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Daily vs. monthly oral vitamin D3 for treatment of symptomatic vitamin D deficiency in infants: a randomized controlled trial

J Pediatr Endocrinol Metab. 2023 May 18. doi: 10.1515/jpem-2023-0146. Online ahead of print.

ABSTRACT

OBJECTIVES: Compare the efficacy and safety of daily vs. monthly oral vitamin D3 in treating symptomatic vitamin D deficiency in infants.

METHODS: 90 infants with symptomatic vitamin D deficiency were randomized into Daily (D) [46 infants] and Bolus (B) [44 infants] groups to receive oral vitamin D3, daily (2000 IU/day) and bolus (60,000 IU/month) for three months respectively. Both groups received daily oral calcium @50 mg/kg/day. Serum calcium (Ca), phosphate (P), alkaline phosphatase (ALP), 25-hydroxy cholecalciferol [25(OH)D], parathyroid hormone (PTH) levels, urine calcium: creatinine ratio and radiological score were assessed at baseline, 4 and 12 weeks. At the end of 12 weeks, 78 infants were available for evaluation of efficacy and safety of both regimens.

RESULTS: Both regimens led to a statistically significant increase in Ca and P levels and fall in ALP and PTH levels from baseline to 4 and 12 weeks of therapy, with no inter-group difference. Infants in group D had statistically significant higher mean 25(OH)D levels as compared to group B at 4 weeks (group D 130.89 ± 43.43 nmol/L, group B – 108.25 ± 32.40 nmol/L; p – 0.012) and 12 weeks (group D – 193.69 ± 32.47 nmol/L, group B – 153.85 ± 33.60 nmol/L; p<0.001). Eight infants [group D – 6/41 (14.6 %); group B – 2/37 (5.4 %), p=0.268] developed mild asymptomatic hypercalcemia without hypercalciuria at 12 weeks that corrected spontaneously within a week.

CONCLUSIONS: Both daily and monthly oral vitamin D3 in equivalent doses are efficacious and safe for treating symptomatic vitamin D deficiency in infants.

PMID:37192500 | DOI:10.1515/jpem-2023-0146

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Tigecycline-Containing Regimens and Multi Drug-Resistant Acinetobacter baumannii: A Systematic Review and Meta-Analysis

Microb Drug Resist. 2023 May 16. doi: 10.1089/mdr.2022.0248. Online ahead of print.

ABSTRACT

Introduction: The use of tigecycline (TG) for the treatment of Acinetobacter baumannii is controversial. In this systematic review and meta-analysis, we aimed to better explore the safety and efficacy of TG for the treatment of multi drug-resistant (MDR) Acinetobacter. Methods: We searched PubMed/MEDLINE, Scopus, Cochrane Central, and Web of Science to identify studies reporting the clinical and microbiological efficacy and safety of regimens containing TG in patients with drug susceptibility testing (DST)-confirmed MDR A. baumannii, published until December 30, 2022. Observational studies were included if they reported clinical and microbiological efficacy of TG-based regimens. The Newcastle-Ottawa Scale (NOS) and Joana Briggs Institute (JBI) critical appraisal tool were used to assess the quality of included studies. Results: There were 30 observational studies, of which 19 studies were cohort and 11 studies were single group studies. Pooled clinical response and failure rates in the TG-containing regimens group were 58.1 (95% confidence interval [CI] 49.2-66.6) and 40.2 (95% CI 31.1-50.0), respectively. The pooled microbiological response rate was 32.1 (95% CI 19.8-47.5), and the pooled all-cause mortality rate was 41.1 (95% CI 34.1-48.4). Pooled clinical response and failure rates in the colistin-based regimens group were 52.7 (42.7-62.5) and 43.1 (33.1-53.8), respectively. The pooled microbiological response rate was 42.9 (16.2-74.5), and the pooled all-cause mortality rate was 34.3 (26.1-43.5). Conclusions: According to our results, the efficacy of the TG-based regimen is the same as other antibiotics. However, our study showed a high mortality rate and a lower rate of microbiological eradication for TG compared with colistin-based regimen. Therefore, our study does not recommend it for the treatment of MDR A. baumannii. However, this was a prevalence meta-analysis of observational studies, and for better conclusion experimental studies are required.

