Analysis of data on capecitabine-related adverse drug reactions from the Korean adverse event reporting system database

作者：Park Jeong Yun

来源：European Journal of Oncology Nursing, 2018, 34: 55-60.

DOI：10.1016/j.ejon.2018.03.004

• Oral chemotherapy
• Capecitabine
• Adverse drug reactions
• Serious adverse events
• Korea institute of drug safety and risk management
• Korean adverse event reporting system database

Purpose: The purpose of this study was to evaluate the adverse drug reactions (ADRs) and serious adverse events associated with capecitabine use in Korean patients by analyzing data from a comprehensive national database of adverse events.
Method Data from all reports concerning capecitabine (Anatomical Therapeutic Chemical code: L01BC06) generated between January 2011 and December 2014 were collected from the Korean Adverse Event Reporting System database (KAERS).
Results: A total of 676 reports and 1069 capecitabine-related ADRs were identified. Ninety-nine cases (14.6%) were classified as serious adverse events. The most commonly reported capecitabine-related ADRs involved gastrointestinal system disorders (324, 30.3%), including diarrhea, nausea, vomiting, and stomatitis, followed by skin and appendage reactions (220, 20.6%), which included symptoms such as skin discoloration/disorder/dryness, itching, and rash.
Conclusions: Patients need to be educated about the common ADRs associated with capecitabine intake in a clinical setting. Patient characteristics must be considered when determining the capecitabine dosage and risk of ADRs, and nursing intervention is critical for preventing exacerbation of these ADRs.

• 出版日期2018-6