中国药物警戒 ›› 2021, Vol. 18 ›› Issue (11): 1020-1024.
DOI: 10.19803/j.1672-8629.2021.11.05

• 药物性肝损伤科学评价与防控专栏 • 上一篇    下一篇

抗生素相关肝损伤不良反应特征及合理用药分析

李佳怡1,2, 葛斐林1, 曹俊岭1,3#, 周晓春1, 高云娟2, 母光頔2, 赵旭2, 曹博雅1, 郭玉明2,*   

  1. 1北京中医药大学中药学院,北京 102488;
    2解放军总医院第五医学中心/肝病医学部,北京100039;
    3北京中医药大学东方医院,北京 100071
  • 收稿日期:2021-04-23 发布日期:2021-11-18
  • 通讯作者: *郭玉明,女,博士,助理研究员,中医药临床评价。E-mail：guoyuming_0520@126.com#为共同通信作者。
  • 作者简介:李佳怡,女,在读硕士,临床中药学。*为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（82074112,81630100）; 国家中医药管理局中医药创新团队及人才支持计划项目（ZYYCXTDC-202005）; 解放军总医院院内项目（2019JQPY003,2019MBD023）

Clinical Characteristics and Rationality of Drug Usage in Antibiotic Agents Related Liver Injury

LI Jiayi1,2, GE Feilin1, CAO Junling1,3#, ZHOU Xiaochun1, GAO Yunjuan2, MU Guangdi2, ZHAO Xu2, CAO Boya1, GUO Yuming2,*   

  1. 1College of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Department of Liver Disease, the Fifth Medical Center of Chinese PLA General Hospital Beijing 100039, China;
    3Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100071, China
  • Received:2021-04-23 Published:2021-11-18

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摘要： 目的 通过对抗生素相关肝损伤药品不良反应（ADR）的临床特征及用药合理性分析,挖掘其肝损伤潜在风险信号,以期为抗生素安全合理用药提供建议及科学依据。方法 对收集到的2012年1月1日至2016年12月31日抗生素相关肝损伤ADR报告进行回顾性研究,分析其主要临床特征及用药规律,并采用报告比值比法（ROR）对相关药物进行风险分层分析。结果 共收集到抗生素相关肝损伤ADR报告2 938份,其中男性患者多于女性（男∶女 = 1.83∶1）,年龄中位数（M）为53岁,45~59岁的患者占比（25.73%）最多。肝损伤报告频次排名前5的抗生素类别分别为其他内酰胺类、喹诺酮类、头孢类、抗真菌药和大环内酯类。对不同类别抗生素的风险分层分析发现,在青霉素类和大环内酯类相关肝损伤中,红霉素（ROR,11.19;95%CI：4.33~28.92）、美洛西林（ROR,5.07;95%CI：1.43~18.04）与ADR风险相关性较强;头孢类中头孢他啶与ADR风险相关性较强（ROR,1.80;95%CI：1.07~3.04）;其他内酰胺类、喹诺酮类以及抗真菌药中,哌拉西林舒巴坦与ADR风险相关性较强（ROR,1.64;95%CI：1.069~2.53）。结论 抗生素相关肝损伤ADR可见于各年龄段人群,但多见于中老年患者,不同类别抗生素发生肝损伤的风险在不同年龄人群具有差异,临床用药应充分评估其风险差异,根据不同人群风险差异安全合理用药。

关键词: 抗生素, 肝损伤, 风险信号, 安全用药, 药品不良反应

Abstract: Objectiv eTo investigate the potential risk signals of liver injury in order to provide data for rational use of antibiotic agents. Methods ADR reports on liver injury related to antibiotic agents and collected between January 1, 2012 and December 31, 2016 were retrospectively analyzed to find the main clinical characteristics and ways in which these drugs were used. The reporting odds ratio (ROR) method was used to analyze the risk stratification. Results There were 2 938 ADR reports and male patients outnumbered female ones (1.83∶1) in our study. The median age of these patients was 53. The largest proportion (25.73%) of these patients was 45-60 years old. Moreover, the top five antibiotic agents were lactams, cephalosporins, quinolones, antifungals and macrolactones. The highest ROR in children aged 0 to 14 versus the entire population was observed for erythromycin (ROR, 11.19; 95% CI: 4.33~28.92) and mezlocillin (ROR, 5.07; 95% CI: 1.43~18.04) in penicillins and macrolides agents. The highest ROR in patients aged 45 to 59 was observed for ceftazidime (ROR, 1.80; 95% CI: 1.07~3.04) in cephalosporins. The highest ROR in patients aged 60 to 74 was observed for piperacillin-sulbactam (ROR, 1.64; 95% CI: 1.069~2.53) in lactams. Conclusion Antibiotic agents related liver injury is more common in elder patients. However, the risk of liver injury caused by different categories of antibiotics varies in different age groups. The risk difference in clinical use of drugs should be fully assessed for the sake of safety.

Key words: antibiotic agents, liver injury, risk signal, drug safety, adverse drug reaction

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