Analysis of L-asparaginase Related Adverse Reaction

OBJECTIVE: 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 the toxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported in a regional pharmacovigilance center of Seoul St. Mary's hospital from January 2014 to December 2015. RESULTS: A total of 83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) were spontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients with ADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinical manifestations 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 longer hospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The most common 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. Further investigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.

The Prevalence of Obesity and Obesity-related Metabolic Complications in Korean Adolescents

BACKGROUND: Obesity in adolescence is a serious health problem because it may proceed to adulthood, cause metabolic complications, and thereby increase mortality. The main purpose of this study was to investigate the prevalence of obesity and other metabolic complications related to obesity among Korean adolescents. METHODS: The subjects of the study were 3,615 adolescents recruited from 12 middle schools nationwide. We measured their height, weight, obesity indices, fasting blood glucose, serum total cholesterol, triglyceride, HDL- cholesterol, ALT, AST, and uric acid levels. The risk factors of obesity were assessed by self-administered questionnaires. RESULTS: Obesity was evident in 16.2% of the subjects (20.7% in boys, 11.0% in girls). Adolescent obesity was closely related to parental obesity (Odds Ratio 2.9, 95% CI (Confidence Interval) 1.7~2.5). Obese adolescents were at higher risk of elevated AST (OR 10.2, 95% CI, 5.2 ~19.9), elevated ALT (OR 12.9, 95% CI, 6.9~24.2), hypercholesterolemia (OR 1.5 95% CI, 1.2~1.8, P<0.05), hypertriglyceridemia (OR 4.0, 95% CI, 3.1~5.3), and hyperuricemia (OR 2.2, 95% CI, 1.7~3.0). More than 70% of obese adolescents had one or more metabolic complications related to obesity. CONCLUSION: Adolescent obesity was closely related to parental obesity and metabolic complications related to the obesity were common among both obese boys and girls.