L-asparaginase 약물 유해 반응 보고 분석
Analysis of L-asparaginase Related Adverse Reaction
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Background: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma,which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. Methods: To evaluate thetoxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported ina regional pharmacovigilance center of Seoul St. Mary’s hospital from January 2014 to December 2015. Results: A total of83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) werespontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients withADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinicalmanifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longerhospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The mostcommon clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/83) of unlabeled ADRs were identified. They were serious ADRs. Conclusion: We identified unlabeled serious ADRs of L-ASP. Also,correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Furtherinvestigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.
Abstract
Background: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma,which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. Methods: To evaluate thetoxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported ina regional pharmacovigilance center of Seoul St. Mary’s hospital from January 2014 to December 2015. Results: A total of83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) werespontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients withADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinicalmanifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longerhospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The mostcommon clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/83) of unlabeled ADRs were identified. They were serious ADRs. Conclusion: We identified unlabeled serious ADRs of L-ASP. Also,correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Furtherinvestigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.
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