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1.
Int J Clin Pharm ; 2020 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-32078105

RESUMO

Background Except for hypertension control, antihypertensive agents play an essential role in the secondary prevention of coronary artery disease. Objective This study aimed to describe the use of antihypertensive agents in patients with hypertension and coronary artery disease by assessing the compliance to the updated European and Chinese hypertension guidelines through analyzing the frequencies, monthly trends and the influencing factors of antihypertensive agents. Setting Beijing Friendship Hospital, Capital Medical University, a 2000-bed tertiary Chinese university teaching hospital. Method Prescriptions of patients diagnosed with hypertension and coronary artery disease were extracted from medical records of this tertiary hospital from 2013 to 2016. Frequencies, trends, co-existing prescription patterns of five classes of antihypertensive agents were analyzed. Influencing factors of prescription patterns were evaluated by logistic regression. Main outcome measure The frequencies and monthly trends of different antihypertensive agents within four years. Result In total, 286,155 prescriptions met the inclusion criteria. ß-blockers (64,0%) were the most widely used antihypertensive agents, followed by calcium channel blockers (53.57%), angiotensin receptor blockers (42.6%), angiotensin-converting-enzyme inhibitors (23.7%) and diuretics (16.4%). During the 4 years, frequencies of ß-blockers, angiotensin receptor blockers, calcium channel blockers and diuretics increased over time, while that of angiotensin-converting-enzyme inhibitors declined. Multivariate logistic regression indicated that gender, age and comorbidities including stroke, diabetes, heart failure and arrhythmia could affect antihypertensive selections to varying degrees. Conclusion The compliance to guidelines is overall well for patients with hypertension and coronary artery disease, but improvements is needed for patients with type 2 diabetes. Multi-center studies with large-scale data are required to further assess the usage of antihypertensive agents in patients.

2.
Obes Surg ; 2020 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-32048152

RESUMO

BACKGROUND: Obesity is a worldwide epidemic leading to non-alcoholic fatty liver disease. Alterations in the liver fat fraction (LFF) assessed by MRI following bariatric surgery is a promising feature; however, few studies have been fully elucidated. PURPOSE: To determine the alterations in the LFF features following surgery using MRI, to determine the correlation with the clinical non-alcoholic steatohepatitis score (C-NASH score), and to identify the predictive factors for postoperative score changes. METHODS: Patients (n = 69) underwent MRI to measure the LFF at baseline and 3 months postoperatively. Paired sample t tests were applied to investigate the alterations in the major parameters. Univariate analyses were performed to evaluate the factors predicting C-NASH score changes after surgery. RESULTS: Compared with the baseline levels, the LFF significantly decreased 3 months postoperatively (P < 0.001). Significant positive correlations were detected between the C-NASH score and LFF levels (P < 0.001). Among the ROC curves for C-NASH score change, the AUC for the ROC curve of LFF was 0.812 (95% CI 0.707, 0.916) and the cut-off value was 6.16%. Weight at baseline was a significant predictive factor for postoperative changes when the C-NASH score was ≥ 3 (P < 0.001). The AUC for the ROC curve of weight was 0.897 (95% CI 0.782, 1.000) and 117 kg was the cut-off value. CONCLUSIONS: LFF decreased following bariatric surgery, which predicted C-NASH score changes after surgery. For patients with a higher risk of NASH (score ≥ 3) at baseline and lower preoperative body weight, we noted significantly greater effects of surgery on score change value.

3.
Pharm Biol ; 58(1): 124-130, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31967912

RESUMO

Context: Burn therapy (MEBT)/moist exposed burn ointment (MEBO) is an effective traditional Chinese medicine method to treat diabetic wound, but the mechanism is unclear. Autophagy has been proved to be closely related with wound healing, so MEBO/MEBT is hypothesized to promote diabetic wound healing by regulating autophagy.Objective: To explore the mechanism of moist exposed MEBT/MEBO promoting diabetic wound repair.Materials and methods: Eighty male Wistar rats were randomly assigned to control (n = 20) and diabetic group induced by intraperitoneal injection of STZ (n = 60), which were further randomly assigned to MEBO, Kangfuxin and model groups (n = 20 each). All rats underwent full-thickness skin resection in the back. Wound healing was dynamically observed and wound tissues were collected at five time points for pathological examination, autophagosome and the expression of PI3K, Akt and mTOR.Results: The healing time in the control group was the shortest, no statistically significant difference was found between the MEBO and the Kangfuxin group (p = 0.76). The morphology of autophagosomes ranged large to small, which was the most obvious in the MEBO group. The mRNA and protein expression of PI3K, Akt and mTOR in each group reached the peak on Day 5, the levels in the MEBO group were the highest (F = 18.43, 19.97, 15.36, p < 0.05). On Day 11, the expression levels in each group began to decline.Discussion and conclusions: In this study, we discussed the molecular mechanism of MEBT/MEBO promoting the repair of diabetic ulcer wounds through autophagy and PI3K-Akt-mTOR signalling pathway, which provides a new way for drug design in the future.

