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Objective: Based on machine learning method, four types of early postoperative frailty risk prediction model of enterostomy patients were constructed to compare the performance of each model and provide the basis for preventing early postoperative frailty of elderly patients with enterostomy. Methods: The prospective convenience sampling method was conducted and 362 early postoperative enterostomy patients were selected in three hospitals from July 2020 to November 2023 in Shanghai, four different prediction models of Support Vector Machine (SVM), Bayes, XG Boost, and Logistic regression were used and compared the test effects of the four models (MCC, F1, AUC, and Brier index) to judge the classification performance of the four models in the data of this study. Results: A total of 21 variables were included in this study, and the predictors mainly covered demographic information, stoma-related information, quality of life, anxiety and depression, and frailty. The validated models on the test set are XGBoost, Logistic regression, SVM prediction model, and Bayes on the MCC and F1 scores; on the AUC, XGBoost, Logistic regression, Bayes, and SVM prediction model; on the Brier scores, Bayes, Logistic regression, and XGBoost. Conclusion: XGBoost based on machine learning method is better than SVM prediction model, Logistic regression model and Bayes in sensitivity and accuracy. Quality of life in the early postoperative period can help guide clinical patients to identify patients at high risk of frailty and reduce the incidence of early postoperative frailty in elderly patients with enterostomy.
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Uranium is causing a hazardous impact on the human population throughout the globe. Different methods of remediation have been documented but the approach of phytoremediation has been praised throughout the globe. The bioaccumulation of uranium especially as a hyper-accumulator, has been documented in limited plant species. Therefore the current studies were conducted to elaborate on the overall U accumulation, biochemical and photochemical reactions in Alternanthera philoxeroides and Eichhornia crassipes to different concentrations of Uranium. The results showed that the accumulation of U in A.philoxeroides is higher; followed by E.crassipes; with maximum amounts of roots accumulation. Overall A.philoxeroides and E.crassipes accumulate as much as 948.88 mg/kg and 801.87 mg/kg on a dry weight basis. The biochemical results showed that Superoxide dismutase (SOD) decreased in the leaves and stem of A.philoxeroides; whereas an increase has been seen in E.crassipes in response to all treatments. peroxidase (POD) and Catalase (CAT) showed irregular response to all treatments; where the main increase was observed at T3 (120 µmol/L) and 72 h up to 138 µ/g-FW (POD) and 178 µ/g-FW (CAT) in A.philoxeroides and 1870 µ/g-FW (POD) and 73 µ/g-FW (CAT) in E.crassipes, respectively. The correlation coefficient between the fluorescence ratio Fv/Fm and the concentrations of U-treatment was significantly negative. It is concluded from the results that Uranium halted the biochemical and photochemical reaction but the plants resisted its impact while accumulating a good amount of uranium which is a good prospect for future interventions for the in-situ remediation of uranium-affected sites.
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Eichhornia , Urânio , Poluentes Químicos da Água , Humanos , Peroxidase , Superóxido Dismutase , Biodegradação Ambiental , Poluentes Químicos da Água/análiseRESUMO
Landscape pattern, an important factor affecting the supply and maintenance of ecosystem services, is the basis for the healthy and stable regional ecosystem and the optimal decision of land use. Taking the Hexi Corridor in the northern sand fixation belt as the study area, we quantified and analyzed the temporal and spatial variations and response relationship between landscape pattern and windbreak and sand fixation services during 2000-2020 by using the software Fragstats 4.2, the revised wind erosion equation and the spatial autocorrelation method. The results showed that, the landscape pattern of land use types changed obviously in the study area during 2000-2020, mainly from Gobi to cultivated land and from grassland to cultivated land, and that the landscape pattern tended to be diversified, heterogeneous, and fragmented. The spatial pattern of windbreak and sand fixation services was generally characterized by "high in southeast and low in northwest", with the amount of windbreak and sand fixation increasing at first and then decreasing. The windbreak and sand fixation capacity was higher in cultivated land and grassland and lower in the bare land and construction land. Shannon's diversity index, patch density and landscape shape index were all positively correlated with windbreak and sand fixation services, while mean patch size was negatively correlated with it. Our results indicated that the increases of landscape heterogeneity, the more uniform distribution, the more patches and the more complex landscape shape had a promoting effect on windbreak and sand fixation services in the Hexi corridor of the northern sand fixation belt with Gobi Desert as the dominant landscape.
