机构：[a]Clinical Research Center, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China医技科室职能科室临床流行病与循证医学中心临床研究中心首都医科大学附属北京儿童医院[b]Center for Clinical Epidemiology and Evidence-Based Medicine, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China职能科室临床流行病与循证医学中心首都医科大学附属北京儿童医院[c]Department of Pharmacy, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China医技科室职能科室临床流行病与循证医学中心药学部首都医科大学附属北京儿童医院[d]Information Center, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China职能科室临床流行病与循证医学中心首都医科大学附属北京儿童医院[e]Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China职能科室医技科室药学部药学部/药剂科首都医科大学附属天坛医院
Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database.Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or DIA were selected. Second, the associations were evaluated by a retrospective cohort study.Results: Ten and five drugs were potentially identified to be associated with DIN and DIA, respectively. Finally, five (oseltamivir, chlorpheniramine, vancomycin, meropenem, and ganciclovir) and two (chlorpheniramine, and vancomycin) drugs were found to be associated with DIN and DIA, respectively. Of these, the association between oseltamivir and neutropenia (P=9.83x10(-9); OR, 2.10; 95% CI, 1.62-2.69) was considered as a new signal for both adults and children. Chlorpheniramine-induced neutropenia (P=3.01x10(-8); OR, 1.59; 95% CI, 1.35-1.87) and agranulocytosis (P=3.16x10(-7); OR, 3.76; 95% CI, 2.25-6.26) were considered as new signals in children. Other drugs associated with DIN or DIA were confirmed by previous studies.Conclusion: A method to detect signals for DIN and DIA has been described. Several pediatric drugs were found to be associated with DIN or DIA.
基金：
This paper was funded by the National Major Scientific and Technological Special Project for ?Significant New Drugs Development? during the 13th Five-year Plan Period (no. 2017ZX09304029) and the National Natural Science Foundation of China (81400766).
第一作者机构：[a]Clinical Research Center, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China
共同第一作者：
通讯作者：
通讯机构：[a]Clinical Research Center, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China[c]Department of Pharmacy, National Center for Children‘s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China[e]Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China[*1]Department of Pharmacy, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, 56 Nanlishi Road, Beijing 100045, China[*2]Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, 119 Nansihuan West Road, Beijing 100160, China
推荐引用方式(GB/T 7714)：
Ran Wei,Lu-Lu Jia,Yun-Cui Yu,et al.Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records[J].EXPERT OPINION ON DRUG SAFETY.2019,18(5):435-441.doi:10.1080/14740338.2019.1604682.
APA：
Ran Wei,Lu-Lu Jia,Yun-Cui Yu,Xiao-Lu Nie,Zi-Yang Song...&Xiao-Ling Wang.(2019).Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records.EXPERT OPINION ON DRUG SAFETY,18,(5)
MLA：
Ran Wei,et al."Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records".EXPERT OPINION ON DRUG SAFETY 18..5(2019):435-441
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