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Objective To explore the clinical effect and safety of Suhexiang Pills () in the treatment of patients with tachycardia after severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Methods A total of 138 patients with tachycardia after SARS-CoV-2 infection admitted to eight hospitals such as 971st Hospital of the PLA Navy, Changzhou Second People's Hospital, Xuzhou First People's Hospital, Henan Provincial People's Hospital, Henan Chest Hospital from February 2023 to March 2023 were randomly divided into control group and treatment group, with 87 patients in the treatment group and 51 in the control group. Patients in the control group were po administered with betaloc, once a day, and the initial dose was 23.75 mg, adjusted in time according to the patient's heart rate. Patients in the treatment group were po administered with Suhexiang Pills, 1 pill/time, twice daily. Patients in two groups were treated for 7 d. The clinical efficacy of the two groups was observed, and the heart rate and cardiac function indexes, RR interval, blood oxygen saturation and adverse reactions were compared between the two groups before and after treatment. Results After treatment, the total effective rate of the treatment group was 98.85%, and the total effective rate of the control group was 90.20%, and the difference between the two groups was statistically significant (P < 0.05). After treatment, heart rates were significantly decreased in both groups (P < 0.05), and the heart rates of the treatment group were significantly better than those of the control group (P < 0.05) on the 7th day of treatment. After treatment, the level of left ventricular ejection fraction (LVEF) in both groups was significantly higher than that before treatment (P < 0.05), and there was statistical difference between the treatment group and the control group (P < 0.05). The levels of left ventricular end diastolic dimension (LVEDD) and left ventricular end-systolic diameter (LVESD) in the treatment group significantly decreased than that before treatment (P < 0.05), and there was no statistical difference compared with the control group (P > 0.05). After treatment, the maximum RR interval in both groups reached the normal range on the third day, and the treatment group was significantly better than the control group (P < 0.05). Blood oxygen saturation of the treatment group was significantly increased on the 7th day of treatment compared with before treatment (P < 0.05), but there was no statistical significance between the two groups (P > 0.05). There was no significant difference in the total incidence of adverse events between the two groups (P > 0.05). Conclusion Suhexiang Pills decrease heart rates in patients with tachycardia after SARS-CoV-2 infection, which was equivalent to the effect of western medicine, and can protect heart, improve heart function to a certain extent.Copyright © 2023 Editorial Office of Chinese Traditional and Herbal Drugs. All rights reserved.
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Background/Objectives: To date, not many studies have been conducted to examine the role of COVID-19 on gestation and fetal development. During COVID-19, pregnant women had difficulty accessing prenatal screening and care due to pandemics restrictions and lockdowns. In this retrospective study we aimed to assess the effect of the SARS-CoV-2 outbreak on fetal development in both prenatal and postnatal outcomes pre-and pre-COVID-19 pandemics in Northern Cyprus. Method(s): A total number of 61 aborted materials were karyotyped during the pre-pandemic period (January 2017 and March 2020) whereas 24 samples were analysed during the peripandemic period (March 2020-November 2021). On the other hand, 25 new-borns blood samples during the pre-pandemic and 44 samples during the pre-pandemic period were analysed. Result(s): No statistically significant difference found in health and abnormal aborted material karyotypes between two periods. On the other hand, a statistical significance was observed in postnatal chromosomal abnormalities (P = 0.04) after two long pandemic lockdowns, which are known as the first and the second waves, dramatically indicating that no baby with Down syndrome was between 2017-2020 whereas seven babies with Down Syndrome were born as consequences of without taking precaution against lockdowns. Conclusion(s): Overall, prenatal care is failed which resulting increased postnatal chromosomal abnormality due to heavy flight restrictions, economic inflation instability, limited access to medical services during COVID-19 pandemic lockdowns in Northern Cyprus.
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Objective: The aim of the cross-over study was to evaluate skill acquisition in lobectomy-naive surgical trainees completing a 4-week program to learn VATS lobectomy on a virtual reality surgical simulator (LapSim). Method(s): Lobectomynaive surgical trainees (year 1 and 2 postgraduation) were enrolled during the COVID pandemic from March to June 2021 for a 4-week course on basic VATS skills and right upper lobectomy. They were divided into 2 groups. Both groups completed an initial assessment, Group 1 completed the course first, then both groups completed a second assessment. Then Group 2 completed the course, and both groups completed a final assessment. Skill acquisition was assessed using instrument movement, procedure time, and blood loss for both the trained operation and an untrained operation (left lower lobectomy). Result(s): 16 trainees were enrolled, 10 completed the training program. There was no difference in baseline assessment. After Group 1 completed the training, they outperformed Group 2 in all metrics but this did not reach statistical significance. After training Group 2 at week 8, there was no longer difference in performance from Group 1. After completing the training program, the entire cohort showed a significant improvement in basic VATS tasks as well as lobectomies. There was statistically significant improvement in both right upper lobectomy instrument movement (P=0.002) and time (P=0.009) and left lower lobectomy time (P=0.047). Conclusion(s): This study showed that VATS simulation training on LapSim allowed junior trainees to learn advanced VATS resection during a pandemic and within 4 weeks. The acquired skills is transferrable to untrained operations. (Table Presented).
