Preliminary study on the process and prognosis of 55 cases of esophageal stricture after circumferential endoscopic submucosal dissection / 中华消化杂志

Objective:To investigate the characteristics, process, and prognosis of esophageal stricture after circumferential endoscopic submucosal dissection (ESD), and to preliminarily analyze the prevention and treatment effects of simple dilation, stent placement, mucosal transplantation, and glucocorticoid (hereinafter referred to as hormone) application in esophageal stricture.Methods:From August 2017 to March 2022, at the First Affiliated Hospital of Zhengzhou University, the clinical and follow-up data of 55 patients who underwent circumferential ESD for early esophageal cancer and precancerous lesions were retrospectively analyzed. According to the prevention and treatment methods for esophageal stricture, the patients were divided into two groups: simple dilation group (23 cases) and combined dilation group (32 cases). The combined dilation group was divided into mucosal transplantation subgroup (9 cases), stent placement subgroup (14 cases), hormone application subgroup (7 cases), and bleomycin subgroup (2 cases, excluded from comparative analysis due to limited cases). Overall prognosis of patients was observed. Treatment efficacy, prognosis, and adverse events were compared among the simple dilation group, mucosal transplantation subgroup, stent placement subgroup, and hormone application subgroup. Independent samples t-test, chi-square test, and Fisher′s exact test were used for statistical analysis. Results:Among the 55 patients, the follow-up time was (894.1±417.7) days. Refractory esophageal stricture (total dilation times ≥ 5) occurred in 33 patients (60.0%). Fifty-two patients (94.5%) achieved clinical remission of the stricture. The total number of dilations was 5.8±4.0, and the average dysphagia-free period was (52.3±37.1) days. The dysphagia-free period of mucosal transplantation subgroup was longer than that of the simple dilation group, stent placement subgroup, and hormone application subgroup ((114.5±50.0) days vs. (40.9±20.0), (39.7±10.0), and (40.9±25.5) days, respectively), and the differences were statistically significant ( t=4.82, 3.77 and 3.14, P<0.001, =0.011, =0.009). There were no statistically significant differences between the simple dilation group and the mucosal transplantation subgroup, stent placement subgroup, and hormone application subgroup in the total number of dilations (6.8±4.8 vs. 3.0±2.5, 5.8±2.2, and 5.7±5.0), stricture remission rate (95.7%, 22/23 vs. 8/9, 13/14, and 7/7), and incidence of adverse events (17.4%, 4/23 vs. 5/9, 5/14, and 2/7; all P>0.05). Conclusions:Esophageal stricture formed after circumferential ESD shows the characteristics of recurrence and intractability. The over all number of dilations is high, and the average dysphagia-free period is short. Most patients can achieve clinical remission of the stricture after multiple times of endoscopic dilation treatment. However mucosal transplantation, stent placement, and hormone application cannot well intervene the natural process of esophageal stricture.

A metal ion orients mRNA to ensure accurate 2'-O ribosyl methylation of the first nucleotide of the SARS-CoV-2 genome

The SARS-CoV-2 nsp16/nsp10 enzyme complex modifies the 2-OH of the first transcribed nucleotide of the viral mRNA by covalently attaching a methyl group to it. The 2-O methylation of the first nucleotide converts the status of mRNA cap from Cap-0 to Cap-1, and thus, helps the virus evade immune surveillance in the host cell. Here, we report two structures of nsp16/nsp10 representing pre- and post-release states of the RNA product (Cap-1). We observe overall widening of the enzyme upon product formation, and an inward twisting motion in the substrate binding region upon product release. These conformational changes reset the enzyme for the next round of catalysis. The structures also identify a unique binding mode and the importance of a divalent metal ion for 2-O methylation. We also describe underlying structural basis for the perturbed enzymatic activity of a clinical variant of SARS-CoV-2, and a previous SARS-CoV outbreak strain.

