含补骨脂中成药肝损伤案例的分析与警戒思考
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摘要
目的通过对含补骨脂中成药肝损伤事件报道的系统梳理,分析其肝损伤不良反应的特点,提出合理使用含补骨脂中成药的警戒思考。方法筛选2017版《国家基本医疗保险、工伤保险和生育保险药品目录》(中成药部分)中含有补骨脂的中成药,检索其与肝损伤有关的文献报道,结合古籍记载,采用回顾性研究和统计学方法对含有补骨脂的中成药的肝损伤事件进行分析。结果筛选到2017版《国家基本医疗保险、工伤保险和生育保险药品目录》(中成药部分)中含补骨脂的中成药有11种,纳入其与肝损伤相关的文献报道26篇,案例42例。该类不良反应的发生主要集中在中老年人群,使用剂量均在正常范围内,但用药疗程较长,预后良好。结论加强含补骨脂中成药的肝损伤风险防范对提高该类药物的安全合理应用具有重要意义。
Objective To analyze the characteristics of hepatic injury caused by the Chinese patent medicine which contained Psoraleae fructus by collecting relevant reports systematically, so as to provide pharmacovigilance thinking for the pharmacovigilance and rational use of them. Methods The article reports about hepatic injury caused by the Chinese patent medicine contained Psoraleae fructus in the National Healthcare Directory were screened and searched.The untoward effects of this Chinese herbal piece were analyzed by using retrospective study and statistical methods and combine with the ancient recordation. Results A total of 42 hepatic injury cases in 26 literatures were collected,which involved 11 kinds of Chinese patent medicine contained Psoraleae fructus. According to the analysis, this kind of ad verse reactions mainly concentrated in the middle-aged and old people with the characteristic of normal dosage and long-term treatment as well as favourable prognosis. Conclusion To strengthen the pharmacovigilance of Chinese patent medicine contained Psoraleae fructus is of great significance in improving the safety and reasonable application of them.
Objective To analyze the characteristics of hepatic injury caused by the Chinese patent medicine which contained Psoraleae fructus by collecting relevant reports systematically, so as to provide pharmacovigilance thinking for the pharmacovigilance and rational use of them. Methods The article reports about hepatic injury caused by the Chinese patent medicine contained Psoraleae fructus in the National Healthcare Directory were screened and searched.The untoward effects of this Chinese herbal piece were analyzed by using retrospective study and statistical methods and combine with the ancient recordation. Results A total of 42 hepatic injury cases in 26 literatures were collected,which involved 11 kinds of Chinese patent medicine contained Psoraleae fructus. According to the analysis, this kind of ad verse reactions mainly concentrated in the middle-aged and old people with the characteristic of normal dosage and long-term treatment as well as favourable prognosis. Conclusion To strengthen the pharmacovigilance of Chinese patent medicine contained Psoraleae fructus is of great significance in improving the safety and reasonable application of them.
引文
[1]国家食品药品监督管理总局药品评价中心.药品不良反应信息通报(第72期)警惕仙灵骨葆口服制剂引起的肝损伤风险[EB/OL].(2016-12-09)[2018-04-02].http://www.cdr-adr.org.cn/xxtb_255/ypblfyxxtb/201612/t20161209_18068.html.
[2]孟雪莲,曾晓非,孙祖越,等.丹参致大鼠肝细胞脂质过氧化损伤的实验研究[J].辽宁大学学报(自然科学版),2005,32(1):31-33.
[3]李时珍.本草纲目[M].胡双元,郭海,张伟,等,校注.太原:山西科学技术出版社,2014:402.
[4]卢多逊.开宝本草[M].尚志钧,辑校.合肥:安徽科学科技出版社,1998:217.
[5]凌奂.本草害利[M].北京:中国古籍出版社,1982:104.
[6]雷学攴.雷公炮炙论[M].清·张骥补辑,施仲安,校注.南京:江苏科学技术出版社,1985:56.
[7]缪希雍.神农本草经疏[M].郑金生,校注.北京:中医古籍出版社,2002:342.
[8]严西亭.得配本草[M].赵贵铭,点校.上海:上海科学技术出版社,1958:59.
[9]Nam S W,Beak J T,Dong S L,et al.A Case of Acute Cholestatic Hepatitis Associated with the Seeds of Psoralea corylifolia(Boh-Gol-Zhee)[J].Clinical Toxicology,2005,43(6):589-591.
[10]Cheung W I,Tse M L,Ngan T,et al.Liver injury associated with the use of Fructus Psoraleae(Bol-gol-zhee or Bu-gu-zhi)and its related proprietary medicine[J].Clin Toxicol,2009,47(7):683-685.
