Background We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. Methods In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov , NCT04501978 . Findings Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–...
A woman (70-years) with a history of iron deficiency anemia and chronic kidney disease presented with two weeks of abdominal pain. Upper endoscopy demonstrated the gastric and duodenal mucosa was black and speckled consistent with diagnosis of pseudomelanosis. Biopsies showed pigment-laden macrophages in the lamina propria, which stained positive for iron and Masson-Fontana trichrome stain consistent with a “melanin-like” pigment. Although an uncommon endoscopic finding, this pigment has been associated with the use of certain medications, antihypertensives and iron supplements, and systemic illnesses, including hypertension, chronic kidney disease, gastric hemorrhage, and diabetes mellitus.
The name of the author Jeffrey Gill was misspelt as Jeffery Gill. We apologize for this error.
The seminal vesicles, particularly the lateral aspect and tips, are among the closest structures to the cavernous nerves and pelvic plexus. Given this proximity it is essential that the seminal vesicle dissection be performed in an athermal and atraumatic fashion during robot-assisted laparoscopic prostatectomy (RALP). Traditionally the seminal vesicle dissection during RALP is performed by dividing the vas deferens and following it proximally to locate the tip of the seminal vesicle. Here we describe a modification to the traditional anterior approach to seminal vesicle dissection. Our modification allows the dissection to be performed athermally and efficiently with use of minimal traction. The dissection proceeds medially between the two terminal vas deferens to identify the medial surface of one of the seminal vesicles. This medial surface is avascular and can be developed easily along the length of the vesicle using blunt dissection. Once its tip is identified it is elevated with the fourth arm medially between the two vas deferens. The ipsilateral vas can then be clipped and divided below the level of the elevated seminal vesicle. The vascular supply to the seminal vesicle is then simply identified entering the lateral aspect of its tip. A hemolock clip is placed directly beneath the tip of the seminal vesicle to control its vasculature. The remainder of the dissection can be performed with sharp dissection. Using this technique the seminal vesicle can be excised entirely with minimal traction and no thermal energy. By elevating the tip medially away from the location of the pelvic plexus and cavernous nerves, inadvertent damage to these neural structures is avoided when placing the hemolock clips.
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