scholarly journals Pharmacokinetics of a New Pharmaceutical Form of Vitamin D3 100,000 IU in Soft Capsule

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 703 ◽  
Author(s):  
Romuald Mentaverri ◽  
Jean-Claude Souberbielle ◽  
Gilles Brami ◽  
Christelle Daniel ◽  
Patrice Fardellone
Keyword(s):  
Single Dose ◽  
Vitamin D3 ◽  
Oral Solution ◽  
Wilcoxon Test ◽  
Late Winter ◽  
Reference Drug ◽  
Significant Difference ◽  
Group 2 ◽  
New Formulation ◽  
Group 1

Vitamin D deficiency is frequent in the general population and both subjects and health professionals could benefit from a broader range of vitamin D3 formulations. We conducted a single-dose, open-label, parallel-group, randomized bioequivalence study to compare a single dose of a newly developed vitamin D3 100,000 IU in a soft capsule (Group 1) with the reference drug vitamin D3 100,000 IU oral solution in ampoule (Group 2) in healthy volunteers over a four-month period. The primary endpoint was the area under the curve (AUC) of serum 25-hydroxyvitamin-D (25(OH)D) concentrations on Day 112. This study was conducted in France from February to June 2014 in 53 young adults with a mean age of 26.9 years. At baseline, low mean serum 25(OH)D levels were observed in both groups (10.6 ng/mL in Group 1 and 9.0 ng/mL in Group 2). On Day 112, the AUC of serum 25(OH)D concentration was 2499.4 ± 463.8 nmol/mL (7.8 ± 0.2 for LogAUC) for Group 1 and 2152.3 ± 479.8 nmol/mL (7.6 ± 0.2 for LogAUC) for Group 2. Bioequivalence of the two treatments was not demonstrated. Superiority of vitamin D3 100,000 IU soft capsule was observed with p = 0.029 for AUC and p = 0.03 for LogAUC using a non-parametric Wilcoxon test. The profile of the serum 25(OH)D concentration showed a significant difference in favor of Group 1 on Days 1, 3, 7, 14 and 90. Mean serum 25(OH)D concentrations in Group 1 were between 20 and 30 ng/mL during the four-month period and under 20 ng/mL throughout the study in Group 2, except on Day 112. Mean Cmax for Group 1 was significantly higher (p = 0.002). Fourteen days were needed to reach Tmax by more than half the subjects in Group 1 compared to 45 days in Group 2. Both treatments were well tolerated, with no severe or related adverse events reported. In conclusion, the pharmacokinetic profile of the new formulation of vitamin D3 100,000 IU soft capsule is superior to that of the oral solution in ampoule. The new formulation increased serum 25(OH)D levels to above 20 ng/mL and maintained levels from 20 ng/mL to 30 ng/mL for four months in late winter and spring.

scholarly journals Can the cytokine adsorber CytoSorb® help to mitigate cytokine storm and reduce mortality in critically ill patients? A propensity score matching analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Christina Scharf ◽  
Ines Schroeder ◽  
Michael Paal ◽  
Martin Winkels ◽  
Michael Irlbeck ◽  
...  
Keyword(s):  
Propensity Score ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Wilcoxon Test ◽  
Relative Reduction ◽  
Cytokine Storm ◽  
Saps Ii ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Abstract Background A cytokine storm is life threatening for critically ill patients and is mainly caused by sepsis or severe trauma. In combination with supportive therapy, the cytokine adsorber Cytosorb® (CS) is increasingly used for the treatment of cytokine storm. However, it is questionable whether its use is actually beneficial in these patients. Methods Patients with an interleukin-6 (IL-6) > 10,000 pg/ml were retrospectively included between October 2014 and May 2020 and were divided into two groups (group 1: CS therapy; group 2: no CS therapy). Inclusion criteria were a regularly measured IL-6 and, for patients allocated to group 1, CS therapy for at least 90 min. A propensity score (PS) matching analysis with significant baseline differences as predictors (Simplified Acute Physiology Score (SAPS) II, extracorporeal membrane oxygenation, renal replacement therapy, IL-6, lactate and norepinephrine demand) was performed to compare both groups (adjustment tolerance: < 0.05; standardization tolerance: < 10%). U-test and Fisher’s-test were used for independent variables and the Wilcoxon test was used for dependent variables. Results In total, 143 patients were included in the initial evaluation (group 1: 38; group 2: 105). Nineteen comparable pairings could be formed (mean initial IL-6: 58,385 vs. 59,812 pg/ml; mean SAPS II: 77 vs. 75). There was a significant reduction in IL-6 in patients with (p < 0.001) and without CS treatment (p = 0.005). However, there was no significant difference (p = 0.708) in the median relative reduction in both groups (89% vs. 80%). Furthermore, there was no significant difference in the relative change in C-reactive protein, lactate, or norepinephrine demand in either group and the in-hospital mortality was similar between groups (73.7%). Conclusion Our study showed no difference in IL-6 reduction, hemodynamic stabilization, or mortality in patients with Cytosorb® treatment compared to a matched patient population.

