目的:了解正常妊娠妇女血清中常用肝功能指标测定结果及变化。方法:分别在早孕（孕10～14周）、中孕（孕20～24周）、晚孕（孕30～34周）及产后（产后12周）四个时期序贯性测定120例正常妊娠妇女血清谷丙转氨酶（ALT）、谷草转氨酶（AST）、γ谷氨酰转移酶（GGT）、乳酸脱氢酶（LDH）、总胆红素（TBIL）、直接胆红素（DBIL）、总蛋白（TP）、白蛋白（ALB）、前白蛋白（PA）的水平并进行比较。结果:ALT、AST在早、中、晚孕及产后各期相对于正常对照均升高（P＜0.01）；TBIL和DBIL在早、中、晚孕均降低（P＜0.01）；TP、ALB随孕期增加逐渐下降,产后回升,到产后12周上升到正常水平（早、中、晚孕P＜0.01,产后P＞0.05）；GGT在孕期中逐渐升高,于晚孕期达最高峰（P＜0.01）,产后稍有下降；LDH在孕早中期无明显变化（P＞0.05）,孕晚期上升,到产后12周仍呈一上升趋势（P＜0.01）；PA在孕早期低于正常对照（P＜0.01）,后随孕期上升,到中孕期后上升到正常（P＞0.05）。结论:本次实验观察到在妊娠期肝功指标ALT、AST、GGT、LDH升高,可能因为孕妇肝脏负荷增加、基础代谢和能量消耗增多、甾体激素水平增高引起。胆红素代谢指标及营养性指标TBIL、DBIL、TP、ALB、PA降低,可能是妊娠期血浆稀释引起。临床诊断妊娠合并肝功能损害时应考虑上述变化。
ObjectiveTo summarize the research progress of early allograft dysfunction (EAD) predictors after liver transplantation. MethodThe literatures about the studies of predictive predictors of EAD after liver transplantation in recent years were reviewed. ResultsThe EAD was closely related to the prognosis and long-term survival of patients. In recent years, there were some reports of serum uric acid, neutrophil and lymphocyte ratio, von Willebrand factor to protein C ratio, serum brain natriuretic peptide, cytokine, hyaluronic acid, soluble CD163, serum lipid, lactic acid, coagulation factor Ⅴ, serum phosphorus etc. new serum biomarkers for early detection and recognition the occurrence and development of the EAD after liver transplantation. It was possible to intervene EAD early and effectively after liver transplantation. Conclusions Early recognition and prevention of EAD after liver transplantation is particularly important. Although some new predictive indicators have been proposed to predict occurrence of EAD after liver transplantation, relevant studies are lesser and there are still many problems to be solved. Further studies will be conducted to verify clinical application value of these new indicators.
ObjectiveTo establish a systematic, scientific, and sensitive index system to provide a scientific basis for quality evaluation and comprehensive quality management of day surgery nursing.MethodsThe databases of Wanfang, China National Knowledge Infrastructure, CQVIP, PubMed, and Web of Science were searched. The retrieval time was from the establishment of the databases to 15th July, 2019. Based on the “structure-process-outcome” management model, Delphi method was used to conduct two rounds of expert consultation for nursing experts related to day surgery in five tertiary hospitals. The results of the consultation were sorted out and the consensus of experts was obtained, so as to determine the quality-sensitive indicators of day surgery nursing.ResultsA total of 20 nursing experts participated in the questionnaire survey. The final evaluation indicators determined by expert correspondence included 1 structural indicator, 9 process indicators, and 4 outcome indicators.ConclusionsThe construction of quality evaluation standard of day surgery nursing not only embodies the connotation of nursing management of day surgery, but also puts forward clear requirements and quality standards for specialized nursing management. It has high reliability, scientificity, and strong operability, which can effectively improve the quality of nursing management and service level of day surgery.
