자발적 약물유해반응 데이터베이스를 이용한 항암제 유해사례 현황 분석

Abstract

본 연구는 국내 자발적 보고된 항암제 유해사례에 대한 서술적 분석이었으며 가장 유해사례 보고가 많은 계열의 항암제는 pyrimidine 유사체였으며 항암제와 관련되어 가장 흔히 보고된 부작용 양상은 위장관계 부작용과 피부, 부속기계 부작용이었다. 또한 본 연구에서 확인된 미반영 유해사례에 대해서는 그 인과 관계를 평가하기 위해서 향후 지속적인 모니터링과 연구가 필요할 것으로 사료된다.

Background/Aims:To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). Methods:Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. Results:In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as ‘unlikely’ and ‘unclassifiable’, based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as ‘serious’ AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. Conclusions:The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.