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首页> 外文期刊>Journal of applied toxicology >Review of L-tyrosine confirming its safe human use as an adjuvant.
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Review of L-tyrosine confirming its safe human use as an adjuvant.

机译：对L-酪氨酸的审查证实了其作为佐剂可以安全地用于人类。

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Although there is a long history of exposure to allergy vaccines containing L-tyrosine, there has been no central publication reviewing its adjuvant properties in animal and human studies together with an assessment of its safe use. This paper summarizes a range of investigational data (unpublished) available to the authors as well as published literature reports. An array of in vitro and in vivo studies showed that L-tyrosine has ideal adjuvant properties, comprising a high adsorptive power for proteins, enhancement of IgG antibody induction with no stimulatory effect on IgE antibody level and action as a short-term depot adjuvant, delaying the bioavailability of allergenic materials rather than directly influencing immunocompetent cells. A series of preclinical safety investigations comprised single-dose parenteral studies in the mouse and rat, repeat-dose parenteral toxicity studies over 28 days in the rat and dog (up to 25 mg kg(-1) day(-1)) plus genotoxicity and local tolerance studies. No signs of toxicity or genotoxicity were seen; repeat-dose toxicity studies showed expected white cell and spleen weight immunostimulatory effects; local-dose site reactions were also seen and were confirmed in local tolerance studies. Findings from a range of clinical studies using allergy vaccines containing L-tyrosine reflected the lack of toxicity seen in animal work and showed evidence of enhanced immunostimulatory activity. Local injection site reactions (a common response to any form of clinical vaccination) in these studies were likely to be due to the presence of L-tyrosine per se. The lack of findings of toxicological concern found during this review supports the hypothesis that L-tyrosine is a safe adjuvant for human use.
机译：尽管接触含有L-酪氨酸的过敏疫苗已有悠久的历史，但尚无中央出版物审查其在动物和人类研究中的佐剂特性以及对其安全使用的评估。本文总结了可供作者使用的一系列研究数据（未发表）以及已发表的文献报告。一系列的体外和体内研究表明，L-酪氨酸具有理想的佐剂特性，包括对蛋白质的高吸附能力，增强IgG抗体诱导作用，而对IgE抗体水平无刺激作用以及作为短期储库佐剂的作用，延缓变应原物质的生物利用度，而不是直接影响免疫活性细胞。一系列的临床前安全性研究包括在小鼠和大鼠中进行单剂量肠胃外研究，在大鼠和狗中进行28天以上的重复剂量肠胃外毒性研究（最高25 mg kg（-1）day（-1））以及遗传毒性和局部耐受性研究。没有看到毒性或遗传毒性的迹象。重复剂量毒性研究表明预期的白细胞和脾脏重量免疫刺激作用;还观察到局部剂量部位反应，并在局部耐受性研究中得到证实。使用含有L-酪氨酸的过敏疫苗进行的一系列临床研究发现，缺乏动物工作所见的毒性，并显示出增强的免疫刺激活性的证据。这些研究中的局部注射部位反应（对任何形式的临床疫苗的常见反应）很可能是由于L-酪氨酸本身的存在。在本综述中缺乏对毒理学问题的发现，支持了以下假设：L-酪氨酸是一种安全的人类佐剂。

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