scholarly journals EFEK PENYUNTIKAN PROSTAGLANDIN F2α (PGF2α) TERHADAP TIMBUL DAN LAMA BIRAHI SAPI BALI PADA PARITAS YANG BERBEDA

2019 ◽  
Vol 44 (2) ◽  
pp. 141
Author(s):  
Abdul Malik
Keyword(s):  
Single Dose ◽  
Prostaglandin F2α ◽  
Estrus Synchronization ◽  
Group 4 ◽  
Significant Difference ◽  
Group 3 ◽  
Estrus Response ◽  
Group 2 ◽  
Time Required ◽  
Group 1

The objective of this study was to evaluate of Effect of injection Prostaglandin F2α on the time required for onset of estrus and estrus durations in Bali cattle with differences of Paritas. A total of 24 Bali cows were divided into four groups, each group was consisting of 6 cows.  Group 1 samples is heifer’s, group 2, samples was paritas1, group 3, samples was paritas 2 and group 4, samples was paritas 3.  All  cows were normal  tract of reproduction  with showing regular cyclic activities and having active of corpus luteum. The parameters in this study were determined including the time required for onset of estrus and duration of estrus. The result showed that percentage estrus response and duration of estrus were non-significant difference (P>0.05) between heifers and paritas 1, 2, and 3 after estrus synchronization with single dose of prostaglandin F2α. It was concluded that injection of PGF2α on heifers and Paritas 1,2 and 3 were  similar result on the time required for onset of estrus and duration of estrus.

scholarly journals A single-dose antibiotic prophylaxis to prevent surgical site infection in clean-contaminated surgery among diabetic patients

2015 ◽  
Vol 1 (2) ◽  
pp. 8-10
Author(s):  
Kamal Koirala ◽  
Rupesh Mukhia ◽  
Suman Sharma ◽  
Sujan Manandhar ◽  
Niroj Banepali ◽  
...  
Keyword(s):  
Single Dose ◽  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Diabetic Patients ◽  
Outpatient Basis ◽  
Site Infection ◽  
Significant Difference ◽  
Group 2 ◽  
Clean Contaminated ◽  
Group 1

Introductions: Guidelines on antibiotics use in surgical patients recommends a single dose prophylaxis for clean-contaminated cases and therapeutic course for contaminated and dirty cases. Compliance to this guideline is poor among diabetic patients. The aim of this study was to test the efficacy of single dose antibiotic prophylaxis on the occurrence of postoperative surgical site infection (SSI) in clean-contaminated surgery in diabetic patients.Methods: Retrospective cross-sectional study was carried out at KIST Medical College and Teaching Hospital from September 2008 to August 2012 involving 144 diabetic patients who underwent major clean-contaminated surgery. Forty eight patients received one gram of ceftriaxone intravenously as prophylactic antibiotic within 30 minutes prior to incision (group 1) and 96 patients received three doses of ceftriaxone (group 2). One dose was given within 30 minutes prior to incision and other two doses were given postoperatively. All patients were followed up for 30 postoperative days on outpatient basis. The SSI rates were compared in two groups. Pus from the infected wound was tested for culture and sensitivity.Results: The SSI rates in group 1 and group 2 were of 5/48 (10.42%) and of 9/96 (9.37%) respectively. There was no significant difference in SSI rates between group 1 and group 2 (p=0.322).Conclusions: Single dose of Ceftriaxone shows the similar effect as three doses in clean-contaminated surgery in diabetic patients.

