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Exploring the Impact of Herbal Therapies on COVID-19 and Influenza: Investigating Novel Delivery Mechanisms for Emerging Interventions 探索草药疗法对COVID-19和流感的影响:研究新兴干预措施的新递送机制
Pub Date : 2023-07-11 DOI: 10.20944/preprints202305.0822.v1
Lucas Fornari Laurindo, Ledyane Taynara Marton, Giulia Minniti, Victória Dogani Rodrigues, Rodrigo Buzinaro Suzuki, Virgínia Maria Cavallari Strozze Catharin, R. Joshi, S. Barbalho
Synthetic antivirals and corticosteroids have been used to treat both influenza and the SARS-CoV-2 disease named COVID-19. However, these medications are not always effective, produce several adverse effects, and are associated with high costs. Medicinal plants and their constituents act on several different targets and signaling pathways involved in the pathophysiology of influenza and COVID-19. This study aimed to perform a review to evaluate the effects of medicinal plants on influenza and COVID-19, and to investigate the potential delivery systems for new antiviral therapies. EMBASE, PubMed, GOOGLE SCHOLAR, and COCHRANE databases were searched. The studies included in this review showed that medicinal plants, in different formulations, can help to decrease viral spread and the time until full recovery. Plants reduced the incidence of acute respiratory syndromes and the symptom scores of the illnesses. Moreover, plants are related to few adverse effects and have low costs. In addition to their significance as natural antiviral agents, medicinal plants and their bioactive compounds may exhibit low bioavailability. This highlights the need for alternative delivery systems, such as metal nanoparticles, which can effectively transport these compounds to infected tissues.
合成抗病毒药物和皮质类固醇已被用于治疗流感和名为新冠肺炎的SARS-CoV-2疾病。然而,这些药物并不总是有效的,会产生一些不良反应,并且成本高昂。药用植物及其成分作用于流感和新冠肺炎病理生理学中涉及的几种不同靶点和信号通路。本研究旨在评估药用植物对流感和新冠肺炎的影响,并研究新的抗病毒疗法的潜在递送系统。检索EMBASE、PubMed、GOOGLE SCHOLAR和COCHRANE数据库。这篇综述中的研究表明,不同配方的药用植物有助于减少病毒传播和完全康复的时间。植物降低了急性呼吸系统综合征的发病率和疾病的症状评分。此外,植物几乎没有不良影响,而且成本低。除了作为天然抗病毒药物的重要性外,药用植物及其生物活性化合物可能表现出较低的生物利用度。这突出了对替代输送系统的需求,如金属纳米颗粒,它可以有效地将这些化合物输送到受感染的组织。
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引用次数: 0
A Review on the Impact of the SARS-CoV-2 Omicron Subvariant on Elderly Patients with Diverse Co-Morbidities SARS-CoV-2组粒亚变体对多种合并症老年患者影响的研究进展
Pub Date : 2023-06-09 DOI: 10.3390/biologics3020008
A. Khadela, Shruti Soni, Kaivalya Megha, Shivam Bhagat, Vivek P. Chavda
The SARS-CoV-2 virus has caused a catastrophic impact on the world for the past 3 years. The virus has now returned with the emergence of the Omicron (B.1.1.529) variant. Within two months of its first emergence in South Africa, Omicron became the most dominating SARS-CoV-2 variant around the world, being the cause of the majority of new infections at present. Omicron has presented with the greatest transmission rate of all the previous variants despite the presence of mass vaccinations and acquired immunity. Several monoclonal antibodies and mRNA vaccines have failed to produce desired effects owing to a large number of mutations present in the Omicron variant. The introduction of the booster dose of the present mRNA vaccines has proven to be a great addition to the therapeutic armamentarium against the Omicron variant. Immunocompromised patients including the elderly, cancer patients, organ transplant recipients, and those with multiple comorbidities have been at a greater risk of developing severe diseases since the pre-Omicron era. The emergence of Omicron again raised a threat against this population. The protection from severe disease and mortality rates through the utilization of multiple immunizations and monoclonal antibodies has been controversial in this subgroup of patients. Thus, designing large-scale studies to evaluate the effectiveness of monoclonal antibodies and vaccines in these patients can provide evidence-based recommendations to improve survival in this population. This article attempts to discuss the different subvariants of Omicron, differences in the mutational aspects along with the particular focus on the consequences of the Omicron infection in the elderly population with diverse comorbidities.
