Surrogate end points for overall survival in breast cancer trials: A review

Our aim was to review the studies which assessed potential surrogate endpoints for overall survival (OS) in breast cancer trials. A Literature search in PubMed database of studies which assessed potential surrogate endpoints for OS in breast cancer trials was conducted. The surrogacy was assessed with the German institute of Quality and efficiency in Health Care’s (IWQiG) framework and the Fleming hierarchy. Thirteen studies were identified. At the neoadjuvant setting, two individual patient data (IPD) meta-analyses and one aggregate data meta-analysis assessing surrogacy of pathological complete response (PCR) were identified. Trial-level association was calculated in one study and the squared correlation was 0.24. Therefore PCR was not judged to be valid surrogate for OS at the neoadjuvant setting according to the IWQiG framework and Fleming hierarchy. At the adjuvant setting, one meta-analysis on aggregate data was identified. 2-year DFS was not judged to be valid surrogate for OS at the neoadjuvant setting according to the IWQiG framework and Fleming hierarchy. At the metastatic setting, six meta-analyses based on aggregate data, three IPD meta-analyses and one retrospective study were identified. Within the IPD meta-analyses, at the trial-level association the squared correlation between the potential surrogates and OS ranged from 0.10 to 0.57 and no endpoint was judged to be valid surrogate for OS at the metastatic setting. The level of evidence available supporting a relationship between OS and potential surrogate endpoints in breast cancer trials is low.     

血清抗体检测在一起本地传播新冠肺炎聚集性疫情溯源调查中的应用

目的 在深圳市一起本地传播COVID - 19聚集性疫情溯源调查中，对重点涉疫人群开展抗体检测，帮助明确疫情扩散范围，追踪可能的源头。方法 采用流行病学调查、大数据手段锁定重点涉疫人群，除对其开展SARS - COV - 2核酸检测外，采用化学发光法检测抗体，对阳性者进一步开展流行病学调查和中和抗体检测，判断其在疫情传播中的作用。结果 该疫情的9名个案在病程中均检测到IgM抗体、IgG抗体阳性。5 606名涉疫人员检测了抗体，26人阳性，初筛阳性率为0.47%，其中11人IgG抗体阳性，15人IgM抗体阳性；但中和抗体实验和核酸检测均阴性。3人曾经出现过呼吸道症状，均否认与深港货车司机、国外入境人员、冷冻进口货物和发热呼吸道病例接触史。某口岸附近小区阳性率高于其他场所，差异有统计学意义（χ2 = 8.29，P = 0.004）。结论 通过核酸和抗体检测结果可判断，本起疫情传播范围较为局限；化学发光抗体检测法有一定假阳性率，可以作为新冠肺炎疫情溯源调查的辅助方法，对有流行病学史的涉疫人员进行筛查，但不宜对一般人群进行大规模筛查。     

自拟舒郁汤联合镇静六穴治疗产后抑郁症的临床研究

目的:探讨自拟舒郁汤联合镇静六穴治疗产后抑郁症的临床效果。方法:选择2019年5月—2020年3月产后抑郁症患者60例,按照投掷硬币法分为对照组和观察组,每组30例。对照组给予盐酸帕罗西汀片治疗,观察组给予自拟舒郁汤联合“镇静六穴”治疗。比较两组患者近期疗效以及治疗前后抑郁症状、产后生活自理能力、照料婴儿能力与生活质量变化情况。结果:观察组治疗总有效率高于对照组,差异有统计学意义(P<0.05);观察组治疗2,4,6,8周末汉密尔顿抑郁量表(HAMD-24)评分均低于对照组,差异有统计学意义(P<0.05);观察组治疗8周末产后生活自理能力评分、照料婴儿能力评分及36条简明健康状况调查表(SF-36)评分均高于对照组,差异有统计学意义(P<0.05)。结论:自拟舒郁汤联合镇静六穴治疗产后抑郁症疗效显著,可有效改善患者抑郁症状,提升产后生活自理能力、照料婴儿能力和生活质量。     

美国妇产科医师学会“妊娠期恶心呕吐指南2015版”要点解读

正妊娠期恶心、呕吐是一种影响孕妇及其胎儿健康的常见疾病。早孕期轻度的恶心、呕吐是一种生理性反应;中度(和)或重度或病情迁延(和)或加重的妊娠期恶心、呕吐,会严重影响孕妇的生活质量,乃至危及母胎生命安全,需及时诊治。美国妇产科医师学会(ACOG)近年来针对妊娠期呕吐,颁布了一系列指南,并提出一些与妊娠期恶心、呕吐诊治有关的新观念及循证医学证据。本文对2015年颁布的第153号《妊娠期恶心     

Superposition of Episodic Memories: Overdistribution and Quantum Models

Memory exhibits episodic superposition, an analog of the quantum superposition of physical states: Before a cue for a presented or unpresented item is administered on a memory test, the item has the simultaneous potential to occupy all members of a mutually exclusive set of episodic states, though it occupies only one of those states after the cue is administered. This phenomenon can be modeled with a nonadditive probability model called overdistribution (OD), which implements fuzzy‐trace theory's distinction between verbatim and gist representations. We show that it can also be modeled based on quantum probability theory. A quantum episodic memory (QEM) model is developed, which is derived from quantum probability theory but also implements the process conceptions of global matching memory models. OD and QEM have different strengths, and the current challenge is to identify contrasting empirical predictions that can be used to pit them against each other.     

Changing epidemiology of invasive non-typhoid Salmonella infection: a nationwide population-based registry study

ObjectivesNon-typhoid Salmonella (NTS) may invade beyond the intestine, causing bacteraemia, sepsis, and infection of normally sterile sites. The epidemiology of invasive NTS (iNTS) infection is under-researched. We determined trends, risk factors, serotype distribution, antimicrobial resistance (AMR), and attributable sources of iNTS infection in a high-income setting.Methods22,837 records of culture-confirmed human salmonellosis cases and 10,008 serotyped Salmonella isolates from five putative animal reservoirs (pigs, cattle, broilers, layers, reptiles) in the Netherlands during 2005–2018 were retrieved from national surveillance registries. Risk factors for iNTS infection were identified using logistic regression analysis. Source attribution modelling was based on serotyping, prevalence, and exposure data.ResultsThe average annual percentage of iNTS infections was 4.6% (range 3.5–5.7%). An increase in iNTS infections was observed since 2012 (odds ratio (OR) 1.09, 95% confidence interval (95% CI) 1.04–1.14). Increased iNTS infection risk was associated with wintertime (OR 1.37, 95% CI 1.12–1.66), male sex (OR 1.73, 95% CI 1.51–1.99), older age (ORs: 3.27 to 16.33, depending on age groups), and living in rural areas (OR 1.54, 95% CI 1.23–1.93). While 52% of iNTS infections (n = 950) were caused by serotypes Enteritidis and Typhimurium, those displaying the highest invasiveness relative to their occurrence were Dublin (32.9%, n = 163), Panama (21.6%, n = 106), and Poona (14.1%, n = 71). Cattle were a larger source of iNTS than non-iNTS infections (12.2% vs. 7.6%). Lower AMR and multi-resistance rates were observed among iNTS (37.9%) than non-iNTS isolates (48.6%).DiscussionThe increase in iNTS infections, which is reported also in other countries, is of public health and clinical concern. The underlying reasons seem to be multi-factorial in nature. iNTS infection risk depends more on the infecting serotypes and patient demographics, and less on the attributable reservoirs and AMR profiles.