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Nevin Manimala Statistics

Efficacy and Safety of Triple versus Dolutegravir-based Dual Therapy in Patients with HIV-1 Infection: A Meta-analysis of Randomized Controlled Trials

AIDS Rev. 2021 Jun 3. doi: 10.24875/AIDSRev.20000103. Online ahead of print.

ABSTRACT

A new strategy of simplification therapy shown the unique benefits in clinical treatment, by reducing pill burden and avoid drug exposure. To provide more evidence for the strategy, we compared the efficacy and safety of dolutegravir (DTG)-containing simplified dual combination antiretroviral therapy (cART) and traditional triple cART for people living with HIV/AIDS. The meta-analysis of randomized controlled trials compared DTG-containing dual therapy with triple cART. The primary outcome was virologic suppression. The secondary outcomes included CD4T cell recovery, lipids change from baseline, and adverse events (AEs). A total of 7 studies, 4852 patients were eligible, 2423 (49.9%) received DTG-based simplified dual cART, and 2429 (50.1%) received triple cART. The viral suppression rate was 94.7% at 24 weeks, 93.0% at 48 weeks, and 96.6% at 96 weeks in dual cART. The viral suppression rate of dual cART was non-inferior to triple cART at 24 weeks (risk difference [RD], -0.00; 95% confidence interval [CI] -0.02-0.01), at 48 weeks (RD, -0.01; 95% CI -0.02-0.01), and at 96 weeks (RD, -0.01; 95% CI -0.02-0.00). Sub-analysis results were consistent with the overall results. With regard to other outcomes (CD4T counts, lipids, any AEs, and AEs grade ≥ 3), there was no significant statistical difference between the two regimens. DTG-based simplified dual cART was non-inferior to triple cART in terms of efficacy and safety. This finding provides strong support for current consensus guidelines recommended the dual regimen as first-line treatment.

PMID:34082439 | DOI:10.24875/AIDSRev.20000103

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Nevin Manimala Statistics

More Is Not Better When It Comes to Treating Rectal Cancer With Multimodal Chemoradiation Beyond the Standard Radiation Dose of 5040 cGy

Dis Colon Rectum. 2021 Jun 1. doi: 10.1097/DCR.0000000000001986. Online ahead of print.

ABSTRACT

BACKGROUND: Radiation dose schedules for neoadjuvant chemoradiation for rectal cancers differs, with the most common dose schedule using 5040 cGy in 28 fractions.

OBJECTIVES: The aim of this retrospective study was to assess the benefit of higher radiation doses beyond 5040cGy in the context of pathological response and follow up events.

SETTING: Database from a provincial tertiary cancer center in Canada.

PATIENTS: Five hundred eight consecutive rectal cancer patients with locally advanced disease (clinical T3/T4 or N1/N2) who received neoadjuvant chemoradiation followed by surgery were included in this study. Of the 508 patients, 281 received the standard radiation dose of 4500-5040 cGy and 227 received a dose >5040 cGy.

MAIN OUTCOME MEASURE: The postsurgical pathology, late toxicities and follow-up outcomes were analyzed. The outcomes were evaluated in relation to the dose of radiation received.

RESULTS: Data regarding the clinical outcomes were comparable between the 4500-5040 cGy and >5040 cGy radiation groups with pathological complete response rates of 20.9% and 15.4% respectively (p=0.104); distant recurrence rates of 17.4% and 19.4%, respectively (p=0.36); local recurrence rates of 3.2% and 3.5%, respectively (p=0.36); and the median overall survival rates of 61 and 60.5 months respectively (p=0.8). No statistically significant correlation of improvement in outcomes was noted with radiation doses beyond 5040 cGy.

LIMITATIONS: This is a retrospective study.

CONCLUSION: Our study showed that dose escalation beyond the standard dose of 4500-5040cGy failed to achieve meaningful clinical outcomes. See Video Abstract at http://links.lww.com/DCR/B633.

PMID:34082437 | DOI:10.1097/DCR.0000000000001986

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Nevin Manimala Statistics

Simple and efficient spectroscopic-based univariate sequential methods for simultaneous quantitative analysis of vandetanib, dasatinib, and sorafenib in pharmaceutical preparations and biological fluids

Spectrochim Acta A Mol Biomol Spectrosc. 2021 May 21;260:119987. doi: 10.1016/j.saa.2021.119987. Online ahead of print.