PMID:37192494 | DOI:10.1089/mdr.2022.0248

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UP360, a Standardized Composition from Extracts of Aloe barbadense, Poria cocos, and Rosemary officinalis Protected Against Sepsis and Mitigated Acute Lung Injury in Murine Models

J Med Food. 2023 May 16. doi: 10.1089/jmf.2022.0136. Online ahead of print.

ABSTRACT

Sepsis is a life-threatening organ dysfunction caused by a dysregulated and unbalanced immune response to microbial infection. Restoring immune homeostasis and infection control are considered the primary strategies to manage sepsis. Natural bioactives such as polysaccharide and polyphenols from botanicals are known for their immune modulation activity. In this study, we evaluated a standardized aloe-based composition, UP360 (constitute of polysaccharides from Aloe barbadense and Poria cocos and polyphenols from Rosemary officinalis) in lipopolysaccharide (LPS)-induced sepsis and acute inflammatory lung injury murine models. Prophylactic oral administration of UP360 for 7 days at an oral dose of 500 mg/kg improved the survival rate of mice by 62.5%, whereas all mice in the vehicle control group were deceased 82 h after LPS injection. The merit of combining these traditional herbs to yield the standardized composition UP360 was also demonstrated in this model with a mortality rate of only 30.8%, whereas 76.9%, 53.9%, and 61.5% were recorded for each individual constituents A. barbadense, P. cocos, and R. officinalis, respectively. Dose-correlated statistically significant reductions in proinflammatory cytokines and chemokine tumor necrosis factor alpha (TNF-α), interleukin (IL)-1β, IL-6, and cytokine-induced neutrophil chemoattractant (CINC)-3 were observed for UP360 when administered at 250 and 500 mg/kg orally for 7 days before induction of acute lung injury (ALI) model in rats. The histopathology data from lung showed statistically significant 37.9% and 37% reductions in the overall lung damage severity and pulmonary edema, respectively, for UP360-treated rats. The aloe-based composition UP360 effectively improved the survival rate of septic animals and mitigated the severity of LPS-induced ALI in vivo. These data warrant further investigation of the composition for a potential application in human as an adjunct supplement in respiratory distress and sepsis.

PMID:37192488 | DOI:10.1089/jmf.2022.0136

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Craniometric aspects in forensic medical identification of the Kazakhstan population

Sud Med Ekspert. 2023;66(3):24-28. doi: 10.17116/sudmed20236603124.

ABSTRACT

The aim of this study is to estimate the variability limits of craniometric skull parameters, revealed in Kazakhstan, and find out significant criteria for forensic medical identification of the local population. The investigation included 25 standard craniometric skull parameters, revealed in Kazakhstan. Standard antropometric tests and tools were used. Current study confirm that the craniometrics indicators of Kazakhstan population have specific regional features. The skulls, revealed in Kazakhstan, are well craniometrically differentiated. Statistically significant differences were found out in 6 craniometric parameters in men (width of skull base, frontal chord, full face height, condylar and bigonial width, mandibular height) and in 4 parameters in women (transverse diameter, width of skull base, mastoid width, width of occipital foramen). The usage of updated data according to the regional features of the craniometrics parameters allow to significantly improve the forensic identification accuracy, study more completely the biological regularities of population formation and assess the comparative efficacy of individual features in the population reconstructions.

PMID:37192455 | DOI:10.17116/sudmed20236603124

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Impact of projectile incidence angle with obstacle during ricochet on the damage characteristics formed in smoothbore weapon shot

Sud Med Ekspert. 2023;66(3):14-17. doi: 10.17116/sudmed20236603114.

