445例药物性肝损伤的临床分析

R575; 目的 描述性分析药物性肝损伤(DILI)的临床特征.方法 回顾性收集2012年1月-2016年12月在上海中医药大学附属曙光医院、上海中医药大学附属普陀医院、上海交通大学医学院附属同仁医院诊断为DILI的445例患者的病史、症状体征、检查结果、治疗与转归等临床资料,分析DILI的临床特征.计量资料以中位数和四分位数间距[M(P25 ~ P75)]表示,组间比较采用Kruskal-Wallis H检验;计数资料组间比较采用x2检验.结果 445例患者中,男136例(30.56%),女309例(69.44%),以40~69岁的人群居多.194例(43.6%)应用西药导致,140例(31...

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Published in临床肝胆病杂志 Vol. 34; no. 2; pp. 354 - 358
Main Authors 朱春雾, 王海南, 袁继丽, 彭渊, 张亚蕾, 薛冬英, 张琴, 刘成海
Format Journal Article
LanguageChinese
Published 上海市中医临床重点实验室,上海201203 2018
上海中医药大学附属曙光医院肝病研究所,上海,201203%国家食品药品监督管理总局,北京,100053%上海中医药大学附属普陀医院感染科,上海,200062%上海交通大学医学院附属同仁医院感染科,上海,200336%上海中医药大学附属曙光医院肝病研究所,上海201203
上海市高校中医内科学E研究院,上海201203
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ISSN1001-5256
DOI10.3969/j.issn.1001-5256.2018.02.027

