The premorbid background and the most significant predictors of the development chronic gastroduodenal pathology in children

The study features of premorbid background and the most significant predictors of the development of chronic gastroduodenal pathology in children and adolescents of school age. Materials and methods. The results of screening questioning of schoolchildren with chronic gastroduodenal pathology (CGDP) - n=286, and practically healthy schoolchildren - n=1023, from 6 to 15 years agо. The survey conducted according to the questionnaire developed by us, which includes 24 questions. The relative risk (RR) calculated using traditional statistical formulas with a confidence interval limit 95% CI (confidence interval). Results. In this study, it was found that the main nutritional reason for the development of СGDP in schoolchildren is a malnutrition - 69.2%, RR=2.25 (CI=1.81-2.79), and food for fast food - 65.0%, RR=4.19 (CI=3.45-5.09). The least observed was the abuse of spicy food - 4.9%, RR=1.24 (CI=0.80-1.91). The 42.7% of patients were constantly in a state of heightened psychoemotional stress - RR=1.6 (CI=1.32-1.93). Helicobacter pylori (HP) - infection was diagnosed in 57.7% of patients - RR=4.84 (CI=4.04-5.79), 29.0% of patients underwent acute intestinal infections - RR=2.74 (CI=2.29-3.27), and 62.3% had a history of hereditary burden of chronic diseases of the gastrointestinal tract - RR=1.65 (CI=1.34-2.02) Conclusion. The most significant predictors and premorbid backgrounds for the development of СGDP in schoolchildren are HP-infection (RR=4.84; CI=4.04-5.79; RRR=3.84), food for fast food (RR=4.19; CI=3.45-5,09; RRR=3.20) with the development of overweight and obesity (RR=3.64; CI=2.97-4.47; RRR=2.64), the presence of chronic foci of infection (RR=2.58; CI=2.05-3.23; RRR=1.58).

Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies

We report here the results of a phase 3 study to assess the efficacy, safety, and tolerability of GC5107, a new 10% liquid intravenous immunoglobulin (IVIG) in preventing serious bacterial infections in patients with primary immunodeficiency (ClinicalTrials.gov: NCT02783482). Over a 12-month study period, 49 patients aged 3 to 70 years with a confirmed diagnosis of primary immunodeficiency received GC5107 at doses ranging from 319 to 881 mg/kg body weight every 21 or 28 days, according to their previous IVIG maintenance therapy. A total of 667 infusions of GC5107 were administered comprising a total of 45.86 patient-years of treatment. A single acute serious bacterial infection occurred during the study, resulting in an incidence of 0.02 events per patient-year (upper 99% one-sided confidence interval limit: 0.21), meeting the prespecified primary efficacy endpoint. The mean incidence of infections other than acute serious bacterial infections was 2.9 infections per patient-year. Efficacy was also demonstrated by the low mean annualized rate of hospitalizations due to infection (0.1 day) and the mean annualized duration of hospitalizations (0.1 day). The mean rate of intravenous and oral antibiotic use was 0.1 day and 13.2 days, respectively. There was a mean of 7.1 days of missed work, school, or daycare days. The proportion of infusions with temporally associated adverse events (TAAEs) occurring during or within 72 hours after GC5107 infusion was 0.24 (upper 95% one-sided confidence interval limit: 0.31), meeting the pre-specified primary safety endpoint. Overall, 149 of 667 infusions (22%) were associated with TAAEs. The most common TAAE was headache, reported by 49% of patients. More than 98% (731/743) of all adverse events that occurred throughout the 12-month study period were mild or moderate. More than 98% of infusions were completed without discontinuation, interruption or rate reduction. There were no treatment-emergent serious adverse events related to GC5107 or study discontinuations due to an adverse event. Overall, pharmacokinetic parameters for GC5107 were within the range of those reported in studies of other marketed IVIG products. Results of the present study demonstrate that GC5107 is an effective, safe and well-tolerated treatment for patients with primary immunodeficiency.

Resistencia a los antihelmínticos en nematodos gastrointestinales de bovinos en municipios de Cundinamarca y Boyacá