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Ecossistema , Areia , Conservação dos Recursos Naturais/métodos , Vento , Análise Espacial , ChinaRESUMO
BACKGROUND: Gut microbiota alterations have been implicated in the pathogenesis of coronavirus disease 2019 (COVID-19). This study aimed to explore gut microbiota changes in a prospective cohort of COVID-19 children and their asymptomatic caregivers infected with the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) Omicron variant. METHODS: A total of 186 participants, including 59 COVID-19 children, 50 asymptomatic adult caregivers, 52 healthy children (HC), and 25 healthy adults (HA), were recruited between 15 April and 31 May 2022. The gut microbiota composition was determined by 16S rRNA gene sequencing in fecal samples collected from the participants. Gut microbiota functional profiling was performed by using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) software. RESULTS: The gut microbiota analysis of beta diversity revealed that the fecal microbial community of COVID-19 children remained far distantly related to HC. The relative abundances of the phyla Actinobacteria and Firmicutes were decreased, whereas Bacteroidetes, Proteobacteria, and Verrucomicrobiota were increased in COVID-19 children. Feces from COVID-19 children exhibited notably lower abundances of the genera Blautia, Bifidobacterium, Fusicatenibacter, Streptococcus, and Romboutsia and higher abundances of the genera Prevotella, Lachnoclostridium, Escherichia-Shigella, and Bacteroides than those from HC. The enterotype distributions of COVID-19 children were characterized by a high prevalence of enterotype Bacteroides. Similar changes in gut microbiota compositions were observed in asymptomatic caregivers. Furthermore, the microbial metabolic activities of KEGG (Kyoto Encyclopedia of Genes and Genomes) and COG (cluster of orthologous groups of proteins) pathways were perturbed in feces from subjects infected with the SARS-CoV-2 Omicron variant. CONCLUSION: Our data reveal altered gut microbiota compositions in both COVID-19 children and their asymptomatic caregivers infected with the SARS-CoV-2 Omicron variant, which further implicates the critical role of gut microbiota in COVID-19 pathogenesis.
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COVID-19 , Microbioma Gastrointestinal , Adulto , Humanos , Criança , SARS-CoV-2 , Cuidadores , Estudos Prospectivos , RNA Ribossômico 16S/genética , Filogenia , Fezes/microbiologiaRESUMO
Objective: To study the effects of cadmium chloride (CdCl(2)) exposure on testicular autophagy levels and blood-testis barrier integrity in prepubertal male SD rats and testicular sertoli (TM4) cells. Methods: In July 2021, 9 4-week-old male SD rats were randomly divided into 3 groups: control group (normal saline), low dose group (1 mg/kg·bw CdCl(2)) and high dose group (2 mg/kg·bw CdCl(2)), and were exposed with CdCl(2) by intrabitoneal injection. 24 h later, HE staining was used to observe the morphological changes of testis of rats, biological tracer was used to observe the integrity of blood-testis barrier, and the expression levels of microtubule-associated protein light chain 3 (LC3) -Ⅰ and LC3-Ⅱ in testicular tissue were detected. TM4 cells were treated with 0, 2.5, 5.0 and 10.0 μmol/L CdCl(2) for 24 h to detect the toxic effect of cadmium. The cells were divided into blank group (no exposure), exposure group (10.0 μmol/L CdCl(2)), experimental group[10.0 μmol/L CdCl(2)+60.0 μmol/L 3-methyladenine (3-MA) ] and inhibitor group (60.0 μmol/L 3-MA). After 24 h of treatment, Western blot analysis was used to detect the expression levels of LC3-Ⅱ, ubiquitin binding protein p62, tight junction protein ZO-1 and adhesion junction protein N-cadherin. Results: The morphology and structure of testicular tissue in the high dose group were obvious changed, including uneven distribution of seminiferous tubules, irregular shape, thinning of seminiferous epithelium, loose structure, disordered arrangement of cells, abnormal deep staining of nuclei and vacuoles of Sertoli cells. The results of biological tracer method showed that the integrity of blood-testis barrier was damaged in the low and high dose group. Western blot results showed that compared with control group, the expression levels of LC3-Ⅱ in testicular tissue of rats in low and high dose groups were increased, the differences were statistically significant (P<0.05). Compared with the 0 μmol/L, after exposure to 5.0, 10.0 μmol/L CdCl(2), the expression levels of ZO-1 and N-cadherin in TM4 cells were significantly decreased, and the expression level of p62 and LC3-Ⅱ/LC3-Ⅰ were significantly increased, the differences were statistically significant (P<0.05). Compared with the exposure group, the relative expression level of p62 and LC3-Ⅱ/LC3-Ⅰ in TM4 cells of the experimental group were significantly decreased, while the relative expression levels of ZO-1 and N-cadherin were significantly increased, the differences were statistically significant (P<0.05) . Conclusion: The mechanism of the toxic effect of cadmium on the reproductive system of male SD rats may be related to the effect of the autophagy level of testicular tissue and the destruction of the blood-testis barrier integrity.
