连花清瘟胶囊(颗粒)抗病毒药理作用及临床应用研究进展

连花清瘟胶囊具有清瘟解毒、宣肺泄热的功效,临床用于治疗流行性感冒属热毒袭肺证,在抗击新型冠状病毒肺炎疫情期间发挥了重要作用,成为国家诊疗方案、各省治疗方案推荐的中成药。从药理作用以及临床应用两个方面来总结连花清瘟胶囊(颗粒)抗新型冠状病毒、流感病毒、呼吸道合胞病毒、肠道病毒、疱疹病毒等的研究进展,以期对连花清瘟胶囊(颗粒)抗病毒作用的研究现状有新的认识,从而更好地推进其抗病毒的深入研究,更加合理地应用于临床。     

新型冠状病毒肺炎诊疗方案中的口服中成药应用综述

新型冠状病毒肺炎(corona virus disease-19,COVID-19)疫情危害近3个月,中西药治疗方案推荐百家争鸣。国家卫生健康委员会先后发布6版《新型冠状病毒肺炎诊疗方案》,根据医学观察期、临床治疗期、重症期和恢复期4个病情阶段,推荐了中医药治疗方案。中成药是中医治疗方案中的重要组成,藿香正气胶囊(丸、水及口服液)、金花清感颗粒、连花清瘟胶囊和疏风解毒胶囊是医学观察期推荐使用的4种口服中成药,本文就其中医治则、临床研究及用药安全进行文献综述,以期为COVID-19防治中的合理用药提供参考。     

方舱医院813例新型冠状病毒肺炎患者治疗用药分析

目的回顾性分析光谷方舱医院新型冠状病毒肺炎(COVID-19)患者资料,了解方舱医院COVID-19患者用药合理性。方法收集光谷方舱医院813例COVID-19患者信息,采用SPSS 25.0版统计软件分析患者性别、年龄、临床诊断、用药、住院时间、转归等。结果 813例COVID-19患者中,男418例(51.41%),女395例(48.59%);有基础疾病者144例(17.71%),COVID-19疑似患者505例(62.12%),COVID-19确诊患者308例(37.88%)。不同年龄组性别、合并基础疾病、临床分型差异有统计学意义(P<0.05);阿比多尔、连花清瘟胶囊在光谷方舱医院应用广泛,对治疗COVID-19发挥了一定作用;阿比多尔、连花清瘟胶囊、清肺排毒汤、莫西沙星使用频数分别为341,339,232,227例;不同年龄组应用连花清瘟胶囊、强力枇杷露、莫西沙星差异有统计学意义(P<0.05),不同年龄患者转归差异有统计学意义(P<0.05)。结论光谷方舱医院不同年龄患者性别组成、基础疾病、COVID-19临床分型、转归均差异有统计学意义。患者用药基本合理...     

连花清瘟颗粒联合洛匹那韦/利托那韦治疗新型冠状病毒肺炎的疗效与安全性回顾性研究

目的:探讨连花清瘟颗粒联合洛匹那韦/利托那韦治疗新型冠状病毒肺炎(COVID-19)的疗效与安全性.方法:回顾性选取截至2020年3月24日安徽医科大学附属六安医院收治的50例住院期间应用连花清瘟颗粒联合洛匹那韦/利托那韦片治疗的COVID-19患者资料,总结和分析治疗前后临床症状、影像学检查和实验室检查的变化及不良反...     

