Communicating regulatory high-throughput sequencing data using BioCompute Objects

This project demonstrates the use of the IEEE 2791–2020 Standard (BioCompute Objects [BCO]) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.     

Sofosbuvir-velpatasvir en pacientes mexicanos con hepatitis C: una revisión retrospectiva

IntroductionThe sofosbuvir-velpatasvir (SOF/VEL) combination is a direct-acting antiviral therapy that is authorized and available in Mexico, making the performance of a real-world multicenter study that evaluates the sustained virologic response at 12 weeks post-treatment a relevant undertaking.MethodsA retrospective review of the case records of 241 patients seen at 20 hospitals in Mexico was conducted to assess hepatitis C treatment with the SOF/VEL combination (n = 231) and the sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) combination (n = 10). The primary efficacy endpoint was the percentage of patients that achieved SVR at 12 weeks after the end of treatment.ResultsOverall SVR was 98.8% (95% CI 97.35-100%). Only three patients did not achieve SVR, two of whom had cirrhosis and a history of previous treatment with peg-IFN. Of the subgroups analyzed, all the patients with HIV coinfection, three patients with genotype 3, and the patients treated with the SOF/VEL/RBV combination achieved SVR. The subgroups with the lower success rates were patients that were treatment-experienced (96.8%) and patients with F1 fibrosis (95.5%). The most frequent adverse events were fatigue, headache, and insomnia. No serious adverse events were reported.ConclusionTreatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.     

西地兰联合胺碘酮治疗急诊重症心衰合并快速性心律失常患者的临床效果分析

目的探析西地兰联合胺碘酮治疗急诊重症心衰合并快速性心律失常患者的临床效果。方法60例急诊重症心衰合并快速性心律失常患者,以电脑Excel表格按照1∶1比例分为对比组和研究组,每组30例,对比组患者采用西地兰治疗,研究组患者采用西地兰联合胺碘酮治疗。比较两组患者治疗前后QT离散度、心功能指标及治疗后临床指标。结果治疗后,两组患者QT离散度均较本组治疗前降低,且研究组患者QT离散度(32.69±2.69)ms低于对比组的(41.32±3.11)ms,差异具有统计学意义(P<0.05)。治疗后,研究组患者心室率(78.51±5.17)次/min低于对比组的(94.23±6.67)次/min,起效时间(18.23±2.11)min短于对比组的(32.11±3.51)min,窦性心律转复率93.33%(28/30)高于对比组的70.00%(21/30),差异具有统计学意义(P<0.05)。治疗后,两组患者左室舒张末期内径、室间隔厚度、左室后壁厚度、左室重量指数、左室射血分数、舒张早期最大流速/舒张晚期最大流速(E/A)、N末端B型脑钠肽前体(NT-proBNP)水平均较本组治疗前改善,且研究组优于对比组,差异具有统计学意义(P<0.05)。结论在急诊重症心衰合并快速性心律失常患者治疗中选择西地兰联合胺碘酮用药方案,能够更好降低QT离散度,提高窦性心律转复率,且心室率更低、起效时间更短,同时,在改善心功能方面效果较显著。     

Abscopal effect in radioimmunotherapy

Abscopal effect is an interesting phenomenon in radiobiology that causes activation of immune system against cancer cells. Traditionally, this phenomenon was known as a suppressor of non-irradiated tumors or metastasis. However, it can be used as a stimulator of the immune system against primary tumor during radiotherapy. Immunotherapy, a novel tumor therapy modality, also triggers immune system against cancer. To date, some immunotherapy types have been developed. However, immune checkpoint blockade is a more common modality and some drugs have been approved by the FDA. Studies have shown that radiotherapy or immunotherapy administered alone have low efficiency for tumor control. However, their combination has a more potent anti-tumor immunity. For this aim, it is important to induce abscopal effect in primary tumors, and also use appropriate drugs to target the mechanisms involved in the exhaustion of cytotoxic CD8+T lymphocytes (CTLs) and natural killer (NK) cells. Among the different radiotherapy techniques, stereotactic body radiation therapy (SBRT) with some few fractionations is the best choice for inducing abscopal effect. On the other hand, programmed cell death 1 (PD-1) is known as one of the best targets for triggering anti-tumor immunity. This combination is known as the best choice among various strategies for radioimmunotherapy. However, there is the need for other strategies to improve the duration of immune system’s activity within tumor microenvironment (TME). In this review, we explain the cellular and molecular mechanisms behind abscopal effect by radiotherapy and evaluate the molecular targets which induce potent anti-tumor immunity.     