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Ratos , Masculino , Animais , Testículo , Cloreto de Cádmio/metabolismo , Cádmio , Barreira Hematotesticular/metabolismo , Ratos Sprague-Dawley , Caderinas/metabolismo , AutofagiaRESUMO
Objective: This study aims to investigate the sleep quality of pregnant women in Xuhui District, Shanghai, and the related factors of sleep disturbances during pregnancy. Methods: From February 2019 to February 2021, we used online integrated sleep questionnaire (including PSQI, BQ, ESS, AIS) in Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital, The International Peace Maternity and Child Health Hospitals of China Welfare Institution, and Shanghai Eighth People's Hospital, to investigate the sleep quality across pregnancy. We also collected maternal physical examination results, childbearing history, sociodemographic, and other clinical data. The prevalences and related factors of various sleep disturbances in pregnant women were analyzed, including insufficient/excessive nighttime sleep, low sleep efficiency, difficulty falling asleep, poor sleep quality, insomnia, daytime sleepiness, and high risk of sleep-disordered breathing (SDB). Results: This study includes 1 898 cases in the first trimester (T1), 3 099 cases in the second trimester (T2), and 1 539 cases in the third trimester (T3). Poor sleep quality (38.6%), daytime sleepiness (mild 41.9%, moderate 17.7%, severe 2.1%), and suspicious insomnia (32.3%) are most prevalent among women in T1 (P<0.01). In comparison, short sleep time (2.7%), long sleep time (8.6%), difficulty falling asleep (12.2%), poor sleep efficiency (35.4%), very poor sleep quality (6.7%), clinical insomnia (21.8%), and high-risk SDB (6.4%) are most prevalent among women in T3 (P<0.05). During pregnancy, late gestation (OR=1.016, 95%CI: 1.006-1.025) and multiple induced/drug abortions (OR=1.329, 95%CI: 1.043-1.692) are risk factors for poor sleep quality (PSQI>5), while multiple full-term deliveries (OR=0.800, 95%CI: 0.675-0.949) is its protective factor. Advanced maternal age (OR=0.976, 95%CI: 0.956-0.997), multiple full-term deliveries (OR=0.808, 95%CI: 0.680-0.959), late gestation (OR=0.983, 95%CI: 0.974-0.992) and hypertension (OR=0.572, 95%CI: 0.401-0.814) are protective factors for daytime sleepiness (ESS>6). The high-risk pregnancy category (OR=9.312, 95%CI: 1.156-74.978) is a risk factor for insomnia (AIS≥4), while multiple full-term deliveries (OR=0.815, 95%CI: 0.691-0.961) is its protective factor. High BMI (OR=1.334, 95%CI: 1.270-1.402) and hypertension (OR=4.427, 95%CI: 2.539-7.719) are risk factors for high-risk SDB in pregnant women. Conclusions: The prevalences of various sleep disturbances are high throughout pregnancy. Noticeably, symptoms of maternal SDB develop along with pregnancy. Different types of sleep disturbances are associated with different factors. Women of high-risk pregnancy category, in late gestation, with high BMI, hypertension, a history of induced/drug abortion, or without a history of full-term delivery can be at high risk of sleep disturbances during pregnancy.
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Criança , Feminino , Humanos , Gravidez , China/epidemiologia , Estudos Transversais , Complicações na Gravidez/epidemiologia , Gestantes , Sono , Qualidade do SonoRESUMO
Objective:To investigate the expression and correlation of H19, matrix metalloproteinase (MMP)-2 and MMP-9 in patients with recurrent spontaneous abortion (RSA).Methods:Human extravillous trophoblast cell line HTR-8 was cultured in vitro. Lentivirus was used to infect the HTR-8 cell line to over-express or knockdown the expression of H19. The concentrations of MMP-2 and MMP-9 protein in cell culture supernatant were detected by enzyme linked immunosorbent assay (ELISA). The expression levels of H19, MMP-2 and MMP-9 mRNA in villi of patients with RSA were detected by real-time fluorescence quantitative polymerase chain reaction (qRT-PCR). Spearman correlation analysis was used to understand the correlation between H19 and the expression levels of MMP-2 and MMP-9. Results:After overexpression of H19, the expression levels of MMP-2 and MMP-9 mRNA and protein concentration in Lv-ph19 group were significantly higher than those in Lv-vector group ( P<0.05); After interfering with the expression of H19, the expression levels of MMP-2 and MMP-9 mRNA and protein concentration in Lv-shH19 group were significantly lower than those in Lv-shcon control group ( P<0.05). The number of spontaneous abortions in patients with recurrent spontaneous abortion was significantly higher than that in the control group ( P<0.05). qRT-PCR showed that the expression levels of H19, MMP-2 and MMP-9 mRNA in villi of patients with RSA were significantly lower than those in the control group ( P<0.05). There was a positive correlation between H19 and the expression levels of MMP-2 and MMP-9 ( P<0.05). Conclusions:H19 regulates the expression of MMP-2 and MMP-9 of trophoblast during early pregnancy, and the abnormal expression of H19, MMP-2, and MMP-9 in human first-trimester villous tissues was related with the incidence of early miscarriage.
