双黄连口服制剂安全性风险分析

doi:10.19803/j.1672-8629.2021.07.18

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 683-685.
DOI: 10.19803/j.1672-8629.2021.07.18

双黄连口服制剂安全性风险分析

于洪礼¹, 于冬梅², 逄瑜¹, 邵波¹, 宋海波^1,*

¹国家药品监督管理局药品评价中心,北京 100022;
²国家市场监督管理总局食品审评中心,北京 100070

收稿日期:2020-01-22 出版日期:2021-07-15 发布日期:2021-07-23
通讯作者: ^*宋海波,男,博士,主任药师,中药上市后安全性研究。E-mail：songhaibo@cdr-adr.org.cn
作者简介:于洪礼,男,硕士,主管药师,中药上市后安全性研究。
基金资助:
国家科技重大专项（2015ZX09501004-001-001）; 中医药行业科研专项（201507004）

Risks of Shuanghuanglian Oral Preparation

YU Hongli¹, YU Dongmei², PANG Yu¹, SHAO Bo¹, SONG Haibo^1,*

¹Center for Drug Reevaluation, NMPA, Beijing 100022, China;
²Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China

Received:2020-01-22 Online:2021-07-15 Published:2021-07-23

摘要/Abstract

摘要： 目的分析双黄连口服制剂安全性风险,为临床合理用药提供参考。方法整理分析我国药品不良反应监测数据库、国内文献数据库中的双黄连口服制剂相关不良反应。结果国家药品不良反应监测系统收到的双黄连口服制剂不良反应/事件报告和文献报道显示,双黄连口服制剂不良反应累及多个系统-器官,临床表现包括皮疹、瘙痒、恶心、呕吐等。结论合理选用双黄连口服制剂,关注其相关不良反应。

关键词: 双黄连, 口服制剂, 不良反应

Abstract: Objective To analyze the risk of Shuanghuanglian oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Shuanghuanglian oral preparation that were retrieved from China adverse drug reaction database and domestic literature were analyzed. Results The adverse drug reaction/adverse event (ADR/AE) reports from the national ADR monitoring system and literature showed that the ADR of Shuanghuanglian oral preparation involved multiple systems and organs, and that the clinical manifestations included rash, pruritus, nausea and vomiting, etc. Conclusion Shuanghuanglian oral preparation should be used with caution and related adverse reactions deserve attention.

Key words: Shuanghuanglian, oral preparation, adverse reaction

中图分类号:

R994.11

于洪礼, 于冬梅, 逄瑜, 邵波, 宋海波. 双黄连口服制剂安全性风险分析[J]. 中国药物警戒, 2021, 18(7): 683-685.

YU Hongli, YU Dongmei, PANG Yu, SHAO Bo, SONG Haibo. Risks of Shuanghuanglian Oral Preparation[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 683-685.

参考文献

[1] National Medical Products Administration. Guan yu Shuang-huanglian ke li deng kou fu zhi ji chu fang yao he fei chu fang yao shuo ming shu de gong gao [EB/OL]. (2020-03-25) [2021-01-20]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypshmshxdgg/20200325174501785.html.
[2] Liu G.A case of allergic shock caused by Shuanghuanglian[J]. Shi Yong Yi Ji Za Zhi(实用医技), 2000, 7(4): 248.
[3] Miao ZF.A case report of severe allergy caused by Shuanghuanglian oral liquid[J]. Chinese Community Doctors(中国社区医师), 2008, 10(23): 32.
[4] Liang L.A case of allergic reaction induced by Shuanghuanglian oral preparation[J]. The Medical Forum(基层医学论坛), 2008, 12(34): 1068.
[5] Chen YF, Zhao ZH, Zhang LQ.A case of Tongue hypertrophy caused by oral Shuanghuanglian[J]. Shui Dian Yi xue Za Zhi(水电医学杂志), 2001, (1): 36.
[6] Fu JL.A case of acute abdominal pain caused by Shuanghuanglian buccal tablets[J]. Strait Pharmaceutical Journal(海峡药学), 2002, 14(4): 95.
[7] Lei XB, Chen J.A case report of adverse drug reactions of Shuanghuanglian oral liquid[J]. Journal of Practical Traditional Chinese Medicine(实用中医药杂志), 2009, 25(8): 566-567.
[8] Yang BG, Qi GZ, Li JH.Two cases of severe allergic reaction caused by Shuanghuanglian oral liquid[J]. Journal of Pediatric Pharmacy(儿科药学杂志), 1999, 5(1): 36.
[9] Wei QL, Yan M.Two cases of adverse drug reactions caused by Shuanghuanglian oral liquid[J]. Chinese Journal of Ethnomedicine and Ethnopharmacy(中国民族民间医药), 2010, 19(11): 238.
[10] Gao WX, Qu XY.A case of allergic reaction caused by Shuanghuanglian oral liquid[J]. Aerospace Medicine(航空航天医药), 2004, 15(2): 70.
[11] Tang YW, Yan L.A case of allergic reaction caused by Shuanghuanglian oral liquid[J]. Med Jndfnc(西北国防医学杂志), 2007, 28(4): 308.
[12] Zhang XL, Xiao LM.A case of allergic reaction caused by Shuang-huanglian oral liquid[J]. Shanxi Clinical Medicine(山西临床医药), 2001, 10(10): 724.
[13] Wang DF, Xiao SW, Meng DB, et al.A case of dermatitis exfoliative generalised caused by Shuanghuanglian oral liquid[J]. Shandong Medical Industry(山东医药工业), 1998, 17(6): 51-52.
[14] Song JH, Qi XH, Xie W.Erythema multiforme inassociation with Shuanghuanglian oral solutiomna child[J]. ADRJ(药物不良反应杂志), 2005, (6): 462.
[15] Lyu XH, Jiang W.A case of urticarial rash caused by Shuanghu-anglian oral liquid[J]. Herald of Medicine(医药导报), 2000, 19(2): 182.
[16] Lyu GB.A case of allergic shock caused by Shuanghuanglian[J]. Journal of Modern Medicine & Health(现代医药卫生), 2005, 21(13): 1673.

双黄连口服制剂安全性风险分析

Risks of Shuanghuanglian Oral Preparation

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