ABSTRACT

Six sequential spectrophotometric-based univariate methods were developed and validated for the simultaneous estimation of three novel anticancer drugs vandetanib (VAN), dasatinib (DAS), and sorafenib (SOR) in a mixture, without the requirement for separation. These methods are novel, simple, precise, and accurate. Different steps including zero crossing, ratio-based, and/or derivative spectra were utilized to develop these analytical methods, namely, ratio difference spectrophotometric method, constant center method, successive derivative ratio method, isoabsorptive method, mean centering of the ratio spectra method, and derivative ratio spectrum-zero crossing method. The calibration curve linearity was ranged from 2 to 9, 2-9, and 3-9 μgmL-1 for VAN, DAS, and SOR, respectively. These established methods were applied for the quantification of the three selected drugs in different biological fluids (spiked human plasma and urine) and pharmaceutical preparations. The aforementioned methods were established for the concurrent estimation of ternary and binary mixtures to enhance the signal-to-noise ratio. The results did not statistically differ from the other reported methods, indicating no significant difference in accuracy and precision at p = 0.05.

PMID:34082354 | DOI:10.1016/j.saa.2021.119987

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Nevin Manimala Statistics

Mirroring risk to investment within the EKC hypothesis in the United States

J Environ Manage. 2021 May 31;293:112890. doi: 10.1016/j.jenvman.2021.112890. Online ahead of print.

ABSTRACT

In reality, economic expansion cannot be paced-up enough. This account for a potential trade-off between income and environmental degradation that is expectedly feasible at a maximum level of income. On this note, the current study looked at the validity of income-environmental degradation (Environmental Kuznets Curve, EKC) hypothesis especially amidst risk to investment in the United States over the period 1984-2017. Considering that the burning of fossil fuels constitutes the largest source of Greenhouse gas (GHG) in the United States, this study employed energy carbon emissions as a proxy for environmental quality and as a dependent variable. While the study employed renewable energy production as additional explanatory variable, it implemented the Autoregressive Distributed Lag (ARDL) technique in addition to a set of cointegration techniques. Importantly, the study found that the EKC hypothesis is valid for the case of the United States but not without a non-significant trade-off of risk to investment. Additionally, renewable energy production exhibits a statistically significant and desirable impact on environmental quality in both the short and long-run. In general, the study posited that while environmental sustainability is achievable at maximum level of income, it is likely attainable at the detriment of risk to investment. Hence, this observation should trigger a potential policy mechanism that minimizes risk to investment in light of the attainment of the country’s sustainable development goals (SDGs).

PMID:34082348 | DOI:10.1016/j.jenvman.2021.112890

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Nevin Manimala Statistics

Dynamic multi-objective programming model for improving consumer satisfaction within water supply system under uncertain environment

J Environ Manage. 2021 May 31;293:112897. doi: 10.1016/j.jenvman.2021.112897. Online ahead of print.

ABSTRACT

Water scarcity poses a real crisis for decision makers of water supply system because satisfying growing demand and, as a result, achieving full consumer satisfaction in different sectors of the system remains a major problem. Therefore, this study develops a dynamic multi-objective model of water supply optimization under different scenarios to improve multisectoral consumer satisfaction. To diminish the negative effects of the water crisis on long-term consumer satisfaction, the performance of the dynamic water supply system is evaluated and optimized, which can change the situation from a state of dissatisfaction to satisfaction. In this regard, to analyze the developed model, a real case study of the Hamoun wetland in southeastern Iran is considered. According to the proposed model, various strategies are performed along with the analysis of two scenarios related to runoff uncertainty in order to investigate the consumer satisfaction status in detail. However, given to the final results, which show the greater impact of the two sensitive factors of reliability and vulnerability on consumer satisfaction, the highest level of dissatisfaction is related to the agricultural sector because it has less reliability and higher vulnerability compared to other sectors. In this regard, by proposing policies such as weight scenarios and demand reduction scheme, the situation of consumer satisfaction has improved much more desirable.

