Category: Statistics

J Natl Cancer Inst. 2021 Aug 28:djab174. doi: 10.1093/jnci/djab174. Online ahead of print.

ABSTRACT

BACKGROUND: Activity and safety of the SARS-CoV2 BNT162b2 vaccine in actively treated patients with solid tumors is currently unknown.

METHODS: We conducted a retrospective study of 326 patients with solid tumors treated with anti-cancer medications to determine the proportion of cancer patients with immunogenicity against SARS-CoV2, following two doses of the BNT162b2 vaccine. Control group was comprised of 164 vaccinated healthy adults. Anti-SARS-CoV-2 S IgG (Immunoglobulin G) antibodies (Abs) were measured, using level>50 AU/ml as cutoff for seropositivity. Adverse effects were collected using a questionnaire. All statistical tests were 2-sided.

RESULTS: Most patients (205, 62.9%) were treated with chemotherapy, either alone or with additional therapy, 55 (16.9%) were treated with immune checkpoint inhibitors (ICI) and 38 (11.7%) with targeted therapy alone, 28 (8.6%) received other combinations. The vaccine was well tolerated and no severe side effects were reported. Among patients with cancer 39 (11.9%) were seronegative, compared to 5 (3.0%) of the control group (P=0.001). Median IgG titers were statistically significant lower among patients with cancer compared to control (931 AU/ml vs. 2817 AU/ml, P=0.003). Seronegativity proportions were higher in the chemotherapy treated group (19, 18.8%) compared to the ICI-treated patients (5, 9.1%) and to those treated with targeted therapy (1, 2.6%) (P=0.02. Titers were also statistically significant different among treatment types (P=0.002).

CONCLUSION: The BNT162b2 vaccine is safe and effective in actively treated patients with cancer. The relatively lower antibody titers and lower proportion of seropositive patients, especially among chemotherapy treated patients, call for continuing the use of personal protective measures in these patients, even following vaccination.

PMID:34453830 | DOI:10.1093/jnci/djab174

Eur Heart J Acute Cardiovasc Care. 2021 Aug 28:zuab074. doi: 10.1093/ehjacc/zuab074. Online ahead of print.

NO ABSTRACT

PMID:34453838 | DOI:10.1093/ehjacc/zuab074

Medicina (B Aires). 2021;81(4):597-601.

ABSTRACT

Medical attention is not free from committing mistakes that can increase mortality and costs. The International Goals for Patient Safety include correct patient identification. The use of wristbands reduces the number of adverse events. The rate of nonidentified patients at the moment of phlebotomy was investigated retrospectively during 2019. The annual rate of non-identified patients was 9.8% and higher rates were observed from April to September. Monday was the day with the highest rate of non-identified. There was statistically significant relationship between the month rate of non-identified patients and the number of discharges from operative unit per month (r=0.6465; p=0.0237) and the bed turnover rate (r=0.7776; p=0.0029). Other wristband identification errors are unknown. The investigation detected failures in patient identification that allowed to make recommendations. In order to reduce the number of missing wristbands it will be necessary to monitor the indicator, especially during the months with the highest number of discharges and bed turnover rate, to evaluate the adherence of the personnel to the current protocol and to carry out training programs.

PMID:34453802

Egypt J Immunol. 2021 Jul;28(3):138-144.

ABSTRACT

Asthma is a common chronic illness among school children, where different cytokines, including IL-8 play a role in its pathogenesis. IL-8 induces chemotaxis and migration of immune cells, especially neutrophils to the site of inflammation. IL-8 level was significantly increased in sputum of severely asthmatic patients, but can it be linked to some asthma phenotypes. Our aim of the study was to detect the IL 8 gene expression in different asthma phenotypes and to determine its relation to asthma severity. This case control study included 320 subjects (160 asthmatic and 160 matched controls) aged from 5 to 16 years old in Beni-Suef governorate. IL-8 gene expression was assessed by a real-time quantitative reverse transcription-polymerase chain reaction (qRT-PCR) and studied regarding its level in cases versus controls and its relations to severity, phenotype and other laboratory parameters. IL-8 gene expression was statistically higher in asthmatic cases (P<0.001) and was significantly correlated to the phenotype (presence of other allergy as urticaria and drug eruption) and degree of asthma symptoms (r=0.869, P<0.001), FEV1(r=0.757, P<0.001) and serum IgE level (r=0.789, P<0.001). IL-8 gene expression level is increased with the degree of severity in asthmatic children and can be looked for in certain asthma phenotypes especially in presence of other atopic manifestation.

