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| 23例肾康注射液新的、严重的不良反应分析 |
| Analysis of 23 Cases New and Serious Adverse Drug Reactions Induced by Shenkang Injection |
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| DOI： |
| 中文关键词: 肾康注射液 药品不良反应，新的，严重的 安全用药 药物警戒 |
| 英文关键词:Shenkang injection Adverse drug reaction, New, Serious Safe medication Pharmacovigilance |
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| 中文摘要: |
| 摘 要 目的：分析肾康注射液新的、严重的药品不良反应（ＡDR）相关因素，为临床安全用药提供参考。方法：检索2000年1月～ 2018 年4月中国期刊全文数据库，同时收集我院上报国家药品不良反应监测系统的ADR报告，筛选出肾康注射液新的、严重的ADR病例报告，并对其性别、年龄及原患疾病、过敏史情况，肾康注射液给药方式、溶媒、合并用药，ADR出现时间、临床表现、关联性评价和转归等进行统计分析。结果：23例肾康注射液ADR中，新的ADR 15例（65.22%），严重的ADR 8例（34.78%），新的、严重的ADR 6例（26.08%）。患者中男11例，女12例，60岁及以上的老年患者占52.17%。5例患者既往有药物过敏史。多数ADR发生在用药后30 min 内。ADR以全身性损害最为常见，表现为发热、寒战、过敏样反应及过敏性休克等。结论：临床应重视肾康注射液ADR 的预防，规范肾康注射液的临床应用，加强用药过程中的监测，从而保障患者用药安全有效。 |
| 英文摘要: |
| ABSTRACT Objective:To analyze the relevant factors of the new and serious adverse drug reactions (ADR) induced by Shenkang injection, and provide reference for clinical use. Methods:Combined with the reports of our hospital in the national ADR monitoring system, 23 cases new and serious ADR of Shenkang injection from January 2000 to April 2018 in the CJFD database were retrieved for analysis. The information of the ADR cases such as patients age and gender, original diseases, allergy, method of administration, the menstruum of the Shenkang injection, drug combination, the occurring time and type of ADR, clinical manifestation and the relevance evaluation and outcome were analyzed statistically. Results: Among the 23 ADR cases, the new ADR had 15 cases (65.22%), severe were 8 (34.78%), the new and serious were 6 cases (26.08%). There were 11 male patients and 12 female patients, elderly patients aged 60 years and over accounting for 52.17%. 5 patients had drug allergy history. Most of the ADRs induced by Shenkang injection occurred within 30 minutes after injection. These ADRs involved in systemic damage, the symptoms including fever, chills, anaphylaxis and the allergic shock. Conclusion:It was necessary to pay attention to prevent the occurrence of ADR induced by Shenkang injection by regulating it usage and strictly monitoring the process of drug use in order to ensure the safety and effectiveness of patients’ medication. |
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