PMID:34082342 | DOI:10.1016/j.jenvman.2021.112897

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Nevin Manimala Statistics

Effects of bentonite on antibiotic resistance genes in biogas slurry and residue from thermophilic and mesophilic anaerobic digestion of food waste

Bioresour Technol. 2021 May 23;336:125322. doi: 10.1016/j.biortech.2021.125322. Online ahead of print.

ABSTRACT

Anaerobic digestion (AD) processes of food waste (FW) have potential risk on environments due to the prevalence and dissemination of antibiotic resistance genes (ARGs). This study investigated the effect of bentonite on methane production and the abundance of ARGs in biogas slurry and residue during AD of FW. Results showed that methane production increased by 68.52% and 56.79% with 3 g/L and 5 g/L of bentonite in mesophilic and thermophilic digestion, respectively. Adding 5 g/L of bentonite effectively reduced the genes of ermB, ermF, tetQ, tetX, sul1, sul2 and intI1 with a range of 80.82% – 100.00% in biogas residue under mesophilic reactor. The abundance of ARGs and intI1 in biogas residue were lower than in slurry under both temperatures with 5 g/L of bentonite. Statistical analysis indicated that bentonite and temperature were main driver factors which could impact ARGs by influencing the abundance and structure of microbial communities.

PMID:34082336 | DOI:10.1016/j.biortech.2021.125322

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Nevin Manimala Statistics

Apolipoprotein E genotype, lifestyle and coronary artery disease: Gene-environment interaction analyses in the UK Biobank population

Atherosclerosis. 2021 May 27;328:33-37. doi: 10.1016/j.atherosclerosis.2021.05.014. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The APOE ε4 genotype has a higher risk for developing coronary artery disease (CAD), but there is preliminary evidence that antioxidative lifestyle factors interact with APOE genotype on CAD risk. Here, we assessed the effect modification of physical activity, oily fish and polyunsaturated fatty acid (PUFA) intake with APOE genotype on risk of incident CAD.

METHODS: The present study comprised 345,659 white European participants from UK Biobank (mean age: 56.5 years, 45.7% men) without a history of CAD. Information regarding physical activity, oily fish intake and PUFA intake was collected through questionnaires, and information on incident CAD through linkage with hospital admission records. Analyses were performed using Cox proportional hazard models adjusted for age and sex.

RESULTS: Higher physical activity level and oily fish intake were both associated with a lower incidence of CAD. However, these associations were similar across the different APOE genotypes (p-values for interaction > 0.05). Most notable, higher PUFA intake was associated with a lower CAD risk in APOE ε4 genotype carriers (hazard ratio: 0.76, 95% confidence interval: 0.63-0.92), and not in APOE ε3/ε3 genotype carriers (0.90; 0.79, 1.02), but without statistical evidence for effect modification (p-valueinteraction = 0.137).

CONCLUSIONS: While higher physical activity and high fish and PUFA intake were associated with a lower risk of incident CAD, no evidence for interaction of these lifestyle factors with APOE genotype was observed in UK Biobank participants. Interventions intended to reduce cardiovascular risk might therefore be similarly effective across the APOE genotype carriers.

PMID:34082327 | DOI:10.1016/j.atherosclerosis.2021.05.014

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Nevin Manimala Statistics

Comparison of two markers of iron sufficiency and neurodevelopmental outcomes

Early Hum Dev. 2021 May 19;158:105395. doi: 10.1016/j.earlhumdev.2021.105395. Online ahead of print.

ABSTRACT

BACKGROUND: Iron deficiency during critical windows of brain development is associated with suboptimal neurodevelopmental outcomes. Identifying markers of neonatal iron status that best correlate with neurodevelopmental outcome is critical for optimal management of iron supplementation of neonates.

AIMS: We aimed to evaluate two markers of iron sufficiency, ferritin and zinc protoporphyrin-to-heme ratios (ZnPP/H), with neurodevelopmental outcomes.

STUDY DESIGN: This is a retrospective cohort study.

SUBJECTS: All infants with concurrent ferritin and ZnPP/H measurements obtained between October 2014 and April 2017 and Bayley Scales of Infant Development, 3rd Edition (BSID-III) evaluated at 24 months corrected age were included.

OUTCOME MEASURES: Associations between iron markers (minimum, maximum and median ferritin and ZnPP/H) and BSID-III score at 24 months were assessed.

