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目的分析香丹注射液不良反应发生的规律和特点,为合理用药提供参考。方法利用国家药品不良反应监测系统的统计功能及Excel筛选的方法对2006年以来淮北市收集的387例香丹注射液不良反应/事件报告表进行统计和分析。结果不良反应男女比例为1.08∶1,无显著性差异,年龄45岁以上患者发生率占77.52%;78.55%不良反应发生在用药30 min内;皮肤及其附件损害最多。结论应进一步加强工艺控制,规范聚山梨酯80的使用量;医护人员要密切注意30 min内不良反应的发生,避免超剂量超范围使用,提高用药的使用安全。
Objective To analyze the regularity and characteristics of the adverse reactions of Xiangdan injection and to provide reference for rational drug use. Methods Statistical analysis of 387 cases of Xiangdan injection adverse reaction / incident report form collected from 2006 in Huaibei City was made based on the statistical function of the national adverse drug reaction monitoring system and Excel screening method. Results The ratio of male to female patients was 1.08:1, with no significant difference. The incidence rate of patients over 45 years old was 77.52%. The adverse reactions of 78.55% occurred within 30 minutes after treatment. The skin and its accessories had the most damage. Conclusion The process control should be further strengthened to regulate the usage of polysorbate 80. The medical staff should pay close attention to the occurrence of adverse reactions within 30 min, avoid the over-range over-dosage, and improve the safety of medication.