Impact of inflammatory reaction levels and culprit plaque characteristics on preprocedural thrombolysis in myocardial infarction flow grade in patients with ST-segment elevation myocardial infarction / 中华心血管病杂志

Objective: To determine the impact of inflammatory reaction levels and the culprit plaque characteristics on preprocedural Thrombolysis in Myocardial Infarction (TIMI) flow grade in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Methods: The is a retrospective study. A total of 1 268 STEMI patients who underwent pre-intervention optical coherence tomography (OCT) examination of culprit lesion during emergency PCI were divided into 2 groups by preprocedural TIMI flow grade (TIMI 0-1 group (n =964, 76.0%) and TIMI 2-3 group (n =304, 24.0%)). Baseline clinical data of the 2 groups were collected; blood samples were collected for the detection of inflammatory markers such as high sensitivity C-reactive protein (hsCRP), myocardial injury marker, blood lipid, etc.; echocardiography was used to determine left ventricular ejection fraction; coronary angiography and OCT were performed to define the lesion length, diameter stenosis degree of the infarct-related arteries, presence or absence of complex lesions, culprit lesion type, area stenosis degree and vulnerability of culprit plaques. Multivariable logistic regression analysis was performed to identify independent correlation factors. The receiver operating characteristic (ROC) curve of continuous independent correlation factors was analyzed, and the best cut-off value of TIMI 0-1 was respectively determined according to the maximum value of Youden index. Results: The mean age of 1 268 STEMI patients were (57.6±11.4) years old and 923 cases were males (72.8%). Compared with TIMI 2-3 group, the patients in TIMI 0-1 group were older and had higher N-terminal-pro-B-type natriuretic peptide level, lower cardiac troponin I (cTnI) level, lower left ventricular ejection fraction, and higher hsCRP level (5.16(2.06, 11.78) mg/L vs. 3.73(1.51, 10.46) mg/L). Moreover, the hsCRP level of patients in TIMI 0-1 group was higher in the plaque rupture subgroup (all P<0.05). Coronary angiography results showed that compared with TIMI 2-3 group, the proportion of right coronary artery (RCA) as the infarct-related artery was higher, the angiographical lesion length was longer, minimal lumen diameter was smaller, and diameter stenosis was larger in TIMI 0-1 group (all P<0.05). The prevalence of plaque rupture was higher (75.8% vs. 61.2%) in TIMI 0-1 group. Plaque vulnerability was significantly higher in TIMI 0-1 group than that in TIMI 2-3 group with larger mean lipid arc (241.27°±46.78° vs. 228.30°±46.32°), more thin-cap fibroatheroma (TCFA, 72.4% vs. 57.9%), more frequent appearance of macrophage accumulation (84.4% vs. 70.7%) and cholesterol crystals (39.1% vs. 25.7%). Minimal flow area was smaller [1.3(1.1-1.7)mm2 vs. 1.4(1.1-1.9)mm2, all P<0.05] and flow area stenosis was higher (78.2%±10.6% vs. 76.3%±12.3%) in TIMI 0-1 group. Multivariable analysis showed that mean lipid arc>255.55°, cholesterol crystals, angiographical lesion length>16.14 mm, and hsCRP>3.29 mg/L were the independent correlation factors of reduced preprocedural TIMI flow grade in STEMI patients. Conclusions: Plaque vulnerability and inflammation are closely related to reduced preprocedural TIMI flow grade in STEMI patients.

A single intranasal or intramuscular immunization with chimpanzee adenovirus vectored SARS-CoV-2 vaccine protects against pneumonia in hamsters.

The development of an effective vaccine against SARS-CoV-2, the etiologic agent of COVID-19, is a global priority. Here, we compared the protective capacity of intranasal and intramuscular delivery of a chimpanzee adenovirus-vectored vaccine encoding a pre-fusion stabilized spike protein (ChAd-SARS-CoV-2-S) in Golden Syrian hamsters. While immunization with ChAd-SARS-CoV-2-S induced robust spike protein specific antibodies capable or neutralizing the virus, antibody levels in serum were higher in hamsters immunized by an intranasal compared to intramuscular route. Accordingly, ChAd-SARS-CoV-2-S immunized hamsters were protected against a challenge with a high dose of SARS-CoV-2. After challenge, ChAd-SARS-CoV-2-S-immunized hamsters had less weight loss and showed reductions in viral RNA and infectious virus titer in both nasal swabs and lungs, and reduced pathology and inflammatory gene expression in the lungs, compared to ChAd-Control immunized hamsters. Intranasal immunization with ChAd-SARS-CoV-2-S provided superior protection against SARS-CoV-2 infection and inflammation in the upper respiratory tract. These findings support intranasal administration of the ChAd-SARS-CoV-2-S candidate vaccine to prevent SARS-CoV-2 infection, disease, and possibly transmission.

