RESUMEN
Interlaboratory agreement of viral load assays depends on the accuracy and uniformity of quantitative calibrators. Previous work demonstrated poor agreement of secondary cytomegalovirus (CMV) standards with nominal values. This study re-evaluated this issue among commercially produced secondary standards for both BK virus (BKV) and CMV, using digital polymerase chain reaction (dPCR) to compare the materials from three different manufacturers. Overall, standards showed an improved agreement compared to prior work, against nominal values in both log10 copies/mL and log10 international unit (IU)/mL, with bias from manufacturer-assigned nominal values of 0.0-0.9 log10 units (either copies or IU)/mL. Standards normalized to IU and those values assigned by dPCR rather than by real-time PCR (qPCR) showed better agreement with nominal values. The latter reinforces prior conclusions regarding the utility of using such methods for quantitative value assignment in reference materials. Quantitative standards have improved over the last several years, and the remaining bias from nominal values might be further reduced by universal implementation of dPCR methods for value assignment, normalized to IU. IMPORTANCE: Interlaboratory agreement of viral load assays depends on accuracy and uniformity of quantitative calibrators. Previous work, published in JCM several years ago, demonstrated poor agreement of secondary cytomegalovirus (CMV) standards with nominal values. This study re-evaluated this issue among commercially produced secondary standards for both BK virus (BKV) and CMV, using digital polymerase chain reaction (dPCR) to compare the materials from three different manufacturers. Overall, standards showed an improved agreement compared to prior work, against nominal values, indicating a substantial improvement in the production of accurate secondary viral standards, while supporting the need for further work in this area and for the broad adaption of international unit (IU) as a reporting standard for quantitative viral load results.
Asunto(s)
Virus BK , Infecciones por Citomegalovirus , Humanos , Citomegalovirus/genética , Infecciones por Citomegalovirus/diagnóstico , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Carga Viral/métodos , Virus BK/genética , ADN ViralRESUMEN
Climate dictates wildfire activity around the world. But East and Southeast Asia are an apparent exception as fire-activity variation there is unrelated to climatic variables. In subtropical China, fire activity decreased by 80% between 2003 and 2020 amid increased fire risks globally. Here, we assessed the fire regime, vegetation structure, fuel flammability and their interactions across subtropical Hubei, China. We show that tree basal area (TBA) and fuel flammability explained 60% of fire-frequency variance. Fire frequency and fuel flammability, in turn, explained 90% of TBA variance. These results reveal a novel system of scrubland-forest stabilized by vegetation-fire feedbacks. Frequent fires promote the persistence of derelict scrubland through positive vegetation-fire feedbacks; in forest, vegetation-fire feedbacks are negative and suppress fire. Thus, we attribute the decrease in wildfire activity to reforestation programs that concurrently increase forest coverage and foster negative vegetation-fire feedbacks that suppress wildfire.
Asunto(s)
Incendios , Incendios Forestales , Ecosistema , Retroalimentación , Bosques , ÁrbolesRESUMEN
AIM: To evaluate the relationship between oesophageal hiatus surface area (OHSA) and gastro-oesophageal reflux disease (GERD). MATERIALS AND METHODS: Patients who underwent 24-h pH monitoring, oesophageal high-resolution manometry, and upper abdominal contrast-enhanced multidetector computed tomography (MDCT) during 2014-2021 were enrolled. Patients with a hiatus hernia (HH) on MDCT or who had a history of gastro-oesophageal surgery were excluded. Multiplanar reconstruction (MPR) of the MDCT image was used for the measurement of OHSA. Correlations of OHSA with acid exposure time (AET) and lower oesophageal sphincter (LOS) pressure of all patients were analysed. RESULTS: Seventy-eight patients were included in the study. OHSA was much less in the AET <4% group than in the AET >6% group (1.61 ± 0.42 versus 2.09 ± 0.55 cm2, p<0.001). Correlation analysis reveals that OHSA correlated positively with AET (correlation coefficient = 0.47, p<0.001). Receiver operating characteristic (ROC) curve analysis reveals that OHSA can significantly distinguish patients in different groups divided by AET (area under the ROC curve [AUC] = 0.76, 95% confidence interval [CI]: 0.63-0.90). OHSA was not related to LOS pressure (correlation coefficient = -0.268, p=0.051). There was no difference in OHSA between the low LOS pressure group and the normal LOS pressure group (1.84 ± 0.61 versus 1.74 ± 0.50 cm2, p=0.52). CONCLUSIONS: OHSA significantly correlated with AET but has no relationship with LOS pressure. It may be an independent risk factor of GERD.
