聚乙二醇干扰素α-2a注射液不良反应报告分析

目的：探讨聚乙二醇干扰素α-2a注射液不良反应发生的特点及相关因素,为临床安全用药提供参考。方法：收集某省药品不良反应监测中心2004～2011年自发呈报系统上报的1 606例聚乙二醇干扰素α-2a注射液的不良反应（ADR）报告,对ADR所涉及的患者年龄、性别,以及ADR年份、类型、结果、临床表现等进行统计分析。结果：1606例报告中,男883例,女723例,30～60岁患者最多（72.6%）;发生严重不良反应243例,新的严重ADR 86例;临床表现以血液系统损害为主占59.95%,其次为肝胆系统损害占10.76%。结论：临床在运用聚乙二醇干扰素α-2a治疗丙肝的过程中,应密切观察其ADR,制定周密的护理计划,积极干预和防治,以有效减少和防止ADR发生。

Analysis of the Reports of Adverse Drug Reactions Induced by PEG-interferon Alfa-2a Injection

Objective ：To probe into the characteristics of adverse drug reactions （ADR） caused by PEG-interferon alfa-2a injection to provide some rational clinical guidance. Methods： 1606 reports of adverse reactions caused by PEG-interferon alfa-2a injection were collected from January 2004 to December 2011 and statistically analyzed in respect of patients＇sex and age, involved type, years, result, clinical manifestations, etc. Results：883 of the 1606 cases were male cases,723 were female cases, and 72.6% were the adults at the age of 30 to 60. The incidence rate of severe ADR were 243 cases, and new and severe ADR were 86 cases. The blood system was the main lesion in ADR cases （59.95%）, and the second was liver and gall system（ 10.76% ）. Conclusion：The corresponding adverse reactions should be closely observed during the clinical use of PEG-interferon alfa-2a in the treatment of hepatitis C. The occurrence of adverse reactions could be effectively reduced and prevented by making a careful nursing plan and conducting an active intervention and control.