SARS-CoV-2 infection severity is linked to superior humoral immunity against the spike

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently causing a global pandemic. The antigen specificity and kinetics of the antibody response mounted against this novel virus are not understood in detail. Here, we report that subjects with a more severe SARS-CoV-2 infection exhibit a larger antibody response against the spike and nucleocapsid protein and epitope spreading to subdominant viral antigens, such as open reading frame 8 and non-structural proteins. Subjects with a greater antibody response mounted a larger memory B cell response against the spike, but not the nucleocapsid protein. Additionally, we revealed that antibodies against the spike are still capable of binding the D614G spike mutant and cross-react with the SARS-CoV-1 receptor binding domain. Together, this study reveals that subjects with a more severe SARS-CoV-2 infection exhibit a greater overall antibody response to the spike and nucleocapsid protein and a larger memory B cell response against the spike.

Association of a SIRT1 polymorphism with changes of gray matter volume in patients with first-episode medication-naïve major depression.

A single nucleotide polymorphism (SNP) rs12415800 of the silent mating type information regulation 2 homolog 1 gene (SIRT1) has shown a genome-wide significant association with major depression disorder (MDD) in a recent GWAS using a large sample. Subsequent studies of SIRT1's biological functions were supportive of a possible role in the pathophysiology of MDD. However, SIRT1-mediated physiopathology of MDD may be brain region specific. In the present study, we investigated the impact of SIRT1 rs12415800 genotypes on gray matter volumes (GMV) among different brain regions in both MDD patients and healthy controls. The rs12415800 was genotyped in 170 patients with first-episode medication-naïve MDD (cases) and 170 healthy controls. Magnetic resonance imaging was conducted and the voxel-based morphometry (VBM) approach was employed to analyze obtained images. When compared with the cases carrying GG genotype, the cases carrying GA or AA genotypes (A for risk allele) showed decreased GMV in right precuneus, left cuneus/precuneus, and right frontal superior. In contrast, the rs12415800-associated GMV abnormalities were not observed in controls. The SIRT1-rs12415800 polymorphism may be associated with the changes of GMV in MDD patients.

Structural Basis of RNA Cap Modification by SARS-CoV-2 Coronavirus

The novel severe acute respiratory syndrome coronoavirus-2 (SARS-CoV-2), the causative agent of COVID-19 illness, has caused over 2 million infections worldwide in four months. In SARS coronaviruses, the non-structural protein 16 (nsp16) methylates the 5-end of virally encoded mRNAs to mimic cellular mRNAs, thus protecting the virus from host innate immune restriction. We report here the high-resolution structure of a ternary complex of full-length nsp16 and nsp10 of SARS-CoV-2 in the presence of cognate RNA substrate and a methyl donor, S-adenosyl methionine. The nsp16/nsp10 heterodimer was captured in the act of 2-O methylation of the ribose sugar of the first nucleotide of SARS-CoV-2 mRNA. We reveal large conformational changes associated with substrate binding as the enzyme transitions from a binary to a ternary state. This structure provides new mechanistic insights into the 2-O methylation of the viral mRNA cap. We also discovered a distantly located ligand-binding site unique to SARS-CoV-2 that may serve as an alternative target site for antiviral development.

Correlation between heart rate variability and exercise ability in patients with cardiac syndrome X / 中国实用内科杂志

OBJECTIVE: To investigate whether heart rate variability(HRV) can assess exercise ability in patients with cardiac syndrome X(CSX). METHODS: A total of 246 subjects(55.2 ± 12.2 years, 68.3% male), who were diagnosed with CSX by the positive exercise stress test and normal coronary angiogram in Cardiovascular Department of the Second Affiliated Hospital of Harbin Medical University from March 2016 to August 2017 were enrolled. The 24-hour dynamic ECG monitoring was used to analyze HRV for long-time frequency domain analysis. The HRV power spectrum index included total power(TP),very low frequency(VLF), low frequency(LF) and high frequency(HF). RESULTS: VLF, LF and TP, but not LF/HF, were higher in the patients with good exercise capacity(≥90% of the age predicted maximal heart rate). After accounting for age, sex, systolic blood pressure and heart rate, VLF, LF and TP remained significantly associated with good exercise capacity. In addition, increased VLF, LF and TP were also associated with increased exercise duration, rate-pressure product, and heart rate recovery. In subgroup analysis, VLF, LF and TP demonstrated similar predictive values related to exercise capacity across various subpopulations, especially in the young. CONCLUSION: In patients with CSX, HRV is independently associated with exercise capacity, and is an independent predictor of ischemic tolerance in CSX patients, which can be used as an important index for evaluating the exercise ability of CSX patients.