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AIMS: This study aims to evaluate and validate a simple quantitative ultrasound (US) method for determining the hepatic fat content (HFC) based on the combination of quantitative US hepatic/renal ratio (US-HRR) and quantitative US hepatic echo-intensity attenuation rate (US-HAR) as compared with [1H]-magnetic resonance spectroscopy (1H-MRS). MATERIAL AND METHODS: There were a total of 242 subjects recruited in the present study. All subjects were examined for HFC by quantitative US and 1H-MRS methods. The QUS-HRR and QUS-HAR were calculated from ordinary ultrasound images of liver and kidney with a triple modality 3D abdominal phantom using the Image J software. RESULTS: The results found that US-HRR and US-HAR correlated with 1H-MRS HFC (US-HRR: r=0.946, p<0.001; US-HAR: r=0.936, p<0.001). The equation for HFC prediction by using quantitative US was: HFC (%) = 28.965 × US-HRR + 218.045 × US-HAR - 8.892. Subgroup analysis in study subjects with body mass index (BMI) ≥28 showed that quantitative US HFC was associated with 1H-MRS HFC (R2=0.953, p<0.001). Receiver operating characteristic (ROC) analysis observed that the cut-off value of fatty liver diagnosis was 6.71% in using the quantitative US model; the sensitivity and specificity for fatty liver diagnosis were 94.15% and 96.30%, respectively. Variability analysis indicated that there was a relative high degree of consistency in the measurement of HFC with different operators or ultrasonic apparatus. CONCLUSIONS: Quantitative US measurement could be regarded as a simple, sensitive tool to accurately assess HFC. It provides a valid alternative to 1H-MRS as an easy, non-invasive option for the precise estimation of HFC in clinical practice.
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Fígado Gorduroso , Fígado , Fígado Gorduroso/diagnóstico por imagem , Humanos , Rim/diagnóstico por imagem , Fígado/diagnóstico por imagem , Espectroscopia de Ressonância Magnética , UltrassonografiaRESUMO
BACKGROUND: Previous literatures have implied that the liver fat deposition plays a crucial role in the development and progression of insulin resistance. In the present study, we aimed to investigate the association of liver fat content (LFC) with glucose metabolism status in the population of newly diagnosed type 2 diabetes mellitus (nT2DM), prediabetes mellitus (PDM) and normal controls (NC), and assessing if the LFC could as an indicator for the prediction of T2DM. METHODS: A total of 242 subjects (including 141 nT2DM patients, 48 PDM subjects and 53 NC) were enrolled. The levels of LFC were quantified by using the proton magnetic resonance spectroscopy ([1H]-MRS) technique. Clinical and laboratory parameters of study subjects were collected by medical records and biochemical detection. One-way ANOVA or nonparametric test (Kruskal-Wallis) was applied for intergroup comparisons; intergroup comparison was performed in using of Bonferroni multiple-significance-test correction. RESULTS: There were significantly increased LFC levels in nT2DM (14.72% ± 6.37%) than in PDM (9.62% ± 4.41%) and that of NC groups (5.11% ± 3.66%) (all p < 0.001). The prevalence of nonalcoholic fatty liver disease (NAFLD) was also found to be increased in nT2DM (91.48%) than in PDM (85.41%) and that of NC (32.07%) groups. Correlation analysis revealed that the increase of LFC positively associated with fast plasma glucose (FPG), 2 h plasma glucose (PG), Delta G30 and homeostatic model assessment of insulin resistance (HOMA-IR), negatively associated with Delta Ins30, Delta C30, Ins30/G30 AUC, CP30/G30 AUC, Ins AUC/G AUC, CP AUC/G AUC, homeostatic model assessment for ß-cell function index (HOMA-ß) and matsuda insulin sensitivity index (Matsuda ISI). Multilinear regression analysis showed that LFC, body mass index (BMI) and diastolic blood pressure (DBP) contributed for the prediction of HOMA-IR, and total cholesterol (TC), age, waist circumference (WC) and low-density lipoprotein cholesterol (LDL-C) were the significant contributors for HOMA-ß. CONCLUSIONS: Our study revealed an increased LFC level and prevalence of NAFLD in nT2DM than in PDM and that of NC groups, the increase of LFC was closely associated with insulin resistance and impaired glucose metabolism status, may be regarded as potential indicator contributing to the development and progression of T2DM.
