Directrices para presentación de informes de ensayos clínicos sobre intervenciones con inteligencia artificial: extensión CONSORT-AI / Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension / Diretrizes para relatórios de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão CONSORT-AI

resumen está disponible en el texto completo

ABSTRACT The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

RESUMO A declaração CONSORT 2010 apresenta diretrizes mínimas para relatórios de ensaios clínicos randomizados. Seu uso generalizado tem sido fundamental para garantir a transparência na avaliação de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence) é uma nova diretriz para relatórios de ensaios clínicos que avaliam intervenções com um componente de IA. Ela foi desenvolvida em paralelo à sua declaração complementar para protocolos de ensaios clínicos, a SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 29 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão CONSORT-AI inclui 14 itens novos que, devido à sua importância para as intervenções de IA, devem ser informados rotineiramente juntamente com os itens básicos da CONSORT 2010. A CONSORT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA está inserida, considerações sobre o manuseio dos dados de entrada e saída da intervenção de IA, a interação humano-IA e uma análise dos casos de erro. A CONSORT-AI ajudará a promover a transparência e a integralidade nos relatórios de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente a qualidade do desenho do ensaio clínico e o risco de viés nos resultados relatados.

Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI / Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension / Diretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI

resumen está disponible en el texto completo

ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.

Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI / Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension / Diretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI

resumen está disponible en el texto completo

ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.

Relationship between different body composition and bone mineral density in Qinhuangdao city

SUMMARY OBJECTIVE: This study aimed to explore the correlation between different body components and bone mineral density in healthy adults. METHODS: A total of 306 non-manual subjects, 161 males and 145 females, were selected from the physical examination center of our hospital from June to September 2019. They were divided into control group, overweight group, and obese group according to body mass index. The muscle mass and fat mass, body fat content, trunk fat mass, upper limb and thigh fat mass, bone density of femoral neck and lumbar vertebra, and bone mineral salt content of the whole body were measured by dual-energy X-ray absorptiometry. RESULTS: Body mass index, systolic blood pressure, diastolic blood pressure, femoral neck bone mineral density, bone mineral salt content, fat mass, muscle mass, upper limb fat mass, thigh fat mass, and trunk fat mass in the overweight group and obese group were all higher than those in the control group (P<0.05). The fat mass, muscle mass, upper limb fat mass, and trunk fat mass were positively correlated with the femoral neck bone mineral density, total lumbar vertebra bone mineral density, and bone mineral salt content (P<0.05). In addition, thigh fat mass was positively correlated with femoral neck bone mineral density and total lumbar spine bone mineral density, whereas body fat content was negatively correlated with bone mineral salt content. CONCLUSION: Body composition was related to bone mineral density and bone mineral salt content, and the correlation between different body composition indexes, and bone mineral density, and bone mineral salt content was different.

Association between screen time and autistic behavior in infants and toddlers / 中国学校卫生