Ginsenoside Rb1 Ameliorates Autophagy of Hypoxia Cardiomyocytes from Neonatal Rats via AMP-Activated Protein Kinase Pathway / 中国结合医学杂志

OBJECTIVE@#To investigate whether ginsenoside-Rb1 (Gs-Rb1) improves the CoCl-induced autophagy of cardiomyocytes via upregulation of adenosine 5'-monophosphate-activated protein kinase (AMPK) pathway.@*METHODS@#Ventricles from 1- to 3-day-old Wistar rats were sequentially digested, separated and incubated in Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum for 3 days followed by synchronization. Neonatal rat cardiomyocytes were randomly divided into 7 groups: control group (normal level oxygen), hypoxia group (500 μmol/L CoCl), Gs-Rb1 group (200 μmol/L Gs-Rb1 + 500 μmol/L CoCl), Ara A group (500 μmol/L Ara A + 500 μmol/L CoCl), Ara A+ Gs-Rb1 group (500 μmol/L Ara A + 200 μmol/L Gs-Rb1 + 500 μmol/L CoCl), AICAR group [1 mmol/L 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR) + 500 μmol/L CoCl], and AICAR+Gs-Rb1 group (1 mmol/L AICAR + 200 μmol/L Gs-Rb1 + 500 μmol/L CoCl). Cells were treated for 12 h and cell viability was determined by methylthiazolyldiphenyl-tetrazolium bromide (MTT) assay and cardiac troponin I (cTnI) levels were detected by enzyme-linked immunosorbent assay (ELISA). AMPK activity was assessed by 2',7'-dichlorofluorescein diacetate (DCFH-DA) ELISA assay. The protein expressions of Atg4B, Atg5, Atg6, Atg7, microtubule-associated protein 1A/1B-light chain 3 (LC3), P62, and active-cathepsin B were measured by Western blot.@*RESULTS@#Gs-Rb1 significantly improved the cell viability of hypoxia cardiomyocytes (P0.05). Gs-Rb1 significantly down-regulated P62 levels of hypoxic cardiomyocytes (P<0.05). The P62 levels of hypoxic cardiomyocytes were inhibited by Ara A (P<0.05) and were not affected by AICAR (P=0.871).@*CONCLUSION@#Gs-Rb1 may improve the viability of hypoxia cardiomyocytes by ameliorating cell autophagy via the upregulation of AMPK pathway.

Pharmacokinetics of α-asarone after intranasal and intravenous administration with PLA-α-asarone nanoparticles / 中国中药杂志

PLA-α-asarone nanoparticles were prepared by using organic solvent evaporation method, and their in vivo distribution and brain targeting after intranasal administration were studied as compared with intravenous administration. The results showed that brain targeting coefficient of PLA-α-asarone nanoparticles after intranasal and intravenous administration was 1.65 and 1.16 respectively. The absolute bioavailability, brain-targeting efficiency and the percentage of nasal-brain delivery of PLA-α-asarone nanoparticles were 74.2%, 142.24 and 29.83%, respectively after intranasal administration. The results of fluorescence labeling showed that the fluorescent intensity of coumarin-6 in the brain tissue was the highest after intranasal administration of PLA-α-asarone fluorescent nanoparticles, achieving the purpose of brain-targeted drug delivery. The fluorescent intensity of coumarin-6 in liver tissue after intravenous administration of PLA-α-asarone nanoparticles was much higher than that after intranasal administration, indicating that intranasal administration of PLA-α-asarone nanoparticles could decrease drug-induced hepatotoxicity. In addition, the fluorescent intensity of coumarin-6 in lung tissue was weaker after intranasal administration, which solved the shortcomings of intranasal administration of α-asarone dry powder prepared by airflow pulverization method. In vivo studies indicated that PLA-α-asarone nanoparticles after intranasal administration had a stronger brain targeting as compared with intravenous administration.