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Objective:To study the effect of spleen and marrow strengthening method combined with CAG regimen on the quality of life(QOL) of elderly patients with acute myeloid leukemia with spleen-kidney Yang deficiency syndrome.Methods:From June 2017 to October 2018, 50 elderly patients with acute myeloid leukemia with spleen-kidney Yang deficiency were randomly divided into treatment group and control group by random number table method, with 25 patients in each group.The patients in the control group were treated with CAG regimen(Ara-C+ Acla+ G-CSF), while the patients in the treatment group were treated with CAG regimen and leukemia prescription I, which was the empirical prescription for spleen and kidney Yang deficiency syndrome in elderly patients with acute myeloid leukemia.The patients were treated for two courses.The traditional Chinese medicine (TCM) syndromes and QOL scores of patients in two groups were compared and observed.Results:Before treatment, there was no statistically significant difference in the score of TCM syndromes between the two groups ( P>0.05). After treatment, the improvement of TCM syndromes in the treatment group had statistically significant difference compared with before treatment[before treatment (9.29±4.22)points, after treatment (5.04±3.83)points, t=3.656, P=0.001], but that in the control group had no statistically significant difference ( P>0.05). The treatment group was better than the control group ( t=-2.081, P=0.044). The total effective rate of the treatment group was 58.33% (14/24), which was significantly higher than that of the control group[26.32% (5/19)], and the difference was statistically significant (χ 2=5.831, P<0.05). Before treatment, there was no statistically significant difference in the total score of QOL between the two groups ( P>0.05). After treatment, the scores of QOL in both two groups were improved, the differences were statistically significant[the control group: (40.37±2.93)points vs.(38.21±2.76)points, t=2.337, P=0.025; the treatment group: (41.46±2.57)points vs.(36.54±2.34)points, t=6.929, P=0.000], and the QOL score of the treatment group was better than that of the control group ( t=-2.145, P=0.038). Conclusion:The improvement of TCM syndromes and QOL of elderly patients with acute myeloid leukemia with spleen-kidney Yang deficiency syndrome treated by spleen and marrow strengthening method combined with CAG regimen is better than that treated by CAG chemotherapy alone.
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Objective:To summarize the early results and follow-up of mitral valve repair for rheumatic heart disease(RHD).Methods:From January 2018 to November 2019, 48 patients with rheumatic heart disease undergoing mitral valve repair in Cardiovascular Surgery Department of GaoZhou People' s Hospital were analyzed retrospectively. Surgical methods: according to the condition of mitral valve disease, the prosthetic mitral annulus was used in rheumatic mitral valve repair by the methods of joint incision, valve thinning, calcification stripping, Chordae tendineae release and papillary muscle splitting. All patients with tricuspid regurgitation were fixed with artificial valve ring(type C ring), and with atrial fibrillation were treated with Maze-IV radiofrequency ablation. Data on extracorporeal circulation time, aortic occlusion time, mechanical ventilation time, ICU stay time, and major postoperative complications were collected. Patients were followed up to assess mitral valve, cardiac function, and cardiac rhythm.Results:According to pathological classification, type Ⅰ were 9 cases, 31 cases as type Ⅱ and 8 cases as type Ⅲ. All patients in type I and type II were repaired successfully, and type III has 1 case who was repaired failed and underwent mitral valve replacement due to moderate regurgitation. Cardiopulmonary bypass(CPB) time was(110.62±27.68) min, Cross-clamp time was(76.63±17.63) min, ICU stay was(46.16±11.37) h, mechanical ventilation was(21.60±10.89) h. All survived at 30 days, 1 case of acute renal failure, 1 case of low cardiac output syndrome, 3 cases of pulmonary infection, no complications such as stroke and malignant Arrhythmia. 47 patients were followed up for(9.86±6.78) months. There were no death, malignant Arrhythmia and reoperation during the follow-up, and the cardiac function was improved significantly( P<0.001). Conclusion:The mitral valve repair of RHD can preserve the intact mitral valve structure, maintain the heart function, and have a good survival and quality of life. On the basis of mastering the repair of heart valve, being familiar with the anatomic features of rheumatic mitral valve disease, strictly grasping the indications, fully evaluating before operation, it is feasible to carry out the repair of rheumatic mitral valve, and the early clinical effect is satisfactory, long-term results recommend long-term follow-up.
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BACKGROUND: Baicalein is an active compound extracted from the roots of Scutellaria baicalensis georgi, which is widely and traditionally used in the anticancer therapy. Notch signaling pathway is usually abnormally activated in kinds of human cancers. The aim of the present study is to investigate the antitumor effects of baicalein in human cervical cancer and explore whether baicalein treatment affects notch signaling pathway in human cervical cancers. MATERIALS AND METHODS: Cervical cancer cells were treated with increasing concentrations of baicalein for 24, 48, and 72 h, respectively. 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay was used to determine cell viability of cervical cancer cells. The apoptosis rate was determined by FACS assay. Furthermore, the molecular mechanism was investigated. The expression levels of Notch 1, Notch 2, Notch 3, hairy enhancer of split-1 (Hes-1), and Hes-5 were determined by western blotting analysis. RESULTS: MTT assay results revealed that baicalein inhibited cell proliferation of HeLa cells and SiHa cells in a time- and dose-dependent manner. The data from FACS assay demonstrated that baicalein-induced cell apoptosis of cervical cancer cells at the final concentration of 100 µM for 24 h. Furthermore, baicalein treatment downregulated Notch 1/Hes-1, Hes-5 signaling pathway, and there was no obvious change on the expression of Notch 2 and Notch 3. CONCLUSION: Baicalein inhibited the proliferation of human cervical cancer cells via Notch 1/Hes signaling Pathway. The study would provide some new clues in the clinical therapy of human cervical cancers.