ABSTRACT

The aim of this study was to establish the degree of projectile incidence angle with obstacle on forensic medical characteristic of gunshot injuries arising from smoothbore weapon fire and bullet ricochet. Based on the comprehensive forensic study results of experimental entry gunshot injuries, statistically significant differences in the following morphological signs were found for two ranges of incidence angle values (10-20° and 30-50°): «Number of MD», «Length 1 MD», «Length 2 MD», «Width 1 MD», «Orientation of AD to the conventional clock face relative to MD 1 or to the group of largest MD (max. value)». The medians and limits of 99% confidence intervals of these features values were observed depending on the range of incidence angle values. The revealed patterns can be used in expert practice during forensic medical examination of gunshot injuries formed as a result of a projectile ricochet after smoothbore weapon fire, as well as to develop a methodology for conducting a forensic study of this gunshot injury type.

PMID:37192453 | DOI:10.17116/sudmed20236603114

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Serum Interleukin-8 as a Determinant of Response to PDE4 Inhibition in Chronic Obstructive Pulmonary Disease

Am J Respir Crit Care Med. 2023 May 16. doi: 10.1164/rccm.202301-0071OC. Online ahead of print.

ABSTRACT

RATIONALE: Phosphodiesterase-4 inhibitors (PDE4i) have demonstrated increased efficacy in COPD patients with chronic bronchitis or higher blood eosinophil counts. Further characterization of patients most likely to benefit is warranted.

OBJECTIVE: To identify determinants of response to the PDE4-inhibitor tanimilast .

METHODS: A PDE4-gene-expression signature in blood was developed by unsupervised clustering of the ECLIPSE study dataset (ClinTrial.gov: NCT00292552; Gene-Expression Series: GSE76705). The signature was further evaluated using blood and sputum transcriptome data from the BIOMARKER study (NCT03004417; GSE133513), enabling validation of the association between PDE4-signaling and target biomarkers. Predictivity of the associated biomarkers against clinical response was then tested in the phase-2b PIONEER tanimilast study (NCT02986321).

MEASUREMENTS AND MAIN RESULTS: The PDE4-gene-expression signature developed in the ECLIPSE dataset classified subgroups of patients associated to different PDE4-signaling in the BIOMARKER cohort with Area-Under the Receiver-Operated-Curve of 98%. In the BIOMARKER study, serum interleukin-8 was the only variable consistently associated to PDE4-signaling, with lower levels associated to higher PDE4-activity. In the PIONEER study the exacerbation rate reduction mediated by tanimilast treatment increased up to 2-fold in patients with lower interleukin-8 levels; 36% vs 18%, reaching statistically significance ≤20pg/mL (p=0.035). The combination with blood eosinophils ≥150µL-1 or chronic bronchitis provided further additive exacerbation rate reduction: 45% (p=0.013) and 47% (p=0.027), respectively.

CONCLUSIONS: This analysis using selected heterogeneous datasets identifies interleukin-8 as an independent predictor of PDE4 inhibition, as tanimilast had a greater effect on exacerbation prevention in COPD patients with lower baseline serum interleukin-8. Testing of this biomarker in other datasets is warranted.

PMID:37192443 | DOI:10.1164/rccm.202301-0071OC

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Efficacy of an Opioid-Sparing Perioperative Multimodal Analgesia Protocol on Posterior Lumbar Fusion in a Hispanic Population: A Randomized Controlled Trial

J Am Acad Orthop Surg. 2023 May 16. doi: 10.5435/JAAOS-D-22-00878. Online ahead of print.

ABSTRACT

INTRODUCTION: Posterior lumbar fusion surgery has become more common amid an aging population, with degenerative disease as its most common indication. Historically, postoperative pain control for spine surgery has relied on opioids. However, opioid use is associated with adverse effects such as dependence, respiratory depression, and altered cognition. Our study aimed to determine whether an opioid-sparing multimodal analgesia regimen (ketorolac, orphenadrine, and gabapentin) could be a viable alternative to diminish opioid use compared with a standard opioid-based regimen in Hispanic patients undergoing posterior lumbar spinal fusion.

