1160例复方甘草片不良反应特征及风险因素分析

doi:10.19803/j.1672-8629.2021.12.17

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1176-1180.
DOI: 10.19803/j.1672-8629.2021.12.17

1160例复方甘草片不良反应特征及风险因素分析

霍艳飞, 谢彦军, 许莉莉, 常虹, 孙春晓, 田月洁^*

山东省药品不良反应监测中心,山东济南 250014

收稿日期:2020-03-24 出版日期:2021-12-15 发布日期:2021-12-16
通讯作者: ^*田月洁,男,硕士,主任药师,药品不良反应监测与评价。E-mail：tianyuejie@shandong.cn。
作者简介:霍艳飞,女,硕士,药师,药品不良反应监测与评价。

1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors

HUO Yanfei, XIE Yanjun, XU Lili, CHANG Hong, SUN Chunxiao, TIAN Yuejie^*

Shandong Center for Adverse Drug Reaction Monitoring, Jinan Shandong 250014, China

Received:2020-03-24 Online:2021-12-15 Published:2021-12-16

摘要/Abstract

摘要： 目的探讨复方甘草片致药品不良反应（ADR）发生的特点及风险因素,为临床合理用药提供参考。方法对山东省ADR数据库（2004年1月1日至2019年12月31日）中1 160例涉及复方甘草片的ADR报告进行回顾性分析。结果复方甘草片ADR主要累及胃肠、皮肤及其附件、神经等多系统和器官损害,恶心为最常见的ADR,过敏性休克为最严重的ADR,低血钾、水肿、低血压、药物依赖等风险在说明书中均未提及。结论生产企业应开展复方甘草片安全性监测,及时更新说明书信息;加强医务人员和经营企业人员的培训和宣传,特别是长期服药引起的药物依赖风险,保障公众用药安全。

关键词: 复方甘草片, 药品不良反应, 风险分析

Abstract: Objective To investigate the characteristics of and risk factors for adverse drug reactions (ADRs) caused by compound liquorice tablets in order to offer reference for clinical rational drug use.Methods A retrospective analysis was made of 1 160 ADR reports of compound liquorice tablets in Shandong ADR database (from January 1, 2004 to December 31, 2019). Results The adverse reactions related to compound liquorice tablets were mainly manifested as the damage to multiple systems and organs, such as the gastrointestinal tract, skin and its accessories. Nausea was the most common adverse reaction, and anaphylactic shock was the most severe one. Risks of hypokalemia, edema, hypotension and drug dependence were not mentioned in the instructions.Conclusion Manufacturers should carry out safety inspections of compound liquorice tablets and update the instructions in time. Health care providers and dealers of pharmaceuticals should become better informed of this drug. In particular, the risk of drug dependence caused by long-term medication should be minimized to ensure the safety of medications.

Key words: compound liquorice tablets, adverse drug reactions, risk analysis

中图分类号:

R969.3R994.11

霍艳飞, 谢彦军, 许莉莉, 常虹, 孙春晓, 田月洁. 1160例复方甘草片不良反应特征及风险因素分析[J]. 中国药物警戒, 2021, 18(12): 1176-1180.

HUO Yanfei, XIE Yanjun, XU Lili, CHANG Hong, SUN Chunxiao, TIAN Yuejie. 1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1176-1180.

参考文献

[1] National Medical Products Administration. Notice on Effectively Strengthening the Sales Management of Part of Compound Preparation Containing Special Drugs [EB/OL]. (2009-08-18) [2019-06-03]. http://www.nmpa.gov.cn/WS04/CL2196/323743.html.
[2] National Medical Products Administration. Notice of the General Office of the State Food and Drug Administration on Further Strengthening the Purchase and Sale Management of Compound Oral Solution, Compound Liquorice Tablet and Compound Diphenoxylate Tablet[EB/OL].(2013-07-08)[2019-06-15]. http://www.nmpa.gov.cn/WS04/CL2196/324008.html.
[3] National Medical Products Administration. Notice of the General Office of the Food and Drug Administration on Further Strengthening the Purchase and Sale Management of Oral Compound Formulations containing Narcotic Drugs and Tramadol. [EB/OL]. (2014-06-05) [2019-06-27]. http://www.nmpa.gov.cn/WS04/CL2196/324062.html.
[4] National Medical Products Administration. Announcement on Revising the Instructions of Compound Liquorice Tablet (No. 14, 2020) [EB/OL].(2020-03-03) [2020-03-24]. http://www.nmpa.gov.cn/WS04/CL2115/375249.html.
[5] Liu ZD, Liu XL, Yang L.A case of anaphylactic shock induced by compound liquorice tablets[J]. Chinese Journal of Misdiagnosis(中国误诊学杂志), 2008, 8(31) : 7812.
[6] Wang ZJ, Wei CQ, Ma AJ.A case of anaphylactic shock induced by compound liquorice tablets[J]. Medicine Industry Information(医药产业资讯), 2006, 3(5): 84.
[7] Zhao HP, Guo YC.Report of anaphylactic shock induced by compound liquorice tablets[J]. Journal of Practical Traditional Chinese Medicine(实用中医药杂志), 2005, 21(2): 107.
[8] Li H.A case of addiction caused by long-term oral administration of compound liquorice tablets[J]. Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志), 2017,10(28): 168.
[9] Zhang N, Luo LX, Zhang ZW.A case report of withdrawal symptoms caused by oral high dose compound liquorice tablets[J]. Chongqing Medicine(重庆医学), 2016, 45(9): 1288-1289.
[10] Tang MQ.Three cases of addiction caused by compound liquorice tablets[J]. Herald Medicine(医药导报), 2003, 22(3): 195.
[11] Wang YX, Yu JH.Two cases of urinary retention caused by compound liquorice tablets[J]. Central Plains Medical Journal(中原医刊), 1985(3): 43.
[12] Fu X, Wu YB.One case of hypokalemia caused by compound liquorice tablets[J]. Medical Journal of the Chinese People’s Armed Police Force(武警医学), 2018, 29(12) : 1163-1164.
[13] Su WL, Yang Y, Miao F, et al.Two cases of hypokalemia caused by compound liquorice tablets[J]. China Journal of Hospital Pharmacy(中国医院药学杂志), 2015, 35(15) : 1439-1440.
[14] Li YJ, Wang DN, Miao QL, et al.One case of severe hypokalemia caused by compound liquorice tablets[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(1) : 58-60.
[15] Na KX.Long-term use of compound liquorice tablets should be vigilant against the occurrence of hypokalemia[J]. Chinese Journal of Clinicians(中国临床医生杂志), 2019, 47(7) : 757-758.
[16] Feng Y, Ma CL, Zhu J.A case of hypertensive crisis caused by compound liquorice tablets[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析), 2013, 13(3): 287.
[17] Wang H.A case of facial and lower limb edema caused by compound liquorice tablets[J]. Chinese Journal of Convalescent Medicine(中国疗养医学), 2013, 22(1): 79.
[18] Li JP, Wu LZ.A Meta-analysis of electroacupuncture for treatment of opiate dependence[J]. Chinese Journal of Drug Dependence(中国药物依赖性杂志), 2014,23(1): 28-35.
[19] Pu B, Xie FD.A case of severe urinary retention induced by morphine controlled-release tablets[J]. Chinese Journal of Misdiagnosis(中国误诊学杂志), 2008, 8(2): 493.

1160例复方甘草片不良反应特征及风险因素分析

1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors

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