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Antineoplásicos Fitogênicos/farmacologia , Flavanonas/farmacologia , Receptor Notch1/metabolismo , Transdução de Sinais/efeitos dos fármacos , Fatores de Transcrição HES-1/metabolismo , Neoplasias do Colo do Útero/metabolismo , Apoptose/efeitos dos fármacos , Fatores de Transcrição Hélice-Alça-Hélice Básicos/metabolismo , Linhagem Celular Tumoral , Proliferação de Células/efeitos dos fármacos , Feminino , Humanos , Proteínas Repressoras/metabolismo , Neoplasias do Colo do Útero/patologiaRESUMO
At present, we are facing challenges in the development of rare disease drugs. The paper introduces the ethical theories of rare disease treatment, the characteristics of pharmacoeconomic evaluation on orphan drugs, the risk of reimbursement in medical insurance funds, the international experiences on the balance between the accessibility and cost containment of high-cost orphan drugs, the orphan drug list promulgated by Hong Kong SAR of China in 2019 and the status quo of orphan drugs in China. The author also analyzes the international practice from different perspec-tives, such as, the Orphan Drug Act(ODA)in the United States, the new concept of high specific technology introduced by National Institute Health and Clinical Excellence(NICE)in the UK, the retrospective review of pharmacoeconomics of orphan drugs by National Centre for Pharmacoeconomics(NCPE)in Ireland, the principles of orphan drug evaluation by TLV in Sweden, a special research program on the cost of orphan drugs in Turkey, and the four measures to control the cost of high-priced drugs in the Republic of Korea. The aim of this paper is to introduce international experiences for reference on the formulation of drug policies in rare diseases and development of related pharmacoeconomics in China.
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Background@#Handan Eye Study (HES), a large population-based cohort study in rural area of northern China, was one of the few studies focusing on the major eye diseases of rural Chinese population. The aim of this study was to introduce the design, methodology and to assess the data quality of the follow-up phase of HES.@*Methods@#All participants were recruited in Yongnian county of Handan city between 2012 and 2013. Main outcomes were measured by visual quality scales and ocular examinations. We performed the Chi-square test to make comparison of categorical data among groups, One-way analysis of variance and Kruskal-Wallis test was applied to make comparison of continuous data among groups, a post-hoc test was done to make further pairwise comparison. Inter-class correlation coefficients (ICCs) and Kappa coefficients were used to evaluate the consistency between different operators. Logistic regression was used to explore the influence factors of death, odds ratio (OR) and 95% confidence interval (CI) were used to estimate the effect size of each influence factor.@*Results@#The follow-up rate was 85.3%. Subjects were classified into three groups: the follow-up group (n = 5394), the loss to follow-up group (n = 929), and the dead group (n = 507), comparison of their baseline information was done. Compared with the other two groups, age of the dead group (66.52 ± 10.31 years) was the oldest (Z = 651.293, P < 0.001), male proportion was the highest (59.0%) (χ2 = 42.351, P < 0.001), only 65.9% of the dead finished middle school education (Z = 205.354, P < 0.001). The marriage percentage, body mass index (BMI), best-corrected visual acuity (BCVA), and intra-ocular pressure of the dead group was the lowest either. Spherical equivalent error (SER) of the dead group was the highest. Besides, history of smoking, hypertension, diabetes, and heart disease were more common in the dead group. Multivariate analysis showed that age (OR = 1.901, 95% CI: 1.074–1.108), gender (OR = 0.317, 95% CI: 0.224–0.448), and BCVA (OR = 0.282, 95% CI: 0.158–0.503) were associated with death. While between the follow-up group and the loss to follow-up group, there was only difference on age, gender, BMI, systolic blood pressure and SER. The Cronbach coefficients of all scales used in the follow-up were ≥0.63 and the cumulative variances were ≥0.61, indicating good reliability and validity. The ICCs and Kappa coefficients between different operators were ≥0.69.@*Conclusions@#HES has a high follow-up rate and a low risk of loss to follow-up bias. Age, gender, and BCVA are influence factors of death. Specifically, male subjects are at a higher risk of death than female, age is a risk factor of death while BCVA is a protective factor for death.
