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Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials. 潜在的2019冠状病毒病(COVID-19)疫苗的开发和实施:疫苗临床试验的系统回顾和荟萃分析
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2021-03-31 eCollection Date: 2021-03-01 DOI: 10.3126/nje.v11i1.36163
Brijesh Sathian, Mohammad Asim, Indrajit Banerjee, Bedanta Roy, Ana Beatriz Pizarro, Maraeh Angela Mancha, Edwin R van Teijlingen, Hamed Kord-Varkaneh, Ahammed A Mekkodathil, Supram Hosuru Subramanya, Israel Júnior Borges do Nascimento, Neema Antony, Ritesh G Menezes, Padam Simkhada, Hanadi Al Hamad

Background: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines.

Methods: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020.

Results: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time.

Conclusion: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.

背景:迄今为止,尚无全面的系统评价和荟萃分析来评估COVID-19疫苗是否适合大规模免疫接种。本系统综述和荟萃分析旨在评估正在进行临床试验评估的新型COVID-19候选疫苗的安全性和免疫原性,并介绍一种潜在疫苗的开发和实施的最新情况。方法:本研究使用PubMed、MEDLINE和Embase电子数据库检索新型冠状病毒与疫苗设计之间界面的符合条件的研究,截止日期为2020年12月31日。结果:我们纳入了14项非随机和随机对照I-III期试验。通过强有力的临床评估,实施安全性和有效性得到证实的普遍疫苗接种规划是预防COVID-19的长期目标。免疫规划必须在大规模生产和可及性方面具有成本效益。尽管在当前的全球紧急情况下,疫苗的快速开发采用了先进技术,但大规模生产和提供有效的COVID-19疫苗可能还需要一些时间。结论:我们的研究结果提示对已报道的征求和非征求的COVID-19候选疫苗的全身不良事件进行重新审视。因此,明智地让数千名参与者在第三阶段试验中接触COVID-19候选疫苗是令人震惊的,这些疫苗有不良事件,而且安全性和有效性证据不足,需要进一步证明。
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引用次数: 14
COVID-19: Are reinfections a global health threat? 2019冠状病毒病:再感染是全球健康威胁吗?
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2021-03-31 eCollection Date: 2021-03-01 DOI: 10.3126/nje.v11i1.34903
Indrajit Banerjee, Jared Robinson, Brijesh Sathian
The SARS-CoV-2 virus has plagued the planet and caused unfathomable disruptions in every facet of our lives. The undue and unforeseen losses as a consequence of this pandemic will take years to quantify and even longer to curtail. This phenomenon creates an innate pressure on humans as it synergistically charges the environment to propel the movement of restarting enterprise and life as it was before the pandemic in order to curb this “loss”. A plethora of hurdles however are still in question. Firstly, the re-opening of enterprise and a country has to be done in a safe manner. To overcome this hurdle the development of multiple vaccinations to this novel virus has been streamlined. The greatest matter in question however, is the efficacy of these vaccines and whether they will be the answer to allow a safe re-ignition of global enterprise and countries as multiple cases of reinfections have been recorded, namely reinfections post recovery from the disease. After the initiation of the immunization with both the Moderna mRNA-1273 vaccine and the Pfizer BNT162b2 vaccine, cases of infection with COVID-19 have been reported.  It is evident that reinfections of the SARS-CoV-2 virus can be attributed to two major benefactors. The first being a decrease in production or failure of natural acquired immunity thus leading to the reinfection by the same strain of the virus rendering the person ill and or asymptomatic. The second benefactor is that of mutations. Mutations of the virus will predispose to reinfections as the already established naturally acquired immunity is not beneficial or useful to combat a mutated strain. It is thus poignant for cases of reinfection to be investigated thoroughly as to determine whether the reinfection was caused due to an innate lack of immunity or due to a new strain where no prior immunity existed. It must however be noted that the cases of reinfections are a rather rare event and even if a reinfection does occur, the case if usually mild and or asymptomatic. The impact of reinfection on immunization at this point of time is difficult to quantify however, initial reports do show positive signs even in cases where the vaccine is not fully effective against a mutated strain.
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引用次数: 3
A contemporary insight of metabolomics approach for COVID-19: Potential for novel therapeutic and diagnostic targets. 对 COVID-19 代谢组学方法的当代见解:新型治疗和诊断目标的潜力。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-12-31 eCollection Date: 2020-12-01 DOI: 10.3126/nje.v10i4.33964
Mohammad Asim, Brijesh Sathian, Indrajit Banerjee, Jared Robinson

