祛湿类中药饮片安全问题分析与用药警戒思考
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摘要
目的:通过对祛湿类中药饮片的安全事件报道的系统梳理,分析其引发不良反应/事件(ADR/ADE)的特点及原因,提出祛湿类中药饮片的药物警戒与合理用药建议。方法:系统检索30年来国内外文献,收集和整理53味祛湿类中药饮片的ADR/ADE报道,采用回顾性研究和统计学方法对该类中药饮片的不良反应进行分析。结果:纳入祛湿类中药饮片ADR/ADE文献报道67篇,病例98例。涉及ADR/ADE的饮片19味,占祛湿类饮片总数的35.85%,其中包含利水渗湿药17味,芳香化湿药2味。祛湿类饮片ADR/ADE的临床表现主要为A型、B型不良反应,以过敏反应和毒副反应较为常见,主要影响因素为药材品种混淆、患者个体差异和超剂量用药等。结论:祛湿类中药饮片发生ADR/ADE累及药味相对较少。因此,临床需对该类饮片可能发生安全问题的因素加以警戒,从而提高安全合理用药水平。
Objective:To analyze the characteristics and reasons of adverse drug reactions/adverse drug events(ADR/ADE),and provide suggestions for the pharmacovigilance and the rational use of prepared slices of Chinese materia medica for eliminating dampness.Methods:The literature reports of 53 kinds of Chinese materia medica for eliminating dampness over last 30 years were reviewed,and then the characteristics and reasons of ADR/ADE were analyzed by retrospective study and statistic methods.Results:The total of 98 ADR/ADE cases were in 67 literature reports,in which 19 kinds of herbs were involved,accounting for about 35.85% of prepared slices of Chinese materia medica for eliminating dampness.The 19 herbs included 17 ones for clearing damp through diuresis,and the other 2 through aromatics.According to the analysis,the above ADR/ADE cases were mainly type A and B,which were toxic and allergic reactions as the most common manifestations.And the main influence factors were misuse of medicinal species,individual differences,overdose,and so on.Conclusion:The ADR/ADE reports of Chinese materia medica for eliminating dampness involve relatively few herbs.Therefore,it is necessary to take pharmacovigilance actions for prepared slices of Chinese materia medica for eliminating dampness so as to improve the safe and rational use.
Objective:To analyze the characteristics and reasons of adverse drug reactions/adverse drug events(ADR/ADE),and provide suggestions for the pharmacovigilance and the rational use of prepared slices of Chinese materia medica for eliminating dampness.Methods:The literature reports of 53 kinds of Chinese materia medica for eliminating dampness over last 30 years were reviewed,and then the characteristics and reasons of ADR/ADE were analyzed by retrospective study and statistic methods.Results:The total of 98 ADR/ADE cases were in 67 literature reports,in which 19 kinds of herbs were involved,accounting for about 35.85% of prepared slices of Chinese materia medica for eliminating dampness.The 19 herbs included 17 ones for clearing damp through diuresis,and the other 2 through aromatics.According to the analysis,the above ADR/ADE cases were mainly type A and B,which were toxic and allergic reactions as the most common manifestations.And the main influence factors were misuse of medicinal species,individual differences,overdose,and so on.Conclusion:The ADR/ADE reports of Chinese materia medica for eliminating dampness involve relatively few herbs.Therefore,it is necessary to take pharmacovigilance actions for prepared slices of Chinese materia medica for eliminating dampness so as to improve the safe and rational use.
