中药注射剂致类过敏反应评价模型研究进展
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摘要
中药注射剂具有生物利用度高,起效快,疗效显著的特点。但随着中药注射剂在临床的广泛应用,其不良反应也引起人们的重视。类过敏是中药注射剂的主要不良反应,严重影响了中药注射剂的应用与推广。迄今为止,国内外尚未建立可靠的中药注射剂致类过敏临床前评价模型。本文通过对现有的模型及评价指标进行总结归纳,以期为中药注射剂的辅料优化,质量控制及临床安全使用提供借鉴和参考。
Traditional Chinese medicine injection(TCMI) has the characteristics of high bioavailability,quick onset and remarkable curative effect.However,with the clinical application and promotion of TCMI,its adverse reactions have also attracted people′s attention.Pseudoallergic reactions(PARs) as the main adverse reaction of TCMI,seriously affects the application and promotion of TCMI.So far,any reliable preclinical evaluation model for PARs induced by TCMI has not been established.In this paper,the existing models and evaluation indicators were summarized in order to provide reference for the optimization of ingredients,quality control and clinical security of TCMI.
Traditional Chinese medicine injection(TCMI) has the characteristics of high bioavailability,quick onset and remarkable curative effect.However,with the clinical application and promotion of TCMI,its adverse reactions have also attracted people′s attention.Pseudoallergic reactions(PARs) as the main adverse reaction of TCMI,seriously affects the application and promotion of TCMI.So far,any reliable preclinical evaluation model for PARs induced by TCMI has not been established.In this paper,the existing models and evaluation indicators were summarized in order to provide reference for the optimization of ingredients,quality control and clinical security of TCMI.
引文
[1]国家药品监督管理局.国家药品监督管理局关于发布国家药品不良反应监测年度报告(2017年)的公告(2018年第3号)[EB/OL].http://www.nmpa.gov.cn/WS04/CL2050/227761.html.
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[3]谭乐俊,王萌,朱彦.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889.
[4]亚莉,范庆国.中药注射剂临床不良反应分析及合理用药建议[J].亚太传统医药,2015,11(2):132-133.
[5]Szebeni J.Complement activation-related pseudoallergy:anew class of drug-induced acute immune toxicity[J].Toxicology,2005,216(2-3):106-121.
[6]Weaver JL,Boyne M,Pang E,et al.Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog[J].Toxicol Appl Pharmacol,2015,287(3):246-252.
[7]Nishikawa H,Kitani S.Gangliosides inhibit bee venom melittin cytotoxicity but not phospholipase A 2-induced degranulation in mast cells[J].ToxicolApliedPharmacol,2011,252(3):228-236.
[8]《中药、天然药物免疫毒性(过敏性、光过敏反应)研究的技术指导原则》课题研究组.中药、天然药物免疫毒性(过敏性、光变态反应)研究技术指导原则[Z].GPT5-1,2005.
[9]梁爱华,李春英,刘婷,等.中药注射剂的类过敏实验动物模型和实验方法研究[J].世界科学技术,2010,12(6):998-1004.
[10]梁爱华,李春英,易艳,等.药物类过敏反应的临床前评价方法研究:小鼠类过敏反应评价方法研究[J].中国中药杂志,2012,37(13):1865-1868.
[11]张宇实,易艳,李春英,等.中药注射剂类过敏反应临床前评价:动物品系和性别差异研究[J].中国中药杂志,2015,40(14):2717-2722.
[12]Hu XG,Wen Y,Liu SS,et al.Evaluation of the anaphylactoid potential of Andrographis paniculata extracts using the popliteal lymph node assay and P815 cell degranulation in vitro[J].J Transl Med,2015,121.
[13]Huang LF,Dong Y,Wu JL,et al.Sinomenine-induced histamine release-like anaphylactoid reactionsare blocked by tranilast via inhibiting NF-κB signaling[J].Pharmacol Res,2017,125:150-160.
[14]Duplancic B,Stambolija V,Holjevac J,et al.Pentadecapeptide BPC 157 and anaphylactoid reaction in rats and mice after intravenous dextran and white egg administration[J].Eur J Pharmacol,2014,727:75-79.
[15]Wang,F,Li,CY,Zheng YF,et al.Study on the anaphylactoid of three phenolic acids in Honeysuckle[J].J Ethnopharmacol,2015,170:1-7.
[16]马丽娜.基于细胞响应谱的中药注射剂质量评控方法研究[D].成都中医药大学,2014.
[17]王志国,王丹巧,吴兆恩,等.清开灵注射液引发Beagle 犬类过敏反应的实验研究[J].中医杂志,2010,51(4):362-364.
