盐酸氨溴索注射剂药品不良反应集中监测与自发报告系统数据分析比较

Analysis and comparison of ambroxol hydrochloride injections adverse drug reaction data from intensive monitoring and spontaneous reporting systems

目的:通过分析盐酸氨溴索注射剂集中监测和自发报告系统收集到的数据,发现盐酸氨溴索葡萄糖注射液和其他盐酸氨溴索注射剂不良反应发生特点,揭示两种监测方法在药品不良反应监测中的地位和作用。方法:数据来自于集中监测研究和自发报告系统,并对相关资料进行处理和分析。结果:盐酸氨溴索葡萄糖注射液组药品不良反应发生率为0.9‰,其他注射用盐酸氨溴索制剂组药品不良反应发生率为1.8‰,两组药品不良反应发生率无统计学差异。两种剂型累及器官系统主要为胃肠系统损害、皮肤及附件损害、呼吸系统损害,其他盐酸氨溴索注射液制剂组全身性损害比例与盐酸氨溴索葡萄糖注射液组相比偏高(P<0.05)。结论:两种监测方法的特点、数据信息均有所不同,但其相辅相成,在监测工作中起到了重要的作用。

Objective： To analyze the ambroxol hydrochloride injections （AHI） adverse reaction data from the intensive monitoring and spontaneous reporting systems in order to compare the characteristics of adverse reac- tions of ambroxol hydrochloride glucose injections （AHGI） and other formulations of ambroxol hydrochloride injec- tions （OAHI） , and reveal the roles of the two monitoring methods in adverse drug reaction （ADR） monitoring. Methods： Data were retrieved from the intensive monitoring and spontaneous reports systems, respectively. Related information was colleetd to analyze the incidences of ADRs. Results： The incidence of ADRs in AHGI group was 1.8‰,while that in OAHI group was 0.9‰. The incidence of ADRs was not significantly different between the two groups. Gastro-intestinal system disorders, skin and appendages disorders and respiratory system disorders were the top three ADRs. The incidence of systemic damages in OAHI group was higher than AHGI group （P 〈 0.05）. Conclusion：Both of the characteristics and collected information of the two monitoring methods are different, but they are complementary and both play an important role in the ADR monitoring work.