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目的:通过对江苏省糖尿病不良反应/事件(ADR/ADE)监测报告进行分析,加深对糖尿病用药不良反应的认识,促进医院临床对糖尿病患者的合理用药,不断提高医疗质量。方法:从江苏省药品不良反应监测中心数据库中筛选出2010-2015年关于糖尿病用药不良反应/事件(ADR/ADE)监测报告,采用回顾性描述统计和卡方检验等方法全面分析其发生情况及特征。结果:5 387份糖尿病用药ADR/ADE报告中,男性略高于女性;40~69年龄段内患者为4 096例,占76%。其中在0~29岁,≥70岁年龄段内严重不良反应占比率较高;给药途径以口服所占比例最大,为3 325例,占57.27%;所有的给药途径中皮下注射严重不良反应占比率最大,为13.6%;糖尿病ADR/ADE累及的系统-器官主要是胃肠系统损害,达2 527例,占33.81%,其次是代谢和营养障碍,达1 222例,占16.34%。结论:医院应加强糖尿病药物使用管理,在临床用药过程中应谨慎对待不同年龄人群,选择合适的剂型和给药途径,最终减少甚至避免不良反应/事件的发生。
Objective: Through the analysis of ADR / ADE surveillance reports in Jiangsu Province, we can deepen our understanding of adverse drug reactions in diabetes, promote the rational use of drugs in clinical patients with diabetes mellitus, and continuously improve the quality of medical care. Methods: From 2010 to 2015, ADR / ADE surveillance reports were screened from the database of ADR surveillance center in Jiangsu Province. The incidence of ADR / ADE was analyzed by retrospectively describing the statistics and Chi-square test. feature. Results: In 5 387 diabetic ADRs / ADEs, men were slightly higher than women. In the 40-69 age group, there were 4 096 cases (76%). Among them, 0 to 29 years old, ≥70 years of age accounted for a higher proportion of serious adverse reactions; route of administration to oral the largest proportion of 3 325 cases, accounting for 57.27%; all routes of administration in severe subcutaneous injection of bad The rate of reaction was the highest, accounting for 13.6%. The systems and organs involved in ADR / ADE were mainly gastrointestinal damage, accounting for 33.81%, accounting for 33.81%, followed by metabolic syndrome and nutritional disorders, accounting for 16.34%. Conclusion: The hospital should strengthen the management of diabetes drug use, should be treated with caution in clinical medication for different age groups, select the appropriate dosage form and route of administration, and ultimately reduce or even avoid the occurrence of adverse reactions / events.