注射用盐酸罗沙替丁醋酸酯致肝肾损伤的自动监测研究  

Automatic monitoring of liver and kidney injury due to roxatidine acetate hydrochloride for injection

作　　者：王啸宇[1] 贾王平[1] 郭代红[1] 寇炜[1] 胡鹏洲 赵博宇[1] 庞宁 

机构地区：[1]解放军总医院药学部临床药学中心,北京100853

出　　处：《药物不良反应杂志》2017年第6期414-419,共6页Adverse Drug Reactions Journal

摘　　要：目的 评价注射用盐酸罗沙替丁醋酸酯（罗沙替丁）对肝、肾功能的影响并分析其危险因素.方法 应用自行研发的＂医疗机构ADE主动监测与智能评估警示系统＂对2016年在解放军总医院住院并使用罗沙替丁患者的电子病历进行自动监测,由临床药师对肝、肾损伤报警病例进行不良反应再评价,计算罗沙替丁致肝、肾损伤的发生率,采用单因素及多因素Logistic回归分析确定该药致肝、肾损伤的危险因素及独立危险因素.结果 共收集到来自泌尿外科、骨科、心外科等34个科室的患者9284例,男性5308例（57.2％）,女性3976例（42.8％）;罗沙替丁用药剂量均为75 mg/次、2次/d,给药途径均为静脉滴注;用药时间1～39 d,中位时间为3（1,5）d.纳入罗沙替丁致肝损伤监测者为8268例,86例（1.0％）判定为肝损伤,关联性评价均为＂可能＂,肝损伤程度均为轻度.86例肝损伤患者平均年龄（59±13）岁,平均BMI（24.6±3.3）kg/m2,平均用药时间（8.1±4.1）d,52例（60.5％）联用头孢曲松钠;单因素Logistic回归分析结果示年龄、用药时间、联用头孢曲松钠是罗沙替丁致肝损伤的危险因素,多因素Logistic回归分析结果显示年龄〉65岁（OR=1.57,95％CI：0.99～2.43）、用药时间〉3 d（OR=14.14,95％CI：6.99～33.81）、联用头孢曲松钠（OR=2.31,95％CI：1.50～3.60）为罗沙替丁致肝损伤的独立危险因素.纳入罗沙替丁致肾损伤监测者为9284例,26例（0.3％）判定为肾损伤,关联性评价均为可能,肾损伤程度均为轻度.26例肾损伤患者平均年龄（59±15）岁,平均BMI（22.0±6.2）kg/m2,平均用药时间（7.5±6.1）d,8例（30.8％）合并肝胆疾病;单因素Logistics回归分析结果示用药时间、合并肝胆疾病是罗沙替丁致肾损伤的危险因素,多因素Logistic回归分析结果显示用药时间〉3 d（OR=3.57,95％CI：1.56～9.16）是罗沙替丁致肾损伤的独立危险因素.结论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 me

关 键 词：罗沙替丁醋酸酯 药物性肝损伤 急性肾损伤 危险因素 

分 类 号：R969.3[医药卫生—药理学]