Category: Statistics

Clin Ther. 2021 May 28:S0149-2918(21)00127-2. doi: 10.1016/j.clinthera.2021.03.015. Online ahead of print.

ABSTRACT

PURPOSE: Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin’s safety and efficacy.

METHODS: Data were pooled from 2 multicenter, double-blind, placebo-controlled, parallel-group, 14-week treatment studies of mirogabalin conducted at ∼350 study sites (Japan, South Korea, Taiwan, Singapore, Malaysia, and Thailand). Eligible patients in both studies were randomized in a 2:1:1:1 ratio, stratified according to a baseline average daily pain score (ADPS) of <6 or ≥6, to placebo, mirogabalin 15-mg once daily (QD), mirogabalin 10-mg twice daily (BID), or mirogabalin 15-mg BID treatment groups. Safety was assessed based on treatment-emergent adverse events identified from the adverse events collected throughout both studies. The primary efficacy end point of both studies was the change from baseline in ADPS at week 14.

FINDINGS: In total, 1587 patients (824 with diabetic peripheral neuropathic pain; 763 with post-herpetic neuralgia) who received at least 1 dose of study drug were analyzed (633 received placebo, 954 treated with mirogabalin). Treatment-emergent adverse events included somnolence (3.8%, 10.8%, 14.5%, and 19.1%) and dizziness (2.7%, 5.7%, 9.1%, and 13.1%) in patients receiving placebo, mirogabalin 15 mg QD, mirogabalin 10 mg BID, and mirogabalin 15 mg BID, respectively. In patients treated with mirogabalin 15 mg QD, 2 (0.6%) of 316 patients discontinued due to somnolence. In the mirogabalin 10-mg BID group, somnolence, edema, and peripheral edema each resulted in 3 (0.9%) of 318 patient discontinuations. In the mirogabalin 15-mg BID group, 6 (1.9%) of 320 patients discontinued due to dizziness and 3 (0.9%) due to somnolence. At week 14, mirogabalin 10 mg BID and 15 mg BID statistically significantly improved ADPS versus placebo, with least squares mean changes (95% CI) of -0.31 (-0.55, -0.08) and -0.63 (-0.86, -0.40). Post hoc analysis showed a statistically significant difference 2 days after administration in the mirogabalin 10-mg and 15-mg BID groups compared with placebo. Female sex, age ≥65 years, and baseline weight <60 kg may influence the safety of mirogabalin, particularly regarding the incidence of somnolence and dizziness, but had no notable impact on efficacy. ClinicalTrials.gov identifiers: NCT02318706 and NCT02318719. (Clin Ther. 2021;43:XXX-XXX) © 2021 Elsevier HS Journals, Inc.

IMPLICATIONS: This pooled analysis showed that mirogabalin was efficacious and well-tolerated by Asian patients with peripheral neuropathic pain.

PMID:34059327 | DOI:10.1016/j.clinthera.2021.03.015

Int J Food Microbiol. 2021 May 24:109248. doi: 10.1016/j.ijfoodmicro.2021.109248. Online ahead of print.

ABSTRACT

This work was carried out to elaborate selenium (Se) bio-enriched fermented Mediterranean fruit juices. To this purpose, pomegranate and table red grape juices were added with sodium selenite (Na₂SeO₃) and fermented by Levilactobacillus brevis CRL 2051 and Fructobacillus tropaeoli CRL 2034 individually or combined. To better evaluate the effect of selenite addition and starter strain inoculums on the total bacterial community of the fruit juices, fermentation trials were performed with raw and pasteurized fruit juices. No statistical significant differences were observed for total mesophilic microorganisms (TMM) and rod-shaped lactic acid bacteria (LAB) levels among raw and pasteurized juices inoculated with the starter strains, while significant differences between those juices with and without selenite were registered. LAB cocci, Pseudomonadaceae and yeasts were detected only for the raw juice preparations. The dominance of L. brevis CRL 2051 and F. tropaeoli CRL 2034 was confirmed by randomly amplified polymorphic DNA (RAPD)-PCR analysis. After fermentation, pH dropped for all inoculated trials and control raw juices. The soluble solid content (SSC) levels of the raw juices were higher than the corresponding pasteurized trials. The thermal treatment affected consistently yellowness of grape juice trials and redness of pomegranate juices. No microbial Se accumulation was registered for pomegranate juices, while F. tropaeoli CRL 2034 accumulated the highest amount of Se (65.5 μg/L) in the grape juice. For this reason, only trials carried out with raw grape juices were investigated by metagenomics analysis by Illumina MiSeq technology. Non-inoculated grape juices were massively fermented by acetic acid bacteria while Fructobacillus and Lactobacillus (previous genus name of Levilactobacillus) represented the highest operational taxonomy units (OTUs) relative abundance % of the trials inoculated with the starter strains as confirmed by this technique.