严重急性呼吸系统综合征冠状病毒2型在过去3年里对世界造成了灾难性影响。随着奥密克戎(B.1.1.529)变种的出现,该病毒现已卷土重来。在南非首次出现的两个月内,奥密克戎成为世界上最主要的严重急性呼吸系统综合征冠状病毒2型变种,是目前大多数新感染病例的原因。尽管存在大规模疫苗接种和获得性免疫力,奥密克戎的传播率在以前的所有变种中都是最高的。由于奥密克戎变异株中存在大量突变,几种单克隆抗体和信使核糖核酸疫苗未能产生预期效果。目前信使核糖核酸疫苗加强剂量的引入已被证明是对奥密克戎变异株治疗药物的一大补充。自奥密克戎时代以来,包括老年人、癌症患者、器官移植受者和患有多种合并症的患者在内的免疫受损患者患严重疾病的风险更大。奥密克戎的出现再次对这一人群构成了威胁。通过使用多种免疫接种和单克隆抗体来预防严重疾病和死亡率在这一亚组患者中一直存在争议。因此,设计大规模研究来评估单克隆抗体和疫苗对这些患者的有效性,可以为提高这一人群的生存率提供循证建议。本文试图讨论奥密克戎的不同亚变体、突变方面的差异,以及奥密克龙感染在患有不同合并症的老年人群中的后果。
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引用次数: 1
Aptamers as Insights for Targeting SARS-CoV-2 核酸适体:靶向SARS-CoV-2的新见解
Pub Date : 2023-05-11 DOI: 10.3390/biologics3020007
Suna Karadeniz Saygılı, A. Szymanowska, G. Lopez-Berestein, Cristian Rodríguez-Aguayo, P. Amero
The Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) continues to be a major cause of high mortality in the world. Despite many therapeutic approaches having been successfully developed, there is still the need to find novel and more effective therapeutic strategies to face the upcoming variants. Here, we will describe the potential use of aptamers, synthetic single-stranded oligonucleotides, as promising tools to target SARS-CoV-2. Since aptamers have been successfully developed against viruses, this review will focus on the latest selection approach method using artificial intelligence, the state-of-the-art in bioinformatics, and we will also summarize the latest discoveries in terms of aptamers against spike protein and other novel receptor proteins involved in SARS-CoV-2 entry and the use of single-cell transcriptomics to define novel promising targets for SARS-CoV-2.
严重急性呼吸综合征冠状病毒(SARS-CoV-2)仍然是世界上高死亡率的一个主要原因。尽管许多治疗方法已经成功开发,仍然需要找到新的和更有效的治疗策略来面对即将到来的变异。在这里,我们将描述适配体的潜在用途,合成单链寡核苷酸,作为靶向SARS-CoV-2的有前途的工具。由于核酸适体已经成功地开发出了针对病毒的核酸适体,因此本文将重点介绍利用人工智能和生物信息学的最新选择方法,并总结针对刺突蛋白和其他参与SARS-CoV-2进入的新型受体蛋白的核酸适体的最新发现,以及使用单细胞转录组学来确定新的有希望的SARS-CoV-2靶点。
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引用次数: 1
Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies 皮肤病学中起源者和生物仿制药之间的转换:真实世界临床研究的系统综述
Pub Date : 2023-04-27 DOI: 10.3390/biologics3020006
M. M. Nicoletti, Erminia Crisci, C. Pentella, Andrea Cantone, Donatella Ruggiero, Antonietta Anatriello, C. Scavone
Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all biologics (both originators and biosimilars) in routine clinical practice is strongly needed given their peculiar safety profile.