Objective To analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine (TCM) clinical efficacy evaluation of chronic heart failure (CHF). Methods To obtain data from the occurrence of surrogate endpoints and cardiogenic death of patients with CHF in 7 hospitals. The causal relationship between surrogate endpoints and cardiogenic mortality was inferred by the Bayesian network model, and the interaction among surrogate endpoints was analyzed by non-conditional logistic regression model. Results A total of 2 961 patients with CHF were included. The results of Bayesian network causal inference showed that cardiogenic mortality had a causal relationship with the surrogate endpoints including NYHA classification (P=0.46), amino-terminal pro-B-type natriuretic peptide (NT-proBNP) (P=0.24), left ventricular ejaculation fraction (LVEF) (P=0.19), and hemoglobin (HB) (P=0.11); non-conditional logistic regression analysis showed that NYHA classification had interaction with NT-proBNP, LVEF, and HB prior to and after adjusting confounders. Conclusions The substitution capability of surrogate endpoints for TCM clinical efficacy evaluation of CHF for cardiogenic mortality are NYHA classification, NT-proBNP, LVEF, and HB in turn, and there is a multiplicative interaction between the main surrogate endpoint NYHA classification and the secondary surrogate endpoints including NT-proBNP, LVEF, and HB, suggesting that when the two surrogate endpoints with interaction exist at the same time, it can enhance the substitution capability of surrogate endpoints for cardiogenic mortality.
ObjectiveTo analyze the risk factors for seizures in patients with autoimmune encephalitis (AE) and to assess their predictive value for seizures. MethodsSeventy-four patients with AE from the First Affiliated Hospital of Xinjiang Medical University from January 2016 to March 2023 were collected and divided into seizure group (56 cases) and non-seizure group (18 cases), comparing the general clinical information, laboratory tests and imaging examinations and other related data of the two groups. The risk factors for seizures in AE patients were analyzed by multifactorial logistic regression, and their predictive value was assessed by receiver operating characteristic (ROC) curves. ResultsThe seizure group had a higher proportion of acute onset conditions in the underlying demographics compared with the non-seizure group (P<0.05). Laboratory data showed statistically significant differences in neutrophil count, calcitoninogen, lactate dehydrogenase, C-reactive protein, homocysteine, and interleukin-6 compared between the two groups (all P<0.05). Multi-factor logistic regression analysis of the above differential indicators showed that increased C-reactive protein [Odds ratio (OR)=4.621, 95% CI (1.123, 19.011), P=0.034], high homocysteine [OR=12.309, 95CI (2.217, 68.340), P=0.004] and onset of disease [OR=4.918, 95% CI (1.254, 19.228), P=0.022] were risk factors for seizures in AE patients, and the area under the ROC curve for the combination of the three indicators to predict seizures in AE patients was 0.856 [95% CI (0.746, 0.966)], with a sensitivity of 73.2% and a specificity of 83.3%. ConclusionHigh C-reactive protein, high homocysteine and acute onset are independent risk factors for seizures in patients with AE, and the combination of the three indices can better predict seizure status in patients.
目的：了解正常妊娠妇女常用血常规指标的变化，建立其参考值范围。方法:分别在早孕（孕10～14周）、中孕（孕20～24周）、晚孕（孕30～34周）及产后（产后12周）四个时期序贯性测定120例正常妊娠妇女血常规指标:红细胞（RBC）、血红蛋白（HB）、红细胞压积（HCT）、血小板（PLT）、白细胞（WBC），并建立参考值范围。同期选取53例健康体检非孕者为对照。结果：RBC、HCT早、中、晚孕相对于正常对照均降低（Plt;0.01）。HB在孕期降低，中、晚孕降低较明显，相对于正常对照差异有统计学意义（Plt;0.01）。PLT早、中孕降低不明显（Pgt;0.05），到晚孕期相对于正常对照降低差异有统计学意义（Plt;0.05）。WBC在妊娠四期相对于正常对照均升高（Plt;0.01）。结论：血常规各项指标随孕期发展均产生不同程度的变化，从该序惯性研究中得出了正常妊娠妇女的5个血常规指标水平的参考值范围，该参考值范围可以用于评估正常妊娠妇女的孕期健康水平。
ObjectiveTo evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.MethodsMulti-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.ResultsA total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.ConclusionIn the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.
