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首页> 美国卫生研究院文献>International Journal of Environmental Research and Public Health >Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union
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Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union

机译：胰蛋白酶口服喷雾（ViruProtect®/coldzyme®）是否防止Covid-19和常见的感冒或诱导突变？欧盟医疗器械规定的警告

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Background: nasal or oral sprays are often marketed as medical devices (MDs) in the European Union to prevent common cold (CC), with ColdZyme®/Viruprotect® (trypsin/glycerol) mouth spray claiming to prevent colds and the COVID-19 virus from infecting host cells and to shorten/reduce CC symptoms as an example. We analyzed the published (pre)-clinical evidence. Methods: preclinical: comparison of in vitro tests with validated host cell models to determine viral infectivity. Clinical: efficacy, proportion of users protected against virus (compared with non-users) and safety associated with trypsin/glycerol. Results: preclinical data showed that exogenous trypsin enhances SARS-CoV-2 infectivity and syncytia formation in host models, while culture passages in trypsin presence induce spike protein mutants. The manufacturer claims >98% SARS-CoV-2 deactivation, although clinically irrelevant as based on a tryptic viral digest, inserting trypsin inactivation before host cells exposure. Efficacy and safety were not adequately addressed in clinical studies or leaflets (no COVID-19 data). Protection was obtained among 9–39% of users, comparable to or lower than placebo-treated or non-users. Several potential safety risks (tissue digestion, bronchoconstriction) were identified. Conclusions: the current European MD regulations may result in insufficient exploration of (pre)clinical proof of action. Exogenous trypsin exposure even raises concerns (higher SARS-CoV-2 infectivity, mutations), whereas its clinical protective performance against respiratory viruses as published remains poor and substandard.
机译：背景：鼻腔或口腔喷雾通常作为欧盟的医疗器械（MDS）销售，以防止常见的感冒（CC），Coldzyme®/Viruprotect®（胰蛋白酶/甘油）口喷雾申请防止感冒和Covid-19病毒根据感染宿主细胞并缩短/降低CC症状作为示例。我们分析了已发表的（前）临记的证据。方法：临床前：验证宿主细胞模型的体外试验比较，以确定病毒感染性。临床：疗效，患有病毒（与非用户相比）和与胰蛋白酶/甘油相关的安全性的疗效。结果：临床前数据显示外源胰蛋白酶在宿主模型中增强SARS-COV-2感染性和同义性形成，而胰蛋白酶存在的培养通道诱导穗蛋白突变体。制造商索赔> 98％SARS-COV-2停用，但临床无关紧要的基于胰蛋白病毒消化，在宿主细胞暴露之前插入胰蛋白酶灭活。在临床研究或传单中没有充分解决疗效和安全性（无Covid-19数据）。在9-39％的用户中获得保护，可与安慰剂治疗或非用户低于或低。确定了几种潜在的安全风险（组织消化，支气管内容）。结论：目前的欧洲MD法规可能导致探索不足（前）临床行动证明。外源性胰蛋白酶暴露甚至提高了令人担忧的（较高的SARS-COV-2感染性，突变），而其公布的呼吸道病毒的临床保护性能仍然是穷人和不合标准。

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