RESUMEN
Xerocomoideae is an ecologically and economically important Boletaceae subfamily (Boletales) comprising 10 genera. Although many studies have focused on Xerocomoideae in China, the diversity, taxonomy and molecular phylogeny still remained incompletely understood. In the present study, taxonomic and phylogenetic studies on Chinese species of Xerocomoideae were carried out by morphological examinations and molecular phylogenetic analyses. Eight genera in Xerocomoideae, viz. Aureoboletus, Boletellus, Heimioporus, Hemileccinum, Hourangia, Phylloporus, Pulchroboletus, and Xerocomus were confirmed to be distributed in China; 97 species of the subfamily were accepted as being distributed in China; one ambiguous taxon was tentatively named Bol. aff. putuoensis; two synonyms, viz. A. marroninus and P. dimorphus were defined. Among the Chinese accepted species, 13 were newly described, viz. A. albipes, A. conicus, A. ornatipes, Bol. erythrolepis, Bol. rubidus, Bol. sinochrysenteroides, Bol. subglobosus, Bol. zenghuoxingii, H. squamipes, P. hainanensis, Pul. erubescens, X. albotomentosus, and X. fuscatus, 36 known species were redescribed, and the other 48 species were reviewed. Keys to accepted species of Aureoboletus, Boletellus, Heimioporus, Hemileccinum, Hourangia, Phylloporus, and Xerocomus in China were also provided. Taxonomic novelties: New species: Aureoboletus albipes N.K. Zeng, Xu Zhang & Zhi Q. Liang, A. conicus N.K. Zeng, Xu Zhang & Zhi Q. Liang, A. ornatipes N.K. Zeng, Xu Zhang & Zhi Q. Liang, Boletellus erythrolepis N.K. Zeng, R. Xue, S. Jiang & Zhi Q. Liang, Bol. rubidus N.K. Zeng, R. Xue, Y.J. Hao & Zhi Q. Liang, Bol. sinochrysenteroides N.K. Zeng, R. Xue & Kuan Zhao, Bol. subglobosus N.K. Zeng, R. Xue, S. Jiang & Zhi Q. Liang, Bol. zenghuoxingii N.K. Zeng, R. Xue, S. Jiang & Zhi Q. Liang, Hemileccinum squamipes N.K. Zeng, Chang Xu & Zhi Q. Liang, Phylloporus hainanensis N.K. Zeng, L.L. Wu, & Zhi Q. Liang, Pulchroboletus erubescens N.K. Zeng, Chang Xu & Zhi Q. Liang, Xerocomus albotomentosus N.K. Zeng, H.J. Xie, Chang Xu & Zhi Q. Liang, and X. fuscatus N.K. Zeng, H.J. Xie, Chang Xu & Zhi Q. Liang. Citation: Xue R, Zhang X, Xu C, Xie HJ, Wu LL, Wang Y, Tang LP, Hao YJ, Zhao K, Jiang S, Li Y, Yang YY, Li Z, Liang ZQ, Zeng NK (2023). The subfamily Xerocomoideae (Boletaceae, Boletales) in China. Studies in Mycology 106: 95-197. doi: 10.3114/sim.2022.106.03.
RESUMEN
OBJECTIVE: To investigate the preparation of decellularized small intestinal submucosa (dSIS) sponge scaffolds with chelated strontium (Sr) ions at different pH values, and to select the appropriate pH values for synthesizing Sr/dSIS scaffolds using the physicochemical properties and biocompatibility of the scaffolds as evaluation indexes. METHODS: (1) Sr/dSIS scaffolds preparation and grouping: After mixing dSIS solution and strontium chloride solution in equal volumes, adjusting pH of the solution to 3, 5, 7, and 9 respectively, porous scaffolds were prepared by freeze-drying method after full reaction at 37â, which were named Sr/dSIS-3, -5, -7, and -9 respectively, and the dSIS scaffolds were used as the control group. (2) Physicochemical property evaluation: The bulk morphology of the scaffolds was observed in each group, the microscopic morphology analyzed by scanning electron microscopy, and the porosity and pore size determined, the surface elements analyzed by energy spectroscopy, the structure of functional groups analyzed by infrared spectroscopy, the chelation rate determined by atomic spectrophotometry, the water absorption rate detected by using specific gravity method, and the compression strength evaluated by universal mechanical testing machine.(3) Biocompatibility evaluation: The cytotoxicity and proliferative effect to bone mesenchymal stem cells (BMSCs) of each group were evaluated by Calcein-AM/PI double staining method. RESULTS: Scanning electron microscopy showed that the scaffolds of each group had an interconnected three-dimensional porous structure with no statistical difference in pore size and porosity. Energy spectrum analysis showed that strontium could be detected in Sr/dSIS-5, -7 and -9 groups, and strontium was uniformly distributed in the scaffolds. Functional group analysis further supported the formation of chelates in the Sr/dSIS-5, -7 and -9 groups. Chelation rate analysis showed that the Sr/dSIS-7 group had the highest strontium chelation rate, which was statistically different from the other groups (P < 0.05). The scaffolds in all the groups had good water absorption. The scaffolds in Sr/dSIS-5, -7 and -9 groups showed significantly improved mechanical properties compared with the control group (P < 0.05). The scaffolds in all the groups had good biocompatibility, and the Sr/dSIS-7 group showed the best proliferation of BMSCs. CONCLUSION: When pH was 7, the Sr/dSIS scaffolds showed the highest strontium chelation rate and the best proliferation effect of BMSCs, which was the ideal pH value for the preparation of the Sr/dSIS scaffolds.
