Analysis of risk signals of liver injuries related to nonsteroidal anti-inflammatory drugs using reporting odds ratio
10.3760/cma.j.issn.1008-5734.2014.03.006
- VernacularTitle:采用报告比值比法挖掘非甾体抗炎药相关肝损伤信号
- Author:
Xi LAN
1
;
Shengfeng WANG
;
Suodi ZHAI
;
Jingtian REN
;
Ligong JIAO
Author Information
1. 100191 北京大学第三医院药剂科; 北京大学药学院药事管理与临床药学系
- Publication Type:Journal Article
- Keywords:
Drug-induced liver injury;
Anti-inflammatory agents,non-steroidal;
Data mining
- From:
Adverse Drug Reactions Journal
2014;(3):143-146
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze risk signals of liver injuries related to nonsteroidal anti-inflammatory drugs( NSAID)and application of reporting odds ratio( ROR)in data mining. Methods A search of adverse drug reaction( ADR ) reports in Beijing of national monitoring system of adverse drug reaction from January 1st 2013 to December 31st 2013 was conducted using keywords "liver" and "gallbladder" . Of these filtered reports,the cases whose causal relationship of drugs and liver injuries was judged as"positive","likely",or "possible" were enrolled into liver injury group and the rest cases were all enrolled into non-liver injury group. Using NSAID as the target drugs and the other drugs as non-target, ROR and its 95% confidence interval( CI)of liver injuries related to NSAID were calculated according to formula of ROR. The lower limit of 95% CI >1 was regarded as suggestive of ADR signal. Results After removing duplication,14 657 patients were enrolled in the study,which comprised liver injury group 626 patients including 35 cases of liver injuries due to NSAID and non-liver injury group 14 031 patients. Of the 35 patients with liver injuries related to NSAID,30 patients were associated with single-preparation NSAID and 6 patients were associated with compound-preparation. The ROR levels and their 95% CI of single-preparation NSAID,compound-preparation NSAID,and general NSAID were respectively 1. 78 (1. 22-2. 61),1. 80(0. 78-4. 15),and 1. 76(1. 24-2. 51). Both of the lower limits of 95% CI of live injuries related to single-preparation NSAID and general NSAID were higher than 1 and there were ADR signals. Thirty-seven kinds of drugs were involved by 35 cases of liver injuries. Of them,the ROR levels and their 95% CI of single-preparation parecoxib, single-preparation aspirin, compound-preparation ibuprofen and pseudoephedrine,and compound-preparation parace-tamol and amantadine hydrochloride were respectively 8. 00(2. 03-27. 78),2. 45(1. 43-4. 21),22. 00(1. 40-359. 32),and 11. 22(1. 02-123. 94) and there were ADR signals. Conclusions Attention should be paid to liver injuries related to NSAID. The method of ROR can help analyze ADR signals and provide useful early-warning of drug safety.