背景尽管近年来生物仿制药的使用越来越多,但人们仍然担心,当从原始生物转为生物仿制药时,可能会失去疗效并改变安全性。互换性对皮肤科医生来说也是一个挑战。对已发表的原创者和生物仿制药之间的转换研究进行了广泛的系统审查,以提供证据,证明在现实生活中转换对疗效和安全性的影响。后果本系统综述共收录了37篇文章(14项研究与阿达木单抗有关,10项研究与依那西普有关,12项研究与英夫利昔单抗有关,阿达木单抗、依那西普和英夫利单抗各1项)。研究主要在欧洲国家之间进行。其中大多数是观察性研究或基于登记的研究。大多数研究招募了被诊断为银屑病或银屑病关节炎的患者,这些患者经历了从始发者到生物仿制药的单一转换。总的来说,研究结果表明,在皮肤病患者的现实生活中,在阿达木单抗、依那西普和英夫利昔单抗起始药和生物仿制药之间切换是安全有效的。只有少数研究强调了疗效丧失风险的增加以及不良事件发生率的增加,这两种情况都被确定为生物仿制药停用的主要原因,可能与众所周知的nocebo效应现象有关。结论从生物始祖转变为其生物仿制品是安全有效的。只有少数研究评估了生物仿制药之间的转变;因此,就疗效和安全性结果而言,这种类型的开关还不能得出确切的结论。根据我们的研究结果,我们认为生物仿制药可以被视为与其参考产品可互换,并且不需要额外的转换研究来支持临床实践中在起始药和生物仿制药之间的转换。然而,鉴于所有生物制剂的特殊安全性,在常规临床实践中,强烈需要对其进行持续监测。
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引用次数: 1
Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies 重塑治疗性蛋白质:挖掘新疗法的宝藏
Pub Date : 2023-04-19 DOI: 10.3390/biologics3020005
Sarfaraz K Niazi, Zamara Mariam
Reinventing approved therapeutic proteins for a new dose, a new formulation, a new route of administration, an improved safety profile, a new indication, or a new conjugate with a drug or a radioactive source is a creative approach to benefit from the billions spent on developing new therapeutic proteins. These new opportunities were created only recently with the arrival of AI/ML tools and high throughput screening technologies. Furthermore, the complex nature of proteins offers mining opportunities that are not possible with chemical drugs; bringing in newer therapies without spending billions makes this path highly lucrative financially while serving the dire needs of humanity. This paper analyzes several practical reinventing approaches and suggests regulatory strategies to reduce development costs significantly. This should enable the entry of hundreds of new therapies at affordable costs.
将批准的治疗蛋白重新用于新剂量、新配方、新给药途径、改进的安全性、新适应症或与药物或放射源的新缀合物,是一种创造性的方法,可以从开发新治疗蛋白的数十亿美元中获益。这些新的机会是最近随着AI/ML工具和高通量筛查技术的出现而创造的。此外,蛋白质的复杂性提供了化学药物所不可能的挖掘机会;在不花费数十亿美元的情况下引入新的疗法,使这条道路在满足人类迫切需求的同时,在经济上非常有利可图。本文分析了几种实用的重新发明方法,并提出了显著降低开发成本的监管策略。这将使数百种新疗法能够以可承受的成本进入市场。
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引用次数: 1
Management of Invasive Infections in Diabetes Mellitus: A Comprehensive Review 糖尿病侵袭性感染的治疗:综述
Pub Date : 2023-03-06 DOI: 10.3390/biologics3010004
Anjum Khanam, G. Hithamani, J. Naveen, S. R. Pradeep, Susmita Barman, K. Srinivasan
Patients with diabetes often have more invasive infections, which may lead to an increase in morbidity. The hyperglycaemic environment promotes immune dysfunction (such as the deterioration of neutrophil activity, antioxidant system suppression, and compromised innate immunity), micro- and microangiopathies, and neuropathy. A greater number of medical interventions leads to a higher frequency of infections in diabetic patients. Diabetic individuals are susceptible to certain conditions, such as rhino-cerebral mucormycosis or aspergillosis infection. Infections may either be the primary symptom of diabetes mellitus or act as triggers in the intrinsic effects of the disease, such as diabetic ketoacidosis and hypoglycaemia, in addition to increasing morbidity. A thorough diagnosis of the severity and origin of the infection is necessary for effective treatment, which often entails surgery and extensive antibiotic use. Examining the significant issue of infection in individuals with diabetes is crucial. Comprehensive research should examine why infections are more common amongst diabetics and what the preventive treatment strategies could be.