scholarly journals Impact of two early treatment protocols for anterior dental crossbite on children’s quality of life

2018 ◽  
Vol 23 (1) ◽  
pp. 71-78 ◽  
Author(s):  
Cristina Batista Miamoto ◽  
Leandro Silva Marques ◽  
Lucas Guimarães Abreu ◽  
Saul Martins Paiva
Keyword(s):  
Quality Of Life ◽  
Early Treatment ◽  
Well Being ◽  
Wilcoxon Test ◽  
Treatment Protocols ◽  
Significant Difference ◽  
Group 2 ◽  
The Impact ◽  
Group 1

ABSTRACT Objective: To assess the impact of two early treatment protocols for anterior dental crossbite on children’s quality of life. Methods: Thirty children, 8 to 10 years of age, with anterior dental crossbite, participated in this study. Individuals were divided into two groups: Group 1 - 15 children undergoing treatment with an upper removable appliance with digital springs; Group 2 - 15 children undergoing treatment with resin-reinforced glass ionomer cement bite pads on the lower first molars. Quality of life was evaluated using the Brazilian version of the Child Perceptions Questionnaire (CPQ8-10), which contains four subscales: oral symptoms (OS), functional limitations (FL), emotional well-being (EW), and social well-being (SW). A higher score denotes a greater negative impact on children’s quality of life. Children answered the questionnaire before treatment (T1) and twelve months after orthodontic treatment onset (T2). Descriptive statistics, the Wilcoxon test and analysis of covariance (ANCOVA) were performed. Results: Children’s mean age was 9.07 ± 0.79 years in Group 1 and 9.00 ± 0.84 years in Group 2. For Group 1, the FL and EW subscale scores and the overall CPQ8-10 were significantly higher in T1 as compared to T2 (p= 0.004, p= 0.012 and p= 0.015, respectively). For Group 2, there were no statistically significant differences. The ANCOVA showed no significant difference regarding quality of life at T2 between groups, after controlling for quality of life measures at T1. Conclusions: The difference regarding the impact on quality of life between groups is not related to the protocol used.

scholarly journals Clinical and parasitological evaluation of pour-on fluazuron and ivermectin for treating canine demodicosis

2014 ◽  
Vol 34 (11) ◽  
pp. 1094-1100
Author(s):  
Clarissa P. Souza ◽  
Regina H.R. Ramadinha ◽  
Fabio B. Scott
Keyword(s):  
Histopathological Examination ◽  
Treatment Protocol ◽  
Wilcoxon Test ◽  
Histological Evaluation ◽  
Significant Difference ◽  
Before And After ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

