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1.
BMJ Case Rep ; 14(3)2021 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-33753387

RESUMO

Carotid-cavernous fistulas (CCFs) are abnormal connections between arteries and the cavernous sinuses. Traditionally, the Barrow Classification system has been used to characterise these fistulas based on their arterial supply from the internal carotid artery (ICA), external carotid artery (ECA) or both. We present a unique case of a patient with a complex CCF with arterial feeders from dural branches of the ECA, ICA and vertebral artery (VA), which, to our knowledge, has not been reported in the literature. Given unique arterial supply pattern involving contribution from the extracranial VA, this CCF falls outside of the traditional Barrow Classification system. The patient ultimately underwent a transfemoral transvenous coil embolisation using multiple dynamic venous routes with obliteration of bilateral CCFs and near complete resolution of her preoperative symptoms.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33779967

RESUMO

BACKGROUND AND OBJECTIVE: Eltrombopag is the first oral, small-molecule, non-peptide thrombopoietin receptor agonist for the treatment of idiopathic thrombocytopenic purpura. This study investigated the pharmacokinetics of eltrombopag in healthy Chinese subjects and evaluated the effect of sex and genetic polymorphisms on its variability. METHODS: Forty-eight healthy subjects were administered a single dose of eltrombopag (25 mg). Plasma concentrations of eltrombopag were determined using a validated liquid chromatography-tandem mass spectrometry method, and platelet counts were determined by blood tests. CYP1A2 rs762551, CYP2C8*3 rs10509681, CYP2C8*3 rs11572080, UGT1A1 rs887829, UGT1A3 rs3806596, and BCRP rs2231142 polymorphisms were genotyped by Sanger sequencing. A back-propagation artificial neural network (BP-ANN) model was constructed to predict pharmacokinetics based on physiological factors and genetic polymorphism data. RESULTS: Compared with male subjects, female subjects who received a single 25-mg dose of eltrombopag exhibited a significantly increased mean maximum plasma concentration (Cmax) and significantly decreased apparent clearance. Additionally, CYP1A2 rs762551 C>A single nucleotide polymorphism influenced distribution and elimination. C-allele carriers exhibited 30% higher systemic exposure and 20% lower apparent clearance compared with homozygous A-allele carriers. Mean percentage increases in platelet counts from baseline to Day 5 were 9.38% and 17.06% in male and female subjects, respectively. The BP-ANN model had a high goodness-of-fit index and good coherence between predicted and measured concentrations (R = 0.98979). CONCLUSION: Sex and CYP1A2 rs762551 C>A were associated with the pharmacokinetic variability of eltrombopag in healthy Chinese subjects. Females exhibited a better platelet-elevating effect compared with males administered the same dosage. The developed BP-ANN model based on physiological factors and genetic polymorphism data could be promising for applications in pharmacokinetic studies. TRIAL REGISTRATIONS: https://www.Chinadrugtrials.org.cn CTR20190898.

4.
Artigo em Inglês | MEDLINE | ID: mdl-33784815

RESUMO

Mechanically strong separators with good electrolyte wettability and low-shrinkage properties are desirable for highly efficient and safe lithium batteries. In this study, multifunctional nanofiber membranes are fabricated by electrospinning a homogeneous solution containing amphiphilic poly(ethylene glycol)diacrylate-grafted siloxane and polyacrylonitrile. After the chemical cross-linking of siloxane, the prepared nanofiber membranes are found to exhibit good mechanical properties, high thermostability, and superior electrolyte-philicity with aqueous and nonaqueous electrolytes. Li-metal cells with the fabricated membrane separator exhibit high cycling stability (Coulombic efficiency of 99.8% after 1000 cycles). Moreover, improved cycling stability of Li-sulfur batteries can be achieved using these membrane separators. These membrane separators can be further used in flexible aqueous lithium-ion batteries and exhibit steady electrochemistry performance. This work opens up a potential route for designing multifunctional universal separators for rechargeable batteries.