PMID:34453785

Egypt J Immunol. 2021 Jul;28(3):145-156.

ABSTRACT

Human tumors including colorectal cancers (CRC) are often infiltrated by immune cells predominantly T lymphocytes especially regulatory T (Treg) cells expressing the forkhead box protein 3 (Foxp3). It has been suggested that CD25+CD4+Foxp3+ regulatory T cells (Tregs) might hamper effective immunosurveillance of emerging cancer cell. The aim of this study was to measure the frequency of total CD4+CD25+ Tregs & CD4+CD25+Foxp3+ subset of Treg cells in peripheral blood of Egyptian CRC patients and their correlation with the tumor stage, histopathology of the tumor and lymph node affection. A total of 31 CRC patients were enrolled in the study. The tumor was categorized using a TNM staging system. Peripheral blood samples were collected within the first 24 h of surgery. The frequency of total CD4+CD25+ Tregs & CD4+CD25+ Foxp3+ subset of Treg cells in peripheral blood mononuclear cells (PBMCs) were measured by flow cytometry and absolute count was determined. High frequency of Tregs was detected in cancer patients with distal margin involvement (44-48 cells/μL) compared with those with free distal margin (5-32 cells/μL). Similarly, higher frequency of Tregs were detected (16-44 cells/μL) in cancers with lymph node involvement compared with cancers without lymph node involvement (5-32 cells/μL). Higher frequency of CD4+CD25+Foxp3+ Tregs were found in mucinous adenocarcinomas than in other histopathological types, although both observations were statistically insignificant. The median value for total absolute lymphocyte count/ μL was 639, out of which CD4+CD25+ subset constituted 35 cells, and about half of this subset were Foxp3+Tregs. In conclusion, CD4+CD25+Foxp3+ Tregs may be a useful marker for predicting invasion, metastasis, and prognosis of colorectal cancer in Egyptian patients.

PMID:34453786

Geriatr Gerontol Int. 2021 Aug 28. doi: 10.1111/ggi.14269. Online ahead of print.

ABSTRACT

AIMS: Sarcopenia, one of the primary diseases of the older adult population, is a condition characterized by loss of skeletal muscle mass, strength and functionality. Due to its considerable economic impact, preventive interventions for sarcopenia play an important role in the older adult population. Urine includes many indicators of physiology and pathophysiology. Urine analysis is used to diagnose many different diseases. The goal of this cohort study was to examine the relationship between urine pH level and skeletal muscle mass.

METHODS: This community-based cross-sectional study was carried out among 9712 Taiwanese individuals (4992 men and 4720 women). We used urine pH as an independent variable and skeletal muscle mass as a dependent variable. Bioelectric impedance analysis was used to measure the percentage of skeletal muscle mass (PSMM). We collected first fasting morning urine samples after overnight fasting, and urine pH was measured with a dipstick. In the by-sex and by-obesity analyses, we stratified the sample into two subgroups and a linear regression model was used for covariate adjustment.

RESULTS: In the fully adjusted model, all-subject analysis showed a statistically significant association between urine pH and the PSMM with a β coefficient of 0.820 (95% CI 0.615-1.025; P < 0.001). Additionally, by-sex analysis showed that urine pH was related to the PSMM in both sexes, with β coefficients of 0.261 (95% CI 0.006-0.516; P = 0.045) in men and 0.179 (95% CI 0.029-0.328; P = 0.019) in women. By-obesity status analysis showed that urine pH was related to the PSMM in the body mass index <27 group with a β coefficient of 0.284 (95% CI 0.101-0.466; P = 0.002) after full adjustment. However, for the body mass index ≥27 group, there was no significant relationship between urine pH and the PSMM (P > 0.05).

CONCLUSION: The results showed the impacts of urine pH levels on skeletal muscle mass in both sexes and non-obese populations. Due to its easily accessible and economical characteristics, urine analysis is a convenient way to approach patients with low skeletal muscle mass and predict sarcopenia. Geriatr Gerontol Int 2021; ••: ••-••.