[18]李峰杰,何萍,唐仁茂.生脉注射液(新工艺)致食蟹猴类过敏反应实验研究[J].中国中药杂志,2012,37(13):1885-1890.
[19]孙伟伟,李贻奎,张金艳,等.鱼腥草注射液致食蟹猴类过敏反应的实验研究[J].中医杂志,2011,(09):773-775.
[20]Yang R,Lao QC,Yu HP,et al.Tween-80 and impurity induce anaphylactoid reaction in zebrafish[J].J Appl Toxicol,2015,35(3):295-301.
[21]徐国良,张卓辉,张增珠,等.双黄连注射剂过敏症动物模型的研究[J].中国临床药理学与治疗学,2008,(02):154-157.
[22]袁进,顾为望.小型猪作为人类疾病动物模型在生物医学研究中的应用[J].动物医学进展,2011,32(02):108-111.
[23]Huang LF,Li T,Zhou H,et al.Sinomenine potentiates degranulation of RBL-2H3 basophils via up-regulation of phospholipase A2 phosphorylation by Annexin A1cleavage and ERK phosphorylation without influencing on calcium mobilization[J].Int Immunopharmacol,2015,28(2):945-951.
[24]赵吟,李钦,张信岳.基于RBL-2H3细胞模型的I型过敏反应和类过敏反应研究[J].中国临床药理学与治疗学,2010,15(11):1310-1315.
[25]Hu X,Wen Y,Liu S,et al.Evaluation of the anaphylactoid potential of Andrographis paniculata extracts using the popliteal lymph node assay and P815 cell degranulation in vitro[J].J Transl Med,2015,13(1):121.
[26]李伟,陈梦,黄芝瑛,等.类过敏反应体外评价模型的建立及其指标的筛选[J].中国新药志,2017,26(14):1649-1660.
[27]高婕.三种细胞用于建立体外肥大细胞脱颗粒模型的比较研究[D].南方医科大学,2012.
[28]胡剑江,侯燕鸣,张倩,等.肥大细胞类过敏反应脱颗粒的实时动态检测方法[J].中国中药杂志,2011,36(14):1860-1864.
[29]Kirshenbaum AS,Akin C,Wu Y,et al.Characterization of novel stem cell factor responsive human mast cell lines LAD1 and 2 established from a patient with mast cell sarcoma/leukemia,activation following aggregation of FcεRI[J].Leuk Res,2003,27(8):677-682.
[30]McNeil BD,Pundir P,Meeker S,et al.Identification of a mast-cell-specific receptor crucial for pseudo-allergic drug reactions[J].Nature,2015,519:237-41.
[31]Wang L,Zhang F,Cao ZY,et al.Ginsenoside F2 induces the release of mediators associated with Anaphylactoid reactions[J].Fitoterapia,2007,9(121):223-228.
[32]刘丽鹤,尹利辉,金少鸿.中药注射剂过敏反应体外评价方法研究进展[J].药物分析杂志,2013,33(8):1439.
[33]谭乐俊,王萌,朱彦,等.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889-3898.
[34]Han SL,Zhang T,Huang J,et al.New method of screening allergenic components from shuanghuanglian injection:with RBL-2H3/CMC model online HPLC/MS system[J].J Pharmaceut Biomed Anal,2014,88:602-608.
[2]冯宇飞,吕邵娃,王艳宏,等.中药注射剂安全性问题分析及对策[J].中国实验方剂学杂志,2011,17(9):278.
[3]谭乐俊,王萌,朱彦.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889.
[4]亚莉,范庆国.中药注射剂临床不良反应分析及合理用药建议[J].亚太传统医药,2015,11(2):132-133.
[5]Szebeni J.Complement activation-related pseudoallergy:anew class of drug-induced acute immune toxicity[J].Toxicology,2005,216(2-3):106-121.
[6]Weaver JL,Boyne M,Pang E,et al.Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog[J].Toxicol Appl Pharmacol,2015,287(3):246-252.
[7]Nishikawa H,Kitani S.Gangliosides inhibit bee venom melittin cytotoxicity but not phospholipase A 2-induced degranulation in mast cells[J].ToxicolApliedPharmacol,2011,252(3):228-236.
[8]《中药、天然药物免疫毒性(过敏性、光过敏反应)研究的技术指导原则》课题研究组.中药、天然药物免疫毒性(过敏性、光变态反应)研究技术指导原则[Z].GPT5-1,2005.
[9]梁爱华,李春英,刘婷,等.中药注射剂的类过敏实验动物模型和实验方法研究[J].世界科学技术,2010,12(6):998-1004.
[10]梁爱华,李春英,易艳,等.药物类过敏反应的临床前评价方法研究:小鼠类过敏反应评价方法研究[J].中国中药杂志,2012,37(13):1865-1868.