The Coronavirus disease 2019 (COVID-19) pandemic is caused by rapidly spreading pathogenic virus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that affects vast majority of population worldwide. Although, around 80% of the cases had mild infection but still remaining 20% had developed respiratory failure and dysfunction of other organs that necessitate urgent oxygen therapy or specific interventions. Therefore, it is imperative to establish novel prognostic approaches to screen patients at high-risk of developing severe complications. The primary focus of current research for COVID-19 is to discover safe and efficacious vaccine for prevention and effective treatment for better management of the patients to overcome the pandemic. To achieve this goal, it is imperative to have better understanding of the molecular pathways involved in the pathophysiology and progression of severe COVID-19. The surge for reliable diagnostics and therapeutics targets for COVID-19 highlighted the great potential of high-throughput approach like metabolomics which may enable the development of personalized medicine.

2019 年冠状病毒病(COVID-19)大流行是由称为严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)的快速传播致病病毒引起的,影响了全球绝大多数人口。虽然约 80% 的病例感染程度较轻,但仍有 20% 的病例出现了呼吸衰竭和其他器官功能障碍,需要进行紧急氧疗或特殊干预。因此,当务之急是建立新的预后方法,以筛查有可能出现严重并发症的高危患者。COVID-19 目前研究的主要重点是发现安全有效的预防疫苗和有效的治疗方法,以便更好地管理患者,战胜大流行病。要实现这一目标,必须更好地了解严重 COVID-19 的病理生理学和进展过程中涉及的分子途径。针对 COVID-19 寻找可靠诊断和治疗目标的热潮凸显了高通量方法(如代谢组学)的巨大潜力,它可以促进个性化医疗的发展。
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引用次数: 0
The relevance of digital mental healthcare during COVID-19: Need for innovations. 2019冠状病毒病期间数字精神卫生保健的相关性:创新需求
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-12-31 eCollection Date: 2020-12-01 DOI: 10.3126/nje.v10i4.32519
Sujita Kumar Kar, Shailendra K Saxena, Russell Kabir
N/A
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引用次数: 6
Common Pitfalls in using Online Platforms for Data collection in COVID times and its implications. 新冠疫情期间使用在线数据收集平台的常见缺陷及其影响。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-12-31 eCollection Date: 2020-12-01 DOI: 10.3126/nje.v10i4.31614
Hariom Kumar Solanki, P Giridara Gopal, Rama Shankar Rath
In recent COVID-19 times conducting online research is the only feasible type of research for many authors. However, like other methods of data collection this method also bears some inherent issues linked to method of the study. The authors must understand the common pitfalls related to online data collection before planning and before interpreting the results. This letter mainly deals with the issues related to the online data collection.
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引用次数: 0
COVID-19 and Artificial Intelligence: the pandemic pacifier. COVID-19 和人工智能:大流行病的安抚者。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-12-31 eCollection Date: 2020-12-01 DOI: 10.3126/nje.v10i4.33334
Indrajit Banerjee, Jared Robinson, Abhishek Kashyap, Poornasha Mohabeer, Brijesh Sathian
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引用次数: 0
Treatment outcome of tuberculosis patient of Samtse General Hospital, Bhutan. 不丹Samtse总医院肺结核病人的治疗结果。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-09-30 eCollection Date: 2020-09-01 DOI: 10.3126/nje.v10i3.28397
Thinley Dorji, Kinley Wangdi

Background: Tuberculosis (TB) is one of the major public health problems in Bhutan. Evaluation of treatment outcomes of TB and identification of the risk factors are important components for the success of National TB control program. Therefore, this study was undertaken to assess the TB treatment outcome and factors associated with it in Samtse General Hospital.

