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| 参麦注射液不良反应/事件分析 |
| Analysis of Adverse Drug Reactions/ Events Induced by Shenmai Injection |
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| DOI： |
| 中文关键词: 参麦注射液 药品不良反应/事件 报告 |
| 英文关键词:Shenmai injection Adverse drug reaction/ event Reports |
| 基金项目: |
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| 中文摘要: |
| 摘 要 目的:分析参麦注射液不良反应发生的基本情况，为临床药品不良反应监测及合理用药提供参考。方法：对166份参麦注射液不良反应/事件报告有关数据进行统计、分析。结果：ADR累及的系统器官主要为皮肤及其附件损害（32.34%）、呼吸系统损害（19.14%）、心血管系统损害（18.48%）、全身性损害（13.86%）；由静脉给药途径所致；严重的报告比例高（28.31%）。结论：参麦注射液导致ADR/ADE原因涉及药品使用、生产等多种因素，建议临床要根据中医辨证进行论治，生产企业应提高参麦注射液生产工艺和质量标准、加强说明书安全性标识信息，加强不良反应监测，降低不良反应 /事件发生。 |
| 英文摘要: |
| ABSTRACT Objective:To investigate the essential features of adverse drug reactions/event (ADR/ADE) induced by Shenmai injection thereby improve rational drug use and its ADR monitoring in the future.Methods:166 ADR reports were downloaded from National Center for ADR Monitoring. The reports were collected and analyzed.Results: The primary systemic damage in the body was found in skin and its accessories(32.34%), respiratory system(19.14%), cardiac system (18.48%); the percentage for general whole body systemic damage was13.86%; 28.31%of these reports were related to severe ADRs. These ADR cases were induced by intravenous administration. Conclusion:Multiple factors leaded to the high concurrency of ADR. In clinical practice, the intravenous administration of Shenmai injection should be used in caution to avoid unnecessary ADRs. To reduce or avoid ADR occurence, it was essential to: ①improve the manufacture technology and quality standards;② provide more safe information in the package inserts;③ strengthen ADR monitoring. |
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