Asunto(s)
Materiales Biocompatibles , Andamios del Tejido , Andamios del Tejido/química , Estroncio/química , Estroncio/farmacología , Iones , Concentración de Iones de Hidrógeno , Ingeniería de Tejidos/métodos , PorosidadRESUMEN
In recent years, many studies have found that vaginal microbiota is closely related to female reproductive tract diseases. However, traditional microbial culture technology has the defects of long culture cycle and most microorganisms cannot be cultured. The development of metagenomics technique has broken the limitations of culture technology, and has been gradually applied to the study of vaginal microorganisms with the characteristics of high throughput, short time, identification of microbial population structure and gene function. It also provides technical support for elucidating the relationship between vaginal microbiota and female reproductive tract diseases. This article mainly introduces the metagenomics techniques and their applications in prevention, screening and diagnosis of common female reproductive tract diseases, and discusses their promising development and limitations to be overcome.
Asunto(s)
Microbiota , Femenino , Humanos , Microbiota/genética , Vagina , Metagenómica/métodosRESUMEN
Sarcopenia has attracted increasing attention with the study of nutrition in patients with liver disease. Sarcopenia is an independent risk factor for a poor prognosis of liver disease and is becoming increasingly common in patients with liver disease. Studies have shown that patients with liver disease and sarcopenic obesity have a worse prognosis than patients with liver disease and simple sarcopenia or obesity. In clinical practice, it is easy to recognize patients with malnutrition and decreased muscle mass, but we often ignore those patients with normal body weight or even obesity who will likewise experience muscle mass loss. Simply relying on the monitoring of body mass and body mass index to assess the nutritional and muscle status of patients with liver disease is not accurate. At present, our understanding of the relationship between chronic liver disease and sarcopenic obesity is still poorly understood. In this paper, the research progress on chronic liver disease, sarcopenia, and sarcopenic obesity in recent years is reviewed so as to provide a theoretical basis for improving the clinical prognosis of patients with liver disease.
Asunto(s)
Hepatopatías , Sarcopenia , Humanos , Sarcopenia/complicaciones , Composición Corporal/fisiología , Obesidad/complicaciones , Factores de Riesgo , Hepatopatías/complicaciones , Músculo EsqueléticoRESUMEN
Objective: To understand the clinical and genetic characteristics of hereditary spherocytosis (HS) combined with cholestasis among pediatric patients. Methods: 12 cases of HS children accompanied by cholestasis at Hunan Children's Hospital were selected as the research subjects between January 2013 and December 2022. Clinical data were collected. Whole-exome sequencing was performed by second-generation sequencing. Suspected pathogenic mutation sites were verified by Sanger sequencing. Results: All pediatric patients were admitted to the hospital due to their yellow skin tone. Eight cases (66.67%) had a positive family history. The clinical manifestations were jaundice, splenomegaly (12/12), abdominal pain, anemia (4/12), and hepatomegaly (5/12). All pediatric patients had decreased hemoglobin, an increased reticulocyte ratio, total bilirubin and direct bilirubin, a positive erythrocyte fragility test, and remarkable spherical erythrocytes in their peripheral blood. Seven cases had elevated aminotransferase; four cases had severely elevated aminotransferase and bilirubin; eight cases had biliary calculi; and two cases had a dilated biliary tract. Liver pathological examination showed mild damage to the liver cells (G1S1) in three pediatric cases. Five children had a total of six unreported mutations: SPTB gene c.2431_2450del, c.4974-2A > G, c.2575G > A, and exon 22-35 deletion; ANK1 gene: c.2379-2380delC; and c .6dupC. Children still had abnormal bilirubin levels following treatment. Two pediatric cases underwent splenectomy. Bilirubin and hemoglobin levels returned to normal after surgery. Conclusion: Children with HS may experience cholestasis, and those with poor treatment results may consider undergoing a splenectomy. Six new types of variants have expanded the HS gene mutation spectrum.