4.
Int J Clin Oncol ; 25(1): 175-186, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31473884

RESUMO

PURPOSE: To determine whether patients can avoid systematic prostate biopsy (PBx) if their Prostate Imaging Reporting and Data System version 2 (PI-RADs v2) score is ≤ 3 and how we clinicians make decisions that can maximize benefit. MATERIALS AND METHODS: We reviewed our prospectively maintained database of consecutive men who received transrectal ultrasound-guided 24-core biopsy as well as pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI). Of the 1276 men who were performed PBx in our institution from 2012 to July 2018, 491 patients conformed to the criteria. Negative predictive value (NPV) of negative mp-MRI (defined as PI-RADs < 3) combined prostate-specific antigen density (PSAD) were calculated. Models based on PI-RADs v2 were developed to predict the absence of clinically significant prostate cancer (CSPCa) and prostate cancer (PCa). Nomograms as well as receiver operating curves (ROC) were established to estimate the discrimination. Calibration curves were used to assess the concordance between predictive value and true risk. Decision curves were made to measure the overall net benefit. RESULTS: Prostate cancer and CSPCa detection rates were 21.6%, 7.3% and 36.7%, 23.4% in PIRADs v2 < 3 cohort and PIRADs v2 = 3 cohort, respectively. Men with biopsy-proved CSPCa had higher prostate-specific antigen (PSA), lower prostate volume (PV) and higher PSAD (all p < 0.05 in the two cohorts) than patients with clinically insignificant prostate cancer (CIPCa) or negative results. NPV of negative mp-MRI for detection of PCa was much higher when the PSAD was less than 0.15 (p < 0.001) and 0.2 for CSPCa (p = 0.007). According to multivariate analysis, we developed the model comprising Age, PSAD and PI-RADs v2 to predict the absence of CSPCa and PCa. The area under the curve (AUC) of the model for non-CSPCa was 0.75 (95% CI 0.68-0.80, PSAD cutoff 0.20), better than 0.71 (95% CI 0.65-0.80, PSAD cutoff 0.15). As for model for non-PCa, the AUC was 0.76 (95% CI 0.70-0.80, PSAD cutoff 0.15), higher than 0.71(95% CI 0.67-0.78, PSAD cutoff 0.20). Internally validated calibration curves showed that the model might overestimated the risk of the absence of CSPCa when the threshold was between 53 and 72%, and if the threshold was between 72 and 87%, it might underestimate the risk. As for the absence of PCa, the model might overestimate the risk between 52 and 76%. Decision curves showed that a better clinical net benefit was met when the threshold was 55% for non-PCa and 70% for non-CSPCa. CONCLUSIONS: NPV of negative mp-MRI for detection of CSPCa and PCa was improved with decreasing PSAD. The nomograms based on PI-RADs v2, age and PSAD showed internally validated high discrimination and calibration for the absence of PCa and CSPCa. When the predictive value was greater than 70% for the absence of CSPCa and 55% for the absence of PCa, we could avoid unnecessary PBx to maximize net benefit.

5.
Med Educ Online ; 24(1): 1679944, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31630670

RESUMO

Background: There is a strong need to include training of research methods in training programs for physicians. International clinical research training programs (CRTP) that comprehensively introduce the methodology of clinical research and combined with practice should be a priority. However, few studies have reported a multimodal international CRTP that provides clinicians with an introduction to the quantitative and methodological principles of clinical research. Objective: This manuscript is intended to comprehensively describe the development process and the structure of this multimodal training program. Methods: The CRTP was comprised of three distinct, sequential learning components: part 1 - a six-week online eLearning self-study; part 2 - a series of three weekly interactive synchronous webinars conducted between Durham, North Carolina, USA and Beijing, China; and part 3 - a five-day in-person workshop held at Beijing Friendship Hospital, Capital Medical University (BFH-CMU). Self-assessment quiz scores and participation rates were used to evaluate effectiveness of the training program. Participants' demographic characteristics, research experience, satisfaction and feedback on the program were collected using questionnaires. Results: A total of 50 participants joined the CRTP. Forty-four participants (88%) completed the program satisfaction questionnaires. The average quiz score of the six eLearning units varied from 31% to 73%. Among the three components of the program, the online eLearning self-study was felt to be the most challenging. Thirty-nine (89%) of the surveyed respondents were satisfied with all components of the training program. Among the respondents, 43 (98%) felt the training was helpful in preparing them for future clinical research projects and expressed willingness to recommend the program to other colleagues. Conclusions: We established a multimodal international collaborative training program. The program demonstrated acceptable participation rates and high satisfaction among Chinese clinicians. It provides a model that may be used by others developing similar international clinical research training programs for physicians.