引文
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[8]钟良宝.大剂量车前草致肾功能损害——附4例分析.中国中西医结合肾病杂志,2002,3(7):401
[9]杨洪涛,林燕,曹式丽,等.关木通制剂致肾衰竭1例.中国中西医结合肾病杂志,2002,3(8):493
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[12]韩晋,金城,刘太华,等.不同采收期和不同部位茵陈药材滨蒿内酯的含量测定与资源利用建议.解放军大学报,2005,21(2):155-156
[13]清·陈士铎.本草新编.北京:中国医药科技出版社,2011:246,138,194
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[16]明·李时珍.本草纲目.山西:山西科学技术出版社,2014:618,685
[17]狄丽霞,王学俊.过食赤小豆致小产二例.广西中医药,1997,14(6):33
[18]明·缪希雍.神农本草经疏.李玉清,成建军,等,校注.北京:中国医药科技出版社,2011:97,104,119,124,198
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[21]梁·陶弘景.本草经集注.尚志钧,尚元胜,辑校.北京:人民卫生出版社,1994:203,189
[22]徐硕,夏路风,金鹏飞,等.泽泻的化学成分及生物活性研究进展.中国医药导报,2015,12(27):47-51
[23]唐·苏敬等.新修本草.尚志钧,辑校.合肥:安徽科学技术出版社,1981:324
[24]刘士敬.治疗肝炎应注意中西药物的配伍禁忌.中华中医药学会全国第十四次肝胆病学术会议论文汇编,2010:19
[25]孟秀丽,郑晓东.中西药联用的药物相互作用.中国社区医师(医学专业半月刊),2008,10(24):17
[26]明·刘文泰.本草品汇精要.北京:人民卫生出版社,1982:507
[27]任仁安.商品木通的生药学鉴定.药学学报,1954,2(1):23-30
[28]Vanherweghem J L,Depierreux M,Tielemans C,et al.Rapidly progressive interstitial renal fibrosis in young women:association with slimming regimen including Chinese herbs.Lancet,1993,341(8842):387-391
[29]田中敬雄,新開五月,糟野健司,など.関西地方におけるChinese herbs nephropathyの多発状况にフいて.日本腎臟学会誌,1997,39(4):438-440
[30]日本カ一ヤ株式会社.天津当归四逆加吴茱萸生姜汤エキス颗粒(KM)医疗用[KM-38]の副作用症例.1997,11:20
[31]黑川清.藥劑有害事象報告.日本腎臟學會誌,1997,39(7):Ⅵ
[32]田中敬雄,新開五月,永江徹也,など.Chinese herbs nephropathy(アリストロキア酸腎症)の3例.日本腎臟学会誌,1997,39(8):796
[33]夕刊讀賣新聞.関木通で腎臟障害.1997,11:29
[34]Izumotani T,Ishimura E,Tsumura K,et al.An adult case of Fanconi syndrome due to a mixture of Chinese crude drugs.Nephron,1993,65:137-140
[35]Lord G M,Tagore R,Cook T,et al.Nephropathy caused by Chinese herbs in the UK.Lancet,1999,354(9177):481-482
[36]张晓明,郑法雷.马兜铃酸引起的肾脏损害.国外医学·泌尿系统分册,2000,20(3):101-103
[37]清·严西亭,施澹宁,洪缉菴同纂.得配本草.上海:上海科学技术出版社,1958:109,67,188
[38]阮富刚,周燕.金钱草、广金钱草、连钱草的鉴别与临床应用.海峡药学.2012,24(7):43-45
[39]薄锋,袁玲,张永和.金钱草总黄酮提取物的抗血栓作用研究.长春中医药大学学报,2007,23(2):10-11
[40]耿放,孙虔,杨莉,等.车前子与车前草利尿作用研究.上海中医药杂志,2009,43(8):72-74
[41]明·倪朱谟.本草汇言.戴慎,陈仁寿,虞舜,点校.上海:上海科学技术出版社,2005:278
[42]杨草根,周建芽.茵陈蒿汤致急性胃炎1例.江西中医药,1996(增刊):68
[43]王变珍,石焱,郭果林.茵陈中毒致混合性心律失常3例.山西医药杂志,1996,25(1):74
[44]清·黄爽.神农本草经.北京:中医古籍出版社,1982:54
[2]张冰.中药药物警戒.北京:人民卫生出版社,2015:31-33
[3]吴松寒.木通所致急性肾功能衰竭二例报告.江苏中医,1964,10:12-13
[4]郑志农,付玉梅,李延国.木通致急性肾功能损害2例.现代中西医结合杂志,2000,9(18):1823
[5]孙德珍,张银梅.木通中毒致肾功能衰竭一例.内蒙古医学院学报,2002,24(3):197-198