RESULTS: 223 lab measurements from 62 infants were assessed. Mean gestational age was 28.1 weeks (SD = 2.6) with a mean birth weight of 1.1 kg (SD = 0.4). Significant associations between maximum and median ZnPP/H and motor score, and between median ZnPP/H and cognitive score were observed. Trends were also seen with higher minimum, median and maximum ZnPP/H associated with lower BSID-III scores, but did not reach statistical significance (p > 0.05). The associations between ferritin values and BSID scores were less consistent.

CONCLUSIONS: A positive association was seen between ZnPP/H values and BSID-III scores. Trends between ferritin and BSID values were less consistent, potentially because ferritin is more affected by inflammation. Consideration should be given to using ZnPP/H preferentially to adjust iron supplementation in the NICU to improve neurodevelopmental outcomes.

PMID:34082259 | DOI:10.1016/j.earlhumdev.2021.105395

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Nevin Manimala Statistics

Analysis of frequency and risk factors for complications of enteral nutrition in children in Poland after percutaneous endoscopic gastrostomy placement

Nutrition. 2021 Apr 15;89:111265. doi: 10.1016/j.nut.2021.111265. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of the study was to assess the complication rate and identify whether age, nutritional status, and history of respiratory aspiration prior to percutaneous endoscopic gastrostomy (PEG) are risk factors for post-PEG placement complications in Polish children. In addition, the safety of two enteral feeding methods (3 h vs. 8 h) after PEG insertion in children was compared.

METHODS: Children with clinical indications for PEG placement were recruited from six medical centers in Poland to participate in the study. The patients were centrally randomized to receive the first bolus feed via a feeding tube at 3 h (group 1) or 8 h (group 2) after PEG placement. The preprocedural preparation, postoperative care, and resumption of feeding were performed on all of patients in accordance with the study protocol. Patients were followed for 12 mo.

RESULTS: Of the 97 randomized patients, 49 were assigned to group 1 and 48 to group 2. Full feed after PEG placement was achieved within 24 to 48 h in most cases (74% vs. 82%). There were no differences between the groups regarding the number of early mild (31.3% vs. 31.3%) and serious (2.1% vs 8.3%) complications or the duration of hospitalization after PEG placement (P > 0.05). The most common serious complication after PEG placement was accidental displacement of PEG. Most reported late complications were mild. The results of the regression analysis indicate no statistically significant effect of age, body mass index standard deviation score, white blood cell count, serum albumin level, and respiratory aspiration in the medical history on the occurrence of mild and severe complications.

CONCLUSIONS: The early initiation of post-PEG feeding was not associated with an increase in the number of complications. Most complications after the PEG procedure were mild. Age, serum albumin level, white blood cells, body mass index standard deviation score, and a history of aspiration to the respiratory tract were not confirmed as a risk factor for post-PEG complications in children.

PMID:34082251 | DOI:10.1016/j.nut.2021.111265

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Nevin Manimala Statistics

Easier and more explanatory indices by integrating leukocyte lymphocyte ratio (LLR) and prognostic nutritional index (PNI) to IPS systems in cases with classical Hodgkin lymphoma

Leuk Res. 2021 Apr 24;107:106586. doi: 10.1016/j.leukres.2021.106586. Online ahead of print.

ABSTRACT

The aim of this study is to determine the power of he international prognostic scoring systems (IPS-7 and IPS-3) and to obtain indices by integrating leukocyte lymphocyte ratio (LLR) and prognostic nutritional index (PNI) factors as prognostic indicators in cases with classical Hodgkin lymphoma (cHL). 1012 patients with cHL were evaluated with 2 different IPS-4 scores with four parameters: stage, age, hemoglobin level, and either LLR or PNI. Statistical package SPSS v 22.0 was used. Two different Cox regression models were obtained for OS and PFS. Model 1 showed LLR ≥ 5,8 as the highest risk for OS and anemia as the highest risk for PFS. Model 2 showed PNI ≤ 45,2 as the highest risk for OS and anemia as the highest risk for PFS. IPS-4 scores obtained by integrating either LLR or PNI to IPS-3 integration of a biologic parameter either LLR or PNI need to be determined with clinical risk scoring parameters.

PMID:34082249 | DOI:10.1016/j.leukres.2021.106586