Automatic monitoring of liver and kidney injury due to roxatidine acetate hydrochloride for injection
10.3760/cma.j.issn.1008-5734.2017.06.004
- VernacularTitle:注射用盐酸罗沙替丁醋酸酯致肝肾损伤的自动监测研究
- Author:
Xiaoyu WANG
1
;
Wangping JIA
1
;
Daihong GUO
1
;
Wei KOU
1
;
Pengzhou HU
1
;
Boyu ZHAO
1
;
Ning PANG
1
Author Information
1. 解放军总医院药学部临床药学中心,北京,100853
- Publication Type:Journal Article
- Keywords:
Roxatidine acetate;
Drug-induced liver injury;
Acute kidney injury;
Risk factors
- From:
Adverse Drug Reactions Journal
2017;19(6):414-419
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the effects of roxatidine acetate hydrochloride for injection (roxatidine)on liver and kidney function and analyze the related risk factors. Methods The electric medical records of the hospitalized patients who received roxatidine during January 1st,2016 to December 31st,2016 in Chinese PLA General Hospital were monitored by the autonomic monitoring system which was researched and developed by ourselves. The adverse drug reactions (ADR)were re-evaluated for the alarmed cases from the autonomic monitoring system by clinical pharmacists. The incidence rates of liver and kidney injury were calculated. The risk factors and the independent risk factors of liver and kidney injury due to roxatidine were confirmed by univariate and multivariate logistic regression analysis. Results Data of a total of 9284 patients who come from 34 clinical departments (Department of Urinary Surgery,Orthopedics, and Cardiac Surgery,etc. )were collected. Of the 9284 patients,5308 (57. 2％)were male,3976 (42. 8％)were female. The dosage of roxatidine was 75 mg twice daily and the route of medication was intravenous infusion. The time of medication was 1-39 days and the median time was 3 (1,5)days. Totally 8268 patients were enrolled into the monitoring for roxatidine related liver injury. Eighty-six patients (1. 0％)were judged to have liver injury,all the relevant evaluations were " possible",the degrees of liver injuries were mild. The 86 patients′ average age was (59 ± 13)years,average body mass index (BMI)was (24. 6 ± 3. 3)kg/ m2 ,average time of medication was (8. 1 ± 4. 1)days. Of 86 patients,52 (60. 5％) were combined with ceftriaxone sodium. The results of univariate logistic regression analysis showed that age, time of medication,and combination with ceftriaxone sodium were the risk factors of liver injury due to roxatidine. The results of multivariate logistic regression analysis showed that > 65 years (OR = 1. 57,95％CI:0. 99-2. 43),> 3 days of medication time (OR = 14. 14,95％ CI:6. 99-33. 81),and combination use of ceftriaxone sodium (OR = 2. 31,95％ CI:1. 50-3. 60)were the independent risk factors of liver injury due to roxatidine. Nine thousand two hundred and eighty-four patients enrolled into the monitoring of roxatidine related kidney injury. Twenty-six patients (0. 3％)were judged as kidney injury,all the relevance evaluations were " possible",the degrees of kidney injuries were mild. The 26 patients′ average age was (59 ± 15)years,average BMI was (22. 0 ± 6. 2)kg/ m2 ,average time of medication was (7. 5 ± 6. 1) days. Of 26 patients,8 patients (30. 8％)suffered from hepatobiliary diseases meanwhile. The results of univariate logistic regression analysis showed that the time of medication and suffering from hepatobiliary diseases were the risk factors of kidney injury due to roxatidine. The result of multivariate logistic regression analysis showed that > 3 days of medication time (OR = 3. 57,95％ CI:1. 56-9. 16)was the independent risk factor of kidney injury due to roxatidine. Conclusions The incidence rates of liver and kidney injuries due to roxatidine are lower. Roxatidine is safe in clinical medication. > 65 years, > 3 days of medication time,and combination use of ceftriaxone sodium are the independent risk factors of liver injury due to roxatidine. > 3 days of medication time is the independent risk factor of kidney injury due to roxatidine.