Assuntos
Pesquisa Biomédica/organização & administração , Internacionalidade , China , Humanos , Internet , Aprendizagem , North Carolina , Avaliação de Programas e Projetos de Saúde , Inquéritos e Questionários
6.
Hepatol Int ; 13(6): 788-799, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31552558

RESUMO

AIMS: Epidemiological studies on primary biliary cholangitis (PBC) show heterogeneity. The aim of the present study was to synthesize the prevalence, incidence and clinical course of PBC in the Asia-Pacific region. METHODS: PubMed, Medline, Cochrane library and EMBASE were searched for epidemiology and clinical course of PBC published up to July, 2019. Meta-analysis was conducted on the epidemiology and clinical course (decompensation, hepatocellular carcinoma and death/liver transplantation) of PBC patients. Random-effect model and fixed-effect model were used to evaluate the pooled prevalence, incidence, mortality/liver transplantation and their 95% confidence intervals as appropriate. Subgroup analysis was performed by stratification with gender, pre- and post-UDCA era, sub-region and publication year. Meta-regression was used to examine the heterogeneity. RESULTS: Out of 3460 studies, 18 studies from 7 countries/regions were finally included. The overall prevalence of PBC was 118.75 cases per million (95% CI 49.96-187.55) in the Asia-Pacific region, with the high, medium and low prevalence being in Japan and China (191.18 cases per million), New Zealand (99.16 cases per million) and South Korea and Australia (39.09 cases per million), respectively. The incidence of PBC was 8.55 cases per million per year (95% CI 8.05-9.06). The 5-year accumulative incidence of decompensation, HCC and death/liver transplantation in PBC patients was 6.95% (95% CI 2.07-11.83%), 1.54% (95% CI 0.9-2.19%) and 4.02% (95% CI 2.49-5.54%), respectively. CONCLUSION: In the Asia-Pacific region, the prevalence and incidence of PBC are higher than once expected. PBC tends to be diagnosed at older age and has a relatively low incidence of HCC in this region.

7.
Acta Otolaryngol ; 139(10): 843-848, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31437058

RESUMO

Background: Stapedotomy has been proved to be one of the most efficient procedure to treat otosclerosis, various factors contribute to the diversity of the outcomes and controversial results exist from previous studies. Objectives: We evaluated clinical characteristics and outcomes of stapedotomy, as well as possible predictive factors of a successful outcome. Materials and methods: This retrospective study evaluated 58 ears from 48 patients with demographic data, plus short-term follow-up of hearing outcomes of 28 ears, and evaluated variables using univariate general linear regression analyses. Results: The average operation age was 41.54 years. A total of 87.5% (42/48) patients presented with bilateral otosclerosis. 39.66% (23/58) ears had CT finding before the surgery. Patients with persistent tinnitus accounted for 53.45% (31/58) and the average preoperative ABG of the 58 ears was 32.22 dB. We achieved good postoperative air-bone gaps (ABGs) overall but poor ABG closure at 4 kHz. No predictive factors were identified in the 28 ears that were followed up. Conclusions and significance: Delayed surgery may be attributable to insufficient recognition of otosclerosis. The fenestration size could be the reason for poor ABG closure at high frequency. However, more cases and longer follow-ups are required to confirm our findings.