Clinical significance of the combined detection of 3 serum markers in early diagnosis of ovarian cancer / 国际检验医学杂志

Objective To explore the best cut-off value of serum human epididymis protein 4(HE4)in the diagnosis of ovarian cancer,and analyze the clinical significance of combined detection of HE4,carbohydrate antigen 125 (CA125)and D-dimer for early screening and diagnosis of ovarian cancer.Methods A total of 49 patients with ovarian cancer,63 patients with benign tumor and 47 healthy women were collected.The content of CA125,HE4 and D-dimer were detected by chemical luminescence immunoassay and turbidimetric inhibition immunoassay,respectively.Results The new cut-off value of HE4 was 54.31 pmol/L.The serum levels of HE4,CA125 and D-dimer in the ovarian cancer group were all significant higher than those in the ovarian benign tumor group and the healthy group(P＜0.05).No significant difference between the healthy group and benign disease group was found in CA125 and D-dimer content(P=0.293,0.359),while a significant difference in HE4 level(P＜0.01).The sensitivity and specificity of combined detection of the HE4+CA125 increased to 91.8％,85.4％,which was higher than that of the diagnosis detection of the three indicators respectively.The sensitivity and specificity of combined detection of the HE4 +CA125 +D-dimer were 95.0％,76.5％,which was higher than the combined detection of the HE4+CA125.Conclusion The combined detection of CA125+HE4+D-dimer could improve the sensitivity for early diagnosis and screening of ovarian cancer.

Association study on serum protein factors and cognitive function in first-episode schizophrenia characterized by positive and negative symptoms / 中华行为医学与脑科学杂志

ObjectiveTo investigate the relationship between the serum concentration of IL-6,S100β,NT-3 and the cognitive functions in first-episode schizophrenia characterized by positive or negative symptoms.Methods44 first-episode schizophrenic patients characterized by positive symptoms (positive group),36 first-episode schizophrenic patients characterized by negative symptoms (negative group) and 50 healthy controls (controls) were collected.The serum levels of IL-6,S100β and NT-3 were measured by enzyme-linked immunosorbent assay (ELISA).The systematic evaluation tool-MCCB was applied to assess cognitive function in patients and controls.ResultsNT-3 serum levels in positive or negative groups were lower than those in controls and the differences were significant((118.39±37.50) ng/L,(112.55±32.29) ng/L vs (141.18±29.67) ng/L) (P<0.01).IL-6 and S100β serum levels in positive or negative groups were higher than those in controls and the differences were statistically significant((5.74±1.00)ng/L,(5.07±1.17)ng/L vs (4.23±0.91)ng/L),((132.98±46.71)ng/L,(124.99±43.14)ng/L vs (103.63±31.57)ng/L)(P<0.01).IL-6 serum levels in the positive group ((5.07±1.17)ng/L) were lower than those in the negative group ((5.74±0.99)ng/L) and the difference was statistically significant (P<0.05).In MCCB test,the TMT scores in patients characterize by positive symptoms or patients characterize by negative symptoms were higher than those in healthy control group (P<0.01).BACS SC,HVLT-R WMS-Ⅲ,SS,NAB,BVMT-R,CF in patients characterize by positive symptoms or by negative symptoms were lower than those in healthy control group(P<0.01).There were no statistical difference in the MCCB scores between the patients with positive symptoms and negative symptoms.In positive group,there was a positive correlation between the IL-6 serum concentration and the general symptom scores in PANSS (P<0.05).In positive group,NT-3 serum concentration was positively correlated with the general symptom scores or total scores of PANSS (P<0.05).BVMT-R scores in MCCB were also positively correlated with IL-6 or NT-3 serum concentration in positive group (P<0.05).ConclusionThe impairment of part of cognitive functions for schizophrenic patients may be related to the serum protein factors.There may be different in pathophysiology between the first-episode schizophrenic patients characterized by positive symptoms and those characterized by negative symptoms.