The objective of the study was to evaluate the efficacy of pour-on formulations of fluazuron and ivermectin in different therapeutic protocols for treatment of demodicosis by means of quantifying mites with skin scraping, histological and clinical evaluation in dogs. Eighteen dogs with skin scrapings positive for Demodex canis were evaluated, divided into three groups. All the animals were treated every 14 days, completing 6 treatments for each animal (days 0, 14, 28, 42, 56 and 70). In group 1, pour-on 2.5% fluazuron was used at the dose of 20mg/kg; in the group 2 pour-on 2.5% fluazuron at a dose of 20 mg/kg in association with pour-on 0.5% ivermectin at the dose of 0.6mg/kg; and in group 3, pour-on 0.5% ivermectin alone was used, at the dose of 0.6mg/kg. The treatment was evaluated and monitored through skin scrapings and clinical follow-up of the lesions every 14 days for 84 days, and through histopathological examination at the end of each treatment protocol. The success rate was defined as the percentage of dogs in each group that had negative skin scrapings after the treatment: this was 16.67% for group 1, and 50% for groups 2 and 3. The reduction in mite counts reached effectiveness of 67.66%, 88.99% and 84.29% for groups 1, 2 and 3 respectively. The Wilcoxon test showed that there was a significant difference between the number of mites before and after treatment in groups 2 and 3. The histopathological examination revealed that only group 1 showed no significant difference in the intensity of infestation between days 0 and 84. Clinically, there was no significant difference between the evaluation before and after treatment in the three groups. pour-on 2.5% fluazuron and pour-on 0.5% ivermectin were not effective for treating canine demodicosis, either in association or as single therapy, when applied every 14 days for a period of 70 days. Quantification of mites using skin scrapings and histological evaluation proved to be ineffective, either one as sole therapeutic evaluation parameters, for canine demodicosis.

scholarly journals Pengaruh Vitamin D3 Terhadap Kadar Hemoglobin Tikus Wistar yang Dipapar Asap Rokok

2019 ◽  
Vol 1 (1) ◽  
pp. 22-28
Author(s):  
Hetti Rusmini ◽  
Dita Fitriani ◽  
Dessy Hermawan ◽  
Diah Adelia Emilda
Keyword(s):  
Cigarette Smoke ◽  
Erythrocyte Membrane ◽  
Vitamin D3 ◽  
Rattus Norvegicus ◽  
Not Given ◽  
White Rats ◽  
Wistar Strain ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Hemoglobin is a tetrametric erythrocyte protein that carries O2 to the tissues and returns CO2 and protons to the lungs. Cigarette smoke is proven that could reduce hemoglobin levels through oxidative stress which causes the erythrocyte membrane to be easily lysed. The lysis erythrocyte membrane causes hemoglobin levels to be low. Vitamin D is included in natural antioxidants which have a neuroprotective tendency through antioxidative mechanisms. To determine the effect of giving vitamin D3 on hemoglobin levels in white rats (Rattus norvegicus) male Wistar strain after being exposed by cigarette smoke. This type of pure experimental research (tue-experiment) used pre and post with control group design. Samples were white rats (Rattus norvegicus) male Wistar strain aged 10-12 weeks with the weight of around 150-200 grams in a total of 24 individuals. Samples were divided into four groups including K1 which is not exposed by cigarette smoke and not given of vitamin D3, K2 is a group exposed by cigarette smoke but not given of vitamin D3, K3 is a group that is not exposed by cigarette smoke but given of vitamin D3 a dose of 0.2 µgr /head, P1 is a group exposed by cigarette smoke and given a vitamin D3 dose of 0.2 µgr /head. The test of paired t-test showed a significant difference p <0.05 in the K2 group with p = 0.044, the K3 group with p = 0.013, and P1 group with p = 0.037. Whereas in group 1 there was no significant difference p = 0.932. The One-way Anova test obtained results with a value of p = 0.027 (p <0.05) which means that there were significant differences between groups. The Post Hoc LSD test showed a significant difference in group 1 whit group 2 p = 0.025 and in group 2 with group 3 p = 0.012.

In-vivo evaluation of the effect of cyanoacrylate on prosthetic vascular graft infection – does cyanoacrylate increase the severity of infection?

