Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (10): 1163-1167.
DOI: 10.19803/j.1672-8629.20230148

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Analysis of 136 reports of adverse reactions related to small molecule kinase inhibitors

JIA Bei1, WANG Weihua1, YANG Liang2, DAI Yuanyuan1, 2, *   

  1. 1Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China;
    2Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital Langfang Campus, Chinese Academy of Medical Sciences, Langfang Hebei 065001, China
  • Received:2023-03-21 Online:2023-10-15 Published:2023-10-16

Abstract: Objective To analyze the characteristics of adverse drug reactions (ADR) of small molecule kinase inhibitors (SMKI), and provide reference for rational use of drugs in clinic. Methods The data on 136 cases of SMKI-related ADR monitored in our hospital between 2011 and 2022 was analyzed while the characteristics and risks of ADR caused by SMKI were studied in terms of patients, drug use, and occurrence of ADR. Results One hundred and thirty-six cases of ADR involved 21 types of SMKI. The average age of the patients was 57.75±12.74, and patients with lung cancer accounted for 54.41%. There were 34 cases of off-label use of drugs. The systems-organs implicated in ADR were mainly the gastrointestinal system, followed by the skin and subcutaneous tissue. 54.41% of the patients with ADR did not have the dosage of SMKI adjusted, 16.91% were severe ADR cases, and 56.62% improved after treatment. Conclusion SMKI-related ADR are tolerable for most of the patients. Some patients require dose reduction and symptomatic treatment. ADR can implicate multiple systems-organs. Patients should be assisted in targeted ADR monitoring and management to improve the safety and compliance of medication.

Key words: small molecule kinase inhibitor, adverse drug reaction, oral targeted drug, lung cancer, gastrointestinal system, skin, subcutaneous tissue, EGFR

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