Assuntos
Otosclerose/cirurgia , Cirurgia do Estribo , Adulto , Idoso , Limiar Auditivo , Feminino , Seguimentos , Audição , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
8.
Obes Surg ; 29(12): 3966-3977, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31468305

RESUMO

BACKGROUND: The concept of metabolic obesity phenotypes has been proposed, but its relevance to metabolic features is unclear. PURPOSE: To determine a new definition of metabolic obesity phenotype, investigate the characteristics of expressing clustered normal and abnormal metabolic parameters, and analyze factors associated with metabolic abnormalities. MATERIALS AND METHODS: Characteristics of 600 patients were analyzed. The definition of metabolic obesity phenotype includes elevated blood pressure, glucose, lipid, and uric acid levels and abnormal lipoprotein levels. Independent sample t test and a general linear model with repeated measures were applied to investigate the differences in metabolic parameters. RESULTS: A total of 108 (18.0%) participants were obese yet metabolically healthy, whereas 492 (82.0%) were obese and metabolically unhealthy. Body weight at baseline was significantly higher in metabolically unhealthy phenotype (P < 0.001). For non-phasic oral glucose tolerance test (OGTT) curve shape, 100% glucose, 100% C-peptide, and 95.8% insulin curves were found in the metabolically unhealthy group. Men had an increased risk for elevated lipid level than women (OR = 1.83, 1.21-2.77). Individuals with class II/III obesity had an increased risk for elevated blood pressure, glucose, and UA levels than did those with class I obesity (OR = 2.22, 1.43-3.44; OR = 1.73, 1.11-2.68; OR = 3.61, 2.29-5.69, respectively). CONCLUSIONS: Approximately one-fifth of individuals with obesity had a metabolically healthy phenotype, and nearly one-third of individuals with class III obesity had this phenotype. Non-phasic OGTT curve shape is a meaningful predictive factor of metabolically unhealthy phenotype before bariatric surgery. Male sex and class II/III obesity are risk factors associated with specific metabolic abnormalities.

9.
J Gastroenterol Hepatol ; 34(10): 1676-1684, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31146297

RESUMO

BACKGROUND AND AIM: Reported incidence and prevalence rates of autoimmune hepatitis (AIH) have been sparse and heterogeneous. The aim of this meta-analysis was to estimate the worldwide incidence and prevalence rates of AIH and reveal population difference. METHODS: Published articles on the epidemiology of AIH in PubMed, Embase, and Cochrane Library were systematically searched from inception to April 28, 2019. Two investigators independently reviewed these literatures and evaluated their quality. A random-effects model was used to pool the overall incidence and prevalence rates. The impact of population difference, gender, age, study period, study quality, diagnostic criteria, and study design was further analyzed with subgroup analysis and meta-regression. RESULTS: A total of 22 studies were included in the meta-analysis. The pooled worldwide annual incidence and prevalence of AIH were 1.37 (95% confidence interval [CI]: 0.95-1.80) and 17.44 (95% CI: 12.01-22.87) per 100 000 persons, respectively. Subgroup analysis showed that the pooled annual incidence for Asian, European, and American population was 1.31 (95% CI: 0.42-2.20), 1.37 (95% CI: 1.10-1.64), and 1.00 (95% CI: 0.44-1.56) per 100 000 persons, respectively; the pooled prevalence for Asian, European, and American population was 12.99 (95% CI: 2.05-23.92), 19.44 (95% CI: 15.63-23.24), and 22.80 (95% CI: -13.48 to 59.07) per 100 000 persons, respectively. In addition, higher incidence and prevalence rates were observed in women than men, and a higher prevalence rate was observed in elderly than young people. CONCLUSIONS: Autoimmune hepatitis is a rare disease, with a similar incidence worldwide and a higher prevalence in European and American than in Asian population.

10.
Hepatol Int ; 13(1): 91-101, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30443702

RESUMO

BACKGROUND AND AIMS: Non-invasive fibrosis assessment has been highly recommended in many liver diseases. However, comparative diagnostic accuracy of laboratory markers, ultrasound and magnetic resonance elastography (MRE) for fibrosis in autoimmune hepatitis (AIH) patients has not been established. METHODS: Medline, Embase and Cochrane Library were searched. Primary outcome was significant fibrosis (SF), advanced fibrosis (AF) and cirrhosis, defined as Metavir stage F ≥ 2, F ≥ 3 and F = 4 according to liver biopsy. Hierarchical summary receiver operating characteristic curve (ROC) model was used to evaluate diagnostic accuracy of non-invasive methods. Summary area under ROC (AUROC) and diagnostic odds ratio (DOR) with 95% confidence interval (CI) were calculated. The Grading of Recommendations Assessment, Development and Evaluation system was used to assess quality of evidence. RESULTS: Overall, 16 studies with 861 patients were included, comparing aspartate aminotransferase to platelet ratio index (APRI), fibrosis-4 index (FIB-4), aspartate aminotransferase/alanine aminotransferase ratio, transient elastography (TE), acoustic radiation force impulse, shear wave elastography and MRE versus liver biopsy. Among all non-invasive markers, TE had good performance for fibrosis staging. Summary AUROCs and DORs of TE were 0.90 (95% CI 0.87, 0.92) and 23.7, 0.91 (95% CI 0.89, 0.93) and 31.6, 0.89 (95% CI 0.86, 0.92) and 80.5 for staging SF, AF and cirrhosis, whereas APRI and FIB-4 showed poor performance for detecting AF (DOR, 4.6 and 4.7) and cirrhosis (DOR, 5.5 and 12.9). CONCLUSIONS: TE performs well to stage liver fibrosis in patients with AIH, compared with other laboratory non-invasive indexes. Nevertheless, diagnostic accuracy of APRI and FIB-4 is poor.