VASA ◽  
2020 ◽  
Vol 49 (4) ◽  
pp. 281-284
Author(s):  
Atıf Yolgosteren ◽  
Gencehan Kumtepe ◽  
Melda Payaslioglu ◽  
Cuneyt Ozakin
Keyword(s):  
Vascular Graft ◽  
Graft Infection ◽  
Vascular Graft Infection ◽  
Group 4 ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Prosthetic Vascular Graft Infection ◽  
Group 1

Summary. Background: Prosthetic vascular graft infection (PVGI) is a complication with high mortality. Cyanoacrylate (CA) is an adhesive which has been used in a number of surgical procedures. In this in-vivo study, we aimed to evaluate the relationship between PVGI and CA. Materials and methods: Thirty-two rats were equally divided into four groups. Pouch was formed on back of rats until deep fascia. In group 1, vascular graft with polyethyleneterephthalate (PET) was placed into pouch. In group 2, MRSA strain with a density of 1 ml 0.5 MacFarland was injected into pouch. In group 3, 1 cm 2 vascular graft with PET piece was placed into pouch and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. In group 4, 1 cm 2 vascular graft with PET piece impregnated with N-butyl cyanoacrylate-based adhesive was placed and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. All rats were scarified in 96th hour, culture samples were taken where intervention was performed and were evaluated microbiologically. Bacteria reproducing in each group were numerically evaluated based on colony-forming unit (CFU/ml) and compared by taking their average. Results: MRSA reproduction of 0 CFU/ml in group 1, of 1410 CFU/ml in group 2, of 180 200 CFU/ml in group 3 and of 625 300 CFU/ml in group 4 was present. A statistically significant difference was present between group 1 and group 4 (p < 0.01), between group 2 and group 4 (p < 0.01), between group 3 and group 4 (p < 0.05). In terms of reproduction, no statistically significant difference was found in group 1, group 2, group 3 in themselves. Conclusions: We observed that the rate of infection increased in the cyanoacyrylate group where cyanoacrylate was used. We think that surgeon should be more careful in using CA in vascular surgery.

Tuberculosis of the meninges and central nervous system. Experience of clinical diagnostics in St. Petersburg for 50 years

MedAlliance ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 14-24
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Medical Errors ◽  
Clinical Diagnostics ◽  
Lethal Outcome ◽  
Significant Difference ◽  
Group 2 ◽  
Allergic Vasculitis ◽  
Tuberculosis Meningitis ◽  
Group 1

The clinic and diagnostics of tuberculosis meningitis (TM) in 926 patients treated in St. Petersburg hospitals in 1965–1994 (group 1) and in 1995–2018 (group 2) is presented. The TM clinic is demonstrated to be determined by the form of tuberculosis and its characteristic generalization nature in the presence of repeated waves of bacteremia and allergic vasculitis of greater or lesser severity. There is clinical peculiarity of TM in primary pulmonary tuberculosis and its early large-focal and late miliar generalization, as well as in hematogenous tuberculosis. In patients of the 1st and 2nd groups the TM clinic shows in some respects a noticeable similarity, in others — a significant difference. Despite the typical symptoms, early diagnosis of TM took place in less than 20% of patients. Clinical examples illustrating the unusual development of TM, contrasting with its usual course, are given. A number of objective and subjective factors contributing to the adverse evolution of TM and its lethal outcome are discussed. These include the peculiarity of modern tuberculosis, especially when associated with HIV infection, as well as medical errors associated with ignorance of the pathogenesis of tuberculosis and failure to comply with the minimum examination for tuberculosis.

Two Adhesive Systems-effect on Adhesion to Tooth Structure

2019 ◽  
Vol 70 (7) ◽  
pp. 2608-2613
Author(s):  
Larisa Simona Deac ◽  
Kamel Earar ◽  
Adela Loredana Colceriu Burtea ◽  
Alexandra Stefania Berghe ◽  
Aurora Antoniac ◽  
...  
Keyword(s):  
Adhesive Systems ◽  
Hybrid Layer ◽  
Tooth Structure ◽  
Selective Etch ◽  
Etch And Rinse ◽  
Significant Difference ◽  
Wisdom Teeth ◽  
Group 2 ◽  
Self Etch ◽  
Group 1