PMID:34059319 | DOI:10.1016/j.ijfoodmicro.2021.109248

Injury. 2021 May 17:S0020-1383(21)00438-1. doi: 10.1016/j.injury.2021.05.013. Online ahead of print.

ABSTRACT

INTRODUCTION: The calcaneus is the most commonly fractured hindfoot bone, accounting for over 60% of all tarsal fractures. The aim of this study was to compare the mechanism of injury and psychological health status in patients presenting with calcaneal fractures to an age- and sex-matched control group with ankle fractures.

PATIENTS AND METHODS: This retrospective study was undertaken within an orthopaedic unit at a tertiary hospital. An electronic medical record chart review was performed to identify eligible patients. Descriptive statistics were used to summarise the demographic and clinical characteristics of the patients. Between-group differences were analysed with the Mann-Whitney U test and Fisher’s exact test for continuous and categorical variables, respectively. Multivariable binary logistic regression was used to determine the relationship between fracture type and underlying psychopathology, adjusting for mechanism of injury.

RESULTS: Two-hundred and fifteen patients met the eligibility criteria for calcaneal fractures and these patients were subsequently matched to 215 ankle fracture patients. Men accounted for 154 (71.6%) of the patients in each group. Over half (51.2%) of all calcaneal fractures were due to an uncontrolled fall above one-metre, as opposed to 26.0% of ankle fractures, p < 0.001. Falling from a standing height was more common in the ankle fracture group, 37 (17.2%) versus 10 (4.7%), p < 0.001. Patients with calcaneal fractures were more likely to have a diagnosed psychological health complaint, 63 (29.3%) versus 32 (14.9%), p < 0.001. Suicidal ideation was significantly more common in the calcaneal fracture group 14 (6.5%) versus 3 (1.4%), p = 0.011. The presence of premorbid psychopathology was associated with calcaneal fracture, after adjusting for mechanism of injury (odds ratio 2.20, 95% confidence interval 1.32 to 3.65, p = 0.003).

CONCLUSION: Calcaneal and ankle fractures display differences in both the mechanism of injury and the history of psychological health conditions. However, after adjusting for the mechanism of injury, diagnosed premorbid psychopathology remains twice as likely in someone with a calcaneal fracture as opposed to an ankle fracture. It may be prudent for orthopaedic surgeons to consider further investigations of psychological health when managing patients with a calcaneal fracture.

PMID:34059323 | DOI:10.1016/j.injury.2021.05.013

Methods Enzymol. 2021;652:321-340. doi: 10.1016/bs.mie.2021.02.018. Epub 2021 Mar 27.

ABSTRACT

During reconstitution, membrane proteins are randomly inserted into liposomes according to Poisson distribution statistics. When the protein to lipid ratios in the reconstitution mixture are varied systematically, the characteristics of this statistical capture permit inferences about the proteins themselves, such as the number of subunits that assemble into a single functional unit. This chapter describes the Poisson distribution as applied to the reconstitution of membrane proteins into proteoliposomes and focuses on an application whereby this statistical behavior is used to determine the number of ion channel subunits that assemble into a functional pore. Practical considerations for performing these experiments are emphasized. Harnessing Poisson dilution statistics provides a function-based method to determine ion channel oligomerization, complementing other biophysical, biochemical, or structural approaches.

PMID:34059289 | DOI:10.1016/bs.mie.2021.02.018

J Prosthet Dent. 2021 May 28:S0022-3913(21)00198-0. doi: 10.1016/j.prosdent.2021.03.023. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The wear of monolithic zirconia against enamel has been widely studied, but how zirconia affects different opposing restorative materials is not clear.

PURPOSE: The purpose of this in vitro study was to investigate the depth of wear and volumetric loss of different restorative materials opposed by monolithic zirconia.

MATERIAL AND METHODS: Sixty-six Ø10×3-mm specimens (n=11) were fabricated from monolithic zirconia, zirconia reinforced ceramic, lithium disilicate ceramic, feldspathic ceramic, ORMOCER, and ceramic optimized polymer. A 2-body pin-on-disk wear test was performed by using monolithic zirconia pins. The specimens were scanned with a noncontact profilometer after the tests. The scan parameters were a frame size area of 1.5×1.5 mm, frequency of 400 Hz, and scan sensitivity of 2 μm. After the evaluation of depth and volume loss, the specimens were analyzed with a scanning electron microscope. The Kruskal-Wallis test was used to analyze the differences in wear values across the specimen groups, and pairwise comparison tests were performed with a post hoc test (α=.05).