Methods: This was a retrospective, cross sectional study using the TB data from Samtse General Hospital from 2008-2019. A univariate and multiple logistic regression was used to check for associations between the outcome and other independent variables.

Results: The study included a total of 634 TB patients. Of this, 44.0% (279) were smear positive TB (PTB+), 36.1% (229) were extra pulmonary TB (EPTB) and 19.9% (126) were smear negative TB (PTB-). During the study period, 56.2% (356) of them completed treatment, 33.3% (211) were declared cured, 0.2% (1) had defaulted, 5.1% (32) died and 5.4% (34) had treatment failure. The mean treatment success rate (TSR) was 89.4% (567). The TSR was highest for EPTB with 96.9% (222/229), followed by PTB- at 88.1% (111/126) and lowest for PTB+ with 83.9% (234/279). Successful treatment outcome was observed in EPTB patients (AOR: 7.3; 95% CI: 2.46-21.36), patients in age 15-28 years (AOR: 3.4; 95% CI: 1.59-7.46) and 29-42 years (AOR: 9.1; 95% CI: 2.44-33.61).

Conclusion: The treatment outcome of TB in Samtse General Hospital is satisfactory and at par with the national level. Since, smear positive TB and elderly patients are prone to develop poor treatment outcome, they need to be monitored and followed up adequately.

背景:结核病是不丹的主要公共卫生问题之一。评价结核病治疗结果和确定危险因素是国家结核病控制规划成功的重要组成部分。因此,本研究旨在评估Samtse总医院的结核病治疗结果及其相关因素。方法:这是一项回顾性横断面研究,使用Samtse总医院2008-2019年的结核病数据。采用单变量和多元逻辑回归来检查结果与其他自变量之间的关联。结果:本研究共纳入634例结核病患者。其中,涂片阳性(PTB+) 279例(44.0%),外肺结核(EPTB) 229例(36.1%),涂片阴性(PTB-) 126例(19.9%)。研究期间,完成治疗356例(56.2%),治愈211例(33.3%),未治愈1例(0.2%),死亡32例(5.1%),治疗失败34例(5.4%)。平均治疗成功率(TSR)为89.4%(567)。EPTB的TSR最高,为96.9% (222/229),PTB-次之,为88.1% (111/126),PTB+最低,为83.9%(234/279)。EPTB患者治疗效果良好(AOR: 7.3;95% CI: 2.46-21.36), 15-28岁患者(AOR: 3.4;95% CI: 1.59-7.46)和29-42岁(AOR: 9.1;95% ci: 2.44-33.61)。结论:Samtse总医院结核病治疗效果满意,达到全国水平。由于涂阳结核病患者和老年患者容易出现不良治疗结果,因此需要对他们进行充分监测和随访。
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引用次数: 1
Artificial Intelligence and Health in Nepal. 尼泊尔的人工智能与健康。
IF 1.7 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-09-30 eCollection Date: 2020-09-01 DOI: 10.3126/nje.v10i3.31649
Alexander van Teijlingen, Tell Tuttle, Hamid Bouchachia, Brijesh Sathian, Edwin van Teijlingen

The growth in information technology and computer capacity has opened up opportunities to deal with much and much larger data sets than even a decade ago. There has been a technological revolution of big data and Artificial Intelligence (AI). Perhaps many readers would immediately think about robotic surgery or self-driving cars, but there is much more to AI. This Short Communication starts with an overview of the key terms, including AI, machine learning, deep learning and Big Data. This Short Communication highlights so developments of AI in health that could benefit a low-income country like Nepal and stresses the need for Nepal's health and education systems to track such developments and apply them locally. Moreover, Nepal needs to start growing its own AI expertise to help develop national or South Asian solutions. This would require investing in local resources such as access to computer power/capacity as well as training young Nepali to work in AI.