Assuntos
Técnicas de Imagem por Elasticidade/normas , Hepatite Autoimune/complicações , Cirrose Hepática/diagnóstico , Humanos , Cirrose Hepática/complicações , Curva ROC , Sensibilidade e Especificidade , Índice de Gravidade de Doença
11.
Obes Surg ; 29(2): 617-625, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30536019

RESUMO

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has become an increasingly popular metabolic surgical procedure. Alteration in motor gastric function is a fundamental feature following LSG but still remains controversial. PURPOSE: To determine the gastric emptying time 3 month after LSG, correlations between gastric emptying time and body weight, weight loss, and glycemia levels, alongside determining predictive factors of weight loss at the 3-month follow-up. MATERIALS AND METHODS: Twenty-one patients were recruited in this study. Gastric emptying time was measured using a standard solid-phase gastric emptying scan at both baseline and 3 months after LSG. Paired sample t tests and a general linear model with repeated measures were applied to investigate the alterations in major parameters after surgery. Univariate analyses were performed to evaluate the factors predicting weight loss at the 3-month follow-up. RESULTS: Compared with baseline levels, gastric emptying time, body weight, and HbA1c levels decreased significantly at 3 months after LSG (P < 0.001). Significant positive correlations were detected between HbA1c levels and gastric emptying time at baseline (P = 0.03). Significant positive correlations were detected between HbA1c levels at baseline and change in gastric emptying time (P = 0.03). Univariate logistic regression revealed a lower baseline BMI level to be independently associated with %EWL (P < 0.001). CONCLUSIONS: The rate of gastric emptying increased following LSG. Patients with a higher risk of type 2 diabetes at baseline had longer gastric emptying times prior to treatment and significantly shortened emptying times following surgery.


Assuntos
Gastrectomia , Esvaziamento Gástrico , Laparoscopia , Adulto , Índice de Massa Corporal , Feminino , Seguimentos , Hemoglobina A Glicada/análise , Humanos , Masculino , Estudos Retrospectivos , Fatores de Tempo
12.
World J Surg Oncol ; 16(1): 102, 2018 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-29859119

RESUMO

BACKGROUND: Our objective is to build a model based on Prostate Imaging Reporting and Data System version 2 (PI-RADs v2) and assess its accuracy by internal validation. METHODS: Patients who took prostate biopsy from 2014 to 2015 were retrospectively collected to compose training cohort according to the inclusion criteria and patients in 2016 composing validation cohort. Diagnostic performance was evaluated by analyzing the area under the curve (AUC), calibration curves, and decision curves. RESULTS: Of the 441 patients involved, the clinically significant prostate cancer (csPCa) detection rate were 40.6% (114/281) and 43.8% (70/160) in the training and validation cohort, respectively. Meanwhile, PCa detection rate were 50.2% (141/281) and 53.8% (86/160). Age, prostate-specific antigen density (PSAD)*10 and PI-RADs v2 score composed the model for PCa (model 1) and csPCa (model 2). The area under the curve of models 1 and 2 was 0.870 (95% CI 0.827-0.912) and 0.753 (95% CI 0.717-0.828) in the training cohort, while 0.845 (95% CI 0.786-0.904) and 0.834 (95% CI 0.787-0.882) in the validation cohort. Both models illustrated good calibration, and decision curve analyses showed good performance in predicting PCa or csPCa when the threshold was 0.35 or above. CONCLUSIONS: The model based on age, PSAD*10 and PI-RADs v2 score showed internally validated high predictive value for both PCa and csPCa. It could be used to improve the diagnostic performance of suspicious PCa.