Objective@#To explore the association between screen time and autistic behavior in infants and young children, and to provide clues to the mechanism for further research.@*Methods@#The primary caregivers of 22 586 children in the district of Longhua in Shenzhen were surveyed. Demographic data and screen time were collected using a selfdisigned questionnaire, and children’s autistic behavior was assessed using the child Autism Behavior Checklist(ABC).The chisquare test was used to analyze the correlation between demographic data and screen time, demographic data and autistic behavior, and screen time and autistic behavior. Unconditioned Logistic regression model was used to study the effect of electronic screen exposure on autistic behavior.@*Results@#The amount of screen time spent in infancy increased with age. For children ages 0-,1- and 2-3 years, 60.1%, 35.0% and 20.2% respectively did not watch TV, and 74.0%, 52.6% and 26.8% respectively did not watch the new generation of electronic products. The positive rate of ABC scale screening was 5.3%, including 6.0% male and 4.4% female, OR(95%CI)=1.37 (1.23-1.54).There was correlations between screen time and autistic behavior in infants at all ages (P<0.05).Screen time increased the risk of autistic behavior in younger age groups than in older age groups. For 1 year olds with moderate screen exposure, increased screen exposure at 2 to 3 years of age was associated with an increased risk of autistic behaviors, while reduced screen exposure at 2 to 3 years of age was associated with a lower risk of autistic behaviors(OR=2.14, 2.77, P<0.05). The higher daily screen time at 0-3 years old was, the greater risk of autistic behaviors. Compared with the noncontact electronic screen group, the OR values of the daily TV screens in the ≥1 h/d group and the ＜1 h/d group were 2.01 and 2.45, respectively (P＜0.05).Compared with the non-contact electronic screen group, the OR values of the screens exposed to the new generation of electronic products in the ≥1 h/d group and the ＜1 h/d group were 2.01 and 2.33, respectively(P<0.05).The higher the time of single exposure to electronic screen between 0 and 3 years old, the greater the risk of autistic behaviors. The OR values were 2.50, 1.79 and 1.47 when ≥1 h/time, 0.5-1 h/time and 15-30 min/time compared with <15 min/time（P<0.05）. @*Conclusion@#Early exposure to electronic screens in infants, excessive total daily exposure to electronic screens, and excessive screen time each time are all likely to increase autistic behavior. Therefore, it is suggested that children under 2 years old should not be exposed to electronic screens every day. Children aged 2-3 years old who are exposed to electronic screens＜0.5 h/d and whose screen time <15 min might not significantly increase autistic behaviors.

Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018) / 中国结合医学杂志

Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.

Effects of Hypoxia on the Growth and Development of the Fetal Ovine Hepatocytes in Primary Culture / 生物医学与环境科学（英文）

OBJECTIVE@#To investigate the development and characterizations of the hepatocytes isolated from fetal ovine and to determine the effect of hypoxia on their growth and metabolism.@*METHODS@#Fresh hepatocytes were isolated from the liver of fetal ovine at late gestation, cultured in specific media, and exposed to normoxia (21% O2) or hypoxia (2% O2). The cellular characteristics and population purity were identified by immunocytochemistry and flow cytometry (FCM). The effects of hypoxia on cell cycle and apoptosis of the hepatocytes were evaluated by FCM, whereas the cellular ultrastructure changes were examined with a transmission electron microscope.@*RESULTS@#The cell purity of hepatocytes was over 95%. Under hypoxia exposure, the hepatocytes showed a gradual increase in proportion at the S phase and in proliferative index, followed with a compatible increase in apoptosis and progressively decreased cell viability. Additionally, the organelles of the hepatocytes demonstrated dramatic changes, including swelling of mitochondria, disorder in cristae arrangement, expansion of endoplasmic reticulum, and a large number of circular lipid droplets emerging in the cytoplasm.@*CONCLUSION@#Fetal ovine hepatocytes could be primarily cultured in a short-term culture system with a high purity of over 95% and with their preserved original characteristics. Hypoxia could induce changes in ultrastructural and inhibit the proliferation of cultured fetal ovine hepatocytes through apoptotic mechanisms.

The diagnosis of cancer therapeutics-related cardiac dysfunction / 医学研究生学报

Cardiac dysfunction is a common and severe side-effect after cancer therapy including thoracic radiation or cytotoxic agents. With the development of the cancer therapy method and the agents, the survival time of the patients has improved while most cancer patients could live with tumor or even be cured. The rate of cancer therapeutics-related cardiac dysfunction have obviously increased which seriously affect the time and life quality of patients with tumor. But there are no authoritative consensus criteria or guideline to diagnose CTRCD at present while it is difficult to identify CTRCD with primary heart disease. In this article，we summarized some diagnosis methods which could identify early CTRCD，and then we may give early drug intervention as soon as possible to reduce the incidence and remission rate of cardiovascular events.

