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2005~2014年我国药物性肝损伤临床综合分析
A Review Analysis of Chinese Literatures 2005-2014:Clinical Features of Drug induced Liver Injury
  
DOI:
中文关键词:  药物性肝损伤  文献分析  临床特点  药物警戒
英文关键词:Drug induced liver injury  Literature analysis  Clinical feature  Pharmacovigilance
基金项目:
作者单位
任张青 王进海 郭晓燕 杨龙宝 白玉茹 ①西安交通大学第二附属医院消化内科(西安 710004) 
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中文摘要:
      摘 要 目的:总结近10年来我国药物性肝损伤(DILI)病例分析的临床特点,了解中国人群DILI的相关流行病学特征。方法:以“药物性肝损伤”、“药物性肝炎”、“药物性肝损害”、“药物性肝病”为关键词,检索2005~2014年中国期刊全文数据库(CNKI),记录文献中患者性别、年龄、基础疾病、用药时间、给药方式、临床分型、用药种类、临床表现及预后等相关数据,进行总结分析。结果:253篇文献中28 958例患者记录了性别,其中男14 787例(51.06%),女14 171例(48.94%),平均年龄45.90岁。65篇文献8 335例记录了基础病史,患有基础肝病的有1 738例(20.85);16篇文献2 007例患者中,有过敏史的252例(12.56%)。56篇文献记录了6 104例患者用药后发生DILI的时间,<4周3 431例(56.21%),4~8周1 282例(21.00%),>8周1 168 例(19.13%)。14篇文献记录了2 273例患者给药方式,口服给药1 526例(67.14%),静脉给药599例(26.35%),肌内注射52 例(2.29%),皮下给药45例(1.98%)及外用药物28例(1.23%)。109篇文献记录了12 459例患者DILI的分型,其中肝细胞型7 261例(58.28%)、胆汁淤积型2 793例(22.42%)、混合型2 405例(19.30%)。253篇文献记录了28 958例患者的用药信息,中药7 264例(25.08%)、抗结核药6 205例(21.43%)、抗微生物药3 815例(13.17%)、抗肿瘤药2 824例(9.75%)、解热镇痛药2 055例(7.10%)。152篇文献记录了17 159例患者的临床表现,主要为乏力10 211例(59.51%)、纳差9 347例(54.48%)、黄疸8 687例(50.63%)。141篇文献记录了16 528例患者的预后信息,其中治愈9 315例(56.36%)、好转5 919例(35.81%)、未愈947例(5.73%)、死亡347例(2.10%)。结论:引起DILI的药物种类繁多,其中中药引起的DILI日益增多,应引起临床高度重视。由于DILI临床表现无特异性,易误诊及漏诊,应加强对相关药物,特别是中药的使用监测,加强中药肝毒性、作用机制的研究,提高合理用药水平。
英文摘要:
      ABSTRACT Objective: To analyse the overall clinical features of drug induced liver injury(DILI)from Chinese literatures published during the recent ten years, and know the epidemiologic feature of DILI in China. Methods:Using drug induced liver injury as key words, cases analyze literatures about DILI from 2005 to 2014 in Chinese Periodical Full text Database were searched, recorded gender, age, basic disease, medication time, ways of medication, clinical classifications, types of drugs, clinical characters and prognosis data, then analyzed and made a conclusion. Results: As 28 958 cases recorded gender in 253 articles recorded information, there were 14 787(51.06%) male and 14 171(48.94%)female, the average age was 45.90 years old.3 431(56.21%) disease time were less than 4 weeks, 1 282(21.00%) were between 4 weeks to 8 weeks,1 168(19.31%) were more than 8 weeks. The ways of medication including 1 526(67.14%) oral medication, 599(26.35%) intravenous medication, 52(2.29%) intramuscular injection, 45(1.98%) subcutaneous medication and 28(1.23%) extemal use. 7 261(58.28%) cases were classified to hepatocellular type, 2 793(22.42%) cases were cholestasis type and 2 405(19.30%) cases were mixed type.Drugs of Chinese herbs, antituberculotics, antimicrobials,antineoplastics and analgesic antipyretic were 7 264(25.08%), 6 205(21.43%), 3 815(13.17%), 2 824(9.75%) and 2 055(7.10%) patients respectively. The main clinical manifestations were fatigue(59.51%), poor appetite(54.48%), jaundice(50.63%). As for the prognosis, 9 315(6.36%) cases cured, 5 919(35.81%) cases improved well, 947(5.73%) cases no change, 347(2.10%) cases worse to dead. Conclusion:A great variety of drugs could induce liver injury, caused by traditional Chinese medicine was increasing. And due to the non specific clinical manifestation, the possibility of its misdiagnosis and missed diagnosis, so great importance should be attached to the monitoring and rational use of the related drugs. Specially strengthening liver toxicity, mechanism of action of traditional Chinese medicine research and its administration of liver function monitoring.The level of rational drug use should be improved.
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