| 夏旭东,徐晓丽.2016-2021年河南省1824例注射用炎琥宁不良反应报告分析[J].中国药事,2023,(2):221-230 |
| 2016-2021年河南省1824例注射用炎琥宁不良反应报告分析 |
| Analysis of 1824 Cases of Adverse Drug Reactions Reports Induced by Yanhuning Injection in Henan Province from 2016 to 2021 |
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| DOI：10.16153/j.1002-7777.2023.02.015 |
| 中文关键词: 注射用炎琥宁 药品不良反应 药物警戒 安全用药 中药注射剂 |
| 英文关键词: Yanhuning injection adverse drug reaction pharmacovigilance medication safety traditional Chinese medicine injection |
| 基金项目:河南省科技攻关计划(编号 212102311047)；河南省药品上市许可持有人药品不良反应风险分级与应用研究 |
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| 中文摘要: |
| 目的：探讨注射用炎琥宁引发药品不良反应的一般特点和规律，为临床安全合理用药、药品说明书修订完善等提供建议和参考。方法：采用回顾性分析方法，对2016-2021年河南省药品不良反应监测系统1824例注射用炎琥宁不良反应报告进行统计分析。结果：1824例药品不良反应报告主要来自基层医疗卫生机构，患者人群特征显示性别无明显差异，0~9岁儿童报告最多，占38.43%(701例)。患者适应症及给药途径与药品说明书描述大致相符，但存在超剂量用药情况，不良反应发生时间主要集中在用药后30分钟内。不良反应累及系统器官损害多以皮肤及皮下组织类疾病、胃肠系统疾病、全身性疾病及给药部位各种反应为主，主要临床表现为皮疹、瘙痒、荨麻疹，与现有药品说明书描述有较大差异；此外，用药后出现的严重过敏反应及相关眼器官疾病也同样值得关注。结论：注射用炎琥宁所致不良反应具有速发性特点，建议医疗机构加强临床用药监测并注重安全合理用药，尤其注意儿童用药的特殊性； 药品上市许可持有人应加强不良反应监测，及时更新药品说明书，促进公众用药安全。 |
| 英文摘要: |
| Objective: To discuss the general features and patterns of adverse drug reaction (ADR) induced by Yanhuning injection, which provides suggestions and reference for clinical rational drug use, revision and improvement of drug instructions, etc. Methods: Retrospective analysis was used to analyze 1824 ADR reports gathered by Henan Province Adverse Drug Reaction Monitoring System from 2016 to 2021. Results: 1824 ADR reports mainly came from primary medical institutions. The characteristics of the patient population showed no signifi cant diff erence between genders. Patients aged 0-9 years old reported the most, accounting for 38.43% (701 cases). The indications and administration routes are compliance with drug instructions, however, overdosing exists in clinical infusion, additionally, time to onset of ADR is mainly within 30 minutes after medication. ADR induced by Yanhuning injection mostly are skin and subcutaneous tissue disorders, gastrointestinal disorders, general disorders and administration site conditions, and the main clinical manifestations are rash, pruritus and nettle rash, which are quite diff erent from the description of drug instruction; additionally, allergic reaction and related eye disorders are also noteworthy. Conclusion: Yanhuning injection can cause immediate ADR. For the sake of promoting public medication safety, it is suggested that medical institutions should strengthen clinical drug monitoring and rational drug use, especially attach importance to the risk of drug use for children. Marketing Authorization Holder (MAH) should reinforce ADR monitoring and update drug instructions timely to promote the drug safety of the public. |
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