This study evaluates and compares by dye penetration method and SEM photomicrographs the sealing obtained using two different classes of adhesive systems (etch-and-rinse and self-etch with selective etching) with SDR (Dentsply) bulk fill composite. 84 class V cavities were prepared on oral and vestibular face of 42 intact, freshly extracted wisdom teeth. The cavities were randomly divided in two groups and restored: Group 1 with prime &bond one select (Dentsply) and SDR (Dentsply) and Group 2 with prime&bond one Etch&Rinse (Dentsply) and SDR (Dentsply). Prime&bond one Select (Dentsply) is a single component adhesive and can be used in self etch mode, in selective enamel etch mode, or in etch-and-rinse mode. We chosen for this study the selective etch of the enamel mode. Prime&bond one Etch Rinse (Dentsply) is a universal etch-and-rinse one-bottle dental adhesive, designed to be used in two steps. The bulk fill composites are commonly used in modern dentistry due to their properties of low polymerization shrinkage and curing in layer of 4 mm depth, offering the practitioner a fast clinical procedure with good results. The results showed a good sealing at enamel and dentin margins with no statistically significant difference between adhesives, even though the mean of enamel infiltration was smaller for Group1. Furthermore the results show that there were differences between the two groups, for the infiltrations at the enamel, the values of microleakage being arithmetically higher for Group 1, but with no statistically difference between the two groups.SEM images showed for both groups a good adhesion surface with the tooth, but the hybrid layer of the total-etch adhesives is different from the hybrid layer formed by self etch adhesives, in terms of thickness, uniformity. In conclusion both adhesive systems have equivalent sealing qualities and can be successfully used with SDR.

Reducing Gingivitis Remotely using the iGAM mHealth app (part 2): Prospective Observational Study (Preprint)

2020 ◽  
Author(s):  
Guy Tobias ◽  
Assaf B Spanier
Keyword(s):  
Oral Health ◽  
Tooth Loss ◽  
Prospective Observational Study ◽  
Dental Clinics ◽  
Significant Difference ◽  
Observational Cohort ◽  
Group 2 ◽  
And Behavior ◽  
Oral Hygiene Habits ◽  
Group 1

BACKGROUND Gingivitis is a non-painful, inflammatory condition that can be treated with home remedies. Left untreated gingivitis can lead to tooth loss. Periodic dental examinations are important for early diagnosis and treatment of gum diseases. In order to contain the spread of the corona virus, governments, including in Israel, have restricted movements of their citizens which has caused routine dental checkups to be postponed. OBJECTIVE This study aimed to examine the ability of an mHealth app- iGAM to reduce gingivitis. METHODS A prospective observational cohort study was performed, 160 unpaid participants were divided into 2 equal groups and downloaded the iGAM app. Group 1 photographed their gums weekly for eight weeks. Group 2 photographed their gums at the time of recruitment and 8 weeks later. After photo submission, the participants received the message "It is recommended to read the information contained within the app regarding maintaining oral hygiene habits". A single blinded researcher examined the images and scored them according to the Modified Gingival Index (MGI). RESULTS The average age of group 1 was 26.77 (S.D. ± 7.43), and 28.53 (S.D. ± 10.44) for group 2. The majority were male (74.7% in group 1 vs. 66.7% in group 2), most participants described themselves as "secular", most were "single", non-smokers (74.7% vs. 78.4%) and did not take medications (85.3% vs. 78.4%). 126 subjects completed the study. A statistically significant difference (P <.001) was found in the dependent variable (MGI) in a linearly negative manner. As time passed, the gum condition improved, there were significantly lower gingivitis scores in group 1 (M = 1.16, S.D. ± 1.18) compared to group 2 (M = 2.16, S.D. ± 1.49), after eight weeks. Those with more recent dental visits had a lower MGI (p = .037). No association was found between knowledge and behavior, most participants were familiar with the recommendations for maintaining oral health, yet they only performed some. CONCLUSIONS A dental selfie taken once a week using an mHealth app (iGAM) reduced the signs of gingivitis and promoted oral health. During the current pandemic where social distancing recommendations may be causing people to avoid dental clinics, this app can remotely promote gum health. CLINICALTRIAL The protocol was approved by Hadassah research ethics committee (IRB, 0212-18-HMO)

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