糖尿病患者通常有更多的侵袭性感染,这可能导致发病率增加。高血糖环境会促进免疫功能障碍(如中性粒细胞活性下降、抗氧化系统抑制和先天免疫受损)、微血管病和神经病变。更多的医疗干预会导致糖尿病患者感染的频率更高。糖尿病患者易患某些疾病,如鼻脑毛霉菌病或曲霉菌病感染。感染可能是糖尿病的主要症状,也可能是该疾病内在影响的诱因,如糖尿病酮症酸中毒和低血糖,此外还会增加发病率。对感染的严重程度和起源进行彻底诊断是有效治疗的必要条件,这通常需要手术和广泛使用抗生素。研究糖尿病患者的重大感染问题至关重要。全面的研究应该研究为什么感染在糖尿病患者中更常见,以及预防性治疗策略可能是什么。
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引用次数: 3
Novel Strategy for Alzheimer’s Disease Treatment through Oral Vaccine Therapy with Amyloid Beta 通过β淀粉样蛋白口服疫苗治疗阿尔茨海默病的新策略
Pub Date : 2023-02-01 DOI: 10.3390/biologics3010003
Y. Matsuzaka, R. Yashiro
Alzheimer’s disease (AD) is a neuropathology characterized by progressive cognitive impairment and dementia. The disease is attributed to senile plaques, which are aggregates of amyloid beta (Aβ) outside nerve cells; neurofibrillary tangles, which are filamentous accumulations of phosphorylated tau in nerve cells; and loss of neurons in the brain tissue. Immunization of an AD mouse model with Aβ-eliminated pre-existing senile plaque amyloids and prevented new accumulation. Furthermore, its effect showed that cognitive function can be improved by passive immunity without side effects, such as lymphocyte infiltration in AD model mice treated with vaccine therapy, indicating the possibility of vaccine therapy for AD. Further, considering the possibility of side effects due to direct administration of Aβ, the practical use of the safe oral vaccine, which expressed Aβ in plants, is expected. Indeed, administration of this oral vaccine to Alzheimer’s model mice reduced Aβ accumulation in the brain. Moreover, almost no expression of inflammatory IgG was observed. Therefore, vaccination prior to Aβ accumulation or at an early stage of accumulation may prevent Aβ from causing AD.
阿尔茨海默病(AD)是一种以进行性认知障碍和痴呆为特征的神经病理学。该疾病归因于老年斑块,老年斑块是神经细胞外淀粉样蛋白β(Aβ)的聚集体;神经原纤维缠结,是神经细胞中磷酸化tau的丝状积聚;以及脑组织中神经元的丧失。用Aβ免疫AD小鼠模型可以消除先前存在的老年斑块淀粉样蛋白,并防止新的淀粉样蛋白积聚。此外,其效果表明,被动免疫可以改善认知功能,而没有副作用,如疫苗治疗AD模型小鼠的淋巴细胞浸润,这表明疫苗治疗AD的可能性。此外,考虑到直接给药Aβ可能产生副作用,安全口服疫苗的实际应用,在植物中表达Aβ。事实上,阿尔茨海默病模型小鼠口服这种疫苗减少了Aβ在大脑中的积累。此外,几乎没有观察到炎性IgG的表达。因此,在Aβ积累之前或在积累的早期接种疫苗可以防止Aβ引起AD。
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引用次数: 0
Validation of Adapted Neutralization Assays Developed to Discriminate Anti-Rabies Virus Activity of Two Different Anti-Rabies Virus Monoclonal Antibodies Administered as a Combination 两种不同的抗狂犬病毒单克隆抗体联合使用的抗狂犬病毒活性鉴定方法的验证
Pub Date : 2023-01-19 DOI: 10.3390/biologics3010002
A. Companjen, S. Moore, B. Boulanger, S. Kostense, W. Marissen
Assessment of rabies virus (RABV) neutralizing antibodies in subjects vaccinated or injected with anti-RABV immunoglobulins is central in determination of rabies protection. The rapid fluorescent focus inhibition test (RFFIT) is used for assessment of anti-RABV activity in serum. The current anti-RABV polyclonal preparations on the market pose difficulties in production and vary in quality. RABV neutralizing monoclonal antibodies (MAbs) are being evaluated as replacements. Different anti-RABV MAbs may neutralize different RABV isolates, thus two or more MAbs directed against different epitopes on the RABV glycoprotein are needed. It is therefore important to ensure neutralizing activity against all RABV isolates in sera of subjects injected with an anti-RABV MAb product consisting of two or more MAbs. The RFFIT, utilizing CVS-11 as challenge virus, cannot discriminate between the activities of different anti-RABV MAbs. We developed and validated two RFFIT methods enabling specific assessment of two different anti-RABV MAbs (CR57 and CR4098) in using two mutant CVS-11 strains resistant to either CR57 or CR4098 neutralization. The validation results demonstrate that both RFFIT assays using MAb resistant RABV are precise, accurate, linear, specific, and stable within the linear range of 0.025 IU/mL to 1.0 IU/mL. This method design can, therefore, be used to determine MAb specific anti-RABV activity in human serum samples.