<p>En 36 fincas lecheras de la Sabana de Bogotá, los Valles de Ubaté y Chiquinquirá y la Región del Tequendama (Cundinamarca, Colombia) se determinó la resistencia a los antihelmínticos en nematodos gastrointestinales de bovinos mediante la prueba <em>in vivo </em>de la reducción del conteo de huevos (RCH). En cada finca se seleccionaron 40 bovinos de tres a 12 meses de edad, los cuales se distribuyeron en cuatro grupos de 10 animales: 1) control (no tratado), 2) albendazol 25% (dosis: 5 mg/kg peso vivo), 3) ivermectina 1% (0,2 mg/kg) y 4) levamisol 18,8% (1 mg/kg). En cada grupo se identificaron mediante coprocultivos seis géneros de parásitos siendo <em>Cooperia spp. </em>el predominante. La resistencia se declaró cuando el porcentaje de RCH fue menor de 95% y el límite inferior del intervalo de confianza (95%), menor a 90. El 25% de las fincas presentó resistencia: en 17% se detectó resistencia al albendazol y en 8% a la ivermectina; para estos dos antihelmínticos, <em>Cooperia spp</em>. fue el nematodo gastrointestinal involucrado. El promedio de reducción de huevos por gramo de heces (<em>hpg</em>), luego de los tratamientos con ivermectina, albendazol y levamisol, fue de 97,89% ± 6% (66% - 100%), 95,9% ± 9,3% (51% - 100%) y 99,4% ± 0,92% (97,6% - 100%), respectivamente. No se detectó resistencia al levamisol. Los factores de riesgo asociados con la resistencia fueron: vermifugación de bovinos adultos, dosificación no acorde con el peso de los animales y uso de un mismo principio activo por un tiempo mayor de cuatro años. </p><p> </p><p><strong>Antihelmintic resistance in gastrointestinal bovine nematodes in municipalities of Cundinamarca and Boyaca (Colombia) </strong></p><p>A study was conducted in 36 farms of the Bogotá Savannah, Ubaté and Chiquinquirá Valleys and Tequendama Region (Cundinamarca), to determine via <em>in vivo </em>egg reduction count test (ERCT) antihelmintics resistance to bovine gastrointestinal nematodes. Resistance was determined in. 40 calves, three to 12 months of age, allotted to four groups of ten animals each one: 1) control (untreated); 2) albendazol 25% (5 mg/kg); 3) ivermectin 1% (0.2 mg/kg) and 4) levamisol 18.8% (1 mg/kg). By feces cultivation techniques, six genera were identified, <em>Cooperia spp</em>. being the predominant one. Resistance was determined when the ERCT was below 95% and the lowest 95% confidence interval limit was 90. Resistance was found in 25% of the farms: albendazol and ivermectin resistance was detected in 17% and 8% of the farms, respectively. <em>Cooperia spp. </em>was involved in both compounds. Average egg per gram (epg) of feces reduction after treatments with ivermectin, albendazol and levamisol, was 97.89% ± 6% (66% - 100%); 95.9% ± 9.3% (51% - 100%) and 99.4% ± 0.92% (97.6 - 100%), respectively. Resistance to levamisol was not detected. Risk factors associated with resistance were: worming of adult cattle, wrong dosage regarding body weight and use of the same active ingredient for more than four years. </p>

Estrogen Priming Effect on Growth Hormone (GH) Provocative Test: A Useful Tool for the Diagnosis of GH Deficiency1

We have studied the effect of estradiol (E2)on the GH-insulin-like growth factor (GH-IGF) axis in 15 prepubertal GH deficiency (GHD) children and 44 prepubertal or early pubertal children with idiopathic short stature (SS). All of them received a daily dose of micronized E2 (1 or 2 mg) or placebo, for 3 days, before a sequential arginine-clonidine test. In SS children, GH maximal responses were 17.8 ± 10.9 on placebo and 27.9 ± 14.5μ g/L on estrogen (P &lt; 0.0001). The lower 95% confidence limits for GH maximal response changed from 3.7 μg/L (without E2) to 8.3 μg/L (on E2). In GHD children, no significant stimulatory effect of estrogen on GH levels was observed. After placebo, a cut-off limit of 3.7 μg/L (the lower 95% confidence interval limit) resulted in 73% sensitivity, 95% specificity, and an overall 90% diagnostic efficiency. After E2, a cut-off limit of 8.3 μg/L resulted in a sensitivity of 87%, a specificity of 98%, and a diagnostic efficiency of 95%. After placebo, 68% of SS showed normal IGF-I levels, and the mean did not change on E2 (13.7 ± 6.3 vs. 14.3 ± 6.8 nmol/L, not significant). In 93% of SS, IGF binding protein (IGFBP)-3 levels were normal during placebo. On E2, mean IGFBP-3 did not change (2.63 ± 0.70 vs. 2.70 ± 0.70 mg/L, not significant). In 14 of 15 GHD patients, IGF-I values were below normal on placebo, and the mean of the group did not change after E2. During placebo, 13 of 15 GHD children presented low IGFBP-3 values. During E2, there was a small significant increase in IGFBP-3 values (1.06 ± 0.58 vs. 1.20 ± 0.69 mg/L, P &lt; 0.02). The highest diagnostic efficiencies for IGF-I and IGFBP-3 were observed during placebo (75% and 91%, respectively). We conclude that GH stimulation tests after E2 priming had the highest diagnostic efficiency. Our findings suggest that the effect of estrogen priming on GH stimulated levels, by reducing the number of false nonresponders, might be useful to better discriminate between normal and abnormal GH status in SS children.