信息技术和计算机能力的增长为处理比十年前更多更大的数据集提供了机会。大数据和人工智能(AI)引发了一场技术革命。也许许多读者会立即想到机器人手术或自动驾驶汽车,但人工智能的内涵远不止于此。本短讯首先概述了人工智能、机器学习、深度学习和大数据等关键术语。本短讯重点介绍了人工智能在医疗卫生领域的发展,这些发展可能会使尼泊尔这样的低收入国家受益,并强调尼泊尔的医疗卫生和教育系统需要跟踪这些发展,并在当地加以应用。此外,尼泊尔需要开始发展自己的人工智能专业知识,以帮助开发国家或南亚解决方案。这就需要对当地资源进行投资,如获得计算机能力,以及培训尼泊尔年轻人从事人工智能工作。
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引用次数: 0
South Africa and its COVID-19 prohibition predilection. 南非及其COVID-19禁止偏好。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-09-30 eCollection Date: 2020-09-01 DOI: 10.3126/nje.v10i3.31543
Indrajit Banerjee, Jared Robinson, Brijesh Sathian, Edwin R van Teijlingen
The year 2020, will forever be marked by the Global pandemic, COVID-19. According to The Department of Health in South Africa until September 15, 2020 3,940,217 tests have been conducted. 651,521 positive cases have been identified, 583,126 recoveries have been reported and there has been a total of 15641 deaths. The South African government have introduced a range of parameters and laws in order to curb the spread of the virus whilst simultaneously endorsing programs to spearhead the preparedness of the healthcare system for the various waves of COVID-19 cases that have been forecast.  In conjunction with the new laws and regulations, the South African Government has exercised lockdown and restriction of movement policies. South Africa’s unique, multifaceted and strategic method of combatting the coronavirus has proven to be effective in using existing resources and redirecting both manpower and personnel, thus being of great benefit to all stakeholders and citizens within the country. The prohibition of alcohol is a unique method employed by the government, the full extent to which this policy reform has benefitted the country, its government and its citizens is yet to be fully calculated and projected as South Africa’s Coronavirus cases are still increasing on a daily basis. This policy reform will likely find itself becoming a popular trend with crisis management protocols of other countries if the long-term benefits thereof are proven to be true.
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引用次数: 10
Impact of COVID-19 on clinical trials and clinical research: A systematic review. COVID-19对临床试验和临床研究的影响:一项系统综述。
IF 3.9 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-09-30 eCollection Date: 2020-09-01 DOI: 10.3126/nje.v10i3.31622
Brijesh Sathian, Mohammad Asim, Indrajit Banerjee, Ana Beatriz Pizarro, Bedanta Roy, Edwin R van Teijlingen, Israel Júnior Borges do Nascimento, Hanadi Khamis Alhamad

Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants' inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19" AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

背景:截至2020年9月21日,世界卫生组织报告了全球超过31,186,000例冠状病毒病-19 (COVID-19)确诊病例,其中962,343例死亡。当前的COVID-19大流行正在影响世界大部分地区的临床研究活动。事实上,专注于开发针对SARS-CoV-2的疫苗和治疗COVID-19,正在扰乱全球许多即将开展和/或正在进行的针对其他疾病的临床试验。2020年3月18日,美国食品药品监督管理局(FDA)发布了当前卫生紧急情况下开展临床试验的最新指南。潜在的挑战,如社交距离和隔离,导致研究参与者和试验人员无法亲自安排研究访问和/或随访。由于新冠肺炎的突发性和广泛影响,其对临床试验和研究管理的影响需要迫切关注。因此,我们对文献进行系统综述,旨在评估COVID-19大流行对开展临床试验和研究的影响。在PubMed、MEDLINE、Embase、Google scholar和Google电子数据库中搜索关键词“COVID-19”和“临床试验”。主要发现包括:大多数正在进行的临床试验延迟受试者入组和操作空白,这反过来对试验规划和数据完整性产生负面影响。在全球范围内,除新冠肺炎以外的大多数临床试验地点都出现了时间表推迟和完全停止运营的情况,从而影响了临床研究成果。
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引用次数: 16
期刊
Nepal Journal of Epidemiology
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