评估接种或注射抗RABV免疫球蛋白的受试者的狂犬病病毒(RABV)中和抗体是确定狂犬病保护的核心。采用快速荧光焦点抑制试验(RFFIT)评价血清抗rabv活性。目前市场上抗rabv多克隆制剂生产困难,质量参差不齐。RABV中和单克隆抗体(mab)正在被评估作为替代品。不同的抗RABV单抗可以中和不同的RABV分离株,因此需要针对RABV糖蛋白上不同表位的两种或两种以上的单抗。因此,确保注射由两种或两种以上单克隆抗体组成的抗RABV单抗产品的受试者血清中对所有RABV分离株的中和活性是很重要的。利用CVS-11作为攻击病毒的RFFIT不能区分不同抗rabv单克隆抗体的活性。我们开发并验证了两种RFFIT方法,使用两种抗CR57或CR4098中和的突变CVS-11菌株,对两种不同的抗rabv单克隆抗体(CR57和CR4098)进行特异性评估。验证结果表明,在0.025 IU/mL ~ 1.0 IU/mL的线性范围内,两种抗单抗RABV RFFIT检测方法均具有精密度、准确度、线性、特异性和稳定性。因此,该方法设计可用于测定人血清样品中单克隆抗体特异性抗rabv活性。
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引用次数: 0
Xeno-miRs and Circulating miRNAs as Novel Biomarkers in Certain Diseases 异种miRs和循环miRNA作为某些疾病的新生物标志物
Pub Date : 2022-12-26 DOI: 10.3390/biologics3010001
Gülsüm Deveci, R. Capasso, D. Ağagündüz
MicroRNAs (miRNAs) are non-coding RNAs consisting of a length of roughly 22 nucleotides that participate in gene regulation [...]
微小RNA(miRNA)是一种非编码RNA,由大约22个核苷酸组成,参与基因调控[…]
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引用次数: 1
Virus-Like Particles (VLPs) as Important Tools for Flavivirus Vaccine Development 病毒样颗粒(vlp)是黄病毒疫苗开发的重要工具
Pub Date : 2022-10-31 DOI: 10.3390/biologics2040018
L. Castilho, Nathalia R. Mattos, Wallace S. Abreu, M. Gutarra
Flaviviruses, such as dengue, zika, yellow fever, West Nile, and Japanese encephalitis virus, are RNA viruses belonging to the Flaviviridae family (genus Flavivirus). They represent an important global health concern, since most areas of the world are endemic for at least one of these viruses. Although vaccines for five flaviviruses currently exist, there is a need for new vaccines to protect from established, emerging, and reemerging flaviviruses. Yellow fever vaccine shortages experienced in the last decade, combined with the risk of YFV spread to Asia and the restrictions of vaccine administration to certain population segments, show that even when a highly efficacious vaccine is available, new and improved vaccines might be needed. Virus-like particles (VLPs) are multiprotein structures that mimic the virus, but do not contain its genetic material. As such, VLPs have an excellent track record of strong immunogenicity and high safety, dating back to the introduction of the first recombinant hepatitis B vaccine in the 1980s. Flavivirus-like particles (FVLPs) have been extensively studied, especially for DENV, JEV, and ZIKV, and could give rise to next-generation recombinant subunit flavivirus vaccines based on VLPs incorporating molecular features intended to ensure high efficacy and minimize the risk of antibody-dependent enhancement (ADE) upon infection with other flaviviruses.
黄病毒,如登革热、寨卡病毒、黄热病、西尼罗河病毒和日本脑炎病毒,是属于黄病毒科(黄病毒属)的核糖核酸病毒。它们代表了一个重要的全球健康问题,因为世界上大多数地区至少有一种病毒是地方病。尽管目前存在五种黄病毒的疫苗,但仍需要新的疫苗来保护已建立、新出现和重新出现的黄病毒。过去十年中经历的黄热病疫苗短缺,加上YFV传播到亚洲的风险,以及对某些人群的疫苗接种限制,表明即使有高效疫苗,也可能需要新的和改进的疫苗。病毒样颗粒(VLP)是模仿病毒的多蛋白结构,但不包含病毒的遗传物质。因此,VLP具有良好的免疫原性和高安全性,可以追溯到20世纪80年代第一种重组乙型肝炎疫苗的推出。黄病毒样颗粒(FVLP)已被广泛研究,特别是针对DENV、JEV和ZIKV,并可能产生基于VLP的下一代重组亚单位黄病毒疫苗,该疫苗结合了旨在确保高效性并将感染其他黄病毒时抗体依赖性增强(ADE)的风险降至最低的分子特征。
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引用次数: 1
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Biologics (Basel, Switzerland)
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