艾烟的作用与安全性评价＊

艾灸作为中医学最古老的疗法之一，作用多样，应用广泛，疗效显著。随着科技的发展，人们对灸法的认识逐渐深入，其中艾烟的相关研究也硕果累累，其安全性广受关注。通过对艾烟作用和安全性评价研究中取得的成果进行归纳分析，以期为艾灸临床安全应用提供指导。     

Infección por el virus de la hepatitis C y nuevas estrategias de tratamiento

Hepatitis C is a major public health problem worldwide. This disease is caused by the hepatitis C virus, which is characterised by its genetic diversity. The infection is usually asymptomatic. However, between 60% and 80% of HCV-infected individuals will progress to chronic hepatitis, 20% to liver cirrhosis in the medium-to long-term and, each year, between 1% and 4% of these patients with cirrhosis will develop hepatocellular carcinoma (HCC). A Spanish consensus document has recently been drafted to diagnose hepatitis C in a single step, consisting of active investigation (antibodies and viremia) in a single sample, which according to the experts, would reduce the time to access treatment and avoid tracking losses. To definitively change the hepatitis C treatment paradigm, direct-acting antiviral drugs (DAAs) have been approved, whose development has been based on achieving cure rates close to 100% regardless of the genotype of the virus, ie, pangenotypes, with good tolerance and bioavailability. These drugs have constituted a real therapeutic revolution. Supplement information: This article is part of a supplement entitled «SEIMC External Quality Control Programme. Year 2016», which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A.© 2019 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosasy Microbiología Clínica. All rights reserved.     

颊颈连续曲线切口在颊癌联合根治术中的应用效果评价

目的 探讨并评估颊颈连续曲线切口在颊癌联合根治术中的应用效果。方法 收集2015年1月—2018年12月收治的颊癌患者87例,其中42例采用颊颈连续曲线切口（实验组）,45例采用传统颈部T形切口联合面颊切口（对照组）。评估术野暴露范围,对比2组切口长度、联合根治术所耗时长和术后颈部并发症发生率。随访时间7~43个月,采用改良温哥华瘢痕量表（Vancouver Scar Scale,VSS）及华盛顿大学生存质量问卷（University of Washington Quality of Life,UW-QOL）,对2组患者术后瘢痕及生存质量进行评估。采用SPSS 22.0软件包进行统计学分析。结果 实验组切口长度为（36.40±5.08）cm,显著小于对照组的（39.93±5.22）cm（P<0.05）;实验组联合根治术所耗时长短于对照组,颈部并发症发生率低于对照组;术后瘢痕评估及生存质量优于对照组,差异均有统计学意义（P<0.05）。2组手术术野显露范围,术后复发、转移率无显著差异。结论 颊颈连续曲线切口与传统切口相比,能获得良好的视野,联合根治耗时短,并能实现原发灶与颈淋巴清扫术整体切除以保证手术彻底性。具有切口短且美观、并发症少、术后生存质量好等优点,是值得推荐的一种颊癌联合根治手术切口。     

Novel β-Coronavirus (SARS-CoV-2): Current and future aspects of pharmacological treatments

The novel coronavirus outbreak has reported to be rapidly spreading across the countries and becomes a foremost community health alarm. At present, no vaccine or specific drug is on hand for the treatment of this infectious disease. This review investigates the drugs, which are being evaluated and found to be effective against nCOVID-19 infection. A thorough literature search was performedon the recently published research papers in between January 2020 to May 2020, through various databases like “Science Direct”, “Google Scholar”, “PubMed”,“Medline”, “Web of Science”, and “World Health Organization (WHO)”. We reviewed and documented the information related with the current and future aspects for the management and cure of COVID-19. As of 21st July 2020 a total of 14,562,550 confirmed cases of coronavirus and 607,781 deaths have been reported world-wide. The main clinical feature of COVID-19 ranges from asymptomatic disease to mild lower respiratory tract illness to severe pneumonia, acute lung injury, acute respiratory distress syndrome (ARDS), multiple organ dysfunction, and death. The drugs at present used in COVID-19 patients and ongoing clinical trials focusing on drug repurposing of various therapeutic classes of drug e.g. antiviral, anti-inflammatory and/or immunomodulatory drugs along with adjuvant/supportive care. Many drugs on clinical trials shows effective results on preliminary scale and now used currently in patients. Adjuvant/supportive care therapy are used in patients to get the best results in order to minimize the short and long-term complications. However, further studies and clinical trials are needed on large scale of population to reach any firm conclusion in terms of its efficacy and safety.