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Introduction: A decrease in operative volume of general surgery chiefs graduating the first year of the COVID-19 pandemic (2020) was previously noted using self-reported Accreditation Council for Graduate Medical Education (ACGME) case logs. The purpose of this study is to examine if this trend was captured in self-reported case logs and if those trends were similarly captured in an automated multi-institution artificial intelligence-based case log. Method(s): The ACGME National Data Report of general surgery cases was queried for mean cases performed as surgeon chief for the pre-pandemic (2018-2019) and pandemic (2019-2020 and 2020- 2021) period. A 24-institute HIPAA-compliant, web-based, surgical education management platform using an embedded artificial intelligence algorithm to generate case logs from electronic operative schedules was also queried. Percent change was calculated and statistical significance was calculated with unpaired T-Test. Result(s): Fifty-three ACGME categories were reviewed. A significant (p<0.05) decrease occurred in 19 categories (35.8%) the first pandemic year compared with pre-pandemic. The second pandemic year (2020-2021) 10 categories (18.8%) had a significant increase (p<0.05). The automated case log system did not see the same trend with only 2.7% of categories (9/324) with a significant decrease the first pandemic year. No subsequent significant increases occurred the second pandemic year. Conclusion(s): ACGME case logs reveal a recovery of operative volume for general surgery chiefs during the second year of the pandemic. However, the 24-institution, automatically logged system did not see the same trend. Regional variation or improved accuracy of automated case logs may explain the discrepancy.
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Objective To investigate the clinical significance of serum interleukin 6 (IL-6) in elderly patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) omicron variant and its correlation with underlying diseases. Methods A total of 22 elderly patients (>80 years old) infected with omicron variant, who were admitted to Department of Infectious Diseases, The First Affiliated Hospital of Naval Medical University (Second Military Medical University) from Apr. to Jun. 2022 and tested positive for SARS-CoV-2 RNA, were included. The level of serum IL-6 was measured by flow cytometry, and the level of serum C reactive protein (CRP) was measured by immunonephelometry. Patients were divided into pneumonia group (16 cases) and non-pneumonia group (6 cases) according to the imaging examination results, and were divided into severe group (severe and critical type, 5 cases) and non-severe group (mild and normal type, 17 cases) according to the condition. Binary logistic regression model and receiver operating characteristic (ROC) curve were used to analyze the correlation between serum IL-6 and CRP levels and the severity of the disease and whether it would progress to pneumonia. Meanwhile, the relationships between underlying diseases and serum IL-6 level were explored. Results Among the 22 patients, 6 were mild, 11 were normal, 3 were severe, and 2 were critical. The baseline serum IL-6 level in the pneumonia group was significantly higher than that in the non-pneumonia group ([20.16+/-12.36]pg/mL vs [5.42+/-1.57] pg/mL, P=0.009), and there was no significant difference in baseline serum CRP level between the 2 groups (P>0.05). There were no significant differences in baseline serum IL-6 or CRP levels between the severe group and the non-severe group (both P>0.05). Logistic regression analysis showed that the baseline serum IL-6 and CRP might be related to pneumonia after infection with omicron variant (odds ratio [OR]=2.407, 95% confidence interval [CI]0.915-6.328;OR=1.030, 95% CI 0.952-1.114). ROC curve analysis showed that the area under curve values of serum IL-6 and CRP in predicting the progression to pneumonia were 0.969 (95% CI 0.900-1.000) and 0.656 (95% CI 0.380-0.932), respectively, with statistical significance (Z=2.154, P=0.030). There were no significant differences in the baseline serum IL-6 level or proportions of severe patients or pneumonia patients among patients with or without hypertension, diabetes mellitus, coronary heart disease, chronic kidney disease or chronic obstructive pulmonary disease (all P>0.05). The baseline serum IL-6 levels of the omicron variant infected elderly patients with 1, 2, and 3 or more underlying diseases were 12.50 (9.15, 21.75), 23.55 (9.63, 50.10), and 10.90 (5.20, 18.88) pg/mL, respectively, with no statistical significance (P>0.05). Conclusion For omicron variant infected patients, serum IL-6 level is significantly increased in patients with pneumonia manifestations and is correlated with disease progression. Serum IL-6 level is of great guiding significance to judge disease progression and evaluate efficacy and prognosis of elderly coronavirus disease 2019 patients.Copyright © 2022, Second Military Medical University Press. All rights reserved.
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[Background] Sleep is closely related to immune function and human health, and adequate sleep is an important foundation for human health. [Objective] This study investigates the sleep status of the first-line medical staff in Wuhan in a fight against the coronavirus disease 2019 (COVID-19) outbreak, provides reference for improving the sleep quality of the first-line medical staff in public health emergencies. [Methods] Through convenience sampling, 112 medical workers (first-line group) who aided the COVID-19 fight in Wuhan and 134 medical staff (non-first-line group) who did not participate in the fight were selected. The Pittsburgh Sleep Quality Index (PSQI) was employed to collect data on the incidence of sleep disorders, time to fall asleep, duration of sleep, sleep efficiency, sleep disorders, use of sleep aid, and daytime functions. In addition, a self-made questionnaire was used to investigate the common concerns and time allocation characteristics of the first-line medical workers in the context of major infectious disease outbreaks. [Results] There were no significant differences between the two groups in demographic variables such as gender, age, job title, educational background, marriage status, number of children, and working years (P > 0.05). In the first-line group, 62 medical workers (55.36%) reported sleep disorders, while in the non-first-line group, 54 medical workers (40.30%) did;the difference was statistically significant (P=0.008). Among the seven components of the PSQI, the median sleep time (component 3) score of the first-line group was 1.5, which was higher than that of the non-first-line group (median 1.0) (P < 0.001);the median sleep efficiency (component 4) score of the first-line group was 1.0, which was higher than that of the non-first-line group (median 0) (P < 0.001). The actual sleep duration of the first-line group [(5.65+/-1.15) h] was lower than that of the non-first-line group [(7.00+/-1.40) h] (P < 0.001). The distributions of common concerns were different between the two group. The top three concerns were being infected (76.79%), exhausted (37.50%), and overloaded (27.68%) in the first-line group, and family members being infected (53.73%), being infected (45.52%), and child care (33.58%) in the non-first-line group. [Conclusion] The first-line medical team members report poor sleep quality, short sleep time, low sleep efficiency, sleep disorders, and many psychological concerns. It is necessary to take appropriate measures to improve their sleep quality.Copyright © 2021, Shanghai Municipal Center for Disease Control and Prevention. All rights reserved.