Multi-level analysis of oral health and its influencing factors in 12-year-old children in Chongqing / 第二军医大学学报

Objective To understand the status of oral health and its influencing factors among 12-year-old children in Chongqing, so as to provide evidence for setting up the intervention policy of oral health for children. Methods The data obtained from “the assessment on the comprehensive intervention effect for oral health among children in Chongqing” in 2015 were used in the present study; multi-level logistic regression model was used to analyze the status of oral health and its influencing factors among children in Chongqing. Results The prevalence of dental caries among 12-year-old children was 45. 5% (922/2 025) in Chongqing, and the status of oral health was clustered at school level (Ωu=0. 412, P=0. 091, α=0. 1). Multi-level logistic regression analysis indicated that the gender, sugar or chocolate intake once a week and above, and “whether children recognizing that oral health is very important for their life” were the individual variables affecting the dental caries incidence in 12-year-old children, and the difference between urban and rural schools was its background variable (P<0. 05, α=0. 05). Conclusion The gender, cognition to oral health, behavioral habit and the difference between urban and rural schools where children study are important factors influencing the oral health of 12-year-old children in Chongqing, and pertinent measures should be taken to improve the oral health among children.

Application of the Integrated Teaching Method of PBL and TBL Based on Cases in Pharmacology Teaching / 昆明医科大学学报

Objective To explore the apphcation of the integrated teaching method of PBL and TBL based on cases in pharmacology teaching.Method Ninety-two students majored in Pharmaceutical Preparations were selected into the control group,and 184 students majored in pharmacy were enrolled into the experimental group.The teaching effect was comprehensively evaluated by using the combination of theoretical examination and student feedback.Results In the experimental group,the average score of students in Pharmacology (73.68 ± 9.40) was significantly higher than that of the control group (67.34 ± 7.18),and the feedback of the students in the experimental group was significantly better than that in the control group.Conclusion Compared with the traditional teaching method,the integrated teaching method can significantly improve the students' theoretical examination results and students' learning interest.

The comparative analysis of survival rate and etoposide plus cisplatin treatment outcome in small-cell lung cancer patients with different hyponatremia / 重庆医学

Objective to investigate the outcome and EP treatment outcome of small‐cell lung cancer (SCLC) patients with different hyponatraemia .Methods This retrospective study analyzed the relationship between the serum sodium ,serum osmolality , urine sodium ,urine osmolality and survival time of 51 patients .Moreover ,we analyzed the survival time and chemotherapy outcome of SCLC patients in hypovolaemic and euvolaemic hyponatraemia .Results The data indicated that the serum sodium and osmolality correlated with the survival time positively ,and the pearson correlation coefficient are 0 .48 [95% CI:(0 .23 to 0 .67)]and 0 .61 [95% CI:(0 .40 to 0 .76)] ,respectively .urine sodium and osmolality correlated with survival time negatively ,and the pearson corre‐lation coefficient are -0 .6 [95% CI:(-0 .75 to -0 .38)] and‐0 .31 [95% CI:(-0 .54 to -0 .04)] ,respectively .Etoposide plus cisplatin treatment showed less effectiveness to the SCLC patients in euvolaemic hyponatraemia (29 .17% VS .66 .7% ,P<0 .05) , and the survival time of SCLC patients in euvolaemic hyponatraemia is shorter (33 .3% VS .92 .6% ,P<0 .05) .Conclusion Euvol‐aemic hyponatraemia could be a risk factor for poor outcome in SCLC .

Analysis on correlation between dietary fatty acid intake of pregnant women and neonateal anthropometry at birth / 临床儿科杂志

Objectives To investigate the correlation between dietary fatty acids intake of pregnant women and neonatal anthropometry at birth. Methods Women in early pregnancy were recruited with appropriate value of weight gain in pregnancy. Instant photography was used to assess the dietary situation in both the second trimester and the third trimester to calculate the intakes of food, energy, macronutrients, and fatty acids. The body weight, height and BMI at birth were evaluated with Z scores. The correlation between dietary fatty acids of pregnant women and neonatal anthropometry at birth were analyzed. Results There were 516 pregnant women recruited in this study. The average intakes of polyunsaturated fatty acids (PUFA) and the proportion of total fatty acids in the two trimesters were 15 . 09 g/d, 23 . 93% and 17 . 18 g/d, 24 . 86%. In the second trimester the intakes of n-6 and n-3 PUFA were 14 . 23 g/d and 3 . 45 g/d, and in the third trimester, n-6 and n-3 PUFA were 16 . 08 g/d and 3 . 81 g/d, the average intakes