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Objective@#To explore the effects of Yiqi Yangyin Liangxue method on platelets, interleukin-10(IL-10) and transforming growth factor beta (TGF-β) of immune thrombocytopenic purpura(ITP) model mice, and to analyze its curative effect and possible mechanism.@*Methods@#A total of 100 ITP model mice were randomly divided into blank group, model group, single Chinese medicine group, single hormone group and Chinese medicine combined with hormone group.Drug intervention was started on the 8th day after the establishment of the model, and the drug was given for a total of 14 days.The blood of mice was collected and the levels of platelets, TGF-β and IL-10 in serum of mice in each group were detected.@*Results@#There was no statistically significant difference in platelet count among all groups before modeling(F=0.556, P>0.05). Before administration, there was statistically significant difference between the model group and the blank group (t=28.207, P<0.01), there were no statistically significant differences between the model group and the traditional Chinese medicine group, hormone group, hormone+ traditional Chinese medicine group (t=-1.96, -0.464, -0.979, all P>0.05). After gastric administration, the platelet counts in the traditional Chinese medicine group[(710.45±124.52)×109/L], hormone group[(768.10±127.42)×109/L], hormone+ traditional Chinese medicine group[(908.05±89.66)×109/L] were significantly higher than that in the model group[(413.55±38.84)×109/L](t=-10.18, -11.90, -22.63, all P<0.01). After gastric administration, there was no statistically significant difference between the traditional Chinese medicine group and the hormone group(t=-1.447, P>0.05). After gastric administration, the platelet count of the hormone+ traditional Chinese medicine group was significantly higher than that of the hormone group and the traditional Chinese medicine group(t=-4.017, -5.759, all P<0.01). There was statistically significant difference in IL-10 level among groups after administration(F=32.20, P<0.01). IL-10 levels between the model group[(20.28±0.75)ng/L] and traditional Chinese medicine group[(21.41±1.40)ng/L], hormone group[(21.79±1.14)ng/L] and traditional Chinese medicine+ hormone group[(23.14±1.34)ng/L] had statistically significant differences (t=-3.18, -4.93, -8.33, all P<0.01). There was no statistically significant difference between the traditional Chinese medicine group and hormone group(t=-0.927, P>0.05). There were statistically significant differences between the traditional Chinese medicine+ hormone group and traditional Chinese medicine group, hormone group (t=-3.97, -3.43, all P<0.01). There was statistically significant difference in TGF-beta level among all groups after administration(F=31.16, P<0.01). The TGF-β levels between the model group[(82.32±3.42)ng/L] and Chinese medicine group[(88.10±8.51)ng/L], hormone group[(90.03±4.50)ng/L] and Chinese medicine combined with hormone group[(94.41±2.53)ng/L] had statistically significant differences (t=-2.82, -6.10, -12.70, all P<0.01). There was no significant difference in TGF-β level between the Chinese medicine group and hormone group(t=-0.90, P>0.05). There were statistically significant differences in in TGF-beta level between the traditional Chinese medicine+ hormone group and Chinese medicine group, hormone group (t=-3.18, -3.79, all P<0.01).@*Conclusion@#Yiqi Yangyin Liangxue method can reduce platelet destruction by regulating the levels of IL-10 and TGF-β and inhibiting immunity, and it has good therapeutic effect on ITP.
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Objective@#To observe the effect of Yiqi Yangyin Liangxue method on peripheral blood platelet count and CD4+ CD25+ regulatory T cells(Treg) in mice model of immune thrombocytopenic purpura(ITP).@*Methods@#A total of 100 mice were randomly divided into blank control group, model group, Chinese medicine group, hormone group, Chinese medicine+ hormone group, with 20 mice in each group.In addition to the blank control group, the other four groups were intraperitoneally injected with guinea pig anti-mouse platelet serum(APS) to establish the ITP model.The peripheral blood platelet counts of mice in each group were determined by animal blood analyzer before modeling, before and after gavage, and CD4+ CD25+ Treg cells in each group were detected by flow cytometry after gavage.@*Results@#After intragastric administration, compared with the model group, the peripheral blood platelet count of mice in the other groups increased significantly[(413.55±38.84)×109/L, (710.45±124.52)×109/L, (768.10±127.42)×109/L, (908.05±89.66)×109/L, t=-10.18, -11.90, -22.63, all P<0.01], and the proportion of CD4+ CD25+ Treg cells in peripheral blood increased significantly[(1.649±0.286)%, (2.000±0.193)%, (2.286±0.271)%, (2.648±1.883)%, t=-4.54, -7.221, -13.031, all P<0.01]. All indicators of the Chinese medicine+ hormone group had statistically significant differences compared with those of the Chinese medicine group and the hormone group(t=-5.759, -4.107, -10.762, -4.902, all P<0.01).@*Conclusion@#Yiqi Yangyin Liangxue method may up-regulate the expression of CD4+ CD25+ Treg cells in peripheral blood of ITP mice, thereby reducing excessive platelet damage.
