中药注射剂上市后非临床安全性再评价类过敏反应相关研究

doi:10.19803/j.1672-8629.2022.02.15

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (2): 185-188.
DOI: 10.19803/j.1672-8629.2022.02.15

中药注射剂上市后非临床安全性再评价类过敏反应相关研究

易艳, 田婧卓, 李春英, 赵雍, 梁爱华^*

中国中医科学院中药研究所,中药鉴定与安全性检测评估北京市重点实验室,创新天然药物与中药注射剂国家重点实验室,北京 100700

收稿日期:2021-05-08 出版日期:2022-02-15 发布日期:2022-02-15
通讯作者: ^*梁爱华,女,博士,研究员,中药药理毒理。E-mail：ahliang@icmm.ac.cn
作者简介:易艳,女,博士,副研究员,中药药理毒理。
基金资助:
重大新药创制国家科技重大专项2015年度（2015ZX09501004）, 国家自然科学基金资助项目（81974534）; 中国中医科学院资助项目（ZZ-13-035-10,GH201919）; 中央级公益性科研院所基本科研业务费专项（ZXKT19014,ZXKT 20022）

Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections

YI Yan, TIAN Jingzhuo, LI Chunying, ZHAO Yong, LIANG Aihua^*

Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Key Laboratory of Beijing for Identification and Safety of Chinese Medicine, State Key Laboratory of Innovative Natural Medicine and TCM Injections, Beijing 100700, China

Received:2021-05-08 Online:2022-02-15 Published:2022-02-15

摘要/Abstract

摘要： 目的为开展中药注射剂（traditional Chinese medicine injection, TCMI）上市后非临床安全性再评价提供思路和参考。方法概述上市后非临床安全性再研究的重要性及TCMI非临床安全性再评价的主要问题和相关原因分析,并基于本团队的相关研究,以TCMI最主要的不良反应—类过敏反应为重点,从TCMI产品类过敏检测和风险控制,类过敏反应机制以及类过敏反应防治等方面,系统阐述TCMI上市后非临床安全性再评价技术体系的建立思路和实践。结果和结论 找准各TCMI品种存在的主要关键问题,分析清楚与这些关键问题相关的各层面因素,系统设计上市后安全性研究方案,研究思路和方法学的创新在该项研究中尤为重要。

关键词: 中药注射剂, 药品不良反应/事件, 非临床安全性再评价, 类过敏反应

Abstract: Objective To advise on post-marketing non-clinical safety evaluation of traditional Chinese medicine injection TCMI. Methods The importance of post marketing non clinical safety reevaluation of TCMI was highlighted while the main problems and causes were discussed. Based on the related research by the author's team and focusing on pesudoallergic reactions which were the main ADR of TCMI, this paper elaborated on ways to establish a post-marketing non-clinical safety re-evaluation technical system of TCMI in terms of detection, risk control and prevention of pseudoallergic reactions. Results and Conclusion It is of special importance to identify the major problems with each type of TCMI, analyze the all the factors related to these problems, systematically design the post-marketing safety research scheme, and innovate the ideas and methodology of research.

Key words: traditional Chinese medicine injection, adverse drug reactions/event, non-clinical safety re-evaluation, pesudoallergic reaction

中图分类号:

R994.11

易艳, 田婧卓, 李春英, 赵雍, 梁爱华. 中药注射剂上市后非临床安全性再评价类过敏反应相关研究[J]. 中国药物警戒, 2022, 19(2): 185-188.

YI Yan, TIAN Jingzhuo, LI Chunying, ZHAO Yong, LIANG Aihua. Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 185-188.