抗新型冠状病毒肺炎(COVID-19)药物的代谢和药动学

以我国新型冠状病毒肺炎诊疗方案(试行第七版)推荐的抗病毒治疗的药物为基础,本文对临床上用于治疗抗新型冠状病毒肺炎(COVID-19)的药物包括瑞德西韦、氯喹和羟氯喹、洛匹那韦/利托那韦、法匹拉韦进行了药物代谢和药动学性质的综述,同时对作者实验室的研究成果包括阿比朵尔、黄芩苷和连花清瘟胶囊主要成分连翘苷的代谢和药动学进行了回顾,以期为治疗COVID-19药物的药效评价和合理用药提供参考。     

治疗新型冠状病毒肺炎中成药的药理作用与临床应用

新型冠状病毒疫情作为国际关注的突发公共卫生事件,已引起全世界的广泛关注。《新型冠状病毒肺炎诊疗方案(试行第六版)》强调中医治疗的积极作用,推荐使用藿香正气胶囊(丸、水、口服液)、金花清感颗粒、连花清瘟胶囊(颗粒)、疏风解毒胶囊(颗粒)、喜炎平注射液、血必净注射液、热毒宁注射液、痰热清注射液、醒脑静注射液、苏合香丸、安宫牛黄丸、参附注射液、生脉注射液和参麦注射液等中成药用于新型冠状病毒肺炎(COVID-19)的治疗。该文检索2003—2020年中文文献,对上述14个中成药用于病毒性感染、肺炎等相关疾病对症治疗或支持治疗的药理作用、临床应用和不良反应等进行综述,以期为临床医生合理使用提供参考。     

口服中成药在新型冠状病毒肺炎治疗中的合理应用与药学监护

我国《新型冠状病毒肺炎诊疗方案(试行第六版)》在中医治疗中推荐了6个品种的口服中成药,包括藿香正气方(胶囊、丸、水、口服液)、金花清感颗粒、连花清瘟方(胶囊、颗粒)、疏风解毒方(胶囊、颗粒)、苏合香丸和安宫牛黄丸。其中藿香正气方、金花清感颗粒、连花清瘟方和疏风解毒方仅推荐在医学观察期使用,但也有用于新型冠状病毒肺炎轻型和普通型患者的报道;而苏合香丸和安宫牛黄丸则仅用于新型冠状病毒肺炎危重症患者。这6种口服中成药的安全性较好,很少有不良反应发生,但临床应用时应注意中医辨证、禁忌证、配伍禁忌,避免主治证型相似的药物叠加使用,加强不良反应的监测。     

清瘟宣泄解毒--连花清瘟

近日,国家卫生健康委员会办公厅、国家中医药管理局办公室发布《新型冠状病毒感染的肺炎诊疗方案》,连花清瘟颗粒/胶囊成为该诊疗方案推荐的其中一种中成药,用于医学观察期临床表现为乏力伴发热的治疗,疗效获得认可。今天,就给大家详细介绍一下连花清瘟颗粒/胶囊。     

连花清瘟胶囊治疗尿毒症肺炎19例疗效观察

目的 观察连花清瘟胶囊治疗尿毒症肺炎效果.方法 尿毒症肺炎19例,应用连花清瘟胶囊治疗,疗程（21±7）d,并做胸片比较.结果 临床治疗总有效率为84.2％,16例患者胸片清晰或好转.结论 连花清瘟胶囊治疗尿毒症肺炎治疗效果明显,减少了抗生素脑病的发生,适于在临床应用.     

倾向性评分探索真实世界中连花清瘟胶囊（颗粒）治疗肺部感染的疗效评价

目的探讨肺部感染患者使用或未使用连花清瘟胶囊(颗粒)的疗效评价差异。方法提取全国18家大型三级甲等医院的医院信息管理系统(HIS)数据库中肺部感染患者诊疗数据,采用非随机对照匹配设计的方法对2004年9月15日至2015年12月15日使用连花清瘟胶囊(颗粒)(连花清瘟组1 395例)和未使用连花清瘟胶囊(颗粒)(对照组1 395例)共计2 790例的肺部感染患者按照年龄分段、性别相同的标准进行1∶1匹配,通过倾向性评分的方法平衡混杂因素,对重新整合后的患者治疗结局进行对比分析。结果控制混杂因素之后,联合使用连花清瘟胶囊(颗粒)相对于未联合使用连花清瘟胶囊(颗粒)组,其针对肺部感染患者的疗效存在统计学差异。结论基于现有的真实世界电子医疗数据和研究方法认为,使用连花清瘟胶囊(颗粒)对肺部感染具有较好的治疗效果,该研究结果仍有待前瞻性研究做进一步证实。     

Identifying potential anti-COVID-19 pharmacological components of traditional Chinese medicine Lianhuaqingwen capsule based on human exposure and ACE2 biochromatography screening

Lianhuaqingwen(LHQW)capsule,a herb medicine product,has been clinically proved to be effective in coronavirus disease 2019(COVID-19)pneumonia treatment.However,...     