Assuntos
Técnicas de Apoio para a Decisão , Imagem por Ressonância Magnética/métodos , Modelos Estatísticos , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/diagnóstico , Idoso , Área Sob a Curva , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Estudos Retrospectivos
13.
Zhonghua Wei Chang Wai Ke Za Zhi ; 21(4): 413-418, 2018.
Artigo em Chinês | MEDLINE | ID: mdl-29682712

RESUMO

OBJECTIVE: To assess the incidence and independent risk factors for clinical anastomotic leakage (AL) in patients undergoing anterior resection(AR) or low anterior resection, (LAR) for rectal cancer. METHODS: This was a retrospective case-control study of 550 patients with rectal cancer who underwent AR or LAR from April 2007 to March 2017 in Beijing Friendship Hospital, Capital Medical University. The relationship between the incidence of AL and clinicopathological manifestations was analyzed by Chi-squared test and Fisher exact test, and the independent risk factors of AL were analyzed using logistic regression analysis. AL is defined as a defect (including necrosis or abscess formation) of the intestinal wall at the anastomotic site, leading to a communication between the intra- and extra-luminal compartments. AL can be divided into three grades. Grade A anastomotic leakage results in no change in the management of patients, whereas grade B leakage requires active therapeutic intervention but is manageable without re-laparotomy. Grade C anastomotic leakage requires re-laparotomy. RESULTS: AL was noted in 32(5.8%) of 550 patients with rectal cancer who underwent AR or LAR, including 15(46.9%), 4(12.5%), and 13 patients (40.6%) with Grades A, B, and C, respectively. Five patients(0.9%, 5/550) died peri-operatively. AL- and non-AL-related deaths occurred in 3 (9.4%, 3/32, all cases were Grade C) and 2 patients(0.4%, 2/518), respectively, with the two mortality rates being significant difference(P=0.002). Chi-squared test or Fisher exact test showed that the incidence of AL was associated with neoadjuvant chemoradiotherapy (P=0.011), intraoperative bleeding(≥100 ml)(χ2=11.980, P=0.001), and tension-reducing suture of anastomosis(P=0.015). The results of logistic regression analysis showed that the independent risk factors of AL were neoadjuvant chemoradiotherapy(OR=2.402, 95%CI: 1.004-5.749, P=0.049), intraoperative bleeding(≥100 ml)(OR=2.971, 95%CI: 1.269-6.957, P=0.012) and tension-reducing suture of anastomosis(OR=2.304, 95%CI: 1.008-5.263, P=0.048). CONCLUSION: The incidence of AL in patients undergoing AR for rectal cancer is 5.8%. The high-risk factors for AL are neoadjuvant chemoradiotherapy, intraoperative bleeding (≥100 ml), and tension-reducing suture of anastomosis. Patients with these three risk factors have a high risk of AL rate, and a defunctioning stoma should be performed.


Assuntos
Anastomose Cirúrgica/efeitos adversos , Fístula Anastomótica/etiologia , Neoplasias Retais/cirurgia , Estudos de Casos e Controles , Humanos , Incidência , Estudos Retrospectivos , Fatores de Risco
14.
J Biopharm Stat ; 28(5): 840-856, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29182430

RESUMO

In recent years, multi-regional clinical trials (MRCT) that conduct clinical trials simultaneously in Asian Pacific region, Europe, and the United States have become very popular for global pharmaceutical development. The main purpose of multi-regional clinical trials is to shorten the time for pharmaceutical development and regulatory submission, and approval around the world. In practice, however, clinical results observed from some regions (sub-population) may not be consistent with the results from other regions and/or all regions combined (entire population). The inconsistency observed may be due to ethnic differences in different regions, differences in medical practice, time points of assessment, or by random chance due to small sample size for the region. Some regional regulatory agencies require consistency evaluation between local country results and overall results. However, the challenge is there is no detailed guidance on the definition of 'consistency' and methodology to evaluate it. Therefore, the questions are: how to evaluate consistency and what statistical methods are appropriate to be used for consistency evaluation? In this article, several statistical tests for consistency (similarity) between clinical results observed from a specific sub-population and the entire population are proposed. These methods are compared through extensive simulation. As most published articles discussed consistency evaluation for superiority situations, we have discussed consistency evaluation for non-inferiority situation in this article through a simulated example concerning consistency in some countries. Recommendations of the statistical methods to be used for consistency evaluation are given. Other aspects that should be considered for consistency evaluation are also provided.