5.
Acta Ophthalmol ; 2020 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-33191611

RESUMO

PURPOSE: To develop and validate a standardized prediction model aiming at 1-year axial length elongation and to guide the orthokeratology lens practice. METHODS: This retrospective study was based on medical records of myopic children treated with orthokeratology. Individuals aged 8-15 years (n = 1261) were included and divided into the primary cohort (n = 757) and validation cohort (n = 504). Feature selection was primarily performed to sort out influential predictors by high-throughput extraction. Then, the prediction model was developed using multivariable linear regression analysis completed by backward stepwise selection. Finally, the validation of the prediction model was performed by evaluation metrics (mean-square error, root-mean-square error, mean absolute error and R ad 2 ). RESULTS: No significant difference was found between primary and validation cohort (all p > 0.05). After the feature selection, the crude model was adjusted by demographic information in multivariable linear regression analysis, and five final predictors were identified (all p < 0.01). The interaction effect of age with 1-month change of zone-3 mm flat K was detected (p < 0.01); hence, two final prediction models were developed based on two age subgroups. The validation proved an acceptable performance. CONCLUSION: An effective multivariable prediction model aiming at 1-year axial length elongation was developed and validated. It can potentially help clinicians to predict orthokeratology efficacy and make valid adjustments. The influential variables revealed in this model can also provide designers directions to optimize the design of lens to improve the efficacy of myopia control.

6.
J Clin Pharm Ther ; 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33201513

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Febuxostat is a well-known drug for treating hyperuricemia and gout. The published methods for determination of febuxostat in human plasma might be unsuitable for high-throughput determination and widespread application. We need to develop a highly selective, sensitive and rapid liquid chromatography-tandem mass spectrometry method. METHODS: The chromatographic separation was achieved on a Hypersil Gold-C18 (2.1 mm × 100 mm, 1.9 µm) column with mobile phase A (Water containing 0.1% formic acid) and mobile phase B (acetonitrile containing 0.1% formic acid). Multiple reaction monitoring (MRM) mode was used for quantification using target ions at m/z 315.3 â†’ m/z 271.3 for febuxostat and m/z 324.3 â†’ m/z 280.3 for Febuxostat-d9 (IS). A backpropagation artificial neural network (BPANN) pharmacokinetic model was constructed by the data of bioequivalence study. RESULTS AND DISCUSSION: After the LC-MS/MS method validated, it was successfully applied to the bioequivalence study of 30 human volunteers under fed condition. The predicted concentrations generated by BPANN model had a high correlation coefficient with experimental values. WHAT IS NEW AND CONCLUSION: A sensitive LC-MS/MS method had been developed and validated for determination of febuxostat in healthy subjects under fed condition, and a BPANN model was developed that can be used to predict the plasma concentration of febuxostat.

7.
JAMA Ophthalmol ; 2020 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-32940622

RESUMO

Importance: Early-onset myopia is well known to progress to high myopia in adulthood. However, no accurate estimation of how a specific age at myopia onset is associated with the probability of developing high myopia in adulthood is available, and a very-long-term follow-up study with data from annual visits is needed. Objective: To estimate the risk of developing high myopia in adulthood associated with a specific age at myopia onset from a data set with a 12-year annual follow-up. Design, Setting, and Participants: This ongoing, population-based prospective cohort study of twins was conducted in Guangzhou, China, on July 11, 2006. Data from baseline to August 31, 2018, were analyzed. The first-born twins completed follow-up until 17 years or older, and the 443 participants (after exclusions) who developed myopia were included in the analysis. Data were analyzed from September 1, 2018, to January 20, 2020. Main Outcomes and Measures: Age at myopia onset was determined by prospective annual cycloplegic refractions (365 participants [82.4%]) or with a questionnaire. Refraction in adulthood was defined as the cycloplegic refraction measured at the last follow-up visit. Results: Among the 443 eligible participants (247 [55.8%] female; mean [SD] age at myopia onset, 11.7 [2.0] years), 54 (12.2%) developed high myopia (spherical equivalent, -6.00 diopters or worse determined by cycloplegic refractions) in adulthood. Among participants with age at myopia onset of 7 or 8 years, 14 of 26 (53.9%; 95% CI, 33.4%-73.4%) developed high myopia in adulthood; among those with onset at 9 years of age, 12 of 37 (32.4%; 95% CI, 18.0%-49.8%); among those with onset at 10 years of age, 14 of 72 (19.4%; 95% CI, 11.1%-30.5%); among those with onset at 11 years of age, 11 of 78 (14.1%; 95% CI, 7.3%-23.8%); and among those with onset at 12 years or older, 3 of 230 (1.3%; 95% CI, 0.2%-3.8%). Results of multivariate logistic regression analysis suggested that the risk of developing high myopia in adulthood decreased significantly with delay in the age at myopia onset (odds ratio, 0.44; 95% CI, 0.36-0.55; P < .001), from greater than 50% for 7 or 8 years of age to approximately 30% for 9 years of age and 20% for 10 years of age. Conclusions and Relevance: These findings suggest that the risk of high myopia is relatively high in children with myopia onset during the early school ages. Each year of delay in the age at onset substantially reduces the chance of developing high myopia in adulthood, highlighting the importance of identifying effective prevention strategies under investigation, such as increasing outdoor time.

