Category: Nevin Manimala

Diabetes Ther. 2021 Jun 12. doi: 10.1007/s13300-021-01092-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Sodium-glucose co-transporter-2 (SGLT2) inhibitors moderately reduce glucose levels in type-2 diabetes mellitus (T2DM). Some cases of diabetic ketoacidosis (DKA) were reported with SGLT2 inhibitors. However, data on the long-term safety of dapagliflozin in Saudi Arabia are lacking. The present study aimed to monitor the safety of dapagliflozin in patients with T2DM and evaluate the change in HbA1c during the observation period compared to baseline.

METHODS: This was a local, prospective, single-arm, non-interventional, regulatory post-marketing study. The study was conducted in Saudi Arabia from May 2017 to September 2019. Patients received either 5 or 10 mg dapagliflozin in conjunction with diet and exercise modifications to treat T2DM. The occurrence of adverse events was observed over the treatment duration and for 3 days after administering the last dose of dapagliflozin.

RESULTS: A total of 527 patients were recruited in the study, 524 of which were eligible for the statistical analysis. About 62% were males. The median (IQR) age was 52.3 (14.8) years, while the median (IQR) body mass index was 31.6 (7.7) kg/m². The median (IQR) duration since the patients were first diagnosed with T2DM was 8.78 (6.73) years. The most common comorbidities were hyperlipidemia (51.1%) and hypertension (41.1%). Almost three-quarters of the study population (73.7%) received other antidiabetic medications in addition to dapagliflozin. Over a period of 12 months, a total of 106 adverse events were experienced by 65 (12.33%) patients. Vulvovaginal pruritus (3.1%), dysuria (2.7%), polyuria (1.3%), urinary tract infections (1%), fatigue (0.8%), and hypoglycemia (0.8%) were among the reported adverse events. One case of DKA (0.2%) was reported. The mean (SD) HbA1c% level significantly decreased from 8.6 (1.6) % at baseline to reach 7.2 (1.2) % after 12 months of treatment (p < 0.0001).

CONCLUSION: Dapagliflozin was found to be a well tolerated and effective treatment option for T2DM patients in Saudi Arabia. Vulvovaginal pruritus and dysuria were the most common adverse events.

PMID:34118010 | DOI:10.1007/s13300-021-01092-0

J Am Geriatr Soc. 2021 Jun 12. doi: 10.1111/jgs.17290. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: To assess whether vitamin D supplementation prevents specific fall subtypes and sequelae (e.g., fracture).

DESIGN: Secondary analyses of STURDY (Study to Understand Fall Reduction and Vitamin D in You)-a response-adaptive, randomized clinical trial.

SETTING: Two community-based research units.

PARTICIPANTS: Six hundred and eighty-eight participants ≥70 years old with elevated fall risk and baseline serum 25-hydroxyvitamin D levels of 10-29 ng/ml.

INTERVENTION: 200 IU/day (control), 1000 IU/day, 2000 IU/day, or 4000 IU/day of vitamin D3.

MEASUREMENTS: Outcomes included repeat falls and falls that were consequential, were injurious, resulted in emergency care, resulted in fracture, and occurred either indoors or outdoors.

RESULTS: After adjustment for multiple comparisons, the risk of fall-related fracture was greater in the pooled higher doses (≥1000 IU/day) group compared with the control (hazard ratio [HR] = 2.66; 95% confidence interval [CI]:1.18-6.00). Although not statistically significant after multiple comparisons adjustment, time to first outdoor fall appeared to differ between the four dose groups (unadjusted p for overall difference = 0.013; adjusted p = 0.222), with risk of a first-time outdoor fall 39% lower in the 1000 IU/day group (HR = 0.61; 95% CI: 0.38-0.97; unadjusted p = 0.036; adjusted p = 0.222) and 40% lower in the 2000 IU/day group (HR = 0.60; 95%CI 0.38-0.97; p = 0.037; adjusted p = 0.222), each versus control.

CONCLUSION: Vitamin D supplementation doses ≥1000 IU/day might have differential effects on fall risk based on fall location and fracture risk, with the most robust finding that vitamin D doses between 1000 and 4000 IU/day might increase the risk of first time falls with fractures. Replication is warranted, given the possibility of type 1 error.

PMID:34118059 | DOI:10.1111/jgs.17290

Equine Vet J. 2021 Jun 12. doi: 10.1111/evj.13488. Online ahead of print.

ABSTRACT

BACKGROUND: There is a lack of understanding of the pathological and/or physiological nature of lumbosacral region pain.