Phosphoglycerate mutase 1 knockdown inhibits prostate cancer cell growth, migration, and invasion / 亚洲男科学杂志(英文版)

Phosphoglycerate mutase 1 (PGAM1) is upregulated in many cancer types and involved in cell proliferation, migration, invasion, and apoptosis. However, the relationship between PGAM1 and prostate cancer is poorly understood. The present study investigated the changes in PGAM1 expression in prostate cancer tissues compared with normal prostate tissues and examined the cellular function of PGAM1 and its relationship with clinicopathological variables. Immunohistochemistry and Western blotting revealed that PGAM1 expression was upregulated in prostate cancer tissues and cell lines. PGAM1 expression was associated with Gleason score (P = 0.01) and T-stage (P = 0.009). Knockdown of PGAM1 by siRNA in PC-3 and 22Rv1 prostate cancer cell lines inhibited cell proliferation, migration, and invasion and enhanced cancer cell apoptosis. In a nude mouse xenograft model, PGAM1 knockdown markedly suppressed tumor growth. Deletion of PGAM1 resulted in decreased expression of Bcl-2, enhanced expression of Bax, caspases-3 and inhibition of MMP-2 and MMP-9 expression. Our results indicate that PGAM1 may play an important role in prostate cancer progression and aggressiveness, and that it might be a valuable marker of poor prognosis and a potential therapeutic target for prostate cancer.

Relationship between expression of CD142 protein and the promoter methylation in the placenta in severe preeclampsia / 西安交通大学学报(医学版)

Objective To explore the relationship between expression of CD142 protein and the promoter methylation in the placenta of severe preeclampsia patients.Methods We assessed 24 patients complicated with severe preeclampsia as case group and 24 normal pregnant women as control group via qRT-PCR, immunohistochemistry and Western blotting for CD142 expression and MSP technology for methylation in CD142 promoter region.Results The relative expression quantity of CD142 mRNA in severe preeclampsia group (1.45± 0.42)was higher than that in normal group (0.25±0.28)(P <0.05).The expression quantity of CD142 protein in severe preeclampsia group (0.857±0.043)was higher than that in normal group (0.248 ±0.035)(P <0.05).The positive rate of CD142 promoter region methylation was lower in severe preeclampsia group than in normal group (29.2% vs .100.0%,χ2 =36.11,P <0.001)while the positive rate of CD142 promoter region unmethylation was higher than that in the latter group (100.0% vs .20.8%,χ2 =29.85,P <0.001).A negative correlation was found between the CD142 promoter methylation level and the expression quantity of CD142 protein (r = -0.909,P <0.05).Conclusion The expression of CD142 protein regulated by the promoter methylation plays a crucial role in the mechanism of severe preeclampsia.

Expression and its clinical significance of ERCC1 in stage Ⅱ colorectal carcinoma / 西安交通大学学报(医学版)

Objective To investigate the expression and clinical significance of excision repair cross complementing gene 1 (ERCC1 )in colorectal carcinoma of stage Ⅱ and its clinical significance.Methods We collected 56 cases of stage Ⅱ postoperative colorectal carcinoma tissue and detected ERCC1 expression with immunofluorescence technique.Statistical analysis was made with SPSS13.0 software.Results ERCC1 expression was obviously lower in stage II postoperative colorectal carcinoma tissue than in normal tissue (P =0.01).In cancer tissue,ERCC1 expression in patients with relapse or metastasis was significantly lower than in those without (P =0.002);ERCC1 expression in patients with T3 was significantly higher than those with T4 (P = 0.044).ERCC1 expression had a positive correlation with the overall survival (OS)and disease-free survival (DFS)(both P =0.000).In the group of high ERCC1 expression patients,five-year OS rate and DFS rate between patients who had received oxaliplatin-based adjuvant chemotherapy and those who did not have no significant difference (P =0.351;P =0.465).In the group of low ERCC1 expression patients,five-year OS rate and DFS rate of patients who received oxaliplatin-based adjuvant chemotherapy were significantly higher than those of patients who did not (P =0.015,P =0.02).ERCC1 (P =0.031 )and relapse or metastasis (P =0.009)were independent factors affecting OS;relapse or metastasis (P =0.000)was an independent factor affecting DFS.Conclusion ERCC1 is an independent factor affecting the OS of patients with stage Ⅱ colorectal carcinoma.Patients with low ERCC1 expression have poor prognosis,but they can benefit from oxaliplatin-based adjuvant chemotherapy.