8.
Eur J Drug Metab Pharmacokinet ; 45(6): 761-770, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32930952

RESUMO

BACKGROUND AND OBJECTIVE: Deferasirox is an oral iron chelator used to reduce iron levels in iron-overloaded patients with transfusion-dependent anemia or non-transfusion-dependent thalassemia. This study investigated the effects of genetic polymorphisms on the pharmacokinetics of deferasirox in healthy Chinese subjects and constructed a pharmacokinetic prediction model based on physiologic factors and genetic polymorphism data. METHODS: Twenty-eight subjects were enrolled in a randomized, open-label, two-period crossover study, and they received a single dose of one of two formulations of deferasirox (20 mg/kg) with a 7-day washout interval between the two periods. The plasma defersirox concentration was determined using a validated liquid chromatography-tandem mass spectrometry method, and pharmacokinetic parameters were calculated using the noncompartmental method. The polymorphisms of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), UGT1A3, multidrug resistance protein 2 (MRP2), cytochrome P450 1A1 (CYP1A1), and breast cancer resistance protein 1 (BCRP1) were genotyped using Sanger sequencing. A back-propagation artificial neural network (BP-ANN) model was used to predict the pharmacokinetics. RESULTS: The UGT1A1 rs887829 C > T single-nucleotide polymorphism (SNP) significantly influenced the area under the plasma concentration-time curve and the terminal half-life. Neither the MRP2 rs2273697 G > A SNP nor BCRP1 rs2231142 G > T SNP altered the absorption, disposition, and excretion of the drug. The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R2 = 0.921). CONCLUSION: Metabolic enzyme-related genetic polymorphisms were more strongly associated with the pharmacokinetics of deferasirox than membrane transporter-related genetic polymorphisms in the Chinese population. TRIAL REGISTRATION: www.Chinadrugtrials.org.cn CTR20191164.


Assuntos
Deferasirox/farmacocinética , Quelantes de Ferro/farmacocinética , Redes Neurais de Computação , Adolescente , Adulto , Área Sob a Curva , Grupo com Ancestrais do Continente Asiático , Estudos Cross-Over , Citocromo P-450 CYP1A1/genética , Composição de Medicamentos , Feminino , Glucuronosiltransferase/genética , Meia-Vida , Voluntários Saudáveis , Humanos , Masculino , Pessoa de Meia-Idade , Proteínas Associadas à Resistência a Múltiplos Medicamentos/genética , Polimorfismo Genético/genética , Polimorfismo de Nucleotídeo Único , Valor Preditivo dos Testes , Adulto Jovem
9.
Cancer Med ; 9(22): 8364-8372, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32902184

