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目的:英夫利西单抗(infliximab,IFX)是首个用于克罗恩病的生物制剂,疗效显著,但30%~60%的患者会出现药物失应答。治疗药物监测(therapeutic drug monitoring,TDM)的应用,可为指导临床用药提供依据,达到安全、合理、有效、经济的用药目的。方法:通过查阅近年来在克罗恩病治疗中IFX药物监测的研究及应用情况,就IFX的药动学特点、影响因素、谷浓度及抗IFX抗体(antibodies to infliximab,ATI)与疗效相关性等作一综述。结果:研究显示,IFX免疫原性、患者病理生理状态、遗传因素、联合用药等与IFX药动学有关,监测IFX谷浓度及ATI水平能预测临床应答、内镜下表现及不良反应。结论:进行TDM可优化IFX药物治疗方案,更好地控制疾病活动度,具有重要的临床指导意义。
OBJECTIVE: Infliximab (IFX) is the first biologic to be used in Crohn’s disease and has demonstrated significant efficacy, but 30% to 60% of patients develop drug failure response. The application of therapeutic drug monitoring (TDM) can provide a basis for guiding the clinical use of drugs, and achieve the goal of safe, reasonable, effective and economical medication. Methods: By referring to the research and application of IFX drug monitoring in the treatment of Crohn’s disease in recent years, the pharmacokinetic characteristics of IFX, influencing factors, trough concentrations and the relationship between anti-IFX antibodies (ATI) For a review. RESULTS: IFX immunogenicity, patient’s pathophysiological status, genetic factors, combination therapy, etc. were related to IFX pharmacokinetics. Monitoring IFX trough concentrations and ATI levels could predict clinical response, endoscopic findings, and adverse reactions. Conclusion: TDM can optimize IFX drug treatment programs, and better control disease activity, has important clinical significance.