OBJECTIVES: To describe the gross variations of the osseous and soft tissues of the lumbosacral region and report the histological findings of sections of nerve tissue in affected and control horses.

STUDY DESIGN: Descriptive post-mortem case series.

METHODS: All horses had undergone full clinical and gait assessment, including ridden exercise. Horses with a substantial response to infiltration of local anaesthetic solution around the sacroiliac joint regions were included in the affected group (n=27). Horses for which the source(s) of pain was confirmed by diagnostic anaesthesia to be distant to the lumbosacral region were included in the control group (n=5). The pelvic regions were isolated and the soft tissues were assessed grossly. Sections of the lumbosacral plexus and cranial gluteal, sciatic and obturator nerves were examined histologically. The osseous specimens were evaluated for anatomical variants and abnormalities. Data were analysed using descriptive statistics.

RESULTS: Gross discolouration of the sciatic or obturator nerves was observed in 7 (26%) affected and no control horses. Grade 3/3 histological abnormality scores were assigned in 22% of nerve sections from affected horses compared with 3% from control horses. Several osseous variants (bifid sacral spinous processes, straight-shaped sacroiliac joint surface, short arrow-shaped sacral alae, left-right asymmetry of sacral alae, sacral curvature, absence of the 4^th -5^th and ankylosis of the 5^th -6^th lumbar articular process joints, left-right asymmetry of caudocranial position of the 4^th -5^th and lumbar-sacral articular process joints) and abnormalities (sacroiliac enthesopathy, extra ventral sacroiliac joint surface, lumbosacral symphyseal periarticular modelling, lumbosacral intertransverse joint pitting-lesions) were more frequently observed in affected horses.

MAIN LIMITATIONS: Both control and affected horses may have had pre-clinical abnormalities.

CONCLUSIONS: Lumbosacral region pain may reflect the presence of a number of pathological changes. Neural pain may play an important role in some horses.

PMID:34118082 | DOI:10.1111/evj.13488

Infect Dis Ther. 2021 Jun 12. doi: 10.1007/s40121-021-00476-w. Online ahead of print.

ABSTRACT

INTRODUCTION: We aimed to explore the real-world clinical application value and challenges of metagenomic next-generation sequencing (mNGS) for pulmonary infection diagnosis.

METHODS: We retrospectively reviewed the results of mNGS and conventional tests from 140 hospitalized patients with suspected pulmonary infections from January 2019 to December 2020. The sample types included bronchoalveolar lavage fluid, lung tissue by transbronchial lung biopsy, pleural effusion, blood, and bronchial sputum. Apart from the mNGS reports that our patients received, an extra comprehensive and thorough literature search was conducted.

RESULTS: Significant differences were noticed in the positive detection rates of pathogens between mNGS and conventional diagnostic testing (115/140, 82.14% vs 50/140, 35.71%, P < 0.05). The percentage of mNGS-positive patients was significantly higher than that of conventional testing-positive patients with regard to bacterial detection (P < 0.01), but no significant differences were found with regard to fungal detection (P = 0.67). Significant statistical differences were found between mixed infection cases (15, 22.70%) and single infection cases (4, 7.84%) in terms of diabetes (P = 0.03). The most frequent pattern of mixed infection was bacteria and fungi mixed infection (40, 40/89 = 44.94%), followed by bacteria mixed infection (29, 29/89 = 32.58%). The sensitivity of mNGS in pulmonary infection diagnosis was much higher than that of conventional test (89.17% vs 50.00%; P < 0.01), but the specificity was the opposite (75.00% vs 81.82%; P > 0.05).

CONCLUSION: mNGS is a valuable tool for the detection of pulmonary infections, especially mixed pulmonary infections. The most common combinations we found were bacterial-fungal coinfection and bacterial-bacterial coinfection. Still, there are many challenges in the clinical application of mNGS in the diagnosis of pulmonary infections. There is still a lot of work to be done in interpreting the mNGS reports, because both clinical judgment and literature analysis strategy need to be refined.

PMID:34117999 | DOI:10.1007/s40121-021-00476-w

Prev Sci. 2021 Jun 12. doi: 10.1007/s11121-021-01261-4. Online ahead of print.