参考文献

[1] LI SJ.Scientific supervision is the secret to the leapfrog development of Chinese medicine injections[J]. China Food & GRUG Administration Magazine(中国食品药品监督), 2015(4): 54-56.
[2] Center for Drug Reevaluation, NMPA. Announcement on the issuance of the national adverse drug reaction monitoring annual report (2018) [EB/OL].(2018-10-18)[2021-08-11]. http:// www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/201910/t20191016_38638.html.
[3] Center for Drug Reevaluation, NMPA. Announcement on the issuance of the national adverse drug reaction monitoring annual report (2019) [EB/OL]. (2020-04-11)[2021-08-11] . http://www.cdr-adr.org.cn/tzgg_home/202004/ t20200410_47300.html.
[4] National Medical Products Administration. Announcement on the issuance of the national adverse drug reaction monitoring annual report (2020)[EB/OL].(2021-04-20)[2021-08-11]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/ 20210325170127199.html.
[5] ZHANG W, XIE YM, YU WY.Exploration of how to formulate guidelines on post-marking traditional Chinese medicine surveillance[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2013, 38(18): 2943-2948.
[6] ZHANG YJ, WANG Q, SUN SG, et al.Research mode thinking on traditional Chinese medicine injections reevaluation after clinical listing[J]. China Journal of Traditional Chinese Medicine and Pharmacy(中华中医药杂志), 2018, 33(6): 2230-2232.
[7] SUN SG, PHARMACY DO.Establishment of reevaluation system of clinical rationality and safety of the traditional Chinese medicine injections[J]. China Journal of Traditional Chinese Medicine and Pharmacy(中华中医药杂志), 2017, 32(4): 1411-1414.
[8] LI CX, LING X, LI XL, et al.Discussion on the study on compreh-ensive evaluation of the safety of post-marketing Chinese patent medicines[J]. Journal of Traditional Chinese Medicine(中医杂志), 2020, 61(12): 1049-1053.
[9] SONG J. ZHAO JN, WU CY.Non-clinical safety study's role on safety reassessment of post-marketing traditional chinese medicine[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2010, 7(12): 730-732.
[10] LU YT, YI Y, LI CY, et al.Characteristics of pseudoallergic reactions of shuanghuanglian injection and analysis of its influencing factors[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2015, 21(9): 97-101.
[11] CUI HY, YI Y, LI C Y, et al.Experimental study on pseudoallergic reaction of Qingkailing injection[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2014, 39(3): 511-514.
[12] YI Y, LI CY, ZHANG YS, et al.Adverse reaction and screening of sensitizing substance of Shuxuening injection[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2017, 42(16): 3198-3205.
[13] YI Y, LI CY, TANG RM, et al.Comparative study on pseudoan-aphylactoid reactions induced by pulse-activating injection before and after improving technology[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2012, 37(13):1875-1879.
[14] LIU T.Material and mechanisms induced pseudo allergicreactions of Yuxingcao injection[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2010, 35(12): 1603-1606.
[15] WANG YT, LI CY, YI Y, et al.Comparative study on pseudoanaphylactoid reactions induced by medicinal tween 80 and injectable tween 80[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2012, 37(13):1890-1893.
[16] LIANG AH, YI Y, ZHANG YS, et al.Pseudoallergic reactions of traditional chinese medicine injections and the approaches for risk prevention and control[J]. Chin Pharm J(中国药学杂志), 2015, 50(15): 1301-1308.
[17] ZHANG YS, YI Y, LI CY, et al.Preclinical evaluation of pseudoallergic reactions on Chinese herbal injections: study on animal strain and gender difference[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2015, 40(14): 2717-2722.
[18] YI Y, LIANG AH, LI CY, et al.Influence of solvent and drug preparation time on Shuanghuanglian injections induce pseudo-allergic reaction[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2015, 40(14): 2723-2726.
[19] LIANG AH, YI Y.Thoughts on the related issues of hypersensitivity evaluation and risk control of traditional Chinese medicine injection[J]. Progress in Pharmaceutical Sciences(药学进展杂志), 2020, 44(10): 752-758.
[20] GAO JB.Research progress about anaphylactoid reactions[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2014, 11(6): 344-346.
[21] HAN J, ZHANG Y, PAN C, et al.Forsythoside a and forsythoside b contribute to shuanghuanglian injection-induced pseudoallergic reactions through the rhoa/rock signaling pathway[J]. International Journal of Molecular Sciences, 2019, 20(24): 1-21.
[22] HAN JY, ZHAO Y, ZHANG YS, et al.RhoA/ROCK signaling pathway mediates shuanghuanglian injection-induced pseudoallergic reactions[J]. Front Pharmacol, 2018, 9: 87-102.
[23] PAN C, ZHANG YS, HAN JY, et al.The Involvement of the RhoA/ROCK signaling pathway in hypersensitivity reactions induced by paclitaxel injection[J]. International Journal of Molecular Sciences, 2019, 20(20): 4988-5004.
[24] HAN J, YI Y, LI C, et al.Involvement of histamine and RhoA/ROCK in penicillin immediate hypersensitivity reactions[J]. SciRep, 2016, 6(1): 1-14.
[25] YI Y, LI CY, ZHANG YS, et al.Pseudoallergic reactions of Xuebijing injection and its rational drug use[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2021, 27(5): 77-83.
[26] China Food Drug Administration. Notice on safety reevaluation of traditional Chinese medicine injection (Supervision and handling by CFDA 2009, No. 359)[EB/OL]. ( 2009-07-20)[ 2021-08-11]. http://www.gov.cn/zwgk/2009-07/20/content_1369959. htm.
[27] China Food Drug Administration. Notice on printing and distributing 7 technical guidelines for safety reevaluation and production process evaluation of traditional Chinese medicine injections ( No. 395. CFDA 2010,)[EB/OL].(2010-11-03)[2021-08-11]. http://tcmic.tjutcm.edu.cn /info/1995 /2326.htm.
[28] State Council of the PRC. Opinions of the State Council on the reform of review and approval system about drug and medical device (No.44 Document of State Council. 2015)[EB/OL].(2017-10-08)[2021-08-11]. http://www. fredamd.com/law/9427.html.
[29] The general office of the CPC Central Committee and the general office of the State Council. Opinions on deepening the reform of review and approval system and encouraging the innovation of drugs and medical devices [EB/OL]. (2020-06-10)[ 2021-08-11].http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm.
[30] Anonymous. Basic technical requirements for traditional Chinese medicine injections and natural medicine injections[J]. World Clin Drug(世界临床药物), 2008, 29(1): 5.
[31] YAN YY, YANG YH, WANG WW, et al.Post-marketing safety surveillance of the salvia miltiorrhiza depside salt for infusion: a real world study[J]. Plos One, 2017, 12: 1-14.
[32] HE B, YANG FY, LI PH, et al.Revaluation of post-marketing safety of Kanglaite injection[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2017, 19(3): 187-194.
[33] DENG JF, WANG ZF, XIE YM, et al.Post-marketing safety reevaluation of Xiyanping injection[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2018, 20(1): 15-22.
[34] JIN XY, WANG KY, ZHAI JB, et al.Post-marketing intensive safety monitoring of injection of Xuesaitong (lyophilized) in 30097 cases[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(20): 5029-5033.

