Cost-effectiveness and budget impact analysis of Daratumumab, Lenalidomide and dexamethasone for relapsed-refractory multiple myeloma.

BACKGROUND: The prominent efficacy in terms of increasing progression-free survival (PFS) of Daratumumab, Lenalidomide and dexamethasone (DRd) triplet therapy versus Carfilzomib, Lenalidomide and dexamethasone (KRd) was proven previously in relapsed-refractory multiple myeloma (RRMM). However, the cost effectiveness of DRd versus KRd is unknown. METHODS: We developed a Markov model by using an Iranian payer perspective and a 10-year time horizon to estimate the healthcare cost, Quality-adjusted life years (QALYs) and life years gain (LYG) for DRd and KRd triplet therapies. Clinical data were obtained from meta-analyses and randomized clinical trials (RCTs). One-way and probabilistic sensitivity analysis were performed to assess model uncertainty. Budget impact analysis of 5 years of treatment under the DRd triplet therapy was also analysed. RESULTS: DRd was estimated to be more effective compared to KRd, providing 0.28 QALY gain over the modelled horizon. DRd-treated patients incurred $264 in total additional costs. The incremental cost utility ratio (ICUR) and cost effectiveness ratio (ICER) were $956/QALY and $472/LYG respectively. The budget impact analysis indicates that adding Daratumumab to Lenalidomide and dexamethasone regimen, in the first 5 years, will increase the healthcare system's expenses by $6.170.582. CONCLUSION: DRd triplet therapy compared to KRd is a cost-effective regimen for RRMM under Iran willingness-to-pay threshold.

Comparative immunogenicity and safety of SpikoGen®, a recombinant SARS-CoV-2 spike protein vaccine in children and young adults: An immuno-bridging clinical trial.

BACKGROUND: SpikoGen® is a recombinant subunit spike protein ectodomain vaccine manufactured in insect cells and formulated with the novel polysaccharide-based Advax-CpG55.2 adjuvant. This study aimed to compare the immunogenicity and safety of SpikoGen® vaccine in children, adolescents and young adults. METHODS: This was a non-randomized, three-arm, open-label, parallel-group, immuno-bridging, non-inferiority trial to compare the immunogenicity and safety of a primary course of two intramuscular doses of SpikoGen® vaccine in children aged 5 to < 12 years, adolescents aged 12 to < 18 years and young adults aged 18 to 40 years. Children 5-12 years received a half dose of 12.5 µg spike protein, whereas the other groups received the full vaccine dose. Vaccine immunogenicity was evaluated via assessment of serum anti-spike and neutralizing antibodies 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Safety assessments including serious adverse events were continued through six months after the second dose in children and adolescents. RESULTS: Two weeks after the second dose, seroconversion rates for neutralizing antibody levels were not significantly different for children (59.50 %), adolescents (52.06 %) and adults (56.01 %). The 95 % confidence interval of the difference in seroconversion rates between children and adults was within the prespecified non-inferiority margin of 10 % (-12 % to 5 %). SpikoGen® vaccine was well tolerated in all age groups with the most common solicited adverse events being injection site pain and fatigue which were generally transient and mild. CONCLUSION: SpikoGen® vaccine was shown to be safe, well tolerated and immunogenic in children as young as 5 years of age, with non-inferior responses to those seen in adults. The Iranian FDA authorisation of SpikoGen® vaccine is now extended down to 5 years of age.

Evaluation of the prevalence and clinical and laboratory features of acute viral myositis in children with influenza referred to the emergency department of Ali Asghar Tehran Hospital in 2019 and 2020.

Introduction: Influenza-related viral myositis is observed mostly in children with influenza, and the disease is more common in influenza type B. The aim of the present study was to evaluate the prevalence, and clinical and laboratory features of acute viral myositis in children with influenza in 2019 and 2020. Methods: This retrospective cross-sectional study was performed in Ali Asghar Hospital, from December 2019 to February 2020. Children aged 2-14 years with symptoms of acute onset of fever, along with the symptoms of influenza with or without muscle pain who referred to the emergency department of Hazrat Ali Asghar Children's Hospital, were included in the study. The data were collected and analyzed by Statistical Package for the Social Sciences (SPSS) version 22. Results: Out of the 105 participants in this study, 62 (59%) were male and the rest were female. The average age of the patients was 5.34 years (SD = 2.63). Clinical signs of lower limb pain, myalgia, lameness, weakness, and lethargy were significantly more common in patients with myositis (P-value < 0.05). In-vitro examination demonstrated that creatine phosphokinase (CPK), aspartate aminotransferase (AST), and aAlanine aminotransferease (ALT) levels were significantly higher in patients with myositis. Conclusion: Based on the present results, the clinical symptoms in patients are quite clear, and based on the symptoms, it is possible to diagnose and treat myositis without relying on laboratory findings; due to the self-limitation of this complication and lack of the need for complex treatments in case of early diagnosis, physicians can diagnose and treat many cases, depending on the clinical symptoms and the accuracy of the examination.

Effects of vitamin D on bone density in healthy children: A systematic review.