PMID:34453776 | DOI:10.1111/ggi.14269

Pediatr Diabetes. 2021 Aug 28. doi: 10.1111/pedi.13260. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with beta thalassemia major (TM) have a higher risk of diabetes and an abnormal oral glucose tolerance test (OGTT), but there is no single agree monitoring parameter that reflects glycemic status. The possible mechanisms include iron overload and blood transfusion, but they require further investigation.

PURPOSE: This study explored the role of glycated hemoglobin A1c (HbA1c), fructosamine, and glycated albumin (GA) in evaluating the glucose dysregulation and to determine the potential relationship between iron deposition and glucose metabolism disorder in beta TM.

METHODS: A cross-sectional study was performed on 118 patients with beta TM and the control group consisted of 33 healthy children with no statistical differences in age, sex, and body mass index (BMI). Fast plasma glucose (FPG), fast insulin (FINS), insulin resistance index (HOMA-IRI), and insulin sensitivity index (HOMA-ISI) were compared between the patient and control groups. HbA1c, GA, fructosamine, and serum ferritin (SF) were measured in the patient group. OGTT, as well as heart and liver magnetic resonance imaging (MRI) T2*, was performed. For all statistical analyses, SPSS 21.0 was used and P<0.05 was accepted as statistically significant RESULTS: FPG, FINS, and HOMA-IRI were significantly increased while HOMA-ISI decreased in the beta TM patients when compared with those in the control group. In patients with beta TM, 17 (14.41%) of patients had been diagnosed with diabetes, while 48 (40.68%) had both impaired fasting glucose (IFG) and glucose tolerance (IGT). HbA1c, GA, and fructosamine were increased according to the degree of abnormal glucose metabolism. Statistically significant differences were found in age, serum ferritin, and cardiac T2* between the abnormal and normal OGTT groups.

CONCLUSION: HbA1c may be used as a significant measure for monitoring glycemic levels in patients with beta TM. Furthermore, glycated albumin and fructosamine were alternative indicators of glucose status. Patients with heart iron deposition or an SF > 4000 μg/L were prone to abnormal glucose metabolism, so chelation therapy should be reinforced. This article is protected by copyright. All rights reserved.

PMID:34453777 | DOI:10.1111/pedi.13260

Acta Parasitol. 2021 Aug 28. doi: 10.1007/s11686-021-00464-7. Online ahead of print.

ABSTRACT

PURPOSE: Toxocara canis is a common intestinal nematode parasite of dogs with recognized zoonotic potential in tropical countries. The purpose of this study was to determine the seroprevalence of anti-T. canis antibodies in two target dog populations: household and community-owned, distributed over three distinct geographical regions of India.

METHODS: Two recombinant proteins of T. canis, cathepsin L-1 (CL-1) and Toxocara excretory-secretory-26 (TES-26), expressed in Escherichia coli, were used for studying the prevalence of anti-T. canis antibodies in dog populations in three distinct geographical regions of the country using an IgG-enzyme-linked immunosorbent assay. A total of 615 sera, 507 from household and 108 from community owned dogs were screened for IgG antibodies.

RESULTS: ELISA with recombinant (r) CL-1 showed 37.7% and 53.7% seroreactivity in household and community owned dogs, respectively. However, the rTES-26 antigen showed higher seroreactivity of 39.6% and 87.9% in the corresponding groups of household and community owned dogs, respectively. Chi-squared analysis of the data indicated that there was not any association in the prevalence of anti-T. canis antibodies between the samples analyzed from the three regions and the two cohorts of dog groups. However, the seroprevalence was higher in community owned dogs compared to household owned dogs.

CONCLUSION: The results of the serological evaluation suggest that both the groups of dogs show high seroreactivity rates and are likely to harbor T. canis infections of tissue dwelling dormant larvae.

PMID:34453704 | DOI:10.1007/s11686-021-00464-7

J Med Virol. 2021 Aug 28. doi: 10.1002/jmv.27304. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The safety of human papillomavirus (HPV) vaccines, one of the major challenges to public vaccination, has been controversial. This study assessed the adverse reactions of various HPV vaccines, including bivalent HPV (2vHPV), quadrivalent HPV (4vHPV), and 9-valent HPV (9vHPV) vaccines.