RESUMO

Local tumor failure remains a major problem after radiation-based nonsurgical treatment for unresectable locally advanced nonsmall cell lung cancer (NSCLC)and inoperable stage II NSCLC. The aim of this study was to evaluate the feasibility of simultaneous integrated boost of intensity-modulated radiation therapy (SIB-IMRT) to stage II-III NSCLC with metastatic lymph nodes (ChiCTR 2000029304). Patients were diagnosed by pathology or PET-CT. PTV was divided into two parts as follows, the PTV of primary tumor (PTVp) and the PTV of metastatic lymph nodes (PTVn). The radiotherapy doses were simultaneously prescripted 78 Gy (BED = 101.48 Gy) for PTVp and 60-65 Gy (BED = 73.6-81.25 Gy) for PTVn, 26f/5.2 weeks. Response was scored according to WHO criteria. Radiotherapy toxicity was scored according to RTOG criteria. Hematology and gastrointestinal toxicity were scored according to CTCAE1.0 criteria. A total of 20 patients were enrolled. Seventeen patients were diagnosed by pathology and three patients were diagnosed by PET-CT. All patients were treated with SIB-IMRT. The objective response rate (ORR) was 90%, with CR 25%, PR 65%, NC 10%, and PD 0%. Although radiotherapy toxicity was common, there were no grade ≥3, with radiation pneumonitis (10 cases), esophagitis (17 cases), and dermatitis (12 cases). The local control rates at 1, 3, and 5 years were 85%, 75%, and 70%, respectively. The overall survival(OS)and local progression-free survival (LPFS) rates at 1, 3, and 5 years were 90%, 42.6%, and 35.5% and 84.4%, 35.5%, and 28.4%, respectively. SIB-IMRT can significantly improve ORR and survival for stage II-III NSCLC with metastatic lymph nodes, with high safety, and satisfactory efficacy. However, due to the limitation of small sample, these findings are needed to confirm by future trials with a larger sample size.

10.
Front Plant Sci ; 11: 1091, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32849679

RESUMO

In wheat breeding, improved quality traits, including grain quality and dough rheological properties, have long been a critical goal. To understand the genetic basis of key quality traits of wheat, two single-locus and five multi-locus GWAS models were performed for six grain quality traits and three dough rheological properties based on 19, 254 SNPs in 267 bread wheat accessions. As a result, 299 quantitative trait nucleotides (QTNs) within 105 regions were identified to be associated with these quality traits in four environments. Of which, 40 core QTN regions were stably detected in at least three environments, 19 of which were novel. Compared with the previous studies, these novel QTN regions explained smaller phenotypic variation, which verified the advantages of the multi-locus GWAS models in detecting important small effect QTNs associated with complex traits. After characterization of the function and expression in-depth, 67 core candidate genes involved in protein/sugar synthesis, histone modification and the regulation of transcription factor were observed to be associated with the formation of grain quality, which showed that multi-level regulations influenced wheat grain quality. Finally, a preliminary network of gene regulation that may affect wheat quality formation was inferred. This study verified the power and reliability of multi-locus GWAS methods in wheat quality trait research, and increased the understanding of wheat quality formation mechanisms. The detected QTN regions and candidate genes in this study could be further used for gene cloning and marker-assisted selection in high-quality breeding of bread wheat.

11.
Artigo em Inglês | MEDLINE | ID: mdl-32620344

RESUMO

PURPOSE: To analyse the one-month change in subfoveal choroidal thickness (SFChT) of myopic children treated with 0.01 % atropine, orthokeratology (OK), or their combination. METHODS: This is a prospective, randomized controlled trial. One hundred fifty-four children aged between 8 and 12 years with a spherical equivalent (SE) of -1.00 to -6.00 diopters were enrolled. Subjects were randomly assigned to receive 0.01 % atropine and orthokeratology (ACO, n = 39), 0.01 % atropine and single vision glasses (atropine, n = 42), orthokeratology and placebo (OK, n = 36), or placebo and single vision glasses (control, n = 37). SFChT was assessed using optical coherence tomography (OCT). Ocular parameters, including axial length (AL), were measured using a Lenstar LS 900. RESULTS: SFChT significantly increased in the ACO (14.12 ± 12.88 µm, p < 0.001), OK (9.43 ± 9.14 µm, p < 0.001) and atropine (5.49 ± 9.38 µm, p < 0.001) groups, while it significantly decreased in the control group (-4.81 ± 9.93 µm, p = 0.006). The one-month change in SFChT was significantly different between the control and treatment groups (p < 0.001). The results of pairwise comparisons among the treatment groups showed that the magnitude of the SFChT change was larger in the ACO group than in the atropine group (p = 0.002). The changes in the ACO and OK groups were not significantly different (p = 0.326). CONCLUSION: The combination of OK and atropine induced a greater increase in SFChT than monotherapy with atropine, which might indicate a better treatment effect for childhood myopia control.