Relationship between expression of CD142 protein and the promoter methylation in the placenta in severe preeclampsia / 西安交通大学学报(医学版)

Objective To explore the relationship between expression of CD142 protein and the promoter methylation in the placenta of severe preeclampsia patients.Methods We assessed 24 patients complicated with severe preeclampsia as case group and 24 normal pregnant women as control group via qRT-PCR, immunohistochemistry and Western blotting for CD142 expression and MSP technology for methylation in CD142 promoter region.Results The relative expression quantity of CD142 mRNA in severe preeclampsia group (1.45± 0.42)was higher than that in normal group (0.25±0.28)(P <0.05).The expression quantity of CD142 protein in severe preeclampsia group (0.857±0.043)was higher than that in normal group (0.248 ±0.035)(P <0.05).The positive rate of CD142 promoter region methylation was lower in severe preeclampsia group than in normal group (29.2% vs .100.0%,χ2 =36.11,P <0.001)while the positive rate of CD142 promoter region unmethylation was higher than that in the latter group (100.0% vs .20.8%,χ2 =29.85,P <0.001).A negative correlation was found between the CD142 promoter methylation level and the expression quantity of CD142 protein (r = -0.909,P <0.05).Conclusion The expression of CD142 protein regulated by the promoter methylation plays a crucial role in the mechanism of severe preeclampsia.

Expression and its clinical significance of ERCC1 in stage Ⅱ colorectal carcinoma / 西安交通大学学报(医学版)

Objective To investigate the expression and clinical significance of excision repair cross complementing gene 1 (ERCC1 )in colorectal carcinoma of stage Ⅱ and its clinical significance.Methods We collected 56 cases of stage Ⅱ postoperative colorectal carcinoma tissue and detected ERCC1 expression with immunofluorescence technique.Statistical analysis was made with SPSS13.0 software.Results ERCC1 expression was obviously lower in stage II postoperative colorectal carcinoma tissue than in normal tissue (P =0.01).In cancer tissue,ERCC1 expression in patients with relapse or metastasis was significantly lower than in those without (P =0.002);ERCC1 expression in patients with T3 was significantly higher than those with T4 (P = 0.044).ERCC1 expression had a positive correlation with the overall survival (OS)and disease-free survival (DFS)(both P =0.000).In the group of high ERCC1 expression patients,five-year OS rate and DFS rate between patients who had received oxaliplatin-based adjuvant chemotherapy and those who did not have no significant difference (P =0.351;P =0.465).In the group of low ERCC1 expression patients,five-year OS rate and DFS rate of patients who received oxaliplatin-based adjuvant chemotherapy were significantly higher than those of patients who did not (P =0.015,P =0.02).ERCC1 (P =0.031 )and relapse or metastasis (P =0.009)were independent factors affecting OS;relapse or metastasis (P =0.000)was an independent factor affecting DFS.Conclusion ERCC1 is an independent factor affecting the OS of patients with stage Ⅱ colorectal carcinoma.Patients with low ERCC1 expression have poor prognosis,but they can benefit from oxaliplatin-based adjuvant chemotherapy.

