical attention and timely intervention.
作者
李娉婷
杨捷
LI Pingting;YANG Jie(Shanghai Geriatric Medical Center,Shanghai,China 201104;Changning Maternity and Infant Health Hospital,Shanghai,China 200051)
出处
《中国药业》
CAS
2024年第24期125-128,I0001,共5页
China Pharmaceuticals