Skeletal growth and bone health are very important in children. The effective role of vitamin D in bone mineral density has been observed in children and adolescents. This systematic review study evaluated the effects of vitamin D on bone density in healthy children with the help of valid databases and the website of clinical trials. The results of experimental, clinical, retrospective, prospective, double-blind, and randomized studies were used. Articles that appropriately covered the topic and had the proper content structure were selected for this review. Out of a total of 132 articles, finally, 13 articles were selected based on inclusion and exclusion criteria for further study, the results of which show the association between serum levels of vitamin D and bone mineral density and health. However, in some articles, the relationship between other influential variables such as age and nutrition on bone density in children was identified. In general, the current systematic review demonstrates the role of vitamin D on bone density in healthy children, so that in children studied, vitamin D is at different levels and complications related to bone density are observed in many children. It is recommended that more clinical and longitudinal studies be performed to further understand the role of vitamin D levels in bone health in children.

Empirically-Derived Dietary Patterns in Relation to Non-Alcoholic Fatty Liver Diseases Among Adult Participants in Amol, Northern Iran: A Structural Equation Modeling Approach.

Dietary modifications remain the mainstay in managing nonalcoholic fatty liver disease (NAFLD). Published data on the effect of overall dietary patterns on NAFLD is scarce. The present study aims to extract the dietary patterns and investigate their association to NAFLD by gender, using structural equation modeling, among adult participants in Amol, northern Iran. In this cross-sectional study, data from 3,149 participants in the Amol cohort study (55.3% men, n = 1,741) were analyzed. Usual dietary intake was assessed by a validated 168-items semiquantitative food frequency questionnaire. We classified major dietary patterns by explanatory factor analysis (EFA) and confirmatory factor analysis (CFA). NAFLD diagnosis was based on ultrasound scanning, including increased hepatic echogenicity, abnormal appearance of hepatic arteries, and diaphragm in the absence of excessive alcohol consumption. Multivariable logistic regression and structural equation modeling (SEM) were used to explore the relationship between dietary patterns and NAFLD. Three distinct dietary patterns, including western, healthy, and traditional/mixed dietary patterns, were identified. Adult male who adhere to the western dietary pattern were more affected with NAFLD risk [Q1, Q2, Q3, Q4, odds ratio (OR) = 1, 1.16, 1.34, 1.39; 95% confidence interval (CI) = 0.83-1.61, 0.96-1.85, 0.98-1.96, p trend = 0.04, respectively]. A full mediating effect of healthy dietary pattern, western dietary pattern, and traditional dietary pattern via dietary acid load (DAL) proxy (of dietary patterns to DAL: ßstd = -0.35, p < 0.006, ßstd = 0.15, p = 0.009, and ßstd = 0.08, p = 0.001, respectively), on NAFLD was found through mediation analysis using SEM. A western dietary pattern comprising frequent intake of salty and sweet snacks, soft drinks, refined grains, processed meats, cooked and fried potatoes, eggs, and coffee was associated with a higher odds of NAFLD in an Iranian male population. Additionally, our findings might provide a mechanistic explanation for the association between dietary patterns and NAFLD via DAL proxy. However, further prospective studies, including assessing acid-base biomarkers, are needed.

Clinical guidelines on pediatric asthma exacerbation in emergency department, a narrative review.

Asthma has been known as a prevalent chronic-type inflammatory disease in children, because of their narrower respiratory airways. The present study aimed to identify guidelines for children asthma treatments. Extensive research was conducted on biomedical and pharmacological bibliographic database PubMed, EMBASE, MEDLINE, LILACS database, global independent network of Cochrane, Science Direct and global health library of Global Index Medicus. A comprehensive literature review was carried out using the terms Pediatric Asthma, epidemiology, management, and related clinical guidelines published from 2000 to 2019. After the primary assessment, quick diagnosis, clinical practice guidelines are useful tools for proper management of pediatric Asthma. By setting proper guidelines for this particular population, a higher improvement in quality of management of of pediatric Asthma is expected. Given the differences between the recommendations arisen by BTS/SIGN and NICE guidelines, critical comparison of the evidence-base guidelines provide suggestions that have more in common than what might seems at the first glance. The analysis of the variations presented in the present article will assist clinicians to make accurate decisions regarding their patients.

Relationship between Height of Ethmoid Skull Base and Length of Lateral Lamella by Sectional Coronal Computed Tomography Scan before Endoscopic Sinus Surgery.

BACKGROUND: Damage to ethmoid skull base (ESB) and lateral lamella (LL) during endoscopic sinus surgery (ESS) causes penetration into the brain. This study is aimed to determine the relationship between the height of ESB and length of LL by sectional coronal computed tomography (CT) scans before ESS. MATERIALS AND METHODS: In a cross-sectional study, 100 patients admitted to ENT clinic of Al-Zahra Hospital, filled the consents regarding the use of CT scan stereotype. Each stereotype was evaluated and using the software on two sides the height of ESB and the length of LL were measured, investigated and recorded. Next, the maximum and minimum height and length in the two sides was measured, and its mean calculated. Then, the relationship between the length of LL and the height of ESB was investigated. RESULTS: There was a direct correlation, with the rate of 0.25 between the length of right LL and height of right ESB that was significant according to Pearson test (P = 0.013). Also, the rate of correlation between the left LL and height of left ESB was 0.15 that was not significant according to Pearson test (P = 0.15). CONCLUSION: Based on this study there was a direct correlation between height of the right ESB and the length of LL, but this correlation is very low, about 0.25 and even this correlation was lower in the case of left, about 0.15, which both of them are not significant. This may be due to other affecting factors, such as length, slope and angle of fovea ethmoidallis from the horizontal line.