12.
BMC Public Health ; 20(1): 1062, 2020 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-32631359

RESUMO

BACKGROUND: Prevention and control of cardiometabolic conditions and cardiovascular disease (CVD) in China may contribute to sustainable CVD reduction globally, given the fact that one-fifth of the worldwide population is in China. Knowing the distribution of behavioral risk factors (e.g., smoking and physical inactivity), especially at a national level in China, would be extremely relevant to the field of public health and CVD prevention. The objectives of this study were to investigate the nationwide prevalence of obesity, smoking, heavy drinking, and physical inactivity in Chinese adults, and further explore whether cardiometabolic conditions would modify the distribution of behavioral risk factors. METHODS: This population-based study is based on the China Health and Retirement Longitudinal Study (2011-2012), including 17,302 adults (≥45 years, mean age 59.67 years, female 51.66%) from 25 provinces in China. Data on demographics, lifestyle factors, health status and history of diseases were collected via structured interviews and laboratory tests. Smoking, heavy drinking, obesity, and physical inactivity were defined following standard guidelines. We performed descriptive analysis and logistic regressions in this study. RESULTS: The overall prevalence of heavy drinking, obesity, current smoking, and physical inactivity among middle-aged and older adults was 7.23% (95% confidence interval 6.53-7.29%), 11.53% (10.43-12.62%), 27.46% (26.30-28.62%), and 44.06% (41.19-46.92%), respectively. The prevalence varied between rural and urban areas as well as among geographic areas, with higher prevalence in the Northern and Northeastern regions. Heavy drinking and obesity were significantly associated with incident hypertension, diabetes, and high cholesterol; while current smoking was significantly associated with incident hypertension. Compared with healthy individuals, participants who self-reported a diagnosis of hypertension, high cholesterol, or diabetes were less likely to smoke currently and drink alcohol heavily, but more likely to be physically inactive and obese. CONCLUSIONS: Among Chinese middle-aged and older adults, the prevalence of behavioral risk factors varies by geographic region. Further effort is required to improve physical activity and fitness for Chinese adults, especially those with cardiometabolic conditions.


Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Obesidade/epidemiologia , Comportamento Sedentário , Fumar/epidemiologia , Idoso , China/epidemiologia , Estudos Transversais , Exercício Físico , Feminino , Nível de Saúde , Humanos , Estilo de Vida , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , População Rural/estatística & dados numéricos , Inquéritos e Questionários , População Urbana/estatística & dados numéricos
13.
Burns Trauma ; 8: tkaa017, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32685563

RESUMO

In recent years, as living standards have continued to improve, the number of diabetes patients in China, along with the incidence of complications associated with the disease, has been increasing. Among these complications, diabetic foot disease is one of the main causes of disability and death in diabetic patients. Due to the differences in economy, culture, religion and level of medical care available across different regions, preventive and treatment methods and curative results for diabetic foot vary greatly. In multidisciplinary models built around diabetic foot, the timely assessment and diagnosis of wounds and appropriate methods of prevention and treatment with internal and external surgery are key to clinical practice for this pathology. In 2019, under the leadership of the Jiangsu Medical Association and Chinese Diabetes Society, the writing group for the Guidelines on multidisciplinary approaches for the prevention and management of diabetic foot disease (2020 edition) was established with the participation of scholars from the specialist areas of endocrinology, burn injury, vascular surgery, orthopedics, foot and ankle surgery and cardiology. Drawing lessons from diabetic foot guidelines from other countries, this guide analyses clinical practices for diabetic foot, queries the theoretical basis and grades and gives recommendations based on the characteristics of the pathology in China. This paper begins with assessments and diagnoses of diabetic foot, then describes treatments for diabetic foot in detail, and ends with protections for high-risk feet and the prevention of ulcers. This manuscript covers the disciplines of internal medicine, surgical, nursing and rehabilitation and describes a total of 50 recommendations that we hope will provide procedures and protocols for clinicians dealing with diabetic foot.

