ABSTRACT
Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.
ABSTRACT
How COVID-19 vaccine is distributed within low- and middle-income countries has received little attention outside of equity or logistical concerns but may ultimately affect campaign impact in terms of infections, severe cases, or deaths averted. In this study we examined whether subnational (urban-rural) prioritization may affect the cumulative two-year impact on disease transmission and burden of a vaccination campaign using an agent-based model of COVID-19 in a representative COVID-19 Vaccines Global Access (COVAX) Advanced Market Commitment (AMC) setting. We simulated a range of vaccination strategies that differed by urban-rural prioritization, age group prioritization, timing of introduction, and final coverage level. Urban prioritization averted more infections in only a narrow set of scenarios, when internal migration rates were low and vaccination was started by day 30 of an outbreak. Rural prioritization was the optimal strategy for all other scenarios, e.g., with higher internal migration rates or later start dates, due to the presence of a large immunological naive rural population. Among other factors, timing of the vaccination campaign was important to determining maximum impact, and delays as short as 30 days prevented larger campaigns from having the same impact as smaller campaigns that began earlier. The optimal age group for prioritization depended on choice of metric, as prioritizing older adults consistently averted more deaths across all of the scenarios. While guidelines exist for these latter factors, urban-rural allocation is an orthogonal factor that we predict to affect impact and warrants consideration as countries plan the scale-up of their vaccination campaigns.
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Objective To analyze the psychological stress of infertile patients after COVID-19 epidemic and its related factors by Chinese version of the perceived stress scale (CPSS). Method The basic information, reproductive history, impact of the epidemic, psychological status of patients undergoing assisted reproductive technology at the General Hospital of Northern Theater Command from March 29, 2021 to April 29, 2021 were collected by questionnaire. According to CPSS, group comparison and correlation analysis were used to explore factors related to patients' psychological stress. Results A total of 251 valid questionnaires were received. The average CPSS score of the patients was 22.43±7.07. During the epidemic, about 33.86% (85/251) of the infertility patients postponed the fertilization plan;there were significant differences in the psychological stress among patients of different genders, occupations, and postponed fertilization plans at different stages of fertilization (P=0.001, P=0.005, P=0.002). There was no significant difference in CPSS score between infertile patients who delayed treatment or not (P>0.05). Correlation analysis showed that the perceived stress of patients was negatively correlated with their age, income, and delay duration (r=-0.192, P=0.002;r=-0.323, P=0.001;r=-0.282, P=0.009). Among all patients who delayed treatment, patients with higher CPSS score would restart treatment sooner;most of the infertile patients knew little about the vaccine. Conclusion The COVID-19 epidemic has caused a certain impact on the psychological pressure of infertile couples who accepted treatment in our hospital. The psychological care for infertile patients is particularly important. In the future, in order to dispel the doubts of infertile patients about the vaccine, we should pay attention to the correct scientific promotion of the COVID-19 vaccine during the treatment process. © 2020 Chinese Medical Journals Publishing House Co.Ltd. All Rights Reserved.
ABSTRACT
Background: The COVID-19 pandemic represents a global mass bereavement event, on a scale seldom witnessed. National health and social care systems are challenged with supporting large numbers of bereaved people whilst also negotiating the ongoing restrictions to provide this support safely. This review aimed to synthesise the evidence regarding system-level responses to mass bereavement events, including natural and human-made disasters, to inform service provision and policy during the pandemic. Methods: A rapid systematic review was conducted in April 2020, with narrative synthesis of results. MEDLINE, Global Health, PsycINFO and Scopus databases were searched for studies published between 2000 and 2020, reporting evidence on system-level responses to mass bereavement events in OECD countries (plus Singapore, China and Taiwan). Citation and reference tracking was conducted and study quality assessed. Results: Six studies were included, reporting on system responses to man-made disasters (e.g. terror attacks in the US and Norway), as well as natural disasters (e.g. Hurricane Katrina and the South-East Asian Tsunami). Despite differences across disaster types, common approaches were identified and positive impacts were reported across a range of individual and group-based support interventions. Key features of service delivery included: a proactive outreach approach, centrally organised but locally delivered interventions, event-specific professional competencies and an emphasis on psycho-educational content. However, study quality was generally low and reliant on data from retrospective evaluation designs. Conclusion: Co-ordinated responses to bereavement support which include the features we identified are required to meet the needs of bereaved people during and beyond the pandemic. Rigorous primary studies investigating the experiences of the bereaved and the services that support them are essential to inform current and future disaster response efforts.