中药注射剂上市后非临床安全性再评价类过敏反应相关研究

Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	张建, 方慧华. 某院活血化瘀类中药注射剂使用评价标准建立的探索[J]. 中国药物警戒, 2024, 21(2): 185-189.
[2]	臧天颖, 刘炳阳, 唐晓军. 万古霉素所致类过敏与过敏反应的鉴别研究进展[J]. 中国药物警戒, 2023, 20(9): 1078-1080.
[3]	何雄, 马俊龙, 阳国平. 基于FAERS对靶向HER2抗体偶联药品不良反应/事件的分析[J]. 中国药物警戒, 2023, 20(8): 915-920.
[4]	孟康康, 刘赛月. 辅酶Q10注射剂上市后安全性分析[J]. 中国药物警戒, 2023, 20(7): 795-798.
[5]	. 国家药品不良反应监测年度报告（2022年）[J]. 中国药物警戒, 2023, 20(6): 712-719.
[6]	柯兵兵, 李燕, 王平慧, 徐晓玲, 沈佳特, 吕晓君. 基于小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）类过敏反应[J]. 中国药物警戒, 2023, 20(12): 1357-1361.
[7]	魏安华, 漆建军, 王璐, 曾露, 贡雪芃, 江莹. 953例口服降糖药不良反应/事件报告分析[J]. 中国药物警戒, 2023, 20(12): 1415-1420.
[8]	彭静, 庹亚莉, 李巧玲, 周荣, 李新林, 彭惠. 基于国外药物警戒安全性自发呈报系统的氯巴占儿童不良事件数据分析[J]. 中国药物警戒, 2023, 20(11): 1264-1268.
[9]	钟露苗, 杜娟, 邓华, 王亚锋, 仇萍, 曾令贵. 药品上市许可持有人开展中药注射剂安全性主动监测研究设计和质量管理的思考[J]. 中国药物警戒, 2022, 19(9): 994-998.
[10]	周鹏, 杨晶晶. 3种清热解毒类中药注射剂的药学监护[J]. 中国药物警戒, 2022, 19(4): 441-445.
[11]	冯承阳, 赵丽, 刘东. 385例茵栀黄制剂不良反应/事件分析[J]. 中国药物警戒, 2022, 19(3): 325-327.
[12]	吴颖其, 朱婷, 童彤, 李民, 沈爱宗. 白蛋白结合型紫杉醇不良反应/事件相关因素分析[J]. 中国药物警戒, 2022, 19(10): 1123-1127.
[13]	于洪礼, 逄瑜, 邵波, 肖爱丽, 于冬梅. 我国基本药物不良反应报告与监测情况浅析[J]. 中国药物警戒, 2021, 18(8): 766-768.
[14]	黄政凯, 张冰, 林志健, 张晓朦, 张丹, 殷玉玲. 蒽醌类中药的安全问题分析及合理应用思考[J]. 中国药物警戒, 2021, 18(6): 532-536.
[15]	游翠玉, 许晓丽, 李莎, 薛思宇, 陈思颖, 王茂义. 某院140例严重药品不良反应/事件报告分析[J]. 中国药物警戒, 2020, 17(9): 617-621.