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Introduction: The COVID-19 pandemic caused significant changes in delivery of healthcare. Telemedicine emerged as a popular option. Numerous studies demonstrate a favorable opinion of telemedicine from patient and physician perspectives. What factors make it more efficient and effective This study explores how type of office visit impacts attitudes towards telemedicine and affects patient's preferences for future visits. Method(s): Surveys were delivered by mail or in person to 1,100 randomly selected patients of Sierra Nevada Gastroenterology, a community-based practice in Grass Valley, CA. Each patient (pt) had a telemedicine visit (TMV) from April 2020-October 2021. Three hundred twenty surveys were returned completed. Surveys contained a 5-point Likert scale set of questions rating the quality, communication, compassion, thoroughness and convenience of TMV. In person visits (IPV) were then directly compared to TMV for the same qualities. Demographics were recorded (Table 1). Surveys were separated into 3 categories based on type of visit: new complaint (NC), follow-up of existing problem (FU), procedure-related visit (PRV). Statistical analysis and chi-square test were used to determine statistical significance. Result(s): Quality, communication, thoroughness and compassion during TMV rated high with Likert scores of 4.3-4.7 (= 0 strongly agree) for all groups. Comparing the 3 groups (NC, FU, PRV) with chi-square testing, no statistical difference in ratings was seen. FU pts had the highest Likert scores in all categories. Pts with new complaints preferred IPV over TMV for quality, communication, thoroughness and compassion, which was rated statistically significantly higher (P< 0.05). TMV was favored for convenience in all groups with highest ranking in FU pts (73%). Conclusion(s): This study showed type of office visit did not affect satisfaction or ratings of TMV. However, type of visit did reveal preferences for either IPV or TMV. Pts with NC preferred IPV and felt compassion is important and delivered more effectively in person. This suggests non-verbal communication such as body language, facial expression and tone is conveyed more effectively in person than over phone or video calls. FU or PRV pts rated TMV as more convenient and preferable over IPV for future visits, suggesting that pts with stable or less acute problems prioritize convenience over other factors when selecting type of visit. Further studies are needed to determine what other factors will influence and improve quality of TMV.
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The course of a new coronavirus infection is associated with immune system disorders during the acute stage of the desease. Administration of effective etiotropic drugs contributes to early elimination of the virus. At the same time, risks of post-COVID immune system disorders are minimized. The aim of the study was to investigate features of the immune response formation against the background of etiotropic therapy in patients who underwent COVID-19. Material and methods. An observational retrospective comparative study was conducted. The study involved patients with COVID-19 3 months after treatment with etiotropic drugs (riamilovir or umifenovir). The study involved 87 patients (52 women and 35 men) with varying degrees of COVID-19 severity. In accordance with the study design, participants were divided into 2 groups: the first group - 41 patients (received riamilovir during the acute period of the disease);the second group - 46 patients (received umifenovir in the acute period of the disease). Statistical processing of the results was carried out using the Statistica 8.0 software package. Extensive indicators, median (Me) and interquarter range Q25-Q75 were calculated. Statistical significance between the indicators of independent samples was assessed by Mann-Whitney nonparametric test and Chi-square test. P-values below 0.05 were considered statistically significant. Results and discussion. Analysis of clinical and laboratory data showed that after suffering COVID-19, not all indicators of the immune system in patients who had had COVID-19 recovered to control values. However, it is noted that in patients of the main group, which using riamilovir, compared to the comparison group was less likely to be diagnosed with chronic systemic syndrome, inflammation, dysregulation of the cellular link of immunity in the early post-COVID period.Copyright © Eco-Vector, 2022.
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Background: The COVID-19 pandemic has disproportionally affected people of black ethnicities, who have been at greater risk of SARS-CoV-2 acquisition, morbidity and mortality than those of white ethnicity. We describe factors associated with severe COVID-19 infection in the GEN-AFRICA cohort of people of black ethnicities living with HIV in the U.K. Method(s): First reported episodes of COVID-19 up to October 2022 were ascertained by direct questioning and/or medical records review. Pre-pandemic immune-virological and comorbidity status was based on measurements obtained prior to 01/2020 and used to identify risk factors for severe (requiring hospitalisation or resulting in death) COVID-19, using logistic regression Results: COVID-19 status was available for 1806 (72%) of 2503 GEN-AFRICA participants (mean age 49.2 [SD 10.2] years;56% female;80% sub-Saharan African and 14% Caribbean ancestry, median CD4 count 555 [IQR 400-733] cells/mm3;93% undetectable HIV RNA [<200 copies/ mL]);573 (32%) reported a clinical illness consistent with COVID-19;63 (3.5%) experienced severe COVID-19 (hospitalisation 59;death 4). Those who experienced severe COVID-19 were older, more often male, had lower CD4 counts and fewer had undetectable HIV RNA;they more often had prior AIDS, hypertension, diabetes mellitus and chronic kidney disease. Region of ancestry, nadir CD4 count, and obesity were not associated with severe COVID-19. In multivariable analysis, CD4 count <350 cells/mm3, diabetes mellitus and chronic kidney disease were associated with increased odds of severe COVID-19 (Table). Sex and a pre-pandemic HIV RNA were associated with severe disease although this did not reach statistical significance. By October 2022, 1534 (88%) of this sample had received >=1 dose of SARS-CoV-2 vaccine;those who experienced severe COVID-19 were less likely to report vaccination (77% vs. 89%, p=0.01). Conclusion(s): By the end of October 2022, nearly onethird of people of Black ethnicities with HIV in this sample had experienced COVID-19;3.5% had developed severe COVID-19 disease. Pre-pandemic immunovirological and comorbidity status were associated with severe COVID-19. Black populations with less favourable HIV control than observed for GEN-AFRICA participants may have suffered greater COVID-19 morbidity and mortality. (Table Presented).
