Asparaginase-related diabetic ketoacidosis: Analysis of the FDA Adverse Event Reporting System (FAERS) data and literature review

作者全名："Li, Dongxuan; Gou, Jinghui; Dong, Jie; Dong, Yuzhu; Xi, Xin; Chen, Cheng; Du, Qian; Liu, Songqing"

作者地址："[Li, Dongxuan; Gou, Jinghui; Dong, Jie; Dong, Yuzhu; Xi, Xin; Chen, Cheng; Du, Qian; Liu, Songqing] Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Chongqing, Peoples R China; [Li, Dongxuan] Chongqing Med Univ, Coll Pharm, Chongqing, Peoples R China; [Du, Qian; Liu, Songqing] Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Shuanghu Rd, Chongqing 401120, Peoples R China"

通信作者："Du, Q; Liu, SQ (通讯作者)，Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Shuanghu Rd, Chongqing 401120, Peoples R China."

来源：JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:000888244000001

JCR分区：Q3

影响因子：2

年份：2022

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Review; Early Access

关键词：asparaginase; diabetic ketoacidosis; FAERS; literature review

摘要："What is Known and Objective: Diabetic ketoacidosis (DKA) may occur during asparaginase use. However, limited by the study population, the association between asparaginase and DKA has not been elucidated. The purpose of this study was to determine the potential association between asparaginase and DKA and analyse related clinical characteristics and possible risk factor. Methods: Disproportionality analysis with the reporting odd ratio (ROR) was used to detect the adverse reaction signals of asparaginase-associated DKA in Food and Drug Administration Adverse Event Reporting System (FAERS). A literature review was conducted to further analyse clinical characteristics, possible risk factor and something noteworthy in asparaginase-associated DKA. Results and Discussion: A total of 12 reports of DKA associated with l-asparaginase (l-asp) and 6 reports associated with pegaspargase (PEG-asp) were extracted in FAERS, more than 50% of the cases were classified as serious adverse events. DKA was a positive signal of l-asp (ROR = 2.397, 95% CI 1.360-4.226), while not closely related to the use of PEG-asp (ROR = 1.602, 95% CI 0.719-3.570). Searched in PubMed, Embase and Web of Science, a total of eight patients were collected. The patients were mainly adolescent patients, aged between 11 and 25 years old with a median age of 16 years. Drug dosage form distribution is unbalanced, 7 patients received l-asp and only 1 received PEG-asp. What is New and Conclusions: The ROR of KDA caused by l-asp was statistically significant, but there was not a statistical association for DKA caused by PEG-asp. Asparaginase dosage form may affect the occurrence of DKA, but further research is needed."

基金机构：Medical Scientific Research Project of JointProject of Chongqing Health Commission andScience and Technology Bureau; [2020MSXM055]

基金资助正文："Medical Scientific Research Project of JointProject of Chongqing Health Commission andScience and Technology Bureau, Grant/AwardNumber: 2020MSXM055"