Assuntos
Simulação por Computador/estatística & dados numéricos , Demografia/estatística & dados numéricos , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Vigilância da População , Demografia/métodos , Humanos , Estudos Multicêntricos como Assunto/métodos , Vigilância da População/métodos
15.
Int J Infect Dis ; 67: 58-64, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29138012

RESUMO

BACKGROUND: The numbers of articles reporting randomized controlled trials (RCTs) on viral hepatitis in China have been increasing, but there have been few systematic studies evaluating the reporting quality of RCTs in this field. This study was performed to assess the reporting quality of RCTs on the treatment of hepatitis B and C in China from 1991 to 2015. METHODS: Articles published between January 1991 and December 2015 were identified via the PubMed, MEDLINE, and Embase databases using the key words "randomized clinical trials", "treatment", "therapy", "hepatitis B", "HBV", "hepatitis C", "HCV", "China", and "Chinese". The reporting quality was assessed against the Consolidated Standards of Reporting Trials (CONSORT) checklist. RESULTS: In total, 211 RCTs on the treatment of hepatitis B or C were included. The number of articles focusing on these RCTs increased rapidly over time, while the reporting quality improved steadily over time. Overall, compliance with the key components of the CONSORT checklist was low, with only 8.5%, 3.8%, and 11.4% of the articles fulfilling the reporting requirements of randomization, allocation concealment, and blinding, respectively. CONCLUSIONS: Both the number and the quality of RCT articles were found to have increased steadily over the last two decades. However, compliance with the key components of the CONSORT checklist still needs improvement. It is hoped that the results of this study will lead to improvements in the reporting quality of clinical trials on hepatitis B and C in China.


Assuntos
Hepatite B , Hepatite C , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Lista de Checagem , China , Humanos
16.
J Immunol ; 198(3): 1210-1219, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-28011931

RESUMO

Adult T cell leukemia/lymphoma (ATL), a CD4+ T cell malignancy with a poor prognosis, is caused by human T cell leukemia virus type 1 (HTLV-1) infection. High proviral load (PVL) is a risk factor for the progression to ATL. We previously reported that some asymptomatic carriers had severely reduced functions of CTLs against HTLV-1 Tax, the major target Ag. Furthermore, the CTL responses tended to be inversely correlated with PVL, suggesting that weak HTLV-1-specific CTL responses may be involved in the elevation of PVL. Our previous animal studies indicated that oral HTLV-1 infection, the major route of infection, caused persistent infection with higher PVL in rats compared with other routes. In this study, we found that Tax-specific CD8+ T cells were present, but not functional, in orally infected rats as observed in some human asymptomatic carriers. Even in the infected rats with immune unresponsiveness against Tax, Tax-specific CTL epitope-pulsed dendritic cell (DC) therapy reduced the PVL and induced Tax-specific CD8+ T cells capable of proliferating and producing IFN-γ. Furthermore, we found that monocyte-derived DCs from most infected individuals still had the capacity to stimulate CMV-specific autologous CTLs in vitro, indicating that DC therapy may be applicable to most infected individuals. These data suggest that peptide-pulsed DC immunotherapy will be useful to induce functional HTLV-1-specific CTLs and decrease PVL in infected individuals with high PVL and impaired HTLV-1-specific CTL responses, thereby reducing the risk of the development of ATL.


Assuntos
Linfócitos T CD8-Positivos/imunologia , Células Dendríticas/imunologia , Produtos do Gene tax/imunologia , Infecções por HTLV-I/terapia , Tolerância Imunológica , Vacinação , Animais , Linhagem Celular , Feminino , Infecções por HTLV-I/imunologia , Infecções por HTLV-I/virologia , Humanos , Interferon gama/biossíntese , Provírus/isolamento & purificação , Ratos , Ratos Endogâmicos F344 , Carga Viral
17.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 39(3): 313-9, 2014 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-24748200

RESUMO

OBJECTIVE: To evaluate the effect of nutrition and food safety education among middle school students in a poverty-stricken county in west China, and to explore the better education model for further education. METHODS: Students of grade 7 to 9 were selected from 4 middle schools in the country through multi-stage cluster sampling for the questionnaire, and the schools were assigned into an intervention group or a control group. After students in the intervention schools completed one year nutrition and food safety education with the textbooks, students were chosen from the same 4 schools to finish the same questionnaire again. RESULTS: A total of 410 students from grade 7 to 9 were selected at the baseline study, and 474 students in the final study. The essential characteristics of the 2 groups were not statistically significant (P>0.05). In the baseline investigation, the differences in the scores on nutrition and food safety knowledge, attitude and practice between the 2 groups were not significant (P>0.05). In the final study, the scores on the knowledge, attitude of nutrition knowledge learning, and dietary habits among students in the intervention group were significantly higher than those in the control group (P<0.05). School-students mixed model demonstrated that the intervention was protective factor on scores of knowledge, in particular with nutrition related diseases and reasonable diet (P<0.05). But the intervention didn't affect the scores on attitude in both ways (P>0.05). CONCLUSION: Nutrition and food safety education can improve the nutrition and food safety knowledge effectively. The curriculum should be further standardized and different emphases should be set up to different grades to cultivate healthy diet behaviors.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Ciências da Nutrição/educação , Pobreza , China , Dieta , Inocuidade dos Alimentos , Educação em Saúde , Humanos , Instituições Acadêmicas , Estudantes , Inquéritos e Questionários
18.
Zhonghua Liu Xing Bing Xue Za Zhi ; 34(9): 879-83, 2013 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-24331962