Asunto(s)
Colestasis , Esferocitosis Hereditaria , Humanos , Niño , Esferocitosis Hereditaria/genética , Esferocitosis Hereditaria/diagnóstico , Esferocitosis Hereditaria/cirugía , Mutación , Bilirrubina , Transaminasas/genética , Hemoglobinas/genéticaRESUMEN
Granular cell tumor (GCT) is a relatively rare tumor that develops in soft tissues at various sites in the body, and GCT originating in the bronchus is rather rare. Here, we reported a case of primary GCT of the bronchial to improve the understanding of this disease.
Asunto(s)
Tumor de Células Granulares , Humanos , Tumor de Células Granulares/patología , Bronquios/patologíaRESUMEN
Quantitative testing of BK virus (BKPyV) nucleic acid has become the standard of care in transplant patients. While the relationship between interassay harmonization and commutability has been well characterized for other transplant-related viruses, it has been less well studied for BKPyV, particularly regarding differences in commutability between matrices. Here, interassay agreement was evaluated among six real-time nucleic acid amplification tests (NAATs) and one digital PCR (dPCR) BKPyV assay. Differences in the commutability of three quantitative standards was examined across all assays using a variety of statistical approaches. Panels, including 40 samples each of plasma and urine samples previously positive for BKPyV, together with one previously negative plasma sample and four previously negative urine samples, were tested using all assays, with each real-time NAAT utilizing its usual quantitative calibrators. Serial dilutions of WHO, National Institute for Standards and Technology (NIST), and commercially produced (Exact/Bio-Rad) reference materials were also run by each assay as unknowns. The agreement of the clinical sample values was assessed as a group and in a pairwise manner. The commutability was estimated using both relativistic and quantitative means. The quantitative agreement across assays in the urine samples was within a single log10 unit across all assays, while the results from the plasma samples varied by 2 to 3 log10 IU/mL. The commutability showed a similar disparity between the matrices. Recalibration using international standards diminished the resulting discrepancies in some but not all cases. Differences in the sample matrix can affect the commutability and interassay agreement of quantitative BKPyV assays. Differences in commutability between matrices may largely be due to factors other than those such as amplicon size, previously described as important in the case of cytomegalovirus. Continued efforts to standardize viral load measurements must address multiple sources of variability and account for differences in assay systems, quantitative standards, and sample matrices.
Asunto(s)
Virus BK , Ácidos Nucleicos , Virus BK/genética , Citomegalovirus , Humanos , Estándares de Referencia , Carga Viral/métodosRESUMEN
OBJECTIVE: To explore clinicians' attitudes and beliefs about physical activity and exercise therapy as treatment for individuals with knee and/or hip osteoarthritis (OA). METHOD: This was a scoping review, mapping available knowledge about the topic derived from qualitative research designs and methods. A comprehensive search of selected databases (MEDLINE, EMBASE; CINAHL; Web of Science) was conducted and data were analysed thematically. RESULTS: Twelve articles met inclusion criteria. Thematic analysis identified three interrelated main themes: 1) Understandings of OA and its trajectory and management; 2) Attitudes to activity and exercise as part of OA management; 3) Clinicians' perceived knowledge of and expertise in OA management. Findings highlight that many clinicians involved in knee/hip OA management, particularly general practitioners and physiotherapists, perceive OA to be a low priority 'wear-and-tear' disease with expected progression of symptoms, making joint replacement surgery eventually inevitable. Further, many clinicians appear to lack knowledge about and interest in physical activity and exercise therapy in the management of knee/hip OA, and seem to show uncertainty about the effectiveness and safety of physical activity and exercise therapy on joint health. CONCLUSION: Clinicians' attitudes and beliefs about physical activity and exercise therapy in OA seem to reflect an outdated narrative which describes OA as a wear-and-tear disease with inevitable disease progression to joint replacement surgery. Clinicians need to adopt a contemporary narrative, which accurately reflects current knowledge and evidence-based practice, thereby ensuring consistent utilisation of exercise therapy as first-line care as recommended in OA guidelines.