Establishment of an anti-inflammation-based bioassay for the quality control of the 13-component TCM formula (Lianhua Qingwen)

ContextOwing to the complexity of chemical ingredients in traditional Chinese medicine (TCM), it is difficult to maintain quality and efficacy by relying only on chemical markers.ObjectiveLianhua Qingwen capsule (LHQW) was selected as an example to discuss the feasibility of a bioassay for quality control.Materials and methodsNetwork pharmacology was used to screen potential targets in LHQW with respect to its anti-inflammatory effects. An in vitro cell model was used to validate the prediction. An anti-inflammatory bioassay was established for the quality evaluation of LHQW in 40 batches of marketed products and three batches of destructed samples.ResultsThe tumor necrosis factor/interleukin-6 (TNF/IL-6) pathway via macrophage was selected as the potential target of LHQW. The IC₅₀ value of LHQW on RAW 264.7 was 799.8 μg/mL. LHQW had significant inhibitory effects on the expression of IL-6 in a dose-dependent manner (p < 0.05). The anti-inflammatory biopotency of LHQW was calculated based on the inhibitory bioactivity on IL-6. The biopotency of 40 marketed samples ranged from 404 U/μg to 2171 U/μg, with a coefficient of variation (CV) of 37.91%. By contrast, the contents of forsythin indicated lower CV (28.05%) than the value of biopotency. Moreover, the biopotencies of destructed samples declined approximate 50%, while the contents of forsythin did not change. This newly established bioassay revealed a better ability to discriminate the quality variations of LHQW as compared to the routine chemical determination.ConclusionsA well-established bioassay may have promising ability to reveal the variance in quality of TCM.     

新型冠状病毒肺炎的免疫失衡及干预策略

冠状病毒是一类在自然界中广泛存在的单链RNA病毒,21世纪头二十年由冠状病毒引起的传染病已在世界范围内引起3次较大规模的流行,加强对冠状病毒的研究势在必行。该文主要以SARS冠状病毒(SARS-CoV)、中东呼吸综合征冠状病毒(MERS-CoV)以及最近在全球爆发的新型冠状病毒(SARS-CoV-2/2019-nCoV)为例,总结了这些冠状病毒在结构、基因、来源、传染力和致病性等方面的异同,基于实验研究和临床报道,从细胞因子风暴、中性粒细胞异常增多、淋巴细胞亚群失衡等方面阐述了新型冠状病毒肺炎发病的免疫失衡现象以及相应的干预策略,并提出后续展望,为新型冠状病毒肺炎的防治提供新策略和新思路。     

Remdesivir and Coronavirus Disease 2019 (COVID-19): Essential Questions and Answers for Pharmacists and Pharmacy Technicians

Objective: To conduct a review of the investigational drug remdesivir and its therapeutic potential for treatment of COVID-19, in the form of a series of questions and answers. The purpose of the review is to narrow gaps in knowledge, clarify concepts, and to investigate research advancements for health care professionals. Data Sources: From June 2020 to August 2020, we conducted comprehensive searches of MEDLINE-PubMed, Scopus, and Google Scholar databases with no time limitations. Search terms were included that contained the terms “remdesivir,” “COVID-19,” “novel coronavirus” and “evidence,” “therapy,” “safety,” “effectiveness,” “efficacy,” “clinical trial.” Study Selection and Data Extraction: The sources of information include all publicly available data from previously published research reports. Reports must have at least one reference to remdesivir as a treatment modality for COVID-19 with no specified outcomes. Data Synthesis: Major research findings on the efficacy and safety of remdesivir are summarized in tabular format and presented in chronological order. Results of this review reveal remdesivir to be an effective therapy in specific clinical contexts; however, in several areas, available data are insufficient to support evidence-based guidance for remdesivir in the treatment of COVID-19. Conclusions: Clinical trials on remdesivir are ongoing, yet questions remain and further research is needed as to the selection of patients, effectiveness, and duration of treatment in the use of remdesivir for treatment of COVID-19.     

