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目的:探索免疫系统类药物药品不良反应(ADR)的发生情况、特点、规律及相关因素,为临床安全用药提供参考。方法:采用回顾性研究方法,提取2009―2014年解放军ADR监测中心数据库中有关免疫系统药物的全部ADR报告,进行统计分析。结果:3 090例ADR报告中新的ADR报告208例(6.73%),严重ADR报告335例(10.84%),其中患者死亡4例(0.13%);注射剂是引起ADR的主要剂型,占64.82%;所有ADR报告与严重ADR报告的比较项不同:所有ADR报告中45~59岁患者所占比例最高,为32.82%,严重ADR报告中18~44岁患者所占比例最高,为33.73%;全部ADR报告中例数最多的为核糖核酸Ⅱ,411例,严重ADR报告中例数最多的为环磷酰胺,71例;所有ADR报告中以皮肤及附件损害为最多(28.88%),严重ADR报告以血液系统损害最多(25.28%)。结论:临床用药过程中应密切关注ADR,加强ADR监测,及时报告,定期分析,重点关注严重ADR,制定主动监测办法,减少ADR发生。
Objective: To explore the occurrence, characteristics, laws and related factors of adverse drug reaction (ADR) of immune system drugs and provide reference for clinical safety medication. Methods: A retrospective study was conducted to extract all ADR reports on immune system drugs in ADR surveillance center database from 2009 to 2014 and carry out statistical analysis. RESULTS: A total of 208 new cases (6.73%) were reported in 3 090 ADR cases and 335 (10.84%) were serious ADR cases, of which 4 died (0.13%). Injections were the main forms of ADR, accounting for 64.82% ; All ADR reports differed from severe ADR reports: the highest percentage of patients aged 45 to 59 years was 32.82% in all ADRs, and the highest percentage of patients aged 33-43 years was 33.73% in all ADRs; all The most frequent cases of ADR were RNA II (411 cases). The most frequent cases of ADR were cyclophosphamide (71 cases). Most of the ADR cases reported the most skin and accessory damage (28.88%). The severe ADR cases The most damage to the blood system (25.28%). Conclusion: The clinical medication should pay close attention to ADR, strengthen the monitoring of ADR, timely reporting, regular analysis, with a focus on severe ADR, develop active monitoring methods to reduce the occurrence of ADR.