[6]赵泰济.茯苓致支气管哮喘1例.中国医院药学杂志,1998,18(3):45
[7]林珍莲.佩兰过敏2例报道.浙江中西医结合杂志,2004,14(2):19
[8]钟良宝.大剂量车前草致肾功能损害——附4例分析.中国中西医结合肾病杂志,2002,3(7):401
[9]杨洪涛,林燕,曹式丽,等.关木通制剂致肾衰竭1例.中国中西医结合肾病杂志,2002,3(8):493
[10]国家药典委员会.中华人民共和国药典(一部).北京:中国医药科技出版社,2015:63,66,257,239,69,219,44,240
[11]张启伟,章育中.滨蒿中利胆成分的含量测定.药学学报,1986,21(12):922
[12]韩晋,金城,刘太华,等.不同采收期和不同部位茵陈药材滨蒿内酯的含量测定与资源利用建议.解放军大学报,2005,21(2):155-156
[13]清·陈士铎.本草新编.北京:中国医药科技出版社,2011:246,138,194
[14]宋·寇宗奭.本草衍义.颜正华,常章富,黄幼群,点校.北京:人民卫生出版社,1990:86
[15]明·陈嘉谟.本草蒙筌.王叔民,陈湘萍,周超凡,点校.北京:人民卫生出版社,1988:116
[16]明·李时珍.本草纲目.山西:山西科学技术出版社,2014:618,685
[17]狄丽霞,王学俊.过食赤小豆致小产二例.广西中医药,1997,14(6):33
[18]明·缪希雍.神农本草经疏.李玉清,成建军,等,校注.北京:中国医药科技出版社,2011:97,104,119,124,198
[19]清·张璐.本经逢原.赵小青,裴晓峰,杜亚伟,校注.北京:中国中医药出版社,2007:60,85-87
[20]清·吴仪洛.本草从新.陆拯,赵法新,陈明显,校点.北京:中国中医药出版社,2013:42,67,64
[21]梁·陶弘景.本草经集注.尚志钧,尚元胜,辑校.北京:人民卫生出版社,1994:203,189
[22]徐硕,夏路风,金鹏飞,等.泽泻的化学成分及生物活性研究进展.中国医药导报,2015,12(27):47-51
[23]唐·苏敬等.新修本草.尚志钧,辑校.合肥:安徽科学技术出版社,1981:324
[24]刘士敬.治疗肝炎应注意中西药物的配伍禁忌.中华中医药学会全国第十四次肝胆病学术会议论文汇编,2010:19
[25]孟秀丽,郑晓东.中西药联用的药物相互作用.中国社区医师(医学专业半月刊),2008,10(24):17
[26]明·刘文泰.本草品汇精要.北京:人民卫生出版社,1982:507
[27]任仁安.商品木通的生药学鉴定.药学学报,1954,2(1):23-30
[28]Vanherweghem J L,Depierreux M,Tielemans C,et al.Rapidly progressive interstitial renal fibrosis in young women:association with slimming regimen including Chinese herbs.Lancet,1993,341(8842):387-391
[29]田中敬雄,新開五月,糟野健司,など.関西地方におけるChinese herbs nephropathyの多発状况にフいて.日本腎臟学会誌,1997,39(4):438-440
[30]日本カ一ヤ株式会社.天津当归四逆加吴茱萸生姜汤エキス颗粒(KM)医疗用[KM-38]の副作用症例.1997,11:20
[31]黑川清.藥劑有害事象報告.日本腎臟學會誌,1997,39(7):Ⅵ
[32]田中敬雄,新開五月,永江徹也,など.Chinese herbs nephropathy(アリストロキア酸腎症)の3例.日本腎臟学会誌,1997,39(8):796
[33]夕刊讀賣新聞.関木通で腎臟障害.1997,11:29
[34]Izumotani T,Ishimura E,Tsumura K,et al.An adult case of Fanconi syndrome due to a mixture of Chinese crude drugs.Nephron,1993,65:137-140
[35]Lord G M,Tagore R,Cook T,et al.Nephropathy caused by Chinese herbs in the UK.Lancet,1999,354(9177):481-482
[36]张晓明,郑法雷.马兜铃酸引起的肾脏损害.国外医学·泌尿系统分册,2000,20(3):101-103
[37]清·严西亭,施澹宁,洪缉菴同纂.得配本草.上海:上海科学技术出版社,1958:109,67,188
[38]阮富刚,周燕.金钱草、广金钱草、连钱草的鉴别与临床应用.海峡药学.2012,24(7):43-45
[39]薄锋,袁玲,张永和.金钱草总黄酮提取物的抗血栓作用研究.长春中医药大学学报,2007,23(2):10-11
[40]耿放,孙虔,杨莉,等.车前子与车前草利尿作用研究.上海中医药杂志,2009,43(8):72-74
[41]明·倪朱谟.本草汇言.戴慎,陈仁寿,虞舜,点校.上海:上海科学技术出版社,2005:278
[42]杨草根,周建芽.茵陈蒿汤致急性胃炎1例.江西中医药,1996(增刊):68
[43]王变珍,石焱,郭果林.茵陈中毒致混合性心律失常3例.山西医药杂志,1996,25(1):74
[44]清·黄爽.神农本草经.北京:中医古籍出版社,1982:54