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伊立替康在成人和儿童中的ADE信号差异分析
Difference analysis of ADE signal for irinotecan in adults and children
- 中国药房 2024年35卷第11期 页码：1369-1373
- 作者机构：
1.苏州大学附属儿童医院药剂科，江苏 苏州 215002
2.苏州市广济医院药剂科，江苏 苏州 215003
- 作者简介：
主管药师，硕士。研究方向：临床药学。E-mail：sudalifang@126.com
主任药师，硕士生导师，博士。研究方向：医院药学。E-mail：zhuzengyan7676@suda.edu.cn
- 基金信息：苏州市科技计划项目(SLJ2021015)
DOI：10.6039/j.issn.1001-0408.2024.11.15
中图分类号： R969.3纸质出版日期：2024-06-15，
收稿日期：2023-10-13，
修回日期：2024-04-14，
扫 描 看 全 文
李芳,杜小换,尚翔等.伊立替康在成人和儿童中的ADE信号差异分析 Δ[J].中国药房,2024,35(11):1369-1373.
LI Fang,DU Xiaohuan,SHANG Xiang,et al.Difference analysis of ADE signal for irinotecan in adults and children[J].ZHONGGUO YAOFANG,2024,35(11):1369-1373.
李芳,杜小换,尚翔等.伊立替康在成人和儿童中的ADE信号差异分析 Δ[J].中国药房,2024,35(11):1369-1373. DOI： 10.6039/j.issn.1001-0408.2024.11.15.
LI Fang,DU Xiaohuan,SHANG Xiang,et al.Difference analysis of ADE signal for irinotecan in adults and children[J].ZHONGGUO YAOFANG,2024,35(11):1369-1373. DOI： 10.6039/j.issn.1001-0408.2024.11.15.
摘要
目的
2
挖掘和分析伊立替康上市后在成人和儿童群体中的药物不良事件（ADE）信号，为临床安全用药提供参考。
方法
2
提取美国FDA不良事件报告系统数据库中2004年第1季度至2023年第1季度的伊立替康ADE报告，采用报告比值比法和比例报告比值比法挖掘该药的风险信号，分别对患者年龄＜18岁（儿童）和≥18岁（成人）的ADE报告及信号进行统计分析。
结果
2
共挖掘到8 013份以伊立替康为首要怀疑药物的ADE报告，其中成人与儿童ADE报告分别有7 656、357份，分别挖掘出518、75个ADE信号，主要累及胃肠系统疾病、血液及淋巴系统疾病和全身性疾病及给药部位各种反应等系统器官分类。信号频度排前20位的ADE信号在伊立替康的药品说明书中大部分有记载；周围神经病、口腔黏膜炎、肺栓塞、表皮痣综合征、生殖毒性等是成人中新的ADE信号，而高血压、进展性肿瘤、肿瘤溶解综合征、栓塞等是儿童中新的ADE信号。
结论
2
临床应用伊立替康时应警惕说明书未提及的上述新的可疑高风险信号。
Abstract
OBJECTIVE
2
To mine and analyze the post-marketing adverse drug event （ADE） signals of irinotecan in adults and children populations， and to provide a reference for clinical safe medication.
METHODS
2
ADE reports of irinotecan from the first quarter of 2004 to the first quarter of 2023 in the US FDA adverse event reporting system database were extracted and the risk signals of irinotecan were detected through the reporting odds ratio and proportional reporting ratio. Statistical analysis was performed for ADE reports and signals of patients aged＜18 years （children） and ≥18 years （adults）.
RESULTS
2
A total of 8 013 ADE reports with irinotecan as the primary suspect drug were identified， including 7 656 and 357 ADE reports in adults and children， respectively. A total of 518 and 75 ADE signals were detected in the adults and children， and the mainly involved systems and organs including gastrointestinal disorders， blood and lymphatic system disorders， systemic disorders and various reactions at the administration site， etc. Most of the top 20 ADE signals in terms of frequency were documented in the drug instructions of irinotecan. New ADE signals in adults included peripheral neuropathy， oral mucosal inflammation， pulmonary embolism， epidermal nevus syndrome and reproductive toxicity， while hypertension， progressive neoplasms， tumor lysis syndromes， and embolism were new ADE signals in children.
CONCLUSIONS
2
The above new suspected high-risk signals not mentioned in the instructions should raise a high level of alertness in clinical practice of irinotecan.