[11]张宇实,易艳,李春英,等.中药注射剂类过敏反应临床前评价:动物品系和性别差异研究[J].中国中药杂志,2015,40(14):2717-2722.
[12]Hu XG,Wen Y,Liu SS,et al.Evaluation of the anaphylactoid potential of Andrographis paniculata extracts using the popliteal lymph node assay and P815 cell degranulation in vitro[J].J Transl Med,2015,121.
[13]Huang LF,Dong Y,Wu JL,et al.Sinomenine-induced histamine release-like anaphylactoid reactionsare blocked by tranilast via inhibiting NF-κB signaling[J].Pharmacol Res,2017,125:150-160.
[14]Duplancic B,Stambolija V,Holjevac J,et al.Pentadecapeptide BPC 157 and anaphylactoid reaction in rats and mice after intravenous dextran and white egg administration[J].Eur J Pharmacol,2014,727:75-79.
[15]Wang,F,Li,CY,Zheng YF,et al.Study on the anaphylactoid of three phenolic acids in Honeysuckle[J].J Ethnopharmacol,2015,170:1-7.
[16]马丽娜.基于细胞响应谱的中药注射剂质量评控方法研究[D].成都中医药大学,2014.
[17]王志国,王丹巧,吴兆恩,等.清开灵注射液引发Beagle 犬类过敏反应的实验研究[J].中医杂志,2010,51(4):362-364.
[18]李峰杰,何萍,唐仁茂.生脉注射液(新工艺)致食蟹猴类过敏反应实验研究[J].中国中药杂志,2012,37(13):1885-1890.
[19]孙伟伟,李贻奎,张金艳,等.鱼腥草注射液致食蟹猴类过敏反应的实验研究[J].中医杂志,2011,(09):773-775.
[20]Yang R,Lao QC,Yu HP,et al.Tween-80 and impurity induce anaphylactoid reaction in zebrafish[J].J Appl Toxicol,2015,35(3):295-301.
[21]徐国良,张卓辉,张增珠,等.双黄连注射剂过敏症动物模型的研究[J].中国临床药理学与治疗学,2008,(02):154-157.
[22]袁进,顾为望.小型猪作为人类疾病动物模型在生物医学研究中的应用[J].动物医学进展,2011,32(02):108-111.
[23]Huang LF,Li T,Zhou H,et al.Sinomenine potentiates degranulation of RBL-2H3 basophils via up-regulation of phospholipase A2 phosphorylation by Annexin A1cleavage and ERK phosphorylation without influencing on calcium mobilization[J].Int Immunopharmacol,2015,28(2):945-951.
[24]赵吟,李钦,张信岳.基于RBL-2H3细胞模型的I型过敏反应和类过敏反应研究[J].中国临床药理学与治疗学,2010,15(11):1310-1315.
[25]Hu X,Wen Y,Liu S,et al.Evaluation of the anaphylactoid potential of Andrographis paniculata extracts using the popliteal lymph node assay and P815 cell degranulation in vitro[J].J Transl Med,2015,13(1):121.
[26]李伟,陈梦,黄芝瑛,等.类过敏反应体外评价模型的建立及其指标的筛选[J].中国新药志,2017,26(14):1649-1660.
[27]高婕.三种细胞用于建立体外肥大细胞脱颗粒模型的比较研究[D].南方医科大学,2012.
[28]胡剑江,侯燕鸣,张倩,等.肥大细胞类过敏反应脱颗粒的实时动态检测方法[J].中国中药杂志,2011,36(14):1860-1864.
[29]Kirshenbaum AS,Akin C,Wu Y,et al.Characterization of novel stem cell factor responsive human mast cell lines LAD1 and 2 established from a patient with mast cell sarcoma/leukemia,activation following aggregation of FcεRI[J].Leuk Res,2003,27(8):677-682.
[30]McNeil BD,Pundir P,Meeker S,et al.Identification of a mast-cell-specific receptor crucial for pseudo-allergic drug reactions[J].Nature,2015,519:237-41.
[31]Wang L,Zhang F,Cao ZY,et al.Ginsenoside F2 induces the release of mediators associated with Anaphylactoid reactions[J].Fitoterapia,2007,9(121):223-228.
[32]刘丽鹤,尹利辉,金少鸿.中药注射剂过敏反应体外评价方法研究进展[J].药物分析杂志,2013,33(8):1439.
[33]谭乐俊,王萌,朱彦,等.中药注射剂的不良反应研究进展[J].中国中药杂志,2014,39(20):3889-3898.
[34]Han SL,Zhang T,Huang J,et al.New method of screening allergenic components from shuanghuanglian injection:with RBL-2H3/CMC model online HPLC/MS system[J].J Pharmaceut Biomed Anal,2014,88:602-608.
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