14.
Eye (Lond) ; 2020 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-32518399

RESUMO

PURPOSE: To evaluate the potential effect of age and refractive error on visual acuity (VA) performance and quick contrast sensitivity function (qCSF) in normal Chinese adults. METHOD: Ninety-two subjects with normal best corrected distance VA (BCDVA) were enrolled in this pilot study. Measurements included BCDVA, best corrected near VA (BCNVA), unaided VA (UNVA), habitual spectacle-corrected near VA (SCNVA) and qCSF. For analyses, subjects were categorized into three age groups (20~40 years, 41~60 year and >60 years) and four refractive groups (hyperopia, emmetropia, myopia and high myopia). Relationships between age, refractive error, types of VA and qCSF were tested using simple and multiple linear regressions analyses. RESULT: Mean age and refractive error of the study participants were 44.04 ± 12.68 years and -1.86 ± 2.91D, respectively. Among the stratified age groups, a hyperopic shift of refraction (-3.24 ± 2.88D vs. -1.24 ± 2.64D vs. 0.39 ± 1.42D, respectively; P < 0.001) and a reduction in BCNVA (P = 0.014), SCNVA (P < 0.001) and cut-off spatial frequency (SF) (P = 0.032) were found with increasing age. Among the four refractive groups, the SCNVA and cut-off SF of hyperopia were worse compared to the other refractive statuses (all P < 0.05). Age was significantly associated with cut-off SF (standardized ß = -0.29, P = 0.005) after adjustment for SER, gender and all types of VA. CONCLUSION: For normal Chinese adults with normal BCDVA, age was the main factor associated with CSF, which may be independent of refractive error.

16.
PLoS One ; 15(5): e0232329, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32357167

RESUMO

Fungus-cultivating termites are successful herbivores largely rely on the external symbiotic fungus-combs to decompose plant polysaccharides. The comb harbors both fungi and bacteria. However, the complementary roles and functions of the bacteria are out of the box. To this purpose, we look into different decomposition stages of fungus-combs using high-throughput sequencing of the 16S rRNA gene to examine bacterial community structure. We also explored the bacterial response to physicochemical indexes (such as moisture, ash content and organic matter) and plant substrates (leaves or branches or mix food). Some specific families such as Lachnospiraceae, Ruminococcaceae, and Peptostreptococcaceae may be involved in lignocellulose degradation, whereas Burkholderiaceae may be associated with aromatic compounds degradation. We observed that as the comb mature there is a shift of community composition which may be an adjustment of specific bacteria to deal with different lignocellulosic material. Our results indicated that threshold amount of physicochemical indexes are beneficial for bacterial diversity but too high moisture, low organic matter and high ash content may reduce their diversity. Furthermore, the average highest bacterial diversity was recorded from the comb built by branches followed by mix food and leaves. Besides, this study could help in the use of bacteria from the comb of fungus-cultivating termites in forestry and agricultural residues making them easier to digest as fodder.


Assuntos
Bactérias/isolamento & purificação , Fungos/isolamento & purificação , Isópteros/microbiologia , Plantas/parasitologia , Animais , Fenômenos Fisiológicos Bacterianos , Biodiversidade , Feminino , Fungos/fisiologia , Isópteros/fisiologia , Masculino , Microbiota , RNA Bacteriano , RNA Ribossômico 16S
17.
Artigo em Inglês | MEDLINE | ID: mdl-32416055

RESUMO

A randomized, open-label, 2-period crossover study was performed to evaluate the pharmacokinetic properties and bioequivalence of 2 erlotinib hydrochloride tablets (a test formulation and a reference formulation) in healthy Chinese subjects. Subjects were randomized to receive a single oral dose of the erlotinib hydrochloride test or reference formulation (150 mg) under fasting conditions. The washout period was 12 days. Blood samples were collected at scheduled time points, and plasma concentrations were determined using a high-performance liquid chromatography-tandem mass spectrometry method. A noncompartmental method was used to calculate pharmacokinetic parameters and to evaluate the bioequivalence of the 2 formulations. Safety assessments were performed during the whole study period. The results suggest that the pharmacokinetic parameter values of the test formulation were similar to those of the reference formulation. The 90% confidence intervals of the geometric least-squares mean ratios of the test to reference formulation were 94.06% to 105.43% for maximum concentration, 88.21% to 97.57% for area under the concentration-time curve to last measurement, and 87.37% to 97.14% for area under the curve extrapolated to infinity, which are all within the accepted bioequivalence range of 80% to 125%. No serious adverse events occurred during the study. These findings suggest that the 2 erlotinib hydrochloride tablets were bioequivalent in accordance with predetermined regulatory criteria.