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Background: The COVID-19 pandemic caused millions of deaths, its impact lessened with effective vaccines and treatments. The subsequent monkeypox outbreak posed another global threat, disproportionately affecting men who have sex with men (MSM), with concerns around increasing community stigma. Vaccinating at risk groups is vital in minimising COVID-19 and monkeypox transmissions and adverse sequalae. Our HIV clinic serves a diverse population in a deprived area with a large immigrant population and high level of co-morbidities, associated with poorer outcomes. We explored factors associated with COVID-19 and monkeypox vaccine uptake. Method(s): We reviewed COVID-19 vaccine first, second and third/booster uptake and first smallpox vaccine among MSMs attending our HIV clinic. Monkeypox vaccination is a two-dose course. Initial limited vaccine availability meant first monkeypox vaccine was prioritised for all eligible patients;we therefore analysed first monkeypox vaccination uptake. 186 MSM PLWH were identified. 164 were included in our analysis;22 were excluded due to insufficient vaccination information. Data was recorded contemporaneously in patients' records. COVID-19 vaccine uptake was verified using NHS Summary Care Record and London Care Record. Data on age and ethnicity was collected. Result(s): Demographics: Age: mean 42.9 years, 49% <=40 years, 51% >40 years Ethnicity: 55% White, 26% Black, 5% Asian, 2% mixed, 7% other, 4% not stated COVID-19 vaccination uptake reached statistical significance between age groups: <=40y 53%, >40y 80% (p = 0.001) and ethnicities: White 73%, Black 50%, Asian 67% (p = 0.026). Monkeypox vaccination uptake did not reach significance: <40y 26%, >40y 29%;ethnicity: White 31%, Black 24%, Asian 33%. Additionally, COVID-19 vaccinated patients were not statistically significantly more likely to accept monkeypox vaccination. Conclusion(s): Monkeypox vaccination uptake was similar across ages and ethnicities. However, monkeypox vaccination uptake was considerably lower than COVID-19 vaccination. Further work is needed to identify and engage at risk groups and address obstacles affecting monkeypox vaccination in marginalised communities. Lessons from COVID vaccination campaigns should be employed to reach unvaccinated high-risk MSMs. (Table Presented).
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Background: People with HIV (PWH) are at a higher risk of severe acute COVID-19;however, their risk of subsequently developing post-acute sequelae of SARS-CoV2 (PASC) remains unclear. Furthermore, although vaccination has been shown to be protective against PASC in the general population, few studies have evaluated its effectiveness in PWH. Method(s): We used the TriNetX health research database to source data from 69 healthcare organizations within the US. We included any adults aged >= 18 years with positive SARS-CoV-2 between January 1, 2020 and September 16, 2022 and categorized them based on their HIV status, baseline sociodemographic characteristics, comorbidities and COVID-19 vaccination status. The primary outcome was risk of PASC, compared by HIV and vaccination status after 1:1 propensity score matching. PASC was defined as either the persistence of COVID-attributable symptoms or the occurrence of new-onset health conditions at least 28 days following COVID-19 diagnosis. For all analysis, statistical significance was set at p < 0.05. Result(s): Of 3,048,792 people with confirmed SARS-CoV-2 infection, 1% (n=28,904) were PWH, with 9% of PWH (n=2592) vaccinated. At 28 days post-COVID-19 diagnosis, PWH had lower mortality compared with their non-HIV counterparts (OR 0.78, 95% CI 0.70-0.87), but higher risk of developing new-onset diabetes (DM) (OR 1.26, 95% CI 1.11-1.42), heart disease (OR 1.27, 95% 1.14-1.41), malignancy (OR 1.66, 95% CI 1.45-1.89), thrombosis (OR 1.25, 95% CI 1.12-1.39) and mental health disorders (OR 1.70 (95% CI 1.53-1.90). Furthermore, vaccinated PWH had significantly lower odds of death (OR 0.63, 95% CI 0.42- 0.93) and each new-onset PASC outcome, as follows: DM (OR 0.51, 95% CI 0.32- 0.82), heart disease (OR 0.44, 95% CI 0.29-0.67), malignancy (OR 0.43 (95% CI 0.25-0.74), thrombosis (OR 0.51, 95% CI 0.33-0.78) and mental health disorders (OR 0.49, 95% CI 0.30-0.79). The risk of PASC was higher during the pre-Delta variant period but did not vary based on CD4 count or HIV viremia. Conclusion(s): HIV infection confers a higher risk of PASC. Importantly, COVID-19 vaccination significantly lowered mortality and was protective against PASC among PWH. With the increase in the number of COVID-19 survivors, vaccination offers an effective preventive strategy to address a burgeoning public health problem. (Table Presented).