With the advancement of research on rare ocular diseases such as inherited retinal dystrophy (IRD) has advanced in recent years, especially breakthroughs in therapeutic approaches represented by cell and gene therapy, potential intervention strategies have emerged for these conditions. Establishing standardized endpoints and evaluation methods for visual function in patients with IRD has become crucial for assessing disease progression, safety, and therapeutic efficacy of innovative treatments. Best corrected visual acuity (BCVA) is widely recognized as one of the primary endpoints for assessing visual function. However, for IRD patients with severe rod photoreceptor dysfunction, who often present with profound low vision or even legal blindness, the applicability of BCVA as a traditional visual function indicator is limited. The multi-luminance mobility test (MLMT) has emerged as a functional visual assessment tool that evaluates the ability to navigate obstacle courses under varying illumination levels. By establishing graded evaluation standards, MLMT objectively quantifies the impact of lighting conditions on patients’ nobility and spatial orientation, providing a novel quantitative tool for assessing visual function in IRD clinical trials. Currently, there is a lack of unified and standardized guidelines for the use of MLMT in China, posing challenges to its implementation in practical clinical research. To address this, Ocular Fundus Disease Society of Chinese Medical Association and Chinese Medical Doctor Association convened a multidisciplinary team comprising clinical experts in genetic retinal diseases, statisticians, and optical specialists to investigate the current applications and technical characteristics of MLMT, ultimately formulating consensus recommendations for its use as a clinical trial endpoint for IRD gene therapies. This consensus aims to provide a set of MLMT operating norms applicable to China's national conditions, guide clinical practice and research in ophthalmology and related disciplines, and promote the standardization process of IRD clinical trials in China, so as to better serve the IRD patient population and promote the development of related fields.
Objective To identify genes associated with hepatocellular carcinoma (HCC) as candidate diagnostic markers in a genome-wide scale. Methods The gene expression profiles of 40 pairs of HCC tumor tissue and peripheral non-tumorous liver tissue were analyzed by using gene chip technology.The gene chips were fabricated at the National Cancer Institute (NCI). Each gene chip contained 9 180 genes. The fluorescent targets were prepared by a direct labeling approach using two kinds of fluorescences as following: 100 μg of total RNA from non-cancerous liver tissue was labeled with Cy3-dUTP and 200 μg of total RNA from HCC was labeled with Cy5-dUTP. The targets were mixed together and hybridized with genes on the gene chips. Unsupervised hierarchical clustering analysis was done by CLUSTER and TREEVIEW software using median centered correlation and complete linkage. Results A total of 10 genes were found up-regulated in over 80% of primary tumors comparing with that of their corresponding non-tumorous liver tissues at a two-fold filter with an unsupervised hierarchical clustering algorithm, including protocadherin-alpha 9, ESTs, Homo sapiens cDNA FLJ, KPNA2, RPS20, SNRPE, CDKN2A, UBD, MDK and ANXA2.Conclusion These genes are supposed to be candidates for the diagnosis of HCC. Further investigation of these genes in a large scale of patients with HCC and patients with non-malignant hepatic diseases will be needed to disclose whether they could be used clinically as novel diagnostic tumor markers for HCC.
ObjectiveTo explore the effect of continuous health data collection system on residents' heath management. MethodsFrom October 2012 to October 2013, 128 employees aged from 35 to 45 from a bank who volunteered to accept the health management were selected. They were to randomly divided into observation group and control group; the control group received routine outpatient management, while the health management group were observed with continuous data collection system (Zhengguangxing E Health System). We evaluate the changes in physiological indices of a healthy lifestyle one year later. ResultsOne year after administration, the poor lifestyle decreased in observation group obviously (smoking, drinking, poor diet and not take any exercise) compared with that in the control group (P<0.05). The relative health indicators including overweight, abnormal blood pressure, dyslipidemia, abnormal fasting blood-glucose, meliorated much more in observation group than that in the control group (P<0.05). ConclusionContinuous health data collection system for population health management is effective on health management.