骨病用药相关肝损伤不良反应流行趋势分析

Epidemiological analysis of liver injury related to bone diseases

该文基于国家药品不良反应监测系统,回顾性分析了1392例骨病用药相关的肝损伤不良反应(liver injury associa-ted adverse drug reaction,LI-ADR)病例(其中单用中药的占18.75%,单用西药的占68.68%)。该类病例占全部药物相关肝损伤不良反应的2.5%,位列全部药物类别前10位,从2012—2016年报告数量和严重病例占比均呈升高趋势。患者平均年龄(54.2±15.8)岁,性别差异不大(男-女1.04∶1),但在类风湿性关节炎的患者中女性明显多于男性(男-女1∶2.6),而在痛风的患者中男性明显多于女性(男-女7.16∶1)。患者的预后较好,痊愈及好转率为85.27%。从服药到发生肝损伤的时间因用药不同有所差异,单用中药组出现肝损伤的时间中位数(27 d)明显晚于单用西药组(11 d)(P<0.05)。骨病用药是临床上药物性肝损伤的重要类别之一,且因骨病用药而出现肝损伤不良反应的病例上报数呈增长趋势,临床应高度关注其安全合理用药;男性与女性LI-ADR因原患疾病不同而有较大差异。中药出现不良反应的时间总体上比西药更长,临床用药应根据不同疾病及所用药物特点监测肝功能。

A total of 1392 reports on liver injury associated adverse drug reaction(LI-ADR)related to bone diseases were retrospectively analyzed based on national ADR monitoring system[18.75%of the patients used traditional Chinese medicine(TCM)alone and 68.68%used Western medicine alone].This kind of cases accounted for 2.5%of all drug-related liver injury adverse reactions,ranking top ten of all drug categories.The number of reported cases and the proportion of serious cases showed an increasing trend from 2012 to 2016.The average age of the patients was(54.2±15.8)years old,and there was little difference in overall gender(male-female 1.04∶1).However,the number of female patients with rheumatoid arthritis was significantly higher than that of male patients(male-female 1∶2.6),while the number of male patients with gout was significantly higher than that of female patients(male-female 7.16∶1).The overall prognosis was good,with the recovery and improvement rate of 85.27%.The time from medication to liver injury varied due to different medicines.The median time to liver injury was 27 days in TCM alone group,later than 11 days in Western me-dicine alone group(P<0.05).Drugs for bone diseases have been one of the important categories for clinical drug-induced liver injury,and the number of reported cases on liver injury caused by drugs for bone diseases is increasing,so we should pay close attention to the safe and rational use of them.The LI-ADRs of male and female were different due to their different diseases,and the latency of adverse reactions in TCM group was generally longer than that in Western medicine group.In clinical medication,liver function should be monitored according to different diseases and characteristics of drugs to prevent the risk of liver injury.