RESUMO

OBJECTIVE: To evaluate the effectiveness of nutrition and food safety educational programs on primary students from grade 4 to 6 in impoverished areas of Western China, under a school-based cluster-randomized trial. METHODS: Twelve primary schools were selected from 2 impoverished counties in West China and assigned to intervention or control groups, randomly, with 6 schools in each group. Self-rating knowledge, attitude and practice questionnaires were used at both baseline and final stages. Textbooks and supportive materials were designed according to the characteristics of baseline data. All students in the intervention group were treated with targeted nutrition and food safety lectures of 0.5 hour per week for 2 semesters. Generalized linear mixed effects model was applied to fit the random effects on individual and clusters as well as to fit the fixed effect of the programs. RESULTS: Three hundred seventy-eight students from grade 4 to 6 were randomly selected at the baseline study and the differences of scores on knowledge, attitude and practice between the 2 groups were statistically insignificant (P > 0.05). No cluster was lost during the trial. In the final investigation, 478 students were randomly selected at the individual level. Scores on knowledge, attitude and practice among students in the intervention group were significantly higher, when comparing to the control group (P < 0.01). At the cluster level, more schools in the intervention group showed significant changes on knowledge and practice, yet the change in attitude was less obvious. Data from the mixed-effects model demonstrated that the program served as an influential factor on scores related to knowledge after the intervention(P = 0.015)but did not affect the scores on related attitude or practice (P > 0.05). CONCLUSION: Lectures seemed to have improved the cognition of nutrition and food safety among primary students from grade 4 to 6. However, long-term observation and larger sample size were needed to evaluate the changes on attitude and practice among the students.


Assuntos
Inocuidade dos Alimentos , Educação em Saúde , Necessidades Nutricionais , Adolescente , Criança , China , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Áreas de Pobreza , Autorrelato , Estudantes , Inquéritos e Questionários
19.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 38(9): 949-53, 2013 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-24071694

RESUMO

Green hospital construction is a new challenge for medical industry after global sustainable development strategy was put forward. The core connotation of green hospital includes green building, green healthcare, patient safety, and doctor-patient harmony. Many countries have established green building evaluation system to deal with energy crisis. Leadership in Energy and Environmental Design (LEED), Green Guide for Health Care (GGHC) in the U.S., and Evaluation System for Green Hospital Building (CSUS/GBC 2-2011) in China have guiding significance for the development of green hospitals in China. The evaluation system of green hospitals home and abroad still focuses on green building, and establishment of suitable synthesis evaluation system of green hospitals in China needs further research.


Assuntos
Química Verde , Hospitais , China , Assistência à Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Liderança
20.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 38(3): 301-6, 2013 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-23545826

RESUMO

OBJECTIVE: To evaluate the rationality and validity of weighted TOPSIS method and weighted RSR method to evaluate drug supervision and supply networks construction in rural areas of Hunan . METHODS: Data of drug network construction in rural Hunan in 2010 were used to establish a comprehensive evaluation model, and weighted TOPSIS and RSR method were applied to this model and the results of which were compared to that of synthetical scored method to examine the validity. RESULTS: A comprehensive evaluation model was established, comprising of 3 primary indices, 8 secondary indices and 56 tertiary ones. The result of weighted RSR method was highly correlated to that of synthetical scored method, yet the result of TOPSIS was less correlated to the formers. All correlations were significant (P<0.01). CONCLUSION: Both weighted RSR and TOPSIS are not perfect methods, but the application of the methods in drug network evaluation is scientific and effective.


Assuntos
Técnicas de Apoio para a Decisão , Honorários e Preços , Preparações Farmacêuticas/provisão & distribução , Preparações Farmacêuticas/normas , Serviços de Saúde Rural , China , Metodologias Computacionais , Modelos Teóricos
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