| アブストラクト | Adverse event reports submitted to the US Food and Drug Administration (FDA) were analyzed to map the safety profile of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs). We conducted a disproportionality analysis of the adverse events (AEs) of EGFR-TKIs (gefitinib, erlotinib, afatinib, osimertinib) by data mining using the FDA adverse event reporting system (AERS) database, and by calculating the reporting odds ratios (ROR) with 95% confidence intervals. The FDA AERS database contained 27,123 EGFR-TKI-associated AERs within the reporting period from January 1, 2004 to March 31, 2018. Thirty-three preferred terms (PTs) were selected for analysis, and significant RORs were most commonly observed in the skin, nail, gastrointestinal tract, hepatic, eyes, and lungs. Unexpected adverse drug reactions were found in the "intestinal obstruction" and "hypokalaemia" in gefitinib and erlotinib, "hyponatraemia" in gefitinib, erlotinib and afatinib, "alopecia"in erlotinib, "hair growth abnormal" in afatinib, but not in "nausea" and "vomiting" listed on drug labels. The results of this study are consistent with clinical observation, suggesting the usefulness of pharmacovigilance research should be corroborated with the real-world FAERS data. |
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| 組織名 | Department of Respiratory and Critical Care Medicine, The First Affiliated;Hospital of Chongqing Medical University, Chongqing, 400016, China.;Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical;University, Chongqing, 400016, China.;Department of Nursing, Chongqing Medical University, Chongqing, 400016, China.;Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western;New England University, 1215 Wilbraham Road, Springfield, MA, 01119, USA.;Department of Pharmacy, Xiangya Hospital Central South University, Changsha,;410008, Hunan, China.;Institute for Rational and Safe Medication Practices, National Clinical Research;Center for Geriatric Disorders, Xiangya Hospital, Central South University,;Changsha, 410008, Hunan, China.;Department of Pharmacy, Shihezi People's Hospital, Shihezi, 832000, China.;hopechen2019@126.com. |
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