中药治疗新型冠状病毒肺炎临床研究文献的质量评价

目的 对迄今发表的中药治疗新型冠状病毒肺炎临床研究文献进行质量评价，找出其中的不足并提出相应的建议，以期推广中药在新冠肺炎治疗中的应用。方法 检索中国知网和PubMed数据库，用“COVID-19” “新冠病毒肺炎” “TCM” “中医药” “Clinical trial” “临床试验” “Lianhua Qingwen” “连花清瘟” “Huoxiang Zhengqi” “藿香正气” “Jinhua Qinggan” “金花清感”等关键词进行搜索，获得所有有关中药治疗新冠肺炎的相关文献，通过对比实验方法、临床疗效、主要症状消失率、体征消失率等指标，对其质量进行评价。结果 共得到中药治疗新冠肺炎相关论文463篇，剔除441篇中药治疗新冠肺炎的网络药理学理论研究文献。在纳入质量分析的22篇中药临床试验研究文献中，有随机对照研究3篇，多中心前瞻性随机对照试验1篇，病例报告2篇，无对照单臂研究5篇，对照试验4篇，回顾性研究7篇。疫情发生至今，虽然已经陆续发表了不少中药治疗新冠肺炎的临床试验文献，但多数工作不够规范，存在着部分试验没有设计对照组、样本量过低、没有设盲等问题，这些问题还需进一步改进和完善。结论 中药治疗新冠肺炎仍然需要进行更多的、设计规范的临床试验验证，产生强有力的循证医学证据，例如，增设对照组、增加样本量、采用盲法等，以此增加临床试验的可信度。     

Difference in the lipid nanoparticle technology employed in three approved siRNA (Patisiran) and mRNA (COVID-19 vaccine) drugs

Nucleic acid therapeutics are developing into precise medicines that can manipulate specific genes. However, the development of safe and effective delivery system for the target cells has remained a challenge. Lipid nanoparticles (LNPs) have provided a revolutionary delivery system that can ensure multiple clinical translation of RNA-based candidates. In 2018, Patisiran (Onpattro) was first approved as an LNP-based siRNA drug. In 2020, during the coronavirus disease 2019 (COVID-19) outbreak, LNPs have enabled the development of two SARS-CoV-2 mRNA vaccines, Tozinameran (Comirnaty or Pfizer-BioNTech COVID-19 vaccine) and Elasomeran (Spikevax or COVID-19 vaccine Moderna) for conditional approval. Here, we reviewed the state-of-the-art LNP technology employed in three approved drugs (one siRNA-based and two mRNA-based drugs) and discussed the differences in their mode of action, formulation design, and biodistribution.     

Review of the 2019 novel coronavirus (SARS-CoV-2) based on current evidence

COVID-19, the disease caused by SARS-CoV-2, is a highly contagious disease. The World Health Organization has declared the ongoing outbreak to be a global public health emergency. Currently, the research on SARS-CoV-2 is in its primary stages. Based on current published evidence, this review systematically summarizes the epidemiology, clinical characteristics, diagnosis, treatment and prevention of COVID-19. It is hoped that this review will help the public to recognize and deal with SARS-CoV-2, and provide a reference for future studies.     

