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阿帕替尼上市后的ADR文献分析
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金秉巾 ，吴雪花，王 欣，张轶惟，松长青，王亚峰（青海省人民医院药学部，西宁 810007）
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中图分类号 R969.3；R979.1 文献标志码 A 文章编号 1001-0408（2024）07-0837-05
DOI 10.6039/j.issn.1001-0408.2024.07.12

摘 要 目的 探讨阿帕替尼所致药物不良反应（ADR）的特点及规律，为其临床安全用药提供参考。方法 检索自阿帕替尼2014
年上市以来，中国知网、万方医学网、维普及PubMed等中英文数据库中关于其ADR及安全性评估的个案和群体报道，经筛选后对
文献资料进行提取及分析。结果 共纳入病例101例，涉及ADR 221例次。发生ADR的患者中，男女比例为1.24∶1，年龄以51～
70 岁最多，给药剂量以 500 mg 及以上者居多，但其中给予小剂量阿帕替尼并联合使用了其他抗肿瘤药物的患者也较易发生
ADR。ADR的种类以1～2种居多，而种类最多者可高达6种。该药的ADR多发生在用药后30 d内，累及器官/系统以心血管系统
损害、皮肤及其附件损害、胃肠系统损害和泌尿系统损害为主，主要临床表现为高血压/加重、手足综合征、腹痛腹泻和蛋白尿等，
其严重ADR以高血压/加重、手足综合征和骨髓抑制多见。多数ADR均可通过停药、减量及对症处理实现好转/痊愈。4例死亡患
者均存在基础病，且美国东部肿瘤协作组评分均≥2分。特殊ADR（如可逆性后部脑病综合征、精神异常和认知障碍等）多由阿帕
替尼自身引起，亦存在阿帕替尼与原发疾病或基础疾病共同引起的可能。结论 高龄、剂量较大、联合用药、存在基础病及体力状
态不佳是使用阿帕替尼患者发生ADR的高危因素。建议对所有使用该药患者的血压、尿蛋白及手足皮肤进行日常监测，并注意
特殊ADR的发生，以便及时发现并给予有效干预，从而避免ADR加重及继发其他ADR。
关键词 阿帕替尼；药物不良反应；文献分析；安全用药；胃癌；食管胃结合部腺癌

Literature analysis of ADR after the listing of apatinib
JIN Bingjin，WU Xuehua，WANG Xin，ZHANG Yiwei，SONG Changqing，WANG Yafeng（Dept. of Pharmacy，
Qinghai Provincial People’s Hospital， Xining 810007， China）

ABSTRACT OBJECTIVE To explore the characteristics and regulations of adverse drug reactions （ADR） caused by apatinib，
and to provide a reference for the safe use of apatinib in clinic. METHODS Case and group reports on ADR and safety evaluation
of apatinib were retrieved from Chinese and English databases such as CNKI， Wanfang medical network， VIP and PubMed since
its listing in 2014， literature data were extracted and statistically analyzed after screening. RESULTS Totally 101 cases were
included， involving 221 ADR. In the above cases， the male-to-female ratio was 1.24∶1， with the highest proportion of patients
aged 51 to 70 years， most of the patients were given a dose of 500 mg or more， and the patients given low dose of apatinib
combined with other antitumor drugs were also likely to have ADR. One to two types of adverse reaction were the most common，
while the types could reach up to six. Most ADR occurred within 30 days after medication， and the systems/organs involved were
mainly the cardiovascular system damage，skin and its accessories damage， gastrointestinal system damage and urinary system
damage； the main clinical manifestations were hypertension/aggravation，hand-foot syndrome，abdominal pain diarrhea and
albuminuria， etc. Hypertension/aggravation， hand-foot syndrome and myelosuppression were the most common serious ADR. Most
ADR could be improved/cured by suspension of administration， dose downregulation and symptomatic treatment. All 4 patients who
died had underlying diseases， and their ECOG scores all ≥2 points. Special ADR （such as reversible posterior encephalopathy
syndrome， psychiatric disorders， and cognitive impairment） were mostly caused by apatinib itself， or may be caused by apatinib in
combination with the primary or underlying disease. CONCLUSIONS Advanced age， large dose， combination medication，
underlying diseases and poor physical condition might be the high risks for ADR caused by apatinib. It is recommended to monitor
the blood pressure，urine protein and skin of hands and feet of all patients with medication on a daily basis，pay attention to the
occurrence of special ADR， and timely detect abnormal states and give effective intervention，so as to avoid the aggravation of ADR
and other secondary ADR.
KEYWORDS apatinib； adverse drug reactions； literature analysis； safe medication； gastric cancer； adenocarcinoma of
gastroesophageal junction

Δ 基金项目 四川省区域创新合作项目（No.2022YFQ-0072） 胃癌和食管胃结合部腺癌在全球新发的恶性肿瘤
＊第一作者 主管药师，硕士。研究方向：临床药学。E-mail：
中居第 5 位，在恶性肿瘤诱发的相关死亡原因中居第 4
249084622@qq.com
[1]
位，每年约有 100 万人因此死亡 。尽管近年来多学科
# 通信作者 主任药师，硕士生导师，博士。研究方向：医院药学。
E-mail：wyf8289@163.com 和多模式合作参与治疗胃癌和食管胃结合部腺癌取得

中国药房 2024年第35卷第7期 China Pharmacy 2024 Vol. 35 No. 7 · 837 ·