Asunto(s)
Actitud del Personal de Salud , Cultura , Terapia por Ejercicio , Ejercicio Físico , Conocimientos, Actitudes y Práctica en Salud , Osteoartritis de la Cadera/terapia , Osteoartritis de la Rodilla/terapia , HumanosRESUMEN
AIM: To develop and validate a radiomics nomogram for prediction of degree of differentiation in lung adenocarcinoma presenting as sub-solid or solid nodules. MATERIALS AND METHODS: A total of 438 patients with histopathologically confirmed adenocarcinoma (248 non-poorly differentiated and 190 poorly differentiated) were divided into training cohort (n=235) and internal validation cohort (n=203) according to surgery sequence. Sixty patients form public TCIA dataset were selected for external validation. One thousand, two hundred and eighteen radiomics features were extracted from each volumetric region of interest and a least absolute shrinkage and selection operator logistic regression was applied to select meaningful radiomic features for building a radiomics score (Rad-score) model. A nomogram model incorporating the Rad-score and type was established after multivariable logistic regression. The discrimination efficiency, calibration efficacy, and clinical utility value of the nomogram were evaluated. RESULTS: The Rad-score model could predict the differentiation degree of lung adenocarcinoma with an area under the curve (AUC) of 0.83 (95% confidence interval [CI]: 0.78-0.89) in the internal validation cohort. The AUC of the nomogram and radiographic model was 0.86 (95% CI: 0.80-0.91), 0.78 (95% CI: 0.72-0.84) in the internal validation cohort respectively. The AUC of the nomogram in the external validation cohort was 0.73 (95% CI: 0.58-0.88). Delong's test showed that the nomogram performed better than radiographic features alone (p=0.001). CONCLUSIONS: The proposed radiomics nomogram has the potential to predict the differentiation degree of lung adenocarcinoma preoperatively.
Asunto(s)
Adenocarcinoma del Pulmón , Adenocarcinoma , Neoplasias Pulmonares , Adenocarcinoma/diagnóstico por imagen , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Adenocarcinoma del Pulmón/diagnóstico por imagen , Adenocarcinoma del Pulmón/patología , Humanos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/patología , Nomogramas , Tomografía Computarizada por Rayos XRESUMEN
Adjuvant therapy and radiotherapy improves the survival of patients with metastatic and locally advanced gastric cancer (GC). However, the resistance to radiotherapy limits its clinical usage. Rhotekin 2 (RTKN2) functions as an oncogene and confers resistance to ultraviolet B-radiation and apoptosis- inducing agents. Here, the role of RTKN2 in radiosensitivity of GC cell lines was investigated. RTKN2 was found to be elevated in GC tissues and cells. A series of functional assays revealed that overexpression of RTKN2 induced GC cell proliferation, promoted GC cell migration and invasion, while inhibiting GC cell apoptosis. However, silence of RTKN2 promoted GC cell apoptosis, while repressing GC cell proliferation, invasion and migration. GC cells were exposed to irradiation, and data from cell survival and apoptotic assays showed that knock-down of RTKN2 enhanced radiosensitivity of GC through up-regulation of apoptosis and down-regulation of proliferation in irradiation-exposed GC cells. Moreover, the protein expression of ß-catenin and c-Myc in GC cells was enhanced by RTKN2 over-expression, but reduced by RTKN2 silence. Interference of RTKN2 down-regulated nuclear ß-catenin expression, while up-regulating cytoplasmic ß-catenin in GC. In conclusion, RTKN2 contributed to cell growth and radioresistance in GC through activation of Wnt/ß-catenin signalling.
Asunto(s)
Neoplasias Gástricas , Línea Celular Tumoral , Movimiento Celular , Proliferación Celular , Regulación Neoplásica de la Expresión Génica , Humanos , Péptidos y Proteínas de Señalización Intracelular/metabolismo , Neoplasias Gástricas/genética , Neoplasias Gástricas/patología , Neoplasias Gástricas/radioterapia , Vía de Señalización Wnt , beta Catenina/metabolismoRESUMEN
BACKGROUND: So far, the risk factors of catheter-related venous thrombosis (CRVT) are not fully understood. We use evidence-based medicine to find the risk factors of CRVT by pooling the current studies that reported the risk factors of CRVT, aiming to provide guidance for clinical diagnosis and treatment. METHODS: We searched PubMed, Embase, and Cochrane Library from the establishment of the database to July 2021. We included studies that reported the risk factors of CRVT, and we excluded duplicate publications, research without full text, incomplete information or inability to conduct data extraction, animal experiments, reviews, and systematic reviews. STATA 15.1 was used to analyze the data. RESULTS: The pooled results show that history of venous thrombosis (odds ratio [OR] = 3.75, 95% confidence interval [CI]: 1.02-13.85; P = 0.047), cancer (OR = 1.74, 95% CI: 1.17-2.57; P = 0.006), infection (OR = 2.13, 95% CI:1.33-3.42; P = 0.002), and multilumina (OR = 3.34, 95% CI:1.48-7.54; P = 0.004) will significantly increase the occurrence of CRVT. However, there is no significant correlation between sex, congenital heart disease, bedridden state, sepsis, mechanical ventilation, anticoagulation therapy, insertion site (left), and CRVT. CONCLUSION: Our research results indicate that history of venous thrombosis, cancer, infection and multilumina are possible risk factors for CRVT, and corresponding preventive measures should be taken clinically.