关键词
伊立替康药物不良事件FAERS数据库风险信号儿童
Keywords
drug adverse eventsFAERS databaserisk signalschildren
references
PAULÍK A，NEKVINDOVÁ J，FILIP S. Irinotecan toxi- city during treatment of metastatic colorectal cancer：focus on pharmacogenomics and personalized medicine[J]. Tumori，2020，106（2）：87-94.
JAAKS P，COKER E A，VIS D J，et al. Effective drug combinations in breast，colon and pancreatic cancer cells[J]. Nature，2022，603（7899）：166-173.
LEE Y M，CHEN Y H，OU D L，et al. SN-38，an active metabolite of irinotecan，enhances anti-PD-1 treatment efficacy in head and neck squamous cell carcinoma[J]. J Pathol，2023，259（4）：428-440.
HAHN R Z，ANTUNES M V，VERZA S G，et al. Pharmacokinetic and pharmacogenetic markers of irinotecan toxicity[J]. Curr Med Chem，2019，26（12）：2085-2107.
GLIMELIUS B，GARMO H，BERGLUND A，et al. Prediction of irinotecan and 5-fluorouracil toxicity and response in patients with advanced colorectal cancer[J]. Pharmacogenomics J，2011，11（1）：61-71.
高鹍，程峰. 基于FAERS数据库挖掘开展的药物安全性研究进展[J]. 中国医院药学杂志，2023，43（3）：337-340.
GAO K，CHENG F. Research progress in drug safety study based on FAERS data-mining[J]. Chin J Hosp Pharm，2023，43（3）：337-340.
SONG Y，XU Y L，LIN Y，et al. Fractures due to aromatase inhibitor therapy for breast cancer：a real-world analysis of FAERS data in the past 15 years[J]. Oncol Res Treat，2020，43（3）：96-102.
王密，李海波. 伊立替康联合奈达铂对比联合顺铂二线治疗复发或难治性小细胞肺癌的疗效及毒副作用回顾分析[J]. 系统医学，2018，3（22）：34-35，38.
WANG M，LI H B. Retrospective analysis of curative effect and side and toxic effect of irinotecan combined with nedaplatin and irinotecan combined with cisplatin in the second-line therapy of recurrent or refractory small cell lung cancer[J]. Syst Med，2018，3（22）：34-35，38.
METTS J L，TRUCCO M，WEISER D A，et al. A phase Ⅰ trial of metformin in combination with vincristine，irinotecan，and temozolomide in children with relapsed or refractory solid and central nervous system tumors：a report from the National Pediatric Cancer Foundation[J]. Cancer Med，2023，12（4）：4270-4281.
LERMAN B J，LI Y M，CARLOWICZ C，et al. Progression-free survival and patterns of response in patients with relapsed high-risk neuroblastoma treated with irinotecan/temozolomide/dinutuximab/granulocyte-macro-phage colony-stimulating factor[J]. J Clin Oncol，2023，41（3）：508-516.
AL-AZRI A R，GIBSON R J，BOWEN J M，et al. Involvement of matrix metalloproteinases （MMP-3 and MMP-9） in the pathogenesis of irinotecan-induced oral mucositis[J]. J Oral Pathol Med，2015，44（6）：459-467.
CONROY T，CASTAN F，LOPEZ A，et al. Five-year outcomes of FOLFIRINOX vs gemcitabine as adjuvant therapy for pancreatic cancer：a randomized clinical trial[J]. JAMA Oncol，2022，8（11）：1571-1578.
CREMOLINI C，ANTONIOTTI C，ROSSINI D，et al. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer （TRIBE2）：a multicentre，open-label，phase 3，randomised，controlled trial[J]. Lancet Oncol，2020，21（4）：497-507.
BOND M J G，BOLHUIS K，LOOSVELD O J L，et al. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases （CAIRO5）：an open-label，multicentre，randomised，controlled，phase 3 study from the Dutch Colorectal Cancer Group[J]. Lancet Oncol，2023，24（7）：757-771.
XU Y，LI Q，MA H Y，et al. Therapeutic effect and side effects of bevacizumab combined with irinotecan in the treatment of paediatric intracranial tumours：meta-analysis and systematic review[J]. J Clin Pharm Ther，2020，45（6）：1363-1371.
BARBAR T，JAFFER SATHICK I. Tumor lysis syndrome[J]. Adv Chronic Kidney Dis，2021，28（5）：438-446.e1.
WITH M D，VAN DOORN L，KLOET E，et al. Irinotecan-induced toxicity：a pharmacogenetic study beyond UGT1A1[J]. Clin Pharmacokinet，2023，62（11）：1589-1597.
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