METHODS: This was a randomized controlled trial of Hispanic patients scheduled to undergo elective posterior spinal fusion. Inclusion criteria included age 30 to 85 years, Hispanic ethnicity, lumbar stenosis between L1 and S1, elective posterior spinal fusion with instrumentation, American Society of Anesthesiologists Score <2, and consent to participate in the study. Patients were randomized into two groups, an experimental multimodal analgesia and control (opioid-based) treatment groups, and outcomes such as morphine milligram equivalents used, visual analog scale score, and length of hospital stay were compared between the groups.

RESULTS: The MMA experimental group used significantly lower amounts of opioid (measured with morphine milligram equivalent) than the opioid-based group during the 12-hour and 24-hour postoperative periods (P-value = 0.023 and P-value = 0.033, respectively). No statistically significant difference was observed in opioid use in the 48-hour postoperative period between both groups (P-value = 0.066). The MMA group had significantly lower VAS scores reported at the 12-hour, 24-hour, and 48-hour postoperative periods compared with the opioid-based group (P-values = 0.016, 0.020, and 0.020, respectively). No difference was observed in the length of hospital stay between groups (P-value = 0.169).

DISCUSSION: Implementing an MMA protocol in Hispanic patients undergoing posterior lumbar fusion resulted in decreased overall opioid use and decreased pain intensity compared with the opioid-based group. MMA is an effective alternative for pain control in patients who want to avoid opioid use.

CLINICAL TRIAL REGISTRATION: Identifier: NCT05413902.

PMID:37192425 | DOI:10.5435/JAAOS-D-22-00878

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Medicare Reimbursement Rates and Utilization Trends in Sacroiliac Joint Fusion

J Am Acad Orthop Surg. 2023 May 16. doi: 10.5435/JAAOS-D-22-00800. Online ahead of print.

ABSTRACT

INTRODUCTION: Sacroiliac joint (SIJ) fusion is a surgical treatment option for SIJ pathology in select patients who have failed conservative management. More recently, minimally invasive surgical (MIS) techniques have been developed. This study aimed to determine the trends in procedure volume and reimbursement rates for SIJ fusion.

METHODS: Publicly available Medicare databases were assessed using the National Summary Data Files for 2010 to 2020. Files were organized according to current procedural terminology (CPT) codes. CPT codes specific to open and MIS SI joint fusion (27279 and 27280) were identified and tracked. To track surgeon reimbursements, the CMS Medicare Physician Fee Schedule Look-Up Tool was used to extract facility prices. Descriptive statistics and linear regression were used to evaluate trends in procedure volume, utilization, and reimbursement rates. Compound annual growth rates were calculated, and discrepancies in inflation were corrected for using the Consumer Price Index.

RESULTS: A total of 33,963 SIJ fusions were conducted in the Medicare population between 2010 and 2020, with an overall increase in procedure volume of 2,350.9% from 318 cases in 2010 to 7,794 in 2020. Since the introduction of the 27279 CPT code in 2015, 8,806 cases (31.5%) have been open and 19,120 (68.5%) have been MIS. Surgeon reimbursement for open fusions increased nominally by 42.8% (inflation-adjusted increase of 20%) from $998 in 2010 to $1,425 in 2020. Meanwhile, reimbursement for MIS fusion experienced a nominal increase of 58.4% (inflation-adjusted increase of 44.9%) from $582 in 2015 to $922 in 2020.

CONCLUSION: SIJ fusion volume in the Medicare population has increased substantially in the past 10 years, with MIS SIJ fusion accounting for most of the procedures since the introduction of the 27279 CPT code in 2015. Reimbursement rates for surgeons have also increased for both open and MIS procedures, even after adjusting for inflation.

PMID:37192412 | DOI:10.5435/JAAOS-D-22-00800

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Improving human papilloma virus vaccination rates among adolescents

J Am Assoc Nurse Pract. 2023 May 16. doi: 10.1097/JXX.0000000000000893. Online ahead of print.

