アブストラクト | OBJECTIVES: To identify and analyze hematopoietic adverse drug reaction (ADR) signals associated with Olaparib, Niraparib, Rucaparib, and Talazoparib - poly(ADP-ribose) polymerase (PARP) inhibitors - using data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, providing guidance for rational clinical use. METHODS: ASCII data related to the target drugs were extracted from the FAERS database, covering the period from Q1 2019 to Q2 2024. Standardized MedDRA queries (SMQ) and Preferred Terms (PT) from the MedDRA Adverse Drug Reaction glossary were used for international terminology standardization and localization. ADR signals were screened using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and the comprehensive MHRA method. The composition ratios of the SMQ data for the four drugs were compared. RESULTS: The study found that hematopoietic adverse reactions for the four PARP inhibitors were concentrated within 30 days post-treatment, with some latency observed, indicating the need for both short-term and long-term monitoring of hematopoietic cells. The most common hematopoietic system adverse events involved cytopenia and leukopenia. Niraparib had the highest number of adverse events and the strongest signal intensity. Both Olaparib and Talazoparib exhibited strong hematotoxicity signals, necessitating careful consideration of their safety profiles. CONCLUSION: Significant differences exist in the number, occurrence, and duration of adverse reactions among the four PARP inhibitors. Clinicians should tailor treatment plans to individual patient conditions to enhance the rationality and safety of PARP inhibitor use. |
ジャーナル名 | Expert opinion on drug safety |
Pubmed追加日 | 2024/12/20 |
投稿者 | Shuai, Qindai; Bai, Xuefei; Li, Gen; Wang, Jia; Chen, Li; Chen, Li |
組織名 | Pharmacy, China Pharmaceutical University, Nanjing, China.;School of Pharmaceutical Science and Technology, Faculty of Medicine, Tianjin;University.;Department of Pharmacy, Sichuan Provincial Maternity and Child Health Care;Hospital, Chengdu, China.;Department of Pharmacy and Evidence-Based Pharmacy Center, West China Second;University Hospital, Sichuan University, Chengdu, China.;Key Laboratory of Birth Defects and Related Diseases of Women and Children,;Sichuan University.;Department of Pharmacy, Chengdu Jinniu District People's Hospital, Chengdu,;China.;Department of Pharmacology, Faculty of Medicine, University of the Basque;Country, UPV/EHU, Leioa, Spain. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39705053/ |