3090例免疫系统药物不良反应报告分析

Analysis of 3090 adverse drug reaction reports on immune system drug from 2009 to 2014

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 investigate the occurrences, features, regular pattern and related factors of adverse drug reaction（ADR） on immune system drug so as to provide references for clinical drug use. Methods： All the ADR data were collected in the database of PLA ADR monitoring center from 2009 to 2014 and analyzed retrospectively. Results： Among the 3 090 ADR reports, 208 cases（6.73%） were new ADRs, and 335 cases（10.84%） were severe ADRs, among which 4 patients（0.13%） died. Injection（64.82%） was the main formulation causing ADR. There were differences between all ADR and severe ADR： of all the ADR reports, patients aged from 45 to 49 years old accounted for the largest proportion（32.82%）, while patients aged from 18 to 44 years old were the largest（33.73%） proportion among the severe ADR; ribonucleic acid II（411） were the mostly reported drug in all the ADRs, while cyclophosphamide（71） were the mostly reported drug in severe ADR; of all the ADR reports, skin and appendages damage（28.88%） was the most frequent ADRs, However, among the severe ADRreports, hematological damage（25.28%） was the most frequent ADRs. Conclusion： During clinical drug use, it＇s important to paying attention to ADRs, reporting timely, analyzing regularly, especially for severe ADRs. Furthermore, active monitoring is very helpful in reducing ADRs.