英夫利西单抗失应答的被动治疗药物监测在炎症性肠病治疗中的药物经济学系统评价

Pharmacoeconomic evaluations on reactive therapeutic drug monitoring of infliximab loss of response in the treatment of inflammatory bowel disease:A systematic review

目的:英夫利西单抗(infliximab,IFX)用于炎症性肠病(inflammatory bowel disease,IBD)治疗可能出现药物失应答,对于IFX失应答,临床采用传统经验增加药物剂量策略或根据治疗药物监测(therapeutic drug monitoring,TDM)策略。为评价其经济性,本研究系统评价IBD患者IFX失应答的被动TDM策略与传统经验增加剂量策略的药物经济学价值。方法:计算机检索PubMed等中英文数据库于1998-2020年发表的IFX失应答的被动TDM策略与传统经验增加剂量比较的经济性评价文献,根据事先确定的纳入与排除标准筛选文献,再按照卫生经济学评价报告标准共识(CHEERS)清单评估,系统评价2种策略经济性。结果:纳入的7项研究中,4项临床研究及3项模型研究,其中6项研究显示,被动TDM给药与传统经验给药具相似有效性,采用被动TDM策略支付更低医疗费用。一项研究发现不检测策略较被动TDM更有效而鉴于证据有限需谨慎看待可能不具成本效果。对7项研究进行质量评估,其中5项(71.4%)均在好至优秀等级。结论:现有证据显示,IBD患者IFX失应答的被动TDM策略较传统经验增加剂量可节省成本或更具成本效果。

OBJECTIVE Patients with inflammatory bowel disease(IBD) non-responsive to therapy with infliximab(IFX) may be managed initially with either empiric dose escalation or therapeutic drug monitoring(TDM)-based strategies.To evaluate the economy of its application,this article systematically evaluated the pharmacoeconomic value of a testing-based strategy and an empiric dose escalation strategy of unresponsive treatment with IFX. METHODS A systematic literature search of cost-effectiveness studies on a reactive TDM-based strategy and an empirical dose management of IFX loss of response in IBD published from 1998 to 2020 was performed from the databases of PubMed,EMbase,Cochrane Library,VIP,Wanfang Data and CNKI.And the references of included studies were also retrieved manually.The studies were screened by the pre-designed inclusion and exclusion criteria and the economy of two strategies was systematically evaluated by a checklist assessment of CHEERS.RESULTS There were four clinical studies and three model studies.Six of them showed that a reactive TDM-based strategy and an empirical dose management had similar effectiveness.And TDM strategy yielded lower medical expenditure than an empirical dose management at similar outcomes.One study revealed that reactive TDM strategy gained lower quality-adjusted life years than an empirical dose management.And the assertion that reactive TDM strategy may not be cost-effective should be viewed cautiously in view of limited evidence.And 5/7(71.4%) studies achieved good to excellent rankings in quality assessment. CONCLUSION As a cost-effective alternative to the strategy of empiric dose escalation,a reactive TDM-based strategy is ideal for managing IBD patients non-responsive to IFX.