Updated evaluation and intervention of adolescent varicocele / 中华男科学杂志

Some physiological and ethical problems make it difficult to obtain semen samples from adolescents with varicocele (VC) and to directly evaluate their fertility. Therefore we can only rely on indirect methods to assess the influence of VC on the future fertility of the adolescent patients. Most of the VC adolescents may have normal semen parameters in the adulthood. Thus whether and when to intervene in adolescent VC remain a controversy in andrology. Physical examination is the most common method for screening adolescent VC and ultrasonography is very effective for its diagnosis and evaluation. Other important diagnostic indicators include the widely accepted testicular atrophy index, recently proposed peak retrograde venous flow, total testis volume, and scrotal temperature. Based on the latest literature, this review offers some proposals for the evaluation and intervention of adolescent VC.

Declaración SPIRIT 2013: definición de los elementos estándares del protocolo de un ensayo clínico / SPIRIT 2013 Statement: defining standard protocol items for clinical trials

El protocolo de un ensayo clínico es la base para planificar, ejecutar, publicar y evaluar el ensayo. Sin embargo, los protocolos y las guías que existen para su elaboración varían enormemente en cuanto a su calidad y contenido. En este artículo se describe la elaboración sistemática y el alcance de la Declaración SPIRIT 2013 (denominada así por la sigla en inglés de Standard Protocol items: Recommendations for Interventional Trials o Elementos estándares de un protocolo: recomendaciones para los ensayos de intervención), una guía en la que se establecen los contenidos mínimos que debe tener el protocolo de un ensayo clínico. La lista de comprobación de la declaración SPIRIT, que consta de 33 elementos, se aplica a los protocolos de todos los ensayos clínicos y se centra más en el contenido que en el formato. En esta lista se recomienda hacer una descripción completa de lo que se ha planificado, aunque no se establece cómo diseñar o ejecutar un ensayo. Al brindar orientación sobre los contenidos fundamentales, las recomendaciones SPIRIT procuran facilitar la redacción de protocolos de alta calidad. El cumplimiento de las recomendaciones SPIRIT debería mejorar la transparencia y la exhaustividad de los protocolos de los ensayos en beneficio de los investigadores, los participantes, los pacientes, los patrocinadores, los financiadores, los comités de ética de la investigación o las juntas de revisión institucionales, los revisores, las revistas biomédicas, los registros de ensayos, los formuladores de políticas, los organismos reguladores y otras partes interesadas clave.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Advances in inhibitors of MDM2 and MDM4 / 中国药科大学学报

@#The protein p53 plays an important role in the regulation of DNA repair, cell cycle arrest, apoptosis, senescence, autophagy and metabolism. MDM2 and MDM4 are the key negative regulatory proteins of p53. Inhibition of MDM2 and MDM4 has become a research hotspot in cancer therapy. Currently, seven MDM2 inhibitors(RG7112, MI-77301, RG7388, AMG232, CGM097, MK-8242, DS-3032b)and one MDM2/MDM4 dual inhibitor(ALRN-6924)have entered clinical trials. This paper highlights small molecule discovery, pharmacological activities and clinical research advances of MDM2 inhibitors in clinical trials, in addition, this review introduces research advances of MDM2/MDM4 dual inhibitors.

Androgen responses to resistance exercise / 中国组织工程研究

BACKGROUND:The androgen response to resistance exercise is one of hot topics in sports science research. At present, the androgen responses to resistance exercise show different results. There are different androgen changing trends under different resistance exercise interventions. OBJECTIVE:To have a deep insight into the influence of resistance exercise on the response of human body androgen, clarify research progress in androgen response to resistance exercise, and provide the basic theory for monitoring resistance training. METHODS:Literatures and paper reports about androgen response to resistance exercise are electronical y retrieved from the American Biological Medical Literature Database PubMed from 1986 and 2013. Final y 46 literatures addressing the research progress is analyzed about androgen responses to resistance exercise were included. RESULTS AND CONCLUSION:Studies have shown that, weight lifting (power snatch and power clean), squating, and deadlifting produced higher testosterone levels than the smal muscle groups. Under the same load, eccentric and concentric contractions produced the same hormone response. Adequate training amount and intensity may change the circulating testosterone levels. Short sports intermittent time led to a higher testosterone response than the long intermittent time. The free testosterone levels in youth group were significantly increased compared with the older group before and after exercise. Nutrition intervention affected acute testosterone responses to resistance exercise. Changes in exercise intensity and amount wil alter quiet testosterone levels, once returned to normal training, testosterone levels wil return to baseline values. Resistance exercise can increase androgen receptor content in human skeletal muscles.