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Abstract R575; 目的 描述性分析药物性肝损伤(DILI)的临床特征.方法 回顾性收集2012年1月-2016年12月在上海中医药大学附属曙光医院、上海中医药大学附属普陀医院、上海交通大学医学院附属同仁医院诊断为DILI的445例患者的病史、症状体征、检查结果、治疗与转归等临床资料,分析DILI的临床特征.计量资料以中位数和四分位数间距[M(P25 ~ P75)]表示,组间比较采用Kruskal-Wallis H检验;计数资料组间比较采用x2检验.结果 445例患者中,男136例(30.56%),女309例(69.44%),以40~69岁的人群居多.194例(43.6%)应用西药导致,140例(31.46%)应用中药导致,中西药联用者92例(20.67%),服用保健品者19例(4.27%).引起肝损伤的中药主要有何首乌及其制剂、仙灵骨葆胶囊、癃闭舒胶囊等;导致肝损伤的西药主要有心血管用药、抗微生物用药、解热镇痛药、抗肿瘤用药、抗结核药等.临床症状主要有乏力、纳差、黄疸、恶心等,其中以乏力(65.17%)最常见.临床分型主要为肝细胞损伤型,占70.11%.不同分型之间的ALT、AST、ALP、TBil和INR峰值比较,差异均有统计学意义(t值分别153.584、97.366、27.781、24.177、6.236,P值均<0.05);中药导致肝损伤患者的ALT、AST及TBil峰值水平明显高于西药(P值均<o.05).不同分型之间的肝损伤评分差异有统计学意义(x2=26.848,P<0.001).98.65%的患者好转,中药与西药引起的肝损伤患者的预后没有明显差异(x2=3.663,P>0.05).结论 DILI以女性及中老年多见;与西药相比,中药导致的肝损伤生化指标异常更明显;多数DILI患者预后良好.
AbstractList R575; 目的 描述性分析药物性肝损伤(DILI)的临床特征.方法 回顾性收集2012年1月-2016年12月在上海中医药大学附属曙光医院、上海中医药大学附属普陀医院、上海交通大学医学院附属同仁医院诊断为DILI的445例患者的病史、症状体征、检查结果、治疗与转归等临床资料,分析DILI的临床特征.计量资料以中位数和四分位数间距[M(P25 ~ P75)]表示,组间比较采用Kruskal-Wallis H检验;计数资料组间比较采用x2检验.结果 445例患者中,男136例(30.56%),女309例(69.44%),以40~69岁的人群居多.194例(43.6%)应用西药导致,140例(31.46%)应用中药导致,中西药联用者92例(20.67%),服用保健品者19例(4.27%).引起肝损伤的中药主要有何首乌及其制剂、仙灵骨葆胶囊、癃闭舒胶囊等;导致肝损伤的西药主要有心血管用药、抗微生物用药、解热镇痛药、抗肿瘤用药、抗结核药等.临床症状主要有乏力、纳差、黄疸、恶心等,其中以乏力(65.17%)最常见.临床分型主要为肝细胞损伤型,占70.11%.不同分型之间的ALT、AST、ALP、TBil和INR峰值比较,差异均有统计学意义(t值分别153.584、97.366、27.781、24.177、6.236,P值均<0.05);中药导致肝损伤患者的ALT、AST及TBil峰值水平明显高于西药(P值均<o.05).不同分型之间的肝损伤评分差异有统计学意义(x2=26.848,P<0.001).98.65%的患者好转,中药与西药引起的肝损伤患者的预后没有明显差异(x2=3.663,P>0.05).结论 DILI以女性及中老年多见;与西药相比,中药导致的肝损伤生化指标异常更明显;多数DILI患者预后良好.
Abstract_FL Objective To investigate the clinical features of drug-induced liver injury (DILI) by descriptive analysis.Methods A retrospective analysis was performed for the clinical data of 445 patients who were diagnosed with DILI in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,and Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine fron January 2012 to December 2016,including medical history,signs and symptoms,examination results,treatment,and prognosis.The clinical features of DILI were analyzed.The continuous data were expressed as median and inter-quartile range M(P25-P75),and the Kruskal-Wallis H test was used for comparison of continuous data between groups;the chi-square test was used for comparison of categorical data between groups.Results Among all 445 patients,there were 136 male patients (30.56%) and 309 female patients (69.44%),and most of the patients were aged 40-69 years.Of all patients,194 (43.6%) had DILI induced by Western medicine,140 (31.46%) had DILI induced by traditional Chinese medicine,92 (20.67%) had DILI induced by Western medicine and traditional Chinese medicine,and 19 (4.27%) had DILI induced by healthcare products.Traditional Chinese medicine which induced DILI included Fallopia muhiflora and its preparation,Xianling Gubao capsules,and Longbishu capsules,and Western medicine which induced DILI included cardiovascular drugs,antimicrobial agents,antipyretic and analgesic drugs,antitumor drugs,and antitubercular agents.Major clinical symptoms included weakness,poor appetite,jaundice,and nausea,among which weakness was the most common symptom,seen in 65.17% of all patients.Of all patients,70.11% had hepatocellular injury type.There were significant differences in peak values of alanine aminotransferase (ALT),aspartate aminotransferase (AST),alkaline phosphatase,total bilirubin (TBil),and international normalized ratio between patients with different types of DILI (t =153.584,97.366,27.781,24.177 and 6.236,all P <0.05),and the patients with liver injury induced by traditional Chinese medicine had significantly higher peak values of ALT,AST,and TBil than those with liver injury induced by Western medicine (all P < 0.05).There was signifieant differences in liver injury score between patients with different types of DILl(x2 =26.848,P <0.001).Of all patients,98.65% achieved improvement,and there was no significant difference in prognosis between the patients with liver injury induced by traditional Chinese medicine and those with liver injury induced by Western medicine (x2 =3.663,P > 0.05).Conclusion DILI is commonly seen in female patients and middle-aged and elderly patients.Compared with those with liver injury induced by Western medicine,the patients with liver injury induced by traditional Chinese medicine have significantly greater abnormalities of biochemical parameters.Most of the patients with DILI have good prognosis.
Author 王海南
彭渊
袁继丽
朱春雾
张亚蕾
薛冬英
张琴
刘成海
AuthorAffiliation 上海中医药大学附属曙光医院肝病研究所,上海,201203%国家食品药品监督管理总局,北京,100053%上海中医药大学附属普陀医院感染科,上海,200062%上海交通大学医学院附属同仁医院感染科,上海,200336%上海中医药大学附属曙光医院肝病研究所,上海201203;上海市中医临床重点实验室,上海201203;上海市高校中医内科学E研究院,上海201203
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DocumentTitle_FL Clinical features of drug-induced liver injury : an analysis of 445 cases
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Keywords drug-induced liver injury
药物性肝损伤
体征和症状
signs and symptoms
Language Chinese
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PublicationTitle 临床肝胆病杂志
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上海中医药大学附属曙光医院肝病研究所,上海,201203%国家食品药品监督管理总局,北京,100053%上海中医药大学附属普陀医院感染科,上海,200062%上海交通大学医学院附属同仁医院感染科,上海,200336%上海中医药大学附属曙光医院肝病研究所,上海201203
上海市高校中医内科学E研究院,上海201203
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