新型冠状病毒肺炎治疗药物研发现状

目的 探讨新型冠状病毒肺炎(简称新冠肺炎)治疗药物研发现状、成效和存在的问题,并提出改进建议。方法 以国家卫生健康委员会《新型冠状病毒肺炎诊疗方案》中药物治疗的演变为切入点,结合临床治疗现状,总结各种治疗新型冠状病毒感染药物的特点,分析新冠肺炎疫情暴发以来登记注册拟开展的药物临床试验研究情况及存在的问题。结果 对于新冠肺炎,目前尚无特效抗病毒治疗方法,国家卫生健康委员会《新型冠状病毒肺炎诊疗方案》中所推荐的药物治疗也是基于突发疫情条件下的试用建议,且需严格监控。针对新冠肺炎疫情下登记注册拟开展的药物临床试验项目整体上普遍存在立题依据、研究基础和研究条件不充分,缺乏必要的临床前试验数据和质量保证体系等问题。结论 针对新冠肺炎,药物选择都是基于既往的严重急性呼吸综合征(SARS)、中东呼吸综合征(MERS)或其他新型流感病毒的治疗经验,积极的对症支持治疗仍是治疗的关键。针对新型冠状病毒的新药研发应回归到认真做好基于药物作用靶点、作用机制的活性筛选的基础工作。     

Current COVID-19 vaccine candidates: Implications in the Saudi population

AimThe purpose of this review is to discuss the current status of local and international efforts undergoing clinical trials aiming at developing a Coronavirus Disease-2019 (COVID-19) vaccine, and to highlight the anticipated challenges of this vaccine globally and in Saudi Arabia.Present FindingsCOVID-19 vaccine development efforts started in early January 2020 when Chinese scientists shared the Coronavirus genomic sequence in public domain. Approximately 321 research groups initiated the search for a vaccine, out of which 41 have reached phase I/II trails and 11 reached phase-III clinical trials, including approved vaccines for early to limited use. Out of these projects are two labs in the Kingdom of Saudi Arabia still in early stages of development of a COVID-19 vaccine. Several vaccine attempts are being tested from traditional, attenuated virus methods, to new nucleic acid-based designs. However, no vaccine has yet completed clinical trials and reached public domain.In spite of the challenges faced during previous vaccine trials, researchers have found that Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), the causative agent of COVID-19 is structurally similar to the (SARS-CoV-1) and the Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), which caused epidemics in 2003 and 2012 respectively. Both SARS strains show identical affinity towards the type-II alveolar pneumocytes angiotensin converting enzyme-2 (ACE-2) receptor binding domains and therefore, similar pathogenicity. The race to develop the vaccine is predominantly for individuals at high risk of developing the infection, i.e. population groups who are most susceptible to experiencing fatal symptoms of the coronavirus. These include patients with comorbidities, above the age of 60 years and people at risk of contracting large viral loads, such as healthcare providers caring for critical admissions in in-patient wards, Intensive Care Units and Emergency Room settings.SummaryMany different vaccine strategies are under development throughout different stages of the research timeline; however, it is estimated that none will show favorable results before end of 2020. For any immunization or interventional prevention/therapy system to reach the public and patients at high risk, it needs to undergo multiple phase trials to ensure safety and effectiveness. In this scoping review we aim to map the literature on COVID-19 vaccines and provide recommendations related to gaps in research, applicability and expected challenges for implementation of nationwide vaccination in Saudi Arabia.     

雾化吸入药物疗法在COVI D-19治疗中的应用及药学监护

新型冠状病毒肺炎(COVID-19)疫情在全世界蔓延,针对COVID-19的临床诊治与药物治疗研究成为热点。目前,尚没有针对COVID-19的特效药物或疫苗,而多项相关的药物临床试验迅速开展,也引起广泛的关注。截至2020年3月18日,共有8项雾化吸入疗法治疗COVID-19的临床试验在国家临床试验中心注册,涉及7种药物。本文介绍了这7种药物的应用研究进展和雾化吸入药学监护,以加强药品使用的风险管理,减少药品使用的不良事件。