PMID- 36270450
OWN - NLM
STAT- MEDLINE
DCOM- 20230112
LR  - 20230112
IS  - 1437-7780 (Electronic)
IS  - 1341-321X (Linking)
VI  - 29
IP  - 2
DP  - 2023 Feb
TI  - Hepatobiliary calculi associated with ceftriaxone treatment: An analysis of FAERS 
      data from 2004 to 2021.
PG  - 136-142
LID - S1341-321X(22)00289-6 [pii]
LID - 10.1016/j.jiac.2022.10.006 [doi]
AB  - INTRODUCTION: The role of gender, age, dose and other factors in the adverse 
      reaction process of pseudocholelithiasis caused by ceftriaxone is controversial. 
      In this study, we further explored potential risk factors using the FAERS 
      database. METHODS: The reported odds ratio (ROR) and the information component 
      (IC) of specific candidate factors were calculated by using the ROR method and 
      the Bayesian confidence promotion neural network (BCPNN) method respectively to 
      detect potential risk factors in adverse events(AEs) of ceftriaxone and 
      hepatobiliary calculi(HBC). One candidate factor will be considered as a 
      suspicious signal, or potential risk factors if its lower limit of 95% confidence 
      interval of ROR (ROR025) is greater than 1 and its lower limit of 95% confidence 
      interval of IC (IC025) is greater than 0. RESULTS: A total of 764 AEs of HBC were 
      used to this analysis to evaluate candidate risk factors: Age group, Gender, 
      Dose. Child (1-12 years): male ROR025 = 6.64, IC025 = 2.42, female ROR025 = 6.66, 
      IC025 = 2.40. Adolescent group (12-18 years): male ROR025 = 5.47, IC025 = 2.08; 
      elderly (>/=65 years): female ROR025 = 1.25, IC025 = 0.22. CONCLUSIONS: Gender was 
      not detected as a risk factor for HBC caused by ceftriaxone. However, Male 
      infants, male children, female children, adolescent male, and elderly female were 
      potential risk factors for HBC caused by ceftriaxone based on criteria ROR025 > 1 
      and IC025 > 0.
CI  - Copyright (c) 2022 Japanese Society of Chemotherapy and The Japanese Association 
      for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
FAU - Liu, Xin
AU  - Liu X
AD  - School of Life Sciences and Biopharmaceuticals, Shenyang Pharmaceutical 
      University, Liaoning, Shenyang, 110000, China.
FAU - Xu, Ze
AU  - Xu Z
AD  - School of Pharmacy, Shenyang Pharmaceutical University, Liaoning, Shenyang, 
      110000, China.
FAU - Ma, Juman
AU  - Ma J
AD  - School of Life Sciences and Biopharmaceuticals, Shenyang Pharmaceutical 
      University, Liaoning, Shenyang, 110000, China.
FAU - Zhang, Aijun
AU  - Zhang A
AD  - School of Pharmacy, Shenyang Pharmaceutical University, Liaoning, Shenyang, 
      110000, China.
FAU - Li, Zhaohang
AU  - Li Z
AD  - School of Pharmacy, Shenyang Pharmaceutical University, Liaoning, Shenyang, 
      110000, China.
FAU - Qi, Guanpeng
AU  - Qi G
AD  - School of Pharmacy, Shenyang Pharmaceutical University, Liaoning, Shenyang, 
      110000, China.
FAU - Li, Zuojing
AU  - Li Z
AD  - School of Medical Devices, Shenyang Pharmaceutical University, Shenyang, 
      Liaoning, 110000, China. Electronic address: zuojing1006@hotmail.com.
FAU - Wei, Fenfang
AU  - Wei F
AD  - Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen, Guangdong, 
      518000, China.
FAU - Zhong, Ling
AU  - Zhong L
AD  - Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen, Guangdong, 
      518000, China.
LA  - eng
PT  - Journal Article
DEP - 20221019
PL  - Netherlands
TA  - J Infect Chemother
JT  - Journal of infection and chemotherapy : official journal of the Japan Society of 
      Chemotherapy
JID - 9608375
RN  - 75J73V1629 (Ceftriaxone)
SB  - IM
MH  - Child
MH  - Infant
MH  - Adolescent
MH  - Humans
MH  - Male
MH  - Female
MH  - Aged
MH  - *Ceftriaxone/adverse effects
MH  - Bayes Theorem
MH  - *Pharmacovigilance
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Adverse Drug Reaction Reporting Systems
OTO - NOTNLM
OT  - Adverse event reporting system
OT  - Ceftriaxone
OT  - Cholelithiasis
OT  - Disproportionality analysis
OT  - Pseudocholelithiasis
COIS- Declaration of competing interest The authors declare no conflict of interest.
EDAT- 2022/10/22 06:00
MHDA- 2023/01/13 06:00
CRDT- 2022/10/21 19:25
PHST- 2022/07/05 00:00 [received]
PHST- 2022/09/27 00:00 [revised]
PHST- 2022/10/12 00:00 [accepted]
PHST- 2022/10/22 06:00 [pubmed]
PHST- 2023/01/13 06:00 [medline]
PHST- 2022/10/21 19:25 [entrez]
AID - S1341-321X(22)00289-6 [pii]
AID - 10.1016/j.jiac.2022.10.006 [doi]
PST - ppublish
SO  - J Infect Chemother. 2023 Feb;29(2):136-142. doi: 10.1016/j.jiac.2022.10.006. Epub 
      2022 Oct 19.