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BACKGROUND@#Handan Eye Study (HES), a large population-based cohort study in rural area of northern China, was one of the few studies focusing on the major eye diseases of rural Chinese population. The aim of this study was to introduce the design, methodology and to assess the data quality of the follow-up phase of HES.@*METHODS@#All participants were recruited in Yongnian county of Handan city between 2012 and 2013. Main outcomes were measured by visual quality scales and ocular examinations. We performed the Chi-square test to make comparison of categorical data among groups, One-way analysis of variance and Kruskal-Wallis test was applied to make comparison of continuous data among groups, a post-hoc test was done to make further pairwise comparison. Inter-class correlation coefficients (ICCs) and Kappa coefficients were used to evaluate the consistency between different operators. Logistic regression was used to explore the influence factors of death, odds ratio (OR) and 95% confidence interval (CI) were used to estimate the effect size of each influence factor.@*RESULTS@#The follow-up rate was 85.3%. Subjects were classified into three groups: the follow-up group (n = 5394), the loss to follow-up group (n = 929), and the dead group (n = 507), comparison of their baseline information was done. Compared with the other two groups, age of the dead group (66.52 ± 10.31 years) was the oldest (Z = 651.293, P < 0.001), male proportion was the highest (59.0%) (χ = 42.351, P < 0.001), only 65.9% of the dead finished middle school education (Z = 205.354, P < 0.001). The marriage percentage, body mass index (BMI), best-corrected visual acuity (BCVA), and intra-ocular pressure of the dead group was the lowest either. Spherical equivalent error (SER) of the dead group was the highest. Besides, history of smoking, hypertension, diabetes, and heart disease were more common in the dead group. Multivariate analysis showed that age (OR = 1.901, 95% CI: 1.074-1.108), gender (OR = 0.317, 95% CI: 0.224-0.448), and BCVA (OR = 0.282, 95% CI: 0.158-0.503) were associated with death. While between the follow-up group and the loss to follow-up group, there was only difference on age, gender, BMI, systolic blood pressure and SER. The Cronbach coefficients of all scales used in the follow-up were ≥0.63 and the cumulative variances were ≥0.61, indicating good reliability and validity. The ICCs and Kappa coefficients between different operators were ≥0.69.@*CONCLUSIONS@#HES has a high follow-up rate and a low risk of loss to follow-up bias. Age, gender, and BCVA are influence factors of death. Specifically, male subjects are at a higher risk of death than female, age is a risk factor of death while BCVA is a protective factor for death.
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Objective To compare the difference between transthoracic device closure of ventricular sep-tal defect and conventional thoracotomy and examine the effect and safety of transesophageal echocardiography (TEE) guided minimally invasive transthoracic device closure of ventricular septal defect. Methods Three hun-dred and sixty-eight patients underwent isolated ventricular septal defect surgery in our hospital from May 2014 to May 2016. There were 40 patients in group A underwent TEE guided minimally invasive transthoracic device clo-sure of ventricular septal defect and 328 patients in group B underwent conventional thoracotomy surgery.By using the method of propensity score matching,we selected 40 conventional thoracotomy patients as a control group in our study. Results All patients were survived after surgery without death and other serious complications. Compared with conventional thoracotomy surgery,patient with transthoracic device closure of ventricular septal defect had sta-tistical improvement in surgery time(1.97 ± 0.48 vs. 3.55 ± 1.95)h, ICU stayed time(21.15 ± 30.52 vs. 38.37 ± 10.91)h,volume of thoracic drainag(28.39 ± 32.67 vs.174.84 ± 85.36)mL,surgery incision length(2.98 ± 0.72 vs. 11.76 ± 2.89)cm.There were no significant differences in postoperative valvular regurgitation,arrhythmia and resid-ual shunt between the two groups.Conclusion TEE guided minimally invasive transthoracic device closure of ven-tricular septal defect is safe,effective,feasible,less trauma,less bleeding,faster recovery and etc.
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Shanghai is the earliest city in China for starting family doctor system at national level. It has actively explored the contract service mechanism between residents and family doctors. It has developed from "soft contract signing of guiding residents to understand, contact and gradually accept family doctor services" to the " main and close contracting using the comprehensive service from medical institutions". This paper systematically analyzed the implementation status in " one community health center, one district hospital and one municipal hospital (1 + 1 + 1)" contractservice system of family doctor in Shanghai from the aspects of adjustment background, design ideas, progress and obstacles of the policy. Based on the analysis of barriers to the policyimplementation, some suggestions were put forward including the improvement of the contract service system in order to increase the number and build the capacity of general practitioners, and the optimization of the existing payment distribution systems.
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Objective:To investigate the expression of H19 long non-coding RNA (IncRNA) and zinc finger E-box-binding protein i (ZEB1) in the trophoblast of women with spontaneous abortion.Methods:A total of 20 women underwent miscarriage were enrolled as a miscarriage group,while 20 women underwent artificial abortion were enrolled as a control group.Reverse transcriptional fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of iH19 lncRNA and miR-200,and Western blot was used to detect the expression of ZEB1.Results:Compared to the control group,a tendency of decreased H19 was detected in the miscarriage group,with no significant difference (1.28±0.08 vs 1.66±0.21,P=0.091).There was no significant difference in miR-200 between the 2 groups (0.75±0.35 vs 0.58±0.33,P=0.0.533).The expression of ZEB 1 was significantly decreased in the miscarriage group compared to that in the control group (0.22±0.03 vs 0.41±0.04,P=0.0003).The expression of i19 lncRNA and ZEB1 was positively correlated (r=0.529,P=0.0005),and the correlation between H19 lncRNA and miR-200 had no statistical significance (r=0.0293,P=0.858).The correlation between miR-200 and ZEB1 also had no statistical significance (r=-0.132,P=0.416).Conclusion:Down-regulation of ZEB1 in the trophoblast might be related to miscarriage.H19 lncRNA may regulate the expression of ZEB1.