ABSTRACT

BACKGROUND: The human papilloma virus (HPV) is the leading cause of cervical cancer worldwide and is responsible for genital warts and five other types of cancers. The HPV vaccine was introduced in 2006 and demonstrated to be safe and more effective than expected, yet adolescent rates of immunization in the United States remain low.

LOCAL PROBLEM: Adolescent HPV vaccine rates were below the national average, and effective vaccine recommendation strategies were not used at an urban pediatric primary care office in southern Florida.

METHODS: The percentage of HPV vaccine rates in this primary care office were measured among adolescents ages 13-17 years using data obtained from Florida’s state vaccine registry before implementation of the intervention, after the intervention, and monthly over a 90-day period.

INTERVENTIONS: Interventions aimed to improve vaccine rates included implementing an HPV protocol consisting of education on providing a strong bundled recommendation, appointing a vaccine champion, implementing standing vaccine orders, and educational materials.

RESULTS: The vaccine rates among adolescents increased by 11% for the initial dose, 7% for the second dose, and 6% for the vaccine completion rate. Chi-square test demonstrated statistical significance, for the initial vaccine.

CONCLUSION: A nurse practitioner-led application of an evidenced-based HPV vaccine protocol positively affected the care of adolescents in this primary care setting.

PMID:37192408 | DOI:10.1097/JXX.0000000000000893

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Combined use of intraoperative MRI and awake tailored microsurgical resection to respect functional neural networks: preliminary experience

Swiss Med Wkly. 2023 May 15;153:40072. doi: 10.57187/smw.2023.40072.

ABSTRACT

INTRODUCTION: The combined use of intraoperative MRI and awake surgery is a tailored microsurgical resection to respect functional neural networks (mainly the language and motor ones). Intraoperative MRI has been classically considered to increase the extent of resection for gliomas, thereby reducing neurological deficits. Herein, we evaluated the combined technique of awake microsurgical resection and intraoperative MRI for primary brain tumours (gliomas, metastasis) and epilepsy (cortical dysplasia, non-lesional, cavernomas).

PATIENTS AND METHODS: Eighteen patients were treated with the commonly used “asleep awake asleep” (AAA) approach at Lille University Hospital, France, from November 2016 until May 2020. The exact anatomical location was insular with various extensions, frontal, temporal or fronto-temporal in 8 (44.4%), parietal in 3 (16.7%), fronto-opercular in 4 (22.2%), Rolandic in two (11.1%), and the supplementary motor area (SMA) in one (5.6%).

RESULTS: The patients had a mean age of 38.4 years (median 37.1, range 20.8-66.9). The mean surgical duration was 4.1 hours (median 4.2, range 2.6-6.4) with a mean duration of intraoperative MRI of 28.8 minutes (median 25, range 13-55). Overall, 61% (11/18) of patients underwent further resection, while 39% had no additional resection after intraoperative MRI. The mean preoperative and postoperative tumour volumes of the primary brain tumours were 34.7 cc (median 10.7, range 0.534-130.25) and 3.5 cc (median 0.5, range 0-17.4), respectively. Moreover, the proportion of the initially resected tumour volume at the time of intraoperative MRI (expressed as 100% from preoperative volume) and the final resected tumour volume were statistically significant (p= 0.01, Mann-Whitney test). The tumour remnants were commonly found posterior (5/9) or anterior (2/9) insular and in proximity with the motor strip (1/9) or language areas (e.g. Broca, 1/9). Further resection was not required in seven patients because there were no remnants (3/7), cortical stimulation approaching eloquent areas (3/7) and non-lesional epilepsy (1/7). The mean overall follow-up period was 15.8 months (median 12, range 3-36).

CONCLUSION: The intraoperative MRI and awake microsurgical resection approach is feasible with extensive planning and multidisciplinary collaboration, as these methods are complementary and synergic rather than competitive to improve patient oncological outcomes and quality of life.

PMID:37192405 | DOI:10.57187/smw.2023.40072