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Background: Infections have historically been a leading cause of death, particularly in children. Medical advances, including vaccines and antimicrobials, have significantly decreased infection-related deaths, but infections remain a cause of pediatric mortality, especially in premature infants. The types of infections implicated in childhood deaths have changed with these advances, for example, meningitis and meningococcal infections were leading causes in 1981 but not in the later period. The incidence and etiologies of infection- related deaths may be altered by major events that modify not only medical practices but also societal attitudes and activities. Examples of such events include the HIV/AIDS epidemic that began in the early 1980s and the more recent COVID-19 pandemic. In order to investigate changes in infection-related pediatric deaths over time, we analyzed and compared autopsy cases performed during 5-year span prior to both the HIV/AIDS epidemic and the COVID-19 pandemic in which infections contributed to death. Method(s): Review of all autopsy cases performed at our institution between 1/1/1975-1/1/1980 and between 1/1/2015-1/1/2020 was performed to identify cases in which infection directly contributed to death, comprising 1262 cases. Only liveborn children were considered, and neonatal sepsis from amniotic sac infections was excluded. Comparison of decedent characteristics and infectious etiologies between the two time periods was performed, identifying age, race, sex, gestational age (for decedents less than 3 months of age), and etiologic class of agent (bacterial, viral, fungal or parasitic). TORCH infections and vaccine-preventable illnesses were specifically assessed. Proportions were compared using 1 (assessing TORCH, vaccine-preventable, and prematurity deaths)- or 2-tailed (all others) z-tests, with significance calculated at the < 0.05 level. Result(s): In the 1970s cohort, 300 infectious autopsy cases were identified in liveborn children;73 were identified in the 2010s. Compared to the 2010s cohort, the 1970s decedents were more likely to be white (85% v 53%, p=0.012), comprise children aged 1-5 and 13+ (22% v 6.8% [p=0.003] and 16.4% v 8.3% [p=0.036]), and were less likely to be premature (66.7% v 80.4%, p=0.039). Vaccine-preventable illnesses (for example: measles) accounted for 36 deaths in the 1970s cohort but only 2 in the 2010s cohort (p=0.009). Thirteen children died of TORCH infections (CMV, toxoplasmosis and HSV) versus 5 in the 2010s (CMV and HSV), which did not reach statistical significance. Conclusion(s): Pediatric mortality secondary to infections has decreased significantly compared to fifty years ago, especially in younger children and in relation to vaccine-preventable infections such as meningococcal disease. This drop is largely attributed to medical advances, including vaccines and antimicrobial medications. Additional contributing factors could include practices adopted post-HIV/AIDS, especially in the community. Further exploration of how such changes in medical and social practice impacted mortality and comparing them to changes occurring in the intra/post-COVID-19 era, is helpful. Yet, with the increased survival of premature infants, they remain at risk of devastating consequences from infections.
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Background: The tolerability of mRNA COVID-19 vaccines among people living with HIV (PLWH) has been understudied in vaccine trials. CoVPN 3008 (Ubuntu) is the largest multicenter Phase 3 efficacy trial of mRNA vaccines in sub-Saharan Africa. Method(s): We enrolled adults age >=18 years living with HIV or another comorbidity associated with severe COVID-19. Previously vaccinated individuals were excluded. Baseline testing included HIV, CD4 count and HIV viral load (VL) (if HIV+), anti-SARS-CoV-2 antibodies, and nasal swab SARS-CoV-2 nucleic acid amplification test (NAAT). All participants receive vaccinations at months 0 and 6, and SARS-CoV-2 seronegative individuals also receive vaccination at month 1. This analysis includes mRNA-1273 vaccinations at months 0 and 1. Reactogenicity (solicited adverse events [AEs]) was assessed among a representative subset of participants (Safety Subset, SS) for 7 days post-vaccination. Baseline characteristics associated with moderate/severe reactogenicity events were assessed by univariate and multivariate logistic regression. Result(s): 14002 participants were enrolled in the trial (1510 into the SS) at 46 sites from 2 Dec 2021 to 9 Sep 2022. At baseline in the SS, 71% (1065) were female, median age 38 years (IQR 32-46), and median BMI 25.0 (IQR 20.7-30.2). 73% (1108) were SARS-CoV-2 seropositive, and 8.7% (131) had a positive nasal NAAT swab. 16% (197) had a history of tuberculosis. 84% (1267) were PLWH, with median CD4 count of 614 cells/muL (IQR 414-861);7.8% had CD4 count < 200. 21% (238) had detectable HIV VL (>=50 copies/mL), with median VL 1660 (IQR 182-23932). 14% (172/1262) and 12% (64/542) of PLWH reported moderate/severe reactogenicity after the 1st and 2nd vaccination (Figure), with no hospitalizations. Female PLWH and CD4 count >500 had 35% (p=0.03) and 44% (p=0.04) increased odds of moderate/severe reactogenicity, respectively. Other baseline characteristics were not associated with the odds of reporting moderate/severe reactogenicity among PLWH after 1st vaccination. Similar trends were seen after the 2nd vaccination, but none reached statistical significance. In multivariate models, female sex remained associated with increased odds of moderate/severe reactogenicity after the 2nd vaccination. Conclusion(s): Similar to observations in HIV-negative populations, mRNA-1273 was well tolerated by PLWH with more reactogenicity in females. Impaired inflammatory responses among participants with CD4 counts < 500 cell/muL may explain less moderate/severe reactions.