18.
Clin Pharmacol Drug Dev ; 9(7): 867-875, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32452647

RESUMO

A backpropagation artificial neural network (BPANN) model was established for the prediction of the plasma concentration and pharmacokinetic parameters of rosuvastatin (RVST) in healthy subjects. The data (demographic characteristics and results of clinical laboratory tests) were collected from 4 bioequivalence studies using reference 10-mg RVST calcium tablets. After the data were cleaned using extreme gradient boosting, 13 important factors were extracted to construct the BPANN model. The model was fully validated, and mean impact values (MIVs) were calculated. The model was used to predict the plasma concentration and pharmacokinetic parameters of oral single-dose RVST in healthy subjects under fasting and fed conditions. The predicted and measured values were compared in order to evaluate the accuracy of prediction. The constructed model performed well in validation. The top 3 factors ranked by MIV related to RVST concentration are fasting/fed, time, and creatinine clearance. The time-concentration profiles of the measured and predicted data agreed well. There were no significant differences (P > .05) in the area under the concentration-time curve from 0 to the last measurable concentration (AUC0-t ) and extrapolated to infinity (AUC0-∞ ), half-time of elimination, peak concentration, and time to peak concentration of the measured data and data predicted by BPANN. The BPANN model has an accurate prediction ability and can be used to predict RVST concentration and pharmacokinetic parameters in healthy subjects.

19.
Invest Ophthalmol Vis Sci ; 61(4): 18, 2020 04 09.
Artigo em Inglês | MEDLINE | ID: mdl-32298436

RESUMO

Purpose: To evaluate the features of the choroidal structures in the eyes of myopic children obtained by enhanced depth imaging optical coherence tomography (EDI-OCT). Methods: Ninety-six myopic children with low to moderate myopia (spherical equivalent refractive error [SER], -5.75 to -1.00 diopter) were included in this cross-sectional study. Ocular biometrics were measured using an optical low-coherence reflectometry device. Data of the choroidal structures extracted from a 7500-µm cross-sectional arc of the choroid extending from the temporal optic disc margin, including the total choroidal area, luminal area, stromal area, and choroidal vascularity index, were determined by image binarization of the EDI-OCT. Associations between demographic factors, ocular parameters, and choroidal structures were evaluated using univariate and multiple linear regression analyses. Results: The study participants (mean age, 11.02 ± 1.70 years) had a mean axial length (AL) of 24.94 ± 0.70 mm. The mean total choroidal area was 2.64 ± 0.49 mm2 (luminal area, 1.68 ± 0.32 mm2; stromal area, 0.95 ± 0.19 mm2), and the choroidal vascularity index was 0.64 ± 0.03. Multiple regression analysis showed that the luminal area was significantly associated with the AL (standard ß = -0.24, P = 0.022) after adjusting for sex and corneal radius (CR), whereas the stromal area (standard ß = -0.30, P = 0.003) and choroidal vascularity index (standard ß = 0.36, P = 0.001) were significantly associated with age after adjusting for sex, CR, and lens thickness (LT). Sex, CR, LT, and SER showed no significant association with choroidal structures after adjusting for age and AL (all P > 0.05). Conclusions: The luminal area of the choroid tends to decrease with a longer AL, whereas the stromal area tends to decrease with increasing age in myopic children. These findings require further exploration in a longitudinal study.


Assuntos
Corioide/patologia , Miopia/complicações , Adolescente , Comprimento Axial do Olho/patologia , Biometria , Criança , Corioide/diagnóstico por imagem , Estudos Transversais , Feminino , Humanos , Estudos Longitudinais , Masculino , Tamanho do Órgão , Tomografia de Coerência Óptica , Acuidade Visual
20.
Phys Chem Chem Phys ; 22(16): 9009-9013, 2020 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-32293609

RESUMO

Plutonium monocarbide, which contains a considerable amount of vacancies in the carbon sublattice, has never been synthesized in a stoichiometric form. The intriguing substoichiometric behavior of plutonium monocarbide is investigated here using first-principles calculations combined with the special quasirandom structure. It is found that the NaCl-type substoichiometric plutonium monocarbide is stable for PuC0.741-0.923, which is in good agreement with the experiment. From the electronic structure calculations and chemical bond analyses, the stabilization of PuC1-x in this range is attributed to strengthened Pu-C bonds opposite the carbon vacancies.

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