Development and evaluation of a MAb-based ELISA for detection of Chlamydophila pneumoniae infection with variable domain 2 and 3 of the major outer membrane protein / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>This paper aims to develop a monoclonal antibodies (MAbs)- based ELISA for detecting Chlamydophila pneumoniae (C. pneumoniae) antigens in humans with the variable domains (VD) 2 and 3 of the major outer membrane protein (MOMPVD2-VD3) and to assess its sensitivity and specificity by comparing with a widely used MAb that is able to recognize the elementary bodies of C. pneumoniae.</p><p><b>METHODS</b>MOMPVD2-VD3 were overexpressed in Escherichia coli and purified by affinity chromatography. Mice were immunized with the recombinant antigen, and hybridomas secreting MAbs were screened. Three stable hybridomas clones were selected and named 5D6, 7G3, and 8C9. The MAbs-based ELISA was scrutinized for species-specific recognition with a number of human throat swab samples from Group I (156 patients with typical respiratory illness clinically confirmed before) and Group II (57 healthy donors).</p><p><b>RESULTS</b>In Group I, 55 positive cases were detected by anti-EB MAb-based ELISA, 51 cases were positive by MAbs 5D6-based ELISA, and 33 and 38 cases were positive by MAb 8C9 and 7G3-based ELISA respectively. Of the 57 samples from Group II "healthy donors", 5 were positive and 52 were negative with both anti-EB and 5D6-based tests, while 2 and 3 positive cases were identified by the other two MAb-based ELISAs respectively.</p><p><b>CONCLUSION</b>The novel MOMPVD2-VD3 MAb-based assay may have higher specificity than the anti-EB MAb, which may possibly be used as an alternative tool for the diagnosis of C. pneumoniae infection.</p>

Transportation function of calcium ion in sarcoplasmic reticulum of skeletal muscle in rat reduced training models after endurance training / 中国组织工程研究

BACKGROUND: Effect of exercise training on ultrastructure of skeletal muscle is a focus of quantified cytobiology in sports medicine. OBJECTIVE: To explore the changes of transportation function of calcium ion in sarcoplasmic reticulum of muscle in the model of reduced training after endurance training. DESIGN, TIME AND SETTING: The randomized animal trial was performed at Xi'an Sports Institute from April to July 2006, and the biochemical test was performed at the Animal Experimental Center of Xi'an Jiaotong University in July 2006. MATERIALS: Thirty-nine healthy 2-month-old male SD weighing (220?20) g were selected. METHODS: Five rats were used in the preliminary experiment, and the others were randomly divided to normal control group (n=8), endurance training group (n=8) and reduced training group (n=18). The increasing training period of endurance training group and reduced training group lasted for 6 weeks, and then reduced training group was randomly divided to 3 groups according to reduced training cycle: 2, 4 and 6 weeks group. The rats did increasing endurance loading exercise on a treadmill, while reduced intensity was used in reduced training group. MAIN OUTCOME MEASURES: Enzyme coupling method and fluorescence probe technology were used to detect sarcoplasmic reticulum Ca2+-ATPase (adenosine triphosphatase) and maximum Ca2+ uptake and release of gastrocnemius muscle. RESULTS: The activity of Ca2+-ATPase in endurance training group was significantly increased compared with normal control group (P 0.05); reduced training 4 and 6 weeks groups were significantly reduced compared with endurance training group (P 0.05); while the maximum uptake and release of Ca2+ in sarcoplasmic reticulum of reduced training 4 and 6 weeks group was significantly reduced (P