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INTRODUCTION AND OBJECTIVE: Research demonstrates the benefits of robotic-assisted prostatectomies (RARP) in regard to blood loss and post-operative recovery, there is a paucity in the literature regarding RARP as an outpatient procedure. With minimal operating room capacity during COVID-19, advances in minimally invasive surgical techniques and a relatively healthy patient population, outpatient RARP may be feasible. The aim of our study was to demonstrate the safety and feasibility of RARP as a same day outpatient procedure. METHOD(S): A retrospective cohort study at a single institution was performed by four fellowship trained surgeons who routinely perform RARP. Patients were identified through billing records who underwent RARP between January 2019 and December 2021. Patients were divided into two cohorts, inpatient (one stay past midnight) and outpatient (defined as same day surgery with no stay past midnight). Individual surgeons admission necessity during COVID-19 limitations. We then extracted data using the electronic health record (EHR). The two groups were then compared using standard statistical methods for cohort studies. Statistical significance was defined as p<0.05. RESULT(S): Over a two-year period, a total of 497 RARP were performed with 139 (28%) outpatient cases. There was no difference in baseline demographics between the cohorts. There was a statistically significant difference in estimated blood loss (142 vs 102 mLs, p>=0.001) and operative time (193 vs 180 mins, p=0.004) in the inpatient vs outpatient cohorts, respectively. There was no significant difference in cancer stage, prostate size, or node/margin positivity between cohorts. There was a higher rate of readmissions (5% vs 0%, p=0.007) and number of ED presentations (0.15 vs 0.05, p=0.019) in the inpatient group. There was no difference in complication rates between the groups. Importantly, there was no significant difference in burden on the clinical staff demonstrated by no difference in number of phone calls to clinic, number of EHR messages, or opioid prescriptions on discharge. CONCLUSION(S): Overall, our data suggests that in a well selected patient group, RARP can safely be performed as an outpatient procedure with no significant differences on clinic staff workload or oncologic outcomes. While there was no pre-defined "algorithm" to determine outpatient vs inpatient surgery, the similarity in demographics and pre-operative characteristics between the groups lends support to performing this procedure as an outpatient with inpatient admission being reserved for select patients.
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Introduction: COVID-19 coagulopathy is associated with poor prognosis and a state of coexisting 'hypercoagulopathy' (HyperC) and hypofibrinolysis, only detected by viscoelastic tests (VET). VET technology has been useful in areas where conventional tests are inadequate, such as screening for HyperC, thrombotic risk assessment and systemic anticoagulants' effect. We aim to characterize the evolution profile of coagulopathy in patients with COVID-19 infection during their intensive care unit (ICU) stay. Method(s): Consecutive recruitment of adult COVID-19 patients admitted to our hospital's ICU, during a 6 months period. Patients with thrombosis in the previous 3 months, pregnancy, under hormone therapy, and congenital coagulopathies were excluded. VET were executed every 5 days, at discharge and in complications and all of them were under low weight molecular heparin (LMWH) therapy. Group 1 (G1), n = 24-less than 10 days in ICU and group 2 (G2), n = 16-more than 10 days in ICU. In G1 there was 1 death (day 3) and in G2 there were 5 deaths (between days 15 and 42). We focused current analysis on VET-Rotem parameters (see Fig. 1). Result(s): Prognostic scores APACHE II, SAPS II and SOFA were higher in G2, but surprisingly G1 patients are more obese. G2 patients had shorter aPTT and lower platelets. The variables CT-HepTem and MCF Extem-MCF-Fib-Tem present a greater difference between groups, but no statistical significance. We observed an initial correlation between basophils number (which is lower) on CT Intem and CT Hep-Tem, lost as progression to cure, probably due to cytoplasm heparin granules. As expected, VET were in accordance with HyperC: short CTs, increased MCFs, and decreased lysis. Conclusion(s): We expected to guide/adjust LMWH dosage, using Rotem profiles, however these were not corrected by LMWH, used transversally, and remained unchanged in all patients during their stay in ICU.
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BACKGROUND: There are few data on the outcome of COVID-19 in patients with IBD, none in the Chilean population. The aim of the study was to describe the demographic and clinical characteristics of patients with IBD who developed COVID-19, the evolution and clinical course of IBD at 1 month follow-up after SARS-CoV-2 infection. METHOD(S): This was an observational, cross-sectional, and analytical study. Patients with positive RT-PCR SARS-Cov-2 who were followed in the IBD Program of Clinica las Condes tertiary referral center (n = 1,493), were studied by spontaneous patient consultation and/or email survey. The clinical IBD data and COVID-19 related symptoms were obtained from the medical record and follow-up telephone interviews. Statistical significance was determined (Fisher's test P < 0.05). RESULT(S): From March 1 to August 31, 2020, 32 patients were reported positive RT-PCR SARSCov- 2, 18 (56%) ulcerative colitis and 14 (44%) Crohn's disease. The median age was 32 years (range 18 - 69), 56% women. Seven patients had an additional comorbidities. At the time of infection, 9 patients and their co-habitants maintained quarantine, isolation and social distancing recommendations. Only 1 patient was clinically active at the time of infection. Ten patients (31%) were on immunomodulator/biologic maintenance treatment, of which 4 were on combination therapy. Sixty percent of patients contacted the IBD clinical team when RT-PCR SARS-Cov-2 resulted positive. The most frequent COVID-19 onset symptoms were headache (66%), myalgia (63%), and fever (50%). Four patients required hospitalization (no 1 in Critical Care Unit), none of them were on immunomodulator nor biologic treatment. Two patients received Azithromycin and 1 received steroids as treatment for COVID-19. In univariate analysis, there were no significant differences in age, diagnosis or IBD treatment in patients who required hospitalization for COVID-19 infection. Seven patients discontinued their IBD treatment during the infection (6 at the direction of the IBD Program and 1 self-discontinued therapy). Two patients had a flare of their IBD during 1 month post-COVID-19 follow-up. CONCLUSION(S): In this cohort of patients, IBD medications, including immunomodulators and biologic therapy, were not associated with a greater severity of COVID-19 infection.