ABSTRACT

Adolescent drinking remains a prominent public health and socioeconomic issue in the USA with costly consequences. While numerous drinking intervention programs have been developed, there is little guidance whether certain strategies of participant recruitment are more effective than others. The current study aims at addressing this gap in the literature using a computer simulation approach, a more cost-effective method than employing actual interventions. We first estimate stochastic actor-oriented models for two schools from the National Longitudinal Study of Adolescent to Adult Health (Add Health). We then employ different strategies for selecting adolescents for the intervention (either based on their drinking levels or their positions in the school network) and simulate the estimated model forward in time to assess the aggregated level of drinking in the school at a later time point. The results suggest that selecting moderate or heavy drinkers for the intervention produces better results compared to selecting casual or light drinkers. The intervention results are improved further if network position information is taken into account, as selecting drinking adolescents with higher in-degree or higher eigenvector centrality values for intervention yields the best results. Results from this study help elucidate participant selection criteria and targeted network intervention strategies for drinking intervention programs in the USA.

PMID:34117976 | DOI:10.1007/s11121-021-01261-4

Cancer Causes Control. 2021 Jun 12. doi: 10.1007/s10552-021-01452-y. Online ahead of print.

ABSTRACT

PURPOSE: Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma. Previous studies have reported geographic clustering of CTCL based on the residence at the time of diagnosis. We explore geographic clustering of CTCL using both the residence at the time of diagnosis and past residences using data from the New Jersey State Cancer Registry.

METHODS: CTCL cases (n = 1,163) diagnosed between 2006-2014 were matched to colon cancer controls (n = 17,049) on sex, age, race/ethnicity, and birth year. Jacquez’s Q-Statistic was used to identify temporal clustering of cases compared to controls. Geographic clustering was assessed using the Bernoulli-based scan-statistic to compare cases to controls, and the Poisson-based scan-statisic to compare the observed number of cases to the number expected based on the general population. Significant clusters (p < 0.05) were mapped, and standard incidence ratios (SIR) reported. We adjusted for diagnosis year, sex, and age.

RESULTS: The Q-statistic identified significant temporal clustering of cases based on past residences in the study area from 1992 to 2002. A cluster was detected in 1992 in Bergen County in northern New Jersey based on the Bernoulli (1992 SIR 1.84) and Poisson (1992 SIR 1.86) scan-statistics. Using the Poisson scan-statistic with the diagnosis location, we found evidence of an elevated risk in this same area, but the results were not statistically significant.

CONCLUSION: There is evidence of geographic clustering of CTCL cases in New Jersey based on past residences. Additional studies are necessary to understand the possible reasons for the excess of CTCL cases living in this specific area some 8-14 years prior to diagnosis.

PMID:34117957 | DOI:10.1007/s10552-021-01452-y

Tech Coloproctol. 2021 Jun 12. doi: 10.1007/s10151-021-02473-0. Online ahead of print.

ABSTRACT

BACKGROUND: Anal squamous cell carcinoma (ASCC) is an uncommon cancer associated with human immunodeficiency virus (HIV) infection. There has been increasing interest in providing organ-sparing treatment in small node-negative ASCC’s, however, there is a paucity of evidence about the use of local excision alone in people living with HIV (PLWH). The aim of this study was to evaluate the efficacy of local excision alone in this patient population.

METHODS: We present a case series of stage 1 and stage 2 ASCC in PLWH and HIV negative patients. Data were extracted from a 20-year retrospective cohort study analysing the treatment and outcomes of patients with primary ASCC in a cohort with a high prevalence of HIV.

RESULTS: Ninety-four patients were included in the analysis. Fifty-seven (61%) were PLWH. Thirty-five (37%) patients received local excision alone as treatment for ASCC, they were more likely to be younger (p = 0.037, ANOVA) and have either foci of malignancy or well-differentiated tumours on histology (p = 0.002, Fisher’s exact test). There was no statistically significant difference in 5-year disease-free survival and recurrence between treatment groups, however, patients who had local excision alone and PLWH were both more likely to recur later compared to patients who received other treatments for ASCC. (72.3 months vs 27.3 months, p = 0.06, ANOVA, and 72.3 months vs 31.8 months, p = 0.035, ANOVA, respectively).

CONCLUSIONS: We recommend that local excision be considered the sole treatment for stage 1 node-negative tumours that have clear margins and advantageous histology regardless of HIV status. However, PLWH who have local excision alone must have access to an expert long-term surveillance programme after treatment to identify late recurrences.

PMID:34117969 | DOI:10.1007/s10151-021-02473-0

Environ Geochem Health. 2021 Jun 12. doi: 10.1007/s10653-021-01001-1. Online ahead of print.

