CFDA, China Food and Drug Administration

  • 文章类型: Journal Article
    未经批准:2019年12月,一种新型冠状病毒,SARS-CoV-2在全球范围内引起一系列急性非典型呼吸道疾病。然而,仍然缺乏疗效明确的药物,疫苗的临床试验研究尚未完全完成。
    UASSIGNED:LH胶囊是批准的中药成药,广泛用于治疗由感冒和流感引起的呼吸道传染病。2020年4月12日,根据通过多中心证明的安全性和有效性,中国食品药品监督管理局(CFDA)正式将LH胶囊和颗粒重新用于轻度COVID-19患者,随机化,对照临床试验。我们希望通过现代药学方法对其进行全面回顾,并试图解释其可能的机制。
    未经授权:使用连花清温黄体胶囊的全称,连花清温和SARS-COV-2、COVID-19作为搜索词的关键词,在各种数据库(如WebofScience和PubMed)中系统地搜索现有的相关论文。并在ClinicalTrials.gov和中国临床试验注册中心完成了临床数据的收集。最后但并非最不重要的,我们通过文献和Selleck整理了LH胶囊的抗炎和抗病毒机制。
    UNASSIGNED:这篇综述系统地梳理了LH胶囊中的活性成分。此外,详细讨论了LH胶囊对SARS-CoV-2,IAV和IBV的相关药理和临床试验。此外,本综述首次概述了LH胶囊中特定物质参与SARS-COV-2感染抗性和抑制IL-6引起的细胞因子风暴综合征(CSS)的潜在分子机制。
    UNASSIGNED:本综述总结了支持使用LH胶囊作为预防和治疗COVID-19的潜在候选药物的现有报告和证据。然而,中医通过多靶点、多途径发挥作用,LH胶囊也不例外。因此,相关机制有待进一步完善和实验验证。
    UNASSIGNED: In December 2019, a novel coronavirus, SARS-CoV-2 caused a series of acute atypical respiratory diseases worldwide. However, there is still a lack of drugs with clear curative effects, and the clinical trial research of vaccines has not been completely finished.
    UNASSIGNED: LH capsules are approved TCM patent medicine that are widely used for the treatment of respiratory tract infectious diseases caused by colds and flu. On April 12, 2020, LH capsules and granules were officially repurposed by the China Food and Drug Administration (CFDA) for patients with mild COVID-19 based on their safety and efficacy demonstrated through multicentre, randomized, controlled clinical trials. We hope to conduct a comprehensive review of it through modern pharmacy methods, and try to explain its possible mechanism.
    UNASSIGNED: Using the full names of LH capsules Lianhuaqingwen, Lianhua Qingwen andSARS-COV-2, COVID-19 as the keywords of the search terms, systemically search for existing related papers in various databases such as Web of Science and PubMed. And completed the collection of clinical data in ClinicalTrials.gov and Chinese Clinical Trial Registry. Last but not least, we have sorted out the anti-inflammatory and antiviral mechanisms of LH capsules through literature and Selleck.
    UNASSIGNED: This review systematically sorted out the active ingredients in LH capsules. Furthermore, the related pharmacological and clinical trials of LH capsule on SARS-CoV-2, IAV and IBV were discussed in detail. Moreover, the present review provides the first summary of the potential molecular mechanism of specific substances in LH capsules involved in resistance to SARS-COV-2 infection and the inhibition of cytokine storm syndrome (CSS) caused by IL-6.
    UNASSIGNED: This review summarizes the available reports and evidence that support the use of LH capsules as potential drug candidates for the prevention and treatment of COVID-19. However, TCM exerts its effects through multiple targets and multiple pathways, and LH capsules are not an exception. Therefore, the relevant mechanisms need to be further improved and experimentally verified.
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  • 文章类型: Journal Article
    小干扰RNA(siRNA)的使用一直在研究中,用于治疗几种未满足的医疗需求。例如包括急性肺损伤/急性呼吸窘迫综合征(ALI/ARDS),其中可实施siRNA以在mRNA水平上修饰促炎细胞因子和趋化因子的表达。清晰的解剖结构,可访问性,和相对较低的酶活性使肺成为局部siRNA治疗的良好靶标。然而,由于裸siRNA的特性,siRNA治疗剂向靶细胞的低效递送阻碍了siRNA的临床翻译。因此,本综述将重点介绍在ALI/ARDS的siRNA治疗药物进入临床之前,可使用的各种给药系统和需要克服的不同障碍,以开发用于人类的稳定可吸入siRNA制剂.
