重组人干扰素α2a和α2b注射液的不良反应对比研究

Comparative Study on Adverse Reactions of Recombinant Human Interferon α2a and α2b Injections

关键词:  重组人干扰素注射液  不良反应  对比研究  合理用药

Key words:  recombinant human interferon injection  adverse drug reactions  comparative study  rational drug use

摘要:

目的 通过重组人干扰素α2a和α2b注射液的不良反应对比研究，为其临床合理安全用药提供参考。方法 收集2010年1月—2021年11月浙江省上报的不同重组人干扰素注射液不良反应报告604例，对不良反应报告的患者性别、年龄、给药途径、不良反应临床表现、不良反应类别、转归等进行分析，并对其不良反应累及系统、器官进行差异性对比研究。结果 重组人干扰素α2b注射液严重报告比例略高于重组人干扰素α2a注射液，给药途径多为肌内注射。重组人干扰素α2b注射液男女比例约为1.6∶ 1，且其血液系统损害远高于重组人干扰素α2a注射液，但重组人干扰素α2a注射液的严重不良反应报告中胃肠系统损害比例远高于重组人干扰素α2b注射液。结论 重组人干扰素α2a和α2b注射液不良反应发生广泛但各有特点，要加强不良反应监测。同时，临床应结合患者的基础疾病进行合理用药。

Abstract:

OBJECTIVE To provide reference for safe and rational use of drugs in clinic, through the comparative study of adverse reactions(ADRs) of recombinant human interferon α2a and α2b injections. METHODS There were 604 ADRs induced by different recombinant human interferon injections as reported by Zhejiang ADR monitoring system from January 2010 to November 2021. They were analyzed in terms of gender, age, route of administration, clinical performance of ADR, ADR type, outcome and so on, and comparative study on the systems, organs involved in ADR. RESULTS The proportion of serious reports and new serious reports for recombinant human interferon α2b injection was slightly higher than recombinant human interferon α2a injection, mostly intramuscular injection. The male to female ratio of recombinant human interferon α2b injection was about 1.6∶1. The blood system damage of recombinant human interferon α2b injection was much higher than that of recombinant human interferon α2a injection. For serious ADRs, the proportion of gastrointestinal system damage of recombinant human interferon α2a injection was much higher than that of recombinant human interferon α2b injection. CONCLUSION The ADRs of recombinant human interferon injections are wide-spread. It’s important to strengthen the monitoring of ADRs. At the same time, rational drug use should be combined with the basic diseases of patients.