ABSTRACT

Geothermal areas of Greece are located in regions affected by recent volcanism and in continental basins characterised by elevated heat flow. Many of them are found along the coast, and thus, water is often saline due to marine intrusion. In the current study, we present about 300 unpublished and literature data from thermal and cold mineral waters collected along Greece. Samples were analysed for major ions, Li, SiO₂ and isotopes in water. Measured temperatures range from 6.5 to 98 °C, pH from 1.96 to 11.98, while Total Dissolved Solutes (TDS) from 0.22 to 51 g/L. Waters were subdivided into four main groups: (1) thermal; (2) cold; (3) acidic (pH < 5); and (4) hyperalkaline (pH > 11). On statistical basis, thermal waters were subdivided into subgroups according to both their temperature [warm (< 29 °C), hypothermal (29-48 °C), thermal (48-75 °C) and hyperthermal (> 75 °C)] and TDS [low salinity (< 4 g/L), brackish (4-30 g/L) and saline (> 30 g/L)]. Cold waters were subdivided based on their pCO₂ [low (< 0.05 atm), medium (0.05-0.85 atm) and high (> 0.85 atm)]. δ¹⁸O-H₂O ranges from – 12.7 to + 2.7‰ versus SMOW, while δ²H-H₂O from – 91 to + 12‰ versus SMOW being generally comprised between the Global Meteoric Water Line and the East Mediterranean Meteoric Water Line. Positive δ¹⁸O shifts with respect to the former are mostly related to mixing with seawater, while only for a few samples these shifts point to high-temperature water-rock interaction processes. Only a few thermal waters gave reliable geothermometric estimates, suggesting reservoir temperatures between 80 and 260 °C.

PMID:34117974 | DOI:10.1007/s10653-021-01001-1

AMB Express. 2021 Jun 12;11(1):88. doi: 10.1186/s13568-021-01249-x.

ABSTRACT

The mammalian gut microbiome participates in almost all life processes in the host. In addition to diet, the breed is the main factor affecting changes in the swine gut microbiota. The composition of the gut microbiota changes significantly during different growth stages. Research on developmental changes in the gut microbiota of indigenous Chinese pig breeds is limited. In this study, the fecal microbiota of Wuzhishan pigs (a Chinese indigenous miniature pig) at different growth stages was investigated using high-throughput 16S rRNA sequencing. Firmicutes and Bacteroidetes were the two dominant phyla, accounting for more than 80% of all sequences. With increasing age, the fecal microbial diversity increased, and the proportion of Firmicutes increased, whereas the proportion of Bacteroidetes decreased. A total of 49 biomarkers with statistical differences were detected in the four growth stages. The different microbiota among groups enhanced the ability to degrade fiber, carbohydrates, and other substances during the growth stages. The endocrine system was different in multiple growth stage paired comparisons, which was attributed to the different body statuses in the growth stages. This study revealed developmental changes in the structure and function of gut microbes in local pigs.

PMID:34117938 | DOI:10.1186/s13568-021-01249-x

Odontology. 2021 Jun 12. doi: 10.1007/s10266-021-00626-z. Online ahead of print.

ABSTRACT

A decline in swallowing function is frequently observed among older residents in nursing homes. We investigated whether swallowing dysfunction was related to the onset of fever in such individuals. Older residents aged ≥ 65 years from three nursing homes were included in this prospective study conducted from July 2017 to May 2019. The follow-up period was 13 months. The outcome was fever incidence in relation to the swallowing dysfunction. Baseline data on the activities of daily living, cognitive function, swallowing function, respiratory function, tongue pressure, and comorbidity conditions were collected. Dates on which the axillary temperature measured ay of participants was > 37.5 °C during the follow-up period were also recorded. For the statistical analyses, swallowing function assessed by the modified water swallow test (MWST) score was used to divide the participants into three groups: scores ≤ 3, 4, and 5. A total of 52 participants [median age, 89.5 years (67-104)] were enrolled. Kaplan-Meier analysis showed that the average periods until onset of fever in participants with MWST scores of ≤ 3, 4, and 5 were 8.0 (6.0-11.0), 10.0 (7.0-12.0), and 12.0 (10.0-13.0) months, respectively. Cox’s proportional hazards regression model revealed that participants with an MWST score ≤ 3 were at a higher risk of fever than those with an MWST score of 5 (hazard ratio 11.5, 95% confidence interval 1.5-63.4, adjusted for possible confounders. The swallowing dysfunction correlated with the risk of fever in older residents of nursing homes.

PMID:34117954 | DOI:10.1007/s10266-021-00626-z