    The use of small interfering RNAs (siRNAs) has been under investigation for the treatment of several unmet medical needs, including acute lung injury/acute respiratory distress syndrome (ALI/ARDS) wherein siRNA may be implemented to modify the expression of pro-inflammatory cytokines and chemokines at the mRNA level. The properties such as clear anatomy, accessibility, and relatively low enzyme activity make the lung a good target for local siRNA therapy. However, the translation of siRNA is restricted by the inefficient delivery of siRNA therapeutics to the target cells due to the properties of naked siRNA. Thus, this review will focus on the various delivery systems that can be used and the different barriers that need to be surmounted for the development of stable inhalable siRNA formulations for human use before siRNA therapeutics for ALI/ARDS become available in the clinic.
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  • 文章类型: Journal Article
    COVID-19的严重程度预测仍然是正在进行的大流行的主要临床挑战之一。这里,我们招募了144例COVID-19患者队列,得出一个数据矩阵,其中包含52天内124种测量的3,065个读数。建立了基于队列的机器学习模型来预测疾病进展,包括训练,验证,和内部测试集。一组11个常规临床因素构建了一个用于COVID-19严重程度预测的分类器,在发现集中实现98%以上的准确率。在包含25名患者的独立队列中验证模型的准确度达到80%。整体灵敏度,特异性,阳性预测值(PPV),阴性预测值(NPV)分别为0.70、0.99、0.93和0.93。我们的模型捕获了乳酸脱氢酶(LDH)和肌酸激酶(CK)的预测动力学,而它们的水平在正常范围内。此模型可在https://www访问。guomics.com/covidAI/用于研究目的。
    Severity prediction of COVID-19 remains one of the major clinical challenges for the ongoing pandemic. Here, we have recruited a 144 COVID-19 patient cohort, resulting in a data matrix containing 3,065 readings for 124 types of measurements over 52 days. A machine learning model was established to predict the disease progression based on the cohort consisting of training, validation, and internal test sets. A panel of eleven routine clinical factors constructed a classifier for COVID-19 severity prediction, achieving accuracy of over 98% in the discovery set. Validation of the model in an independent cohort containing 25 patients achieved accuracy of 80%. The overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 0.70, 0.99, 0.93, and 0.93, respectively. Our model captured predictive dynamics of lactate dehydrogenase (LDH) and creatine kinase (CK) while their levels were in the normal range. This model is accessible at https://www.guomics.com/covidAI/ for research purpose.
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  • 文章类型: Journal Article
    草药的质量控制过程一直存在问题。黄酮类化合物是黄芩汤的主要活性成分(HQT,中药配方)。在这项研究中,我们使用了一种由色谱指纹图谱(高效液相色谱;HPLC)组成的组合方法,定量方法和药效学评价模型分析不同来源的HQT黄酮。采用HPLC指纹图谱法对10批HQT进行分析,共检出26个共有峰,其中23个峰与HQT的化学图谱相对应。此外,通过LC-MS分析(液相色谱-串联质谱仪;LC-MS(n))鉴定了11个主要化合物,并通过HPLC定量方法进行了定量。发现所研究的10批HQT在其组成上是均匀的,相似性在0.990和1.000之间。发现11种鉴定的化合物的分布在批次中非常相似。在不同批次之间仅检测到轻微的药效学差异,确认HQT的同质性。本研究结果证明,色谱指纹图谱与定量分析相结合,可方便地用于中草药的全面质量控制。
    The quality control processes for herbal medicines have been problematic. Flavonoids are the major active components of Huangqin Tang (HQT, a traditional Chinese medicine formula). In this study, we used a combinative method approach consisting of chromatographic fingerprinting (high performance liquid chromatography; HPLC), quantitative methods and a pharmacodynamic evaluation model to analyze the flavonoids of HQT obtained from different sources. Ten batches of HQT were analyzed by the HPLC fingerprinting method and 26 common peaks were detected, of which 23 peaks corresponded with the chemical profile of HQT. In addition, 11 major compounds were identified by LC-MS analysis (liquid chromatography-tandem mass spectrometer; LC-MS (n) ) and quantified by the HPLC quantitative method approach. The studied 10 batches of HQT were found to be homogeneous in their composition with a similarity between 0.990 and 1.000. The distribution of the 11 identified compounds was found to be very similar among the batches. Only slight pharmacodynamic differences were detected between the different batches, confirming the homogeneity of HQT. The results of this study prove that the combination of chromatographic fingerprinting and quantitative analysis can be readily used for comprehensive quality control of herbal medicines.
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