RESULTS: Maximum depth of wear was 257.55 ±18.88 μm for lithium disilicate ceramic, 295.36 ±14.46 μm for zirconia reinforced ceramic, 421.82 ±214.49 μm for ORMOCER, 333.73 ±79.09 μm for ceramic optimized polymer, 146.27 ±22.86 μm for feldspathic ceramic, and 41.55 ±5.04 μm for monolithic zirconia. The depth of wear was not significantly different among lithium disilicate, zirconia-reinforced ceramic, ORMOCER, and ceramic optimized polymer (P<.05). However, the depth of wear of monolithic zirconia and feldspathic ceramic was less than that of other materials (P<.001). Volume loss of lithium disilicate was 1.68 ±0.25 mm³, 1.08 ±0.35 mm³ for zirconia reinforced ceramic, 4.29 ±2.91 mm³ for ORMOCER, 2.46 ±0.63 mm³ for resin ceramic, 1.07 ±0.09 mm³ for feldspathic ceramic, and 0.19 ±0.02 mm³ for monolithic zirconia. Feldspathic ceramic and monolithic zirconia had significantly less volume loss than the other groups (P<.001), and the difference between them for volume loss was statistically insignificant (P>.05).

CONCLUSIONS: The tested ceramic-based materials had favorable wear resistance compared with the tested composite resin-based ones. However, the ceramics tended to crack formation than the composite resins.

PMID:34059295 | DOI:10.1016/j.prosdent.2021.03.023

Facial Plast Surg. 2021 May 31. doi: 10.1055/s-0041-1730385. Online ahead of print.

ABSTRACT

The short nose represents one of the greatest challenges in rhinoplasty. It is characterized by a reduced distance from the nasal radix to the tip-defining points, often associated with inadequate tip projection. Several techniques have been described for correction of short nose with the common objective of replacing and rebuilding the osteocartilaginous framework. One of the most effective method to correct the short nose is the septal extension graft. The authors describe the caudal septum pivot (CSP) technique, a simple method to elongate short noses by using a graft inserted in the dorsal septum after its division using as pivot the caudal portion, without detaching it from its natural anchorage to the anterior nasal spine. A retrospective analysis was performed reviewing the clinical charts and the operative records of 315 patients who underwent revision rhinoplasty from January 2015 to June 2019; among this group, 34 were considered eligible for the study. The patients (8 men, 26 women; mean age: 25.4 years; age range: 22-53 years) were divided into two groups: in 12 patients (Group 1) the CSP technique was performed, while Group 2 was composed of 22 patients who received a more classic treatment with a septal extension graft. To evaluate the outcomes, nasal length, tip projection, and tip rotation were measured pre- and 1 year postoperatively on digital photographs of each patient. Nasal anthropometric measurements revealed, at 12-month visit follow-up, an improvement in nasal length, tip projection, and nasolabial angle was achieved in all the patients. The comparison of the pre- and postoperative values showed a statistically significant reduction in the nasolabial angle (p < 0.05) and an increase in the tip projection (p < 0.05) and in the nasal lengthening (p < 0.05) in both groups. In authors’ experience, the CSP technique could be considered a safe, reliable, and effective alternative technique in selected patients.

PMID:34058786 | DOI:10.1055/s-0041-1730385

ORL J Otorhinolaryngol Relat Spec. 2021 May 31:1-8. doi: 10.1159/000516243. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to evaluate the effects of nasal surgery on airflow characteristics in patients with obstructive sleep apnea (OSA) by comparing the alterations of airflow characteristics within the nasal and palatopharyngeal cavities.

METHODS: Thirty patients with OSA and nasal obstruction who underwent nasal surgery were enrolled. A pre- and postoperative 3-dimensional model was constructed, and alterations of airflow characteristics were assessed using the method of computational fluid dynamics. The other subjective and objective clinical indices were also assessed.

RESULTS: By comparison with the preoperative value, all postoperative subjective symptoms statistically improved (p < 0.05), while the Apnea-Hypopnea Index (AHI) changed little (p = 0.492); the postoperative airflow velocity and pressure in both nasal and palatopharyngeal cavities, nasal and palatopharyngeal pressure differences, and total upper airway resistance statistically decreased (all p < 0.01). A significant difference was derived for correlation between the alteration of simulation metrics with subjective improvements (p < 0.05), except with the AHI (p > 0.05).

CONCLUSION: Nasal surgery can decrease the total resistance of the upper airway and increase the nasal airflow volume and subjective sleep quality in patients with OSA and nasal obstruction. The altered airflow characteristics might contribute to the postoperative reduction of pharyngeal collapse in a subset of OSA patients.

PMID:34058743 | DOI:10.1159/000516243

Am J Perinatol. 2021 May 31. doi: 10.1055/s-0041-1730436. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to investigate the neonatal outcomes of infants born to mothers on hemodialysis.