Asunto(s)
Neoplasias , Trombosis de la Vena , Catéteres/efectos adversos , Humanos , Factores de Riesgo , Trombosis de la Vena/epidemiología , Trombosis de la Vena/etiología , Trombosis de la Vena/prevención & controlRESUMEN
The prolongation of patient's overall survival is the accepted as gold standard to prove clinical values of anti-cancer drugs. However, if overall survival is taken as the primary endpoint in clinical trials for cancer types with a relatively good prognosis in the process of new anti-cancer drug research and development, the time to market the drugs will be prolonged due to the long follow-up time. In addition, overall survival is often interfered by confounding factors such as follow-up treatment. Therefore, regulatory agencies have established an accelerated review model using surrogate endpoints for the approval of new anti-cancer drugs, but there are still some problems in the use of surrogate endpoints in cancer clinical trials. From the perspective of new drug review, the authors expounds the key points of confirming and rationally using surrogate endpoints in clinical trials of anti-cancer drugs, which will improve the level of clinical trials of new anti-cancer drugs and accelerate the development of anti-tumor drugs.
Asunto(s)
Antineoplásicos , Neoplasias , Humanos , Neoplasias/terapia , Antineoplásicos/uso terapéutico , BiomarcadoresRESUMEN
Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.
Asunto(s)
Antineoplásicos , Neoplasias , Antineoplásicos/uso terapéutico , Ensayos Clínicos como Asunto , Humanos , Mercadotecnía , Neoplasias/tratamiento farmacológico , Proyectos de Investigación , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVE: To compare the effects of three different crosslinkers on the biocompatibility, physical and chemical properties of decellularized small intestinal submucosa (SIS) porous scaffolds. METHODS: The SIS porous scaffolds were prepared by freeze-drying method and randomly divided into three groups, then crosslinked by glutaraldehyde (GA), 1-ethyl-3-(3-dimethylaminopropyl) carbodi-imide (EDC) and procyanidine (PA) respectively. To evaluate the physicochemical property of each sample in different groups, the following experiments were conducted. Macroscopic morphologies were observed and recorded. Microscopic morphologies of the scaffolds were observed using field emission scanning electron microscope (FESEM) and representative images were selected. Computer software (ImageJ) was used to calculate the pore size and porosity. The degree of crosslinking was determined by ninhydrin experiment. Collagenase degradation experiment was performed to assess the resistance of SIS scaffolds to enzyme degradation. To evaluate the mechanical properties, universal mechanical testing machine was used to determine the stress-strain curve and compression strength was calculated. Human bone marrow mesenchymal cells (hBMSCs) were cultured on the scaffolds after which cytotoxicity and cell proliferation were assessed. RESULTS: All the scaffolds remained intact after different crosslinking treatments. The FESEM images showed uniformed interconnected micro structures of scaffolds in different groups. The pore size of EDC group[(161.90±13.44) µm] was significantly higher than GA group [(149.50±14.65) µm] and PA group[(140.10±12.06) µm] (P < 0.05). The porosity of PA group (79.62%±1.14%) was significantly lower than EDC group (85.11%±1.71%) and GA group (84.83%±1.89%) (P < 0.05). PA group showed the highest degree of crosslinking whereas the lowest swelling ratio. There was a significant difference in the swelling ratio of the three groups (P < 0.05). Regarding to the collagenase degradation experiment, the scaffolds in PA group showed a significantly lower weight loss rate than the other groups after 7 days degradation. The weight loss rates of GA group were significantly higher than those of the other groups on day 15, whereas the PA group had the lowest rate after 10 days and 15 days degradation. PA group showed better mechanical properties than the other two groups. More living cells could be seen in PA and EDC groups after live/dead cell staining. Additionally, the proliferation rate of hBMCSs was faster in PA and EDC groups than in GA group. CONCLUSION: The scaffolds gained satisfying degree of crosslinking after three different crosslinking treatments. The samples after PA and EDC treatment had better physicochemical properties and biocompatibility compared with GA treatment. Crosslinking can be used as a promising and applicable method in the modification of SIS scaffolds.
