Page 102 - 《中国药房》2023年15期

基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析

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高茂威 ，杨小娟 ，纵尚尚（1.皖北煤电集团总医院药学部，安徽 宿州 234000；2.皖北煤电集团总医院药物
1 ＊
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临床试验机构办公室，安徽 宿州 234000）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2023）15-1884-07
DOI 10.6039/j.issn.1001-0408.2023.15.18

摘 要 目的 为阿巴西普的临床安全使用提供参考依据。方法 以美国FDA不良事件报告系统（FAERS）数据库为基础，以药品
通用名“abatacept”与商品名“Orencia”作为检索关键词，检索首要怀疑药物为阿巴西普的药物不良事件（ADE）信号，并采用比例失
衡法中的报告比值比法和比例报告比值法以及 Excel 2020 软件对信号进行挖掘与分析。结果 共检索出阿巴西普 ADE 报告
93 189 份，以女性病例（75.98%）为主，年龄主要集中于 18～64 岁（35.17%）；数据上报的主要国家为美国（47.41%）与加拿大
（30.59%），上报的数量总体呈逐年递增的趋势。共筛选出ADE信号3 092个，其中与阿巴西普的药品说明书描述相似的是与原发
疾病相关的ADE信号，如类风湿性关节炎、关节痛、关节肿胀等；其次是与输液反应相关的ADE信号，包括疼痛、乏力、皮疹等。所
有筛选出的ADE信号共涉及27个系统器官分类，主要为全身疾病及给药部位各种反应，肌肉骨骼和结缔组织疾病，伤害、中毒和
手术并发症，感染和侵袭类疾病，胃肠疾病，神经系统疾病，呼吸、胸腔和纵隔疾病，心脏疾病，良性、恶性和未特指的肿瘤，生殖系
统和乳腺疾病等。报告例数排前50位的ADE信号中未被阿巴西普药品说明书收录的共有22个，包括乏力、药物不耐受、腹部不
适、肿胀、红斑狼疮、周围肿胀、天疱疮、腹泻、肝酶升高与下呼吸道感染等。结论 临床在使用阿巴西普的过程中应格外注意感染
及其致癌性，同时评估患者的呼吸及心血管系统疾病风险，当患者合并这2类基础疾病时，应权衡利弊后谨慎选用；此外，该药在
神经、胃肠及生殖系统的ADE也不容忽视。
关键词 阿巴西普；药物不良事件；数据挖掘；药物不良反应；比例失衡法

Signal mining and analysis of adverse drug events of abatacept based on FAERS database
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GAO Maowei ，YANG Xiaojuan ，ZONG Shangshang（1. Dept. of Pharmacy， General Hospital of Wanbei Coal
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Power Group， Anhui Suzhou 234000， China；2. Office of Drug Clinical Trial Institutions， General Hospital of
Wanbei Coal Power Group， Anhui Suzhou 234000， China）
ABSTRACT OBJECTIVE To provide a reference for the safe use of abatacept in clinic. METHODS Based on the United States
FDA Adverse Event Reporting System （FAERS） database， the generic name of the drug “abatacept” and the trade name “Orencia”
were used as the search keywords to retrieve drug adverse event （ADE） signal of abatacept as primary suspected drug. The reported
odds ratio method and proportional reporting ratio method in the proportional imbalance method and Excel 2020 software were used
to mine and analyze the signals. RESULTS A total of 93 189 abatacept-induced ADE reports were retrieved， mainly female cases
（75.98%）， and the age was mainly concentrated in 18-64 years old （35.17%）； main countries reporting data were the United States
（47.41%） and Canada （30.59%）， and the number of reports was generally increasing year by year. A total of 3 092 ADE signals
were screened， of which the signals associated with the primary disease were similar to those described in the drug instruction of
abatacept， such as rheumatoid arthritis， arthralgia， joint swelling， etc.； followed by ADE signals related to infusion reactions，
including pain， fatigue， rash， etc. All selected ADE signals involved 27 system organ classes， mainly involved systemic diseases
and drug site conditions， musculoskeletal and connective tissue diseases， injury， poisoning and surgical complications， infections
and invasive diseases， gastrointestinal diseases， neurological diseases， respiratory， thoracic and mediastinal diseases， heart
diseases， benign， malignant and unspecified tumors and reproductive system and breast diseases， etc. A total of 22 ADE signals
were not included in the drug instructions of abatacept among the top 50 ADE signals in the number list of reported cases，
including fatigue， drug intolerance， abdominal discomfort， swelling， lupus erythematosus， peripheral swelling， cell sores，
diarrhea， elevated liver enzymes and lower respiratory tract infection， etc. CONCLUSIONS In the process of clinical use of
abatacept， special attention should be paid to infection and its carcinogenicity， while assessing the risk of respiratory and
cardiovascular system diseases in patients； when patients suffer from these two underlying diseases， the pros and cons should be
weighed carefully before selecting drug； in addition， the drug-induced ADE in the neurological， gastrointestinal and reproductive
system cannot be ignored.
KEYWORDS abatacept； adverse drug events； data mining；
＊第一作者 主管药师。研究方向：临床药学、药物警戒。E-mail：
403349212@qq.com adverse drug reactions； proportional imbalance method

· 1884 · China Pharmacy 2023 Vol. 34 No. 15 中国药房 2023年第34卷第15期