体外诊断对有效使用治疗药物的贡献——来自体外诊断行业的观点——。

Shinichi Eda
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引用次数: 0

摘要

近年来创新治疗药物的发展改变了诊断学与治疗药物之间的关系。其中一个主要变化是个性化医疗保健和伴随诊断;许多创新药物,如赫赛汀(Herceptin)、阿勒替尼(Alectinib)和阿特唑单抗(Atezolizumab),已与相应的伴随诊断一起开发和推出。近年来创新药物的另一个方面是利用高水平的生物技术和开发基于抗体的治疗药物。以抗体为基础的药物通常会诱导异亲性抗体,如人抗小鼠抗体(HAMA)。考虑到这一点,在体外诊断的发展过程中,对HAMA的干扰进行了深入的研究,并通过采用诸如添加猝灭蛋白、利用碎片化抗体和嵌合体抗体等对策来消除HAMA。有了这些措施,干扰的发生率可以降低到可接受的水平,检测可以产生可靠的结果,这有助于有益的治疗。另一方面,最近创新独特治疗药物的发展有时会导致诊断分析的干扰,这是在开发过程中没有预料到的。一个例子是在一种治疗心力衰竭的新药——血管紧张素受体-neprilysin抑制剂(ARNI)诱导的BNP检测中观察到的干扰。当患者服用ARNI时,BNP值升高而不是心力衰竭的改善。由于这一观察结果,NT-proBNP不受ARNI影响,通常用于监测药物的效果。本文还讨论了耐药细菌的问题,以及诊断对抗菌药物有效使用的潜在贡献。(审查)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Contribution of In- Vitro Diagnostics to Effective Use of Therapeutic Drugs -Perspectives from IVD Industry-].

The recent development of innovative therapeutic drugs has changed the relationship between diagnostics and therapeutic drugs. One of the major changes is personalized healthcare and companion diagnostics; many of innovative drugs such as Herceptin, Alectinib, and Atezolizumab have been developed and launched together with their corresponding companion diagnostics. Another aspect of the recent innovative drugs is the utilization of high-level biotechnology and develop- ment of antibody-based therapeutic drugs. Antibody-based drugs often induce heterophilic antibodies such as human anti-mouse antibody (HAMA). Taking this into account, the interference of HAMA is investigated intensively during the development of in-vitro diagnostics, and it is eliminated by employing countermeasures such as the addition of quench proteins, and utilization of fragmented antibodies as well as chimera-antibodies. With those measures, the incidence of interference can be reduced to acceptable levels and the assays can generate reliable results, which contribute to beneficial therapy. On the other hand, the recent development of innovative unique therapeutic drugs sometimes leads to interference in diagnostic assays, which were not expected during development. One example is interference observed in the BNP assay induced by a new drug for heart failure: angiotensin receptor-neprilysin inhibitor (ARNI). When patients take ARNI, BNP values increase instead of the improved condition of heart failure. Due to this observation, NT-proBNP, which is unaffected by ARNI, is usually used for monitoring the effect of the drug. The issue of drug-resistant bacteria is also discussed in conjunction with the potential contribution of diag- nostics for the effective use of antimicrobial agents. [Review].

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