STUDY DESIGN: This retrospective, case-control, and observational study included 17 infants born to 16 mothers on dialysis in 2003 to 2016. We compared their clinical characteristics to those of 51 gestational age- and sex-matched control infants. Statistical comparisons were made between the two groups by using the Wilcoxon-Mann-Whitney test for continuous variables and the Chi-square test or Fisher’s exact test for categorical variables.

RESULTS: Of the 16 pregnancies of mothers on dialysis, 15 (94%) deliveries were premature (<37 weeks), and 16/17 (94%) infants survived to discharge. The incidences of neonatal complications, such as intraventricular hemorrhage, bronchopulmonary dysplasia, patent ductus arteriosus, and periventricular leukomalacia, were not significantly different between the groups. However, 5/17 (29%) of the infants had congenital anomalies.

CONCLUSION: Although infants born to mothers on dialysis have a high risk of prematurity, they do not have any additional risk of neonatal complications, except for congenital anomalies. The potential risk of congenital anomalies should be investigated further.

KEY POINTS: · Preterm birth rate among mothers on hemodialysis was 94%.. · Complications in these infants were similar to controls.. · Twenty-nine percent of infants had congenital anomalies..

PMID:34058762 | DOI:10.1055/s-0041-1730436

Eur J Dent. 2021 May 31. doi: 10.1055/s-0040-1721315. Online ahead of print.

ABSTRACT

OBJECTIVES: The low resistance to fracture has limited the use of indirect composite resins for dental restorations, particularly in regions that are exposed to strong occlusal forces. To overcome this issue, different types of reinforcement for composites have been proposed, one of which is carbon nanotubes (CNTs). The aim of this study was to evaluate the flexural resistance of one commercial indirect composite resin (Sinfony, 3M/ESPE) after incorporation of single-wall carbon nanotubes (SWCNTs; Sigma-Aldrich, Inc., St. Louis, Missouri, United States) with or without the silanization form.

MATERIALS AND METHODS: Specimens of composite resin were fabricated in a Teflon mold. The composite resin was prepared according to the manufacturer’s instructions (n = 10 for each group), with SWCNTs in three concentrations.

STATISTICAL ANALYSIS: The SWCNTs and SWCNT/SiO₂-ATES specimens were evaluated by transmission electron microscopy, and a flexural test was conducted according to the ISO 4049/2009. Flexural strength data in MPa were submitted to one-way ANOVA following Tukey (p < 0.05).

RESULTS: The SWCNTs did not improve the flexural strength of indirect composite resin when compared with the control, independent of the concentration added (p > 0.05). However, when SWCNTs and SWCNTs/SiO2-ATES were compared, the SWCNTs/SiO2-ATES showed higher values than the three concentrations of SWCNTs (p < 0.05).

CONCLUSION: The silanization process improves the SWCNTs strength proprieties, but the modification of chemical bonding between SWCNT and SWCNT/SiO₂-ATES modified resins, in different concentrations, did not improve the composite resin flexural strength.

PMID:34058771 | DOI:10.1055/s-0040-1721315

Arch Oral Biol. 2021 May 27;128:105172. doi: 10.1016/j.archoralbio.2021.105172. Online ahead of print.

ABSTRACT

OBJECTIVE: The position and size of the major cusps in mammalian molars are arranged in a characteristic pattern that depends on taxonomy. In humans, the cusp which locates distally within each molar is smaller than the mesially located cusp, which is referred to as “distal reduction”. Although this concept has been well-recognized, it is still unclear how this reduction occurs. Current study examined whether senescence-accelerating mouse prone 8 (SAMP8) mice could be a possible animal model for studying how the mammalian molar cusp size is determined.

DESIGN: SAMP8 mice were compared with parental control (SAMR1) mice. Microcomputed tomography images of young and aged mice were captured to observe molar cusp morphologies. Cusp height from cement-enamel junction and mesio-distal length of molars were measured. The statistical comparison of the measurements was performed by Mann-Whitney U test.

RESULTS: SAMP8 mice showed reduced development of the disto-lingual cusp (entoconid) of lower second molar when compared with SAMR1 mice. The enamel thickness and structure was disturbed at entoconid, and aged SAMP8 mice displayed severe wear of the entoconid in lower second molar. These phenotypes were observed on both sides of the lower second molar.

CONCLUSIONS: In addition to the general senescence phenotype observed in SAMP8 mice, this strain may genetically possess molar cusp phenotypes which is determined prenatally. Further, SAMP8 mice would be a potential model strain to study the genetic causes of the distal reduction of molar cusp size.

PMID:34058725 | DOI:10.1016/j.archoralbio.2021.105172