METHODS: PubMed, Embase, and Central databases were searched for randomized controlled trials (RCTs) on the comparative safety of HPV vaccines. A network meta-analysis was performed based on the Bayesian framework random-effects model.

RESULTS: This study included 23 RCTs. Analysis across these reports indicated that the 2vHPV vaccine was associated with significantly more systemic adverse events than the 4vHPV vaccine (risk ratio [RR]: 1.28, 95% credible interval [CrI]: 1.14 to 1.44), 9vHPV vaccine (RR: 1.25, 95% CrI: 1.06 to 1.49), and placebo (RR: 1.31, 95% CrI: 1.18 to 1.46). However, there were no statistically significant differences in serious adverse events between the vaccinated and placebo groups. For injection site adverse events, there were substantial inconsistencies between the direct and indirect effects; therefore, the analysis results of the safety were presented only for systemic and serious adverse events.

CONCLUSIONS: The 2vHPV vaccine resulted in more systemic adverse events than other vaccines and placebo. No significant differences in serious adverse events were observed. Further studies are needed to obtain more information regarding the safety of HPV vaccines. This article is protected by copyright. All rights reserved.

PMID:34453758 | DOI:10.1002/jmv.27304

Diabetes Ther. 2021 Aug 28. doi: 10.1007/s13300-021-01139-2. Online ahead of print.

ABSTRACT

INTRODUCTION: In the randomized, open-label, parallel-arm, active-controlled phase III AWARD-CHN2 trial, once-weekly dulaglutide plus concomitant oral antihyperglycemic medications (OAMs) improved HbA1c over 26 weeks compared with once-daily insulin glargine in patients with type 2 diabetes mellitus (T2DM). This post-hoc subgroup analysis of AWARD-CHN2 investigated the pancreatic safety of dulaglutide in Chinese patients with T2DM, stratified by potential influencing factors.

METHODS: Changes in pancreatic enzyme (pancreatic amylase, total amylase, and lipase) levels over 26 weeks were assessed and stratified by patient age (< 60, ≥ 60 years), sex (female, male), duration of diabetes (< 10, ≥ 10 years), baseline weight (< 70, ≥ 70 kg), BMI (< 25, ≥ 25 kg/m²), HbA1c (< 8.5, ≥ 8.5%), triglycerides (< 2.3, ≥ 2.3 mmol/L), and concomitant OAMs (metformin, sulfonylurea, metformin plus sulfonylurea).

RESULTS: A total of 203 Chinese patients with T2DM were included in this post-hoc analysis. Pancreatic enzyme levels increased within the normal range from baseline to Week 26, and no pancreatitis events were confirmed by independent adjudication. Least-squares mean increase in pancreatic amylase (U/L) from baseline to Week 26 was comparable across all subgroups with no statistically (all P-values > 0.05) or clinically significant between-group differences for age (< 60 years: 5.34; ≥ 60 years: 6.71), sex (female: 5.85; male: 5.66), duration of diabetes (< 10 years: 6.15; ≥ 10 years: 4.85), weight (< 70 kg: 6.19; ≥ 70 kg: 5.39), BMI (< 25 kg/m²: 5.92; ≥ 25 kg/m²: 5.61), HbA1c (< 8.5%: 6.82; ≥ 8.5%: 4.08), triglycerides (< 2.3 mmol/L: 4.94; ≥ 2.3 mmol/L: 8.04), and concomitant OAMs (metformin: 5.68; sulfonylurea: 5.44; metformin plus sulfonylurea: 5.87). Similar results were observed for total amylase and lipase.

CONCLUSION: In Chinese patients with T2DM receiving dulaglutide 1.5 mg in AWARD-CHN2, elevations of pancreatic enzymes over 26 weeks were within the normal range and were neither associated with pancreatitis nor baseline factors, which suggests the clinical use of dulaglutide in Chinese patients with T2DM is not associated with pancreatic safety issues.

CLINICAL TRIAL REGISTRATION: NCT01648582.

PMID:34453682 | DOI:10.1007/s13300-021-01139-2