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Objective: The primary objective was to assess the difference in rates of hypoglycemia (blood glucose (BG) <=70 mG/dL) when using reduced-dose (5 units) vs. standard-dose (10 units) of IV regular insulin for hyperkalemia treatment in renal insufficiency. Secondary objectives include the efficacy of insulin dose on potassium reduction and evaluating the difference in rates of severe hypoglycemia (BG <=54 mG/dL) between the groups. Method(s): This was a retrospective chart review of patients with renal insufficiency treated with IV regular insulin for hyperkalemia at a tertiary care teaching hospital from June 2020 to June 2021, with institutional review board approval. Inclusion criteria encompassed patients aged 18 years and older with elevated baseline potassium (>=5.5 mEq/L), estimated glomerular filtration rate < 30 mL/min/1.73m2, end stage renal disease, or presence of acute kidney injury, having received either 5 or 10 units of IV regular insulin for hyperkalemia, and had documented glucose and potassium levels after insulin administration. Patients who were pregnant, had diabetic ketoacidosis, or a baseline BG <=70 mG/dL were excluded. Data collection included patient demographics, diabetes history, relevant labs at time of elevated potassium, doses of insulin and dextrose administered for hyperkalemia treatment, presence of coronavirus-19 infection, glucose levels within 6 hours and first potassium level within 24 hours following insulin administration, concurrent use of potassium-lowering agents, insulin outside of hyperkalemia treatment, or steroids, and mortality. Result(s): Out of 409 patients included, 92 were in the 10-unit group and 317 in the 5-unit group. The rate of hypoglycemia in the 5-unit arm vs. the 10-unit arm was 6.9% vs. 8.7% (p=0.649), respectively. The rate of severe hypoglycemia between the 5-unit arm and the 10-unit arm was 3.2% vs 5.4% (p=0.682), respectively. The percent normalization of potassium was not statistically different between the 5-unit group and the 10-unit group (59% vs. 68%;p=0.115), with the same mean reduction in potassium from baseline (0.8 mEq/L (p=0.947)). Administration of concurrent treatments for hyperkalemia was similar between the groups, with dialysis being the only one with statistical significance in normalization of potassium. Patient characteristics that could have an impact on risk of hypoglycemia were studied and analyzed, including pre-treatment BG, history of diabetes mellitus, insulin naive, and patient weight. In patients with hypoglycemia (n=30) vs. those without hypoglycemia (n=379), there was a significantly different mean pre-treatment BG (113 mG/dL vs. 178 mG/dL, p<0.001). Discussion/Conclusion: There was no significant difference in rates of hypoglycemia and severe hypoglycemia between the 5-unit vs. 10-unit groups. There was no significant change in potassium normalization between the two insulin doses. Because of the small number of hypoglycemia events, larger studies are needed to better understand if 5 units of regular insulin is a safer option for the treatment of hyperkalemia in renal insufficiency.Copyright © 2023
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Background: At least 10% of SARS-CoV-2 infected patients suffer from persistent symptoms for >12 weeks, known as post-COVID-19 condition (PCC) or Long Covid. Reported symptomatology is diverse with >200 physical and neurological debilitating symptoms. Here, we analyzed pro-inflammatory cytokine levels as a potential mechanism underlying persistent symptomatology. Method(s): Clinical data and samples used belong to the KING cohort extension, which includes clinically well characterized PCC (N=358, 59 persistent symptoms evaluated), COVID-19 recovered and uninfected subjects. We used Gower distances to calculate symptom's similarity between PCC and Ward's hierarchical clustering method to identify different symptom patterns among PCC patients. Cytokine levels of randomly selected PCC, recovered and uninfected subjects (N=193) were measured on plasma samples collected >6 months after acute infection using the 30-Plex Panel for Luminex. Mann- Whitney t-test was used to compare PCC vs recovered groups and Kruskal-Wallis t-test for >2 groups comparisons (PCC vs recovered vs Uninfected and within PCC clusters). FDR correction was applied for statistical significance (p-adj). Result(s): Hierarchical clustering identified 5 different PCC clusters according to their symptomatology, where PCC3 and PCC5 clusters showed higher prevalence of women ( >80%) and more persistent symptoms, while acute COVID-19 was mild in >80% of the patients. We selected 91 PCC (belonging to each cluster), 57 recovered and 45 uninfected subjects for cytokine profiling (Table 1). 13 soluble markers were significantly elevated (IL-1beta, Eotaxin, MIP-1beta, MCP-1, IL-15, IL-5, HGF, IFN-alpha, IL-1RA, IL-7, MIG, IL-4 and IL-8) in PCC and recovered groups compared to uninfected subjects (all p-adj< 0.04). In addition, PCC subjects tended towards higher levels of IL-1RA compared to recovered group (padj= 0.071). Within PCC clusters, FGF-basic and RANTES were elevated while IL-2 and MIG were decreased in PCC3 and PCC5 compared to the other PCC clusters (all p-adj< 0.04). TNF-alpha, IP-10, G-CSF and MIP-1alpha were decreased in PCC3 and PCC5 not reaching statistical significance (all p-adj=0.07). Conclusion(s): Some cytokines remained altered in all SARS-CoV-2 infected subjects independently of persistent symptoms after 6 months from acute infection. Differences between PCC and recovered individuals are limited after correction. Importantly, PCC cytokine profiles showed differences between clusters, which suggests different PCC subsyndromes with distinct etiology. Subjects Characteristics (Table Presented).