Asunto(s)
Ingeniería de Tejidos , Andamios del Tejido , Materiales Biocompatibles/química , Reactivos de Enlaces Cruzados/química , Humanos , Porosidad , Ingeniería de Tejidos/métodos , Andamios del Tejido/química , Pérdida de PesoRESUMEN
Objective: To evaluate the quality of life and influencing factors of patients with herpes zoster (HZ) seen in hospitals. Methods: Based on Zoster Brief Pain Inventory (ZBPI) and Five-level EuroQol Five-dimensional Questionnaire (EQ-5D-5L), a cross-sectional survey was conducted to evaluate the pain severity and quality of life of 332 HZ cases seen in 22 hospitals of Lu'an City (Anhui Province), Zibo City (Shandong Province) and Tongchuan City (Shaanxi Province) from October to December 2021. The censored least absolute deviations (CLAD) model was used to analyze the related factors affecting the changes of patients' health utility values. Results: The 45.5% of 332 HZ cases were male. The median (Q1,Q3) age was 59 (50, 68) years. 59.64% of them assessed by ZBPI had moderate to severe pain in the past 24 hours (worst pain score≥5), and that of PHN cases was 84.8%(39/46). 77.7% (258/332), 77.4% (257/332) and 74.1% (246/332) of all patients reported that pain interfered with sleep, mood and general activities, respectively. Aging [ß40-49y (95%CI)=-0.11 (-0.15, -0.08); ß50-59y (95%CI)=-0.03 (-0.05, 0.00); ß60-69y (95%CI)=-0.09 (-0.12, -0.06); ß70-90y(95%CI)=-0.16 (-0.19, -0.12)], working status (unemployed) [ßfarmer (95%CI)=0.15 (0.13, 0.18); ßretirees(95%CI)=0.21 (0.18, 0.24); ßemployee (95%CI)=0.13 (0.10, 0.16) ], complications[ßPHN (95%CI)=-0.08 (-0.13, -0.04); ßother complications (95%CI)=-0.12 (-0.15, -0.08)], within 30 days after onset [ß(95%CI)=-0.01 (-0.03, 0.01)] and treatment [ßother complications (95%CI)=-0.09 (-0.11, -0.06)] were related factors for the decline of health utility value (all P values <0.05). Conclusions: More than half of the patients with HZ had moderate to severe pain in the past 24 hours, which had a serious negative impact on the physical and mental health of the patients. Elderly patients, acute patients and patients with complications had lower health utility values and worse health status. We suggest that eligible people be vaccinated with HZ vaccine as soon as possible.
Asunto(s)
Herpes Zóster , Calidad de Vida , Humanos , Masculino , Anciano , Femenino , Radioisótopos de Itrio , Estudios Transversales , Herpes Zóster/complicaciones , Herpes Zóster/prevención & control , Herpesvirus Humano 3 , Dolor/etiología , Factores de RiesgoRESUMEN
Objective: To analyze the trust in vaccination and its influencing factors in parents of children aged 0-6 years. Methods: In June 2021, a cross-sectional survey was conducted to collect the basic information of parents of children aged 0-6 years, including their trust in vaccination and their attitudes towards vaccination. The χ2 test was used to compare the difference between different groups, and logistic regression was used to analyze the influencing factors. Results: A total of 10 916 parents of children aged 0-6 years were investigated in this study, and their trust in vaccine was 67.20%, of which safety (55.80%) was the key factor limiting the trust in vaccination. 37.94% (4 142/10 916) of the parents were willing to vaccinate more than two kinds of vaccines at the same time, and 85.07% (9 286/10 916) of the parents feared that abnormal reactions would occur after vaccination. The parents' age, education level and annual family income were the promoting factors of their trust in vaccination (P<0.05). Obtaining vaccine knowledge through vaccination APP or official account (OR=1.330, 95%CI: 1.188-1.489) and popular science leaflets distributed by vaccination clinics (OR=1.120, 95%CI: 1.020-1.228) were the promoting factors of parents' trust in vaccination. Young children and parents, high family income and education level were the promoting factors for parents to be willing to vaccinate at the same time (P<0.05), and young children and parents, low family income and education level were the inducing factors for fear of abnormal reaction after vaccination (P<0.05). Parents of children in the central region had a high acceptance of simultaneous vaccination for children, while parents of children in the western region had a low degree of concern about abnormal reactions after vaccination (P<0.05). Parents of children who read books and got vaccine knowledge online (OR=1.257, 95%CI: 1.153-1.371), urban residents (OR=1.173, 95%CI: 1.062-1.295) and with jobs (OR=1.109, 95%CI: 1.015-1.212) were more willing to vaccinate at the same time. The choice of imported vaccine was a promoting factor for parents to worry about abnormal reactions after vaccination (P<0.05). Conclusion: There is room for parents of children aged 0-6 years to further improve their trust in vaccination. At this stage, it is necessary to innovate the way of health education and health promotion, and pay attention to the publicity of vaccine safety knowledge, so as to improve parents' trust in vaccination.
