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Objective: We assessed the effectiveness of oral Hydroxychloroquine (HC), Azithromycin (AZ) and Oseltamivir (OS), alone or combined, among patients hospitalized with mildly symptomatic coronavirus infectious disease (COVID-19). Methods: Following the approval of the National Bioethics Committee and prospective registration (clinicaltrials.gov NCT04338698), a multicenter randomized clinical trial of adaptive design was conducted at 10 multispecialty hospitals in Pakistan. Patients were randomized into seven treatment groups. Starting April 15, 2020, consenting, eligible, otherwise healthy adult patients or those with co-morbidities under control, were recruited if they presented with mildly symptomatic COVID-19 (scored 3 on a 7-point ordinal scale anchored between 1 = not hospitalized, able to undertake normal activities, to 7 = death) confirmed by quantitative Real-Time Polymerase Chain Reaction (qRT-PCR). Two primary outcomes were assessed by day seven: Turning qRT-PCR negative; and clinical improvement of two points from the baseline. Outcome rates were compared using a chi-square test. Multiple imputations were applied to handle missing data. An interim data analysis was carried out on July 19, 2020, following which the study continued without treatment group changes. Data Safety and Monitoring Board advised to stop recruitment due to its futility on January 18, 2021. Results: Of 471 patients randomized, a total of 426 (90.4%) completed the follow-up for primary outcomes. Based on imputed data analyses at day seven: Total qRT-PCR negative cases were 137/471 (29%, 95% CI 25.0 - 33.4). By day seven, a total of 111/471 (23.5%, 95% CI 19.8 - 27.6) showed clinical improvement. No serious or non-serious adverse event was reported. Conclusions: Among patients with mild COVID-19, there was no statistically significant difference in the effectiveness of oral antimalarial, antiviral, or antibiotic treatments.Clinicaltrials.gov ID: NCT04338698.
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BACKGROUND AND AIMS: When colon polyps are removed in the setting of inflammatory bowel disease (IBD) involving the large intestine, biopsy sampling of the flat mucosa surrounding such polyps have been recommended, but there are no data to support this practice. METHODS: We reviewed endoscopic and pathologic findings in IBD patients who had dysplastic polyps removed and biopsy sampling of the adjacent flat mucosa. We assessed risk for subsequent neoplasia based on the presence or absence of dysplasia in the peri-polyp flat mucosa and based on number and grade of index polypoid lesions. Kaplan-Meier survival analysis was performed. RESULTS: Fifty-six IBD patients (68% ulcerative colitis [UC]) underwent 102 colonoscopies, in which 129 dysplastic polyps were resected. Five hundred three biopsy procedures of the surrounding flat mucosa were performed (mean, 3.9 biopsy samples per polyp), of which 16 (3.2%) were dysplastic. Thirty-four patients (21 UC) had follow-up in a median of 1.7 years (range, .02-15) and 147 colonoscopies. The presence of dysplasia in peri-polyp biopsy specimens during index colonoscopy was not associated with risk of developing high-grade dysplasia (HGD) or cancer (Pearson χ2 test = .19). The size and number of dysplastic polyps were not predictive of neoplastic outcomes, but the probability of developing subsequent advanced neoplasia for polypoid low-grade dysplasia was 18%, 29%, and 40% by 1, 3, and 5 years, respectively, and for polypoid HGD was 50%, 60%, and 70% by 1, 3, and 5 years, respectively (hazard ratio, 7.0; standard error, 4.8). CONCLUSIONS: In patients with IBD-associated colitis, biopsy sampling of the mucosa adjacent to discrete dysplastic polypoid lesions are low yield and do not predict findings in follow-up examinations. However, the grade of dysplasia of the polyp itself is predictive of subsequent advanced neoplasia.
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Adenocarcinoma/patologia , Colite Ulcerativa/patologia , Neoplasias do Colo/patologia , Pólipos do Colo/patologia , Doença de Crohn/patologia , Mucosa Intestinal/patologia , Biópsia , Colite/patologia , Colonoscopia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Modelos de Riscos Proporcionais , Estudos RetrospectivosRESUMO
BACKGROUND AND AIMS: Gestational diabetes mellitus (GDM) is delineated by the presence of glucose intolerance at any level that manifests or is initially identified during pregnancy. Factor I fibrinogen is among the most essential blood coagulation proteins. The concentration of fibrinogen influences platelet aggregation and blood viscosity. This study aimed to determine the correlation between fetal cord blood fibrinogen and plasma fibrinogen in pregnant women with GDM and between fetal cord blood fibrinogen and maternal blood sugar. METHODS: A cross-sectional study was executed at Al-Elwiya Maternity Teaching Hospital in the obstetrics and gynecology department. The sample included 90 term pregnant women: 45 were confirmed to have GDM, and 45 healthy pregnant women served as control. Estimation of prelabor maternal fasting and random plasma glucose and plasma fibrinogen was performed. During delivery, blood was drawn from the umbilical cord to estimate neonatal plasma glucose and fibrinogen levels. RESULTS: The mean maternal plasma fibrinogen level exhibited a notable increase in women with GDM compared to the control (330.11 ± 56.92 mg/dl versus 254.89 ± 41.01 mg/dl). The infants of diabetic mothers had significantly lower mean cord plasma glucose levels (65.71 ± 14.63 mg/dl versus 77.80 ± 7.81 mg/dl) and higher mean cord plasma fibrinogen levels (269.42 ± 25.91 mg/dl versus 229.69 ± 21.29 mg/dl). Umbilical cord plasma fibrinogen was correlated positively with maternal plasma sugar and fibrinogen. CONCLUSION: A positive correlation between maternal and fetal cord fibrinogen levels was determined in women with GDM. Monitoring plasma fibrinogen levels in neonates of mothers with GDM could be facilitated by longitudinal, large-scale validation studies enabled by artificial intelligence as a new, evolving technique that contributes to more valuable outcomes. This would shed additional light on the course and function of plasma fibrinogen for a more comprehensive analysis of the fetal clotting system.