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Purpose of Study: Previous Osteopathic manipulative treatment (OMT) research has shown evidence of increased lymphatic movement resulting in increased leukocyte and cytokine flow. One study even showed increased antibody titer response in patients when used in conjunction with the Hepatitis B vaccine. Given previous studies, our group conducted a year-long longitudinal randomized controlled clinical trial to evaluate the ability of OMT to improve the COVID-19 vaccine immune response. Methods Used: Subjects were randomized into either the control arm or OMT intervention arm. OMT consisted of myofascial release of the thoracic inlet, pectoral traction, diaphragm release with MFR, splenic pump, and thoracic pump applied the day of and the day following each vaccination session. All subjects in each group received the Pfizer mRNA COVID-19 vaccine. All subjects had blood drawn on day 0 (1st vaccine), day 7, day 21 (2nd vaccine), days 28, 90, 210, and 365. Anti-spike IgG immunoglobulin titers (AS IgG) were measured at all time points for all subjects. Side effects, adverse events, and medication usage in response to the vaccines or OMT was documented. Breakthrough cases with symptomology and medication usage was documented for both groups. The study was approved by the WesternU IRB committee, protocol #FB21/IRB026. Summary of Results: Data for 91 subjects were analyzed with 41 male (45.1%) and 50 female (54.9%). Age distribution was comparable between the two groups. Side effects and medication usage reported by the subjects was similar between groups (p>0.1). AS IgG measured at baseline distinguished between previously infected individuals and those naive to COVID-19, regardless of OMT treatment. For all time points measured, the average AS IgG in subjects trended higher in OMT group than control group. Two-way ANOVA analysis showed statistical significance at 1 week after 2nd injection (p<0.001) in the COVID-19 naive population. 13 symptomatic breakthrough infections were reported in the control group and 12 in the OMT group. Length of symptoms were reported as 8.36 +/- 4.60 days (control) and 4.62 +/- 2.60 days (OMT) (p<0.05). Length of medication usage was 3.64 +/- 3.58 days (control) and 1.23 +/- 1.24 days (OMT) (p<0.1). Conclusion(s): Both groups had comparable side effects after COVID-19 vaccination with no adverse events linked to OMT, indicating that OMT is a safe adjunct that can be used with COVID-19 vaccination. The data showed an enhanced immune response by OMT, as evidenced by increased levels of AS IgG in previously naive subjects. Although both control and OMT groups had similar rates of symptomatic breakthrough infection, the OMT data shows reduced length of symptoms and medication duration in this population when compared to control breakthrough infections. This study is underpowered for statistical significance at each time point and future vaccination studies should recruit more patients to confirm the trends seen here.
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INTRODUCTION AND OBJECTIVE: We performed a shamcontrolled, randomized prospective trial in men with ED using an electrohydraulic shockwave device FDA cleared for connective tissue activation and improved blood flow. METHOD(S): This single-blind study was performed in men with ED naive to acoustic wave and shockwave therapy. Patients were randomized to treatment and assigned to active low intensity shockwave therapy (LiSWT) (4 Hz, 0.12 mJ/mm2) or sham treatment, 2:1. Arm 1 consisted of 3 treatments of 5000 shocks every 3 weeks. Arm 2 consisted of 5000, 3000, and 3000 shocks during weeks 1, 2, and 3, respectively, followed by an identical cycle of treatment 3 weeks later. Doppler ultrasound and grayscale imaging with a 15.4 MHz probe were performed under pharmacologic erection at weeks 20 and 32. Subjects completing sham treatment were unblinded and crossed over to the opposite arm for active treatment. Post-treatment end diastolic velocity (EDV) and peak systolic velocity (PSV) were measured, and visual grading scores were used to assess extent of hypoechoic regions in the corpora cavernosa. Data were analyzed by 2-way repeated measures ANOVA with Geisser-Greenhouse correction. Pairwise comparisons were performed to baseline used Dunnett's multiple comparison test. Missing data were imputed by "last observation carried forward". RESULT(S): Although powered for 60, recruitment was limited due to COVID and 36 subjects (22 active, 14 sham) were randomized. Sham treatments showed no significant changes in outcome measures. The number of subjects with improved visual grading scores in the proximal region was consistently higher in active LiSWT vs sham (Arm 1=88.9% vs. 11.1%;Arm 2=40.0% vs. 20.0%, respectively) with statistical significance in Arm 1 at weeks 20 (p=0.005) and 32 (p=0.001). Sham subjects rolled over to active LiSWT also had improved grayscale ratings (Arm 1=33.3% vs. 11.1%;Arm 2=40.0% vs. 20.0%). After LiSWT, greater numbers of patients had higher PSV, lower EDV, or no worsening of blood flow parameters relative to baseline. Decrease in EDV was statistically significant in active treatment Arm 2 at Week 32 (p=0.003). Mean IIEF-EF scores were nominally higher in subjects in active treatment who had improved visual grading scores vs those with no improvement. Adverse events were transient. CONCLUSION(S): Flaccid penile LiSWT appears to be safe and efficacious for treating ED based on statistically significant changes from baseline between sham and active treatments in primary outcome measures.