[11]谭沛,赵超,周昆,等.补骨脂灌胃30天对大鼠肝毒性的实验研究[J].新疆中医药,2010,20(2):11-13.
[12]周昆,代志,柳占彪,等.补骨脂水提物引起的大鼠肝损害[J].天津中医药大学学报,2013,32(4):221-224.
[13]毕亚男,李震,卢国彦,等.补骨脂水提物对小鼠的肝毒性及胆汁酸转运的影响[J].药物评价研究,2015,38(3):267-270.
[14]陈仲康,王悦晴,成东海,等.丹参致肝功能异常1例[J].药物流行病学杂志,2002,11(6):310-310.
[15]杨竹芳,陈利霞,孟卉秦.丹参注射液治疗急性黄疸型肝炎疗效分析[J].吉林医学,2012,33(18):3869-3870.
[16]徐厚明,倪俊杰.142例中药引起肝功能异常病例分析[J].药学与临床研究,2011,19(3):275-276.
[17]孙思邈.千金翼方[M].胡双元,郭海,张伟,等,校注.太原:山西科学技术出版社,2010:272.
[18]赵晓卫,徐灿丽.仙灵骨葆胶囊与奥美拉唑联用致肝损害及乙型肝炎再活动[J].药物不良反应杂志,2012,14(1):60-61.
[19]赵梅英.奥美拉唑致急性肝损害1例[J].中国药师,2007,10(8):824-824.
[20]郑明节,周耘,吕小琴.仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J].中国药物警戒,2014,11(8):507-508.
[2]孟雪莲,曾晓非,孙祖越,等.丹参致大鼠肝细胞脂质过氧化损伤的实验研究[J].辽宁大学学报(自然科学版),2005,32(1):31-33.
[3]李时珍.本草纲目[M].胡双元,郭海,张伟,等,校注.太原:山西科学技术出版社,2014:402.
[4]卢多逊.开宝本草[M].尚志钧,辑校.合肥:安徽科学科技出版社,1998:217.
[5]凌奂.本草害利[M].北京:中国古籍出版社,1982:104.
[6]雷学攴.雷公炮炙论[M].清·张骥补辑,施仲安,校注.南京:江苏科学技术出版社,1985:56.
[7]缪希雍.神农本草经疏[M].郑金生,校注.北京:中医古籍出版社,2002:342.
[8]严西亭.得配本草[M].赵贵铭,点校.上海:上海科学技术出版社,1958:59.
[9]Nam S W,Beak J T,Dong S L,et al.A Case of Acute Cholestatic Hepatitis Associated with the Seeds of Psoralea corylifolia(Boh-Gol-Zhee)[J].Clinical Toxicology,2005,43(6):589-591.
[10]Cheung W I,Tse M L,Ngan T,et al.Liver injury associated with the use of Fructus Psoraleae(Bol-gol-zhee or Bu-gu-zhi)and its related proprietary medicine[J].Clin Toxicol,2009,47(7):683-685.
[11]谭沛,赵超,周昆,等.补骨脂灌胃30天对大鼠肝毒性的实验研究[J].新疆中医药,2010,20(2):11-13.
[12]周昆,代志,柳占彪,等.补骨脂水提物引起的大鼠肝损害[J].天津中医药大学学报,2013,32(4):221-224.
[13]毕亚男,李震,卢国彦,等.补骨脂水提物对小鼠的肝毒性及胆汁酸转运的影响[J].药物评价研究,2015,38(3):267-270.
[14]陈仲康,王悦晴,成东海,等.丹参致肝功能异常1例[J].药物流行病学杂志,2002,11(6):310-310.
[15]杨竹芳,陈利霞,孟卉秦.丹参注射液治疗急性黄疸型肝炎疗效分析[J].吉林医学,2012,33(18):3869-3870.
[16]徐厚明,倪俊杰.142例中药引起肝功能异常病例分析[J].药学与临床研究,2011,19(3):275-276.
[17]孙思邈.千金翼方[M].胡双元,郭海,张伟,等,校注.太原:山西科学技术出版社,2010:272.
[18]赵晓卫,徐灿丽.仙灵骨葆胶囊与奥美拉唑联用致肝损害及乙型肝炎再活动[J].药物不良反应杂志,2012,14(1):60-61.
[19]赵梅英.奥美拉唑致急性肝损害1例[J].中国药师,2007,10(8):824-824.
[20]郑明节,周耘,吕小琴.仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J].中国药物警戒,2014,11(8):507-508.