Asunto(s)
Confianza , Vacunas , Niño , Humanos , Preescolar , Estudios Transversales , Conocimientos, Actitudes y Práctica en Salud , VacunaciónRESUMEN
Objective: To explore the clinical value of von Willebrand Factor (vWF) and VITRO score (vWF:Ag/platelet count) in assessing disease progression in patients with HBV infection. Methods: Randomly collect relevant clinical data of 308 patients with HBV infection (including 154 cases of chronic hepatitis B, 66 cases of hepatitis B cirrhosis in compensatory period, 88 cases of hepatitis B cirrhosis in decompensated period) from December 1, 2018 to January 5, 2021 in the Second Affiliated Hospital of Chongqing Medical University. The vWF values are measured by a uniform optical method, and all data are included using a uniform standard. Analyze the difference and significance of plasma vWF level and VITRO score in chronic hepatitis B, hepatitis B cirrhosis in the compensatory phase and decompensated phase. Results: The plasma vWF level and VITRO score of the chronic hepatitis B group were (139.47±76.44) and (0.86±0.8), respectively, and the hepatitis B cirrhosis compensated group was (164.95±67.12 and 1.44±1.14), respectively. Hepatitis cirrhosis decompensated group were (317.48±103.32 and 6.81±4.98), respectively; plasma vWF level and VITRO score increased with the progression of HBV infection, and the difference was statistically significant (F=133.669,P=0.000F=137.598,P=0.000).The plasma vWF level and VITRO score in patients with hepatitis B cirrhosis were (185.65±85.07 and 2.3±2.37) in the Child-Pugh A group, (304.74±105.81 and 6.37±5.19) in the B grade group, and (369.48±73.238.28±5.38) in the C grade group; plasma vWF level and VITRO score in patients with hepatitis B cirrhosis increased with the increase of Child-Pugh grade, and the difference was statistically significant (F=60.236, P=0.000F=32.854, P=0.000). The area under the curve (AUC) of plasma vWF level and VITRO score for diagnosing the decompensated stage of hepatitis B cirrhosis were 0.897 [95% confidence interval (CI): 0.855-0.940, Pï¼0.01], 0.949 [95% CI: 0.916-0.982, Pï¼0.01). When the vWF level and VITRO score were taken as cut-off values of 238.5% and 1.65, respectively, the sensitivity of diagnosing the decompensated stage of hepatitis B cirrhosis was 79.5% and 94.3%, the specificity was 92.3% and 87.7%, and the positive predictive value was 80.5% and 94.3%, the negative predictive value was 91.9% and 97.5%, and the diagnostic accuracy was 88.6% and 89.3%. Among the patients with decompensated hepatitis B cirrhosis, the level of vWF in the group with gastrointestinal bleeding (367.24±68.29)% was significantly higher than that in the group without gastrointestinal bleeding (286.15±109.69)%, and the difference was statistically significant (Pï¼0.001) The VITRO score of the group with gastrointestinal bleeding (9.12±5.4) was significantly higher than that of the group without gastrointestinal bleeding (5.36±4.13), and the difference was statistically significant (Pï¼0.01). The vWF level in the spontaneous peritonitis group was (341.73±87.92)% higher than that in the non-spontaneous peritonitis group (296.32±111.74)%, and the difference was statistically significant (Pï¼0.05). There was no statistical difference in VITRO score between the two groups. significance. Conclusion: Plasma vWF level and VITRO score can evaluate the progression of liver disease and the degree of decompensation of liver cirrhosis in patients with HBV infection, and have a predictive effect on various complications after decompensation of liver cirrhosis, and have certain guiding significance for early intervention measures.