188例门冬氨酸钾镁注射液不良反应分析报告

188例门冬氨酸钾镁注射液不良反应分析报告

吴勇

马鞍山市食品药品检验所

收稿日期:2013-01-18 修回日期:2013-02-26 出版日期:2013-02-25 发布日期:2013-01-25

188 cases Analysis of Adverse Drug Reaction Induced by Potassium Aspartate and Magnesium Aspartate

wuyong

Ma’anshan Institute for Food and Drug Control of Anhui Province

Received:2013-01-18 Revised:2013-02-26 Online:2013-02-25 Published:2013-01-25

摘要/Abstract

摘要： [摘要] 目的:对门冬氨酸钾镁注射液所致不良反应/事件病例进行分析，探讨其发生不良反应的规律及特点，为临床合理用药提供参考。方法:采用回顾性研究方法，对188例门冬氨酸钾镁注射液不良反应/事件进行统计和分析。结果:门冬氨酸钾镁引起的不良反应未见性别差异，ADR在各年龄组段均有分布，所致不良反应/事件主要有胃肠系统34例(20.21％)，中枢及外周神经系统23例(12.23％)，呼吸系统16例（8.51%），全身性46例（24.47%），用药部位32例（17.02%），心血管系统18例（9.58%），皮肤及其附件15例(7.98％)等多系统损害。不良反应的发生涉及药品本身和临床使用两个主要因素。结论:应加强门冬氨酸钾镁注射液不良反应的监测，生产企业应加强质量标准的研究，注重优化生产工艺，完善药品说明书；医生、患者应严格按照药品说明书的规定合理用药，避免超适应证使用，以减少药品不良反应的发生，确保用药安全、有效。

Abstract: [Abstract] Objective:To analyse the safety of Potassium Aspartate and Magnesium Aspartate, to discuss the general rules and characteristics of adverse reactions and to provide a reference for clinical medication. Methods: By retrospective study, 187case of adverse reactions of potassium Aspartate and Magnesium Aspartate were statistically analyzed. Results: The adverse reactions of potassium Aspartate and Magnesium Aspartate had no gender difference, ADR distributing in all age groups. Main adverse reactions included 34 cases of gastrointestinal system (20.21％), 23 cases of central and peripheral nervous system(12.23%), 16 cases of respiratory system(8.51%), 46 cases of systemic(24.47%), 32 cases of administration site(17.02%), 18 cases of cardiovascular system(9.58%), 15 cases of skin and appendages (7.98％) and more other system damage. Adverse reactions involving drugs itself and clinical use two major factors. Conclusin: It is very necessary to strengthen the potassium Aspartate and Magnesium Aspartate monitoring. Production enterprises should strengthen quallty standard research, pay attention to optimize production process, improve the drug instruction . doctors, patients should be in strict accordance with the provisions of the pharmaceutical manual rational drug use, in order to reduce the adverse reactions happen, to ensure the safe and effective use of drugs.

吴勇. 188例门冬氨酸钾镁注射液不良反应分析报告[J]. .

wuyong. 188 cases Analysis of Adverse Drug Reaction Induced by Potassium Aspartate and Magnesium Aspartate[J]. .