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目的:了解严重药品不良反应(ADR)发生的特点和规律,促进ADR监测,为临床安全用药提供参考。方法:收集我院2009年1~12月报告的41例严重ADR病例,按ADR发生的关联性因素进行统计、分析与评价。结果:41例ADR报告中抗感染药所占比例最大(54.71%),其次为中药注射剂(15.09%)和神经系统用药(9.44%);ADR累及器官或系统主要为皮肤及其附件损害、全身性损害;29例(70.73%)ADR由静脉给药途径所致。结论:重视ADR监测工作,特别是抗感染药和中药注射剂的安全性监测;加强临床合理用药,以减少严重ADR的发生。
Objective: To understand the characteristics and rules of serious adverse drug reaction (ADR), to promote the monitoring of ADR, and to provide a reference for clinical safety medication. Methods: A total of 41 cases of severe ADR reported in our hospital from January to December in 2009 were collected and statistically analyzed, analyzed and evaluated according to the related factors of ADR. Results: The proportion of anti-infectives in 41 ADR cases was the highest (54.71%), followed by Chinese traditional medicine injection (15.09%) and nervous system medication (9.44%). ADR involved organ or system mainly damaged the skin and its appendages, 29 cases (70.73%) ADR caused by intravenous route of administration. Conclusion: The monitoring of ADR is emphasized, especially the safety monitoring of anti-infectives and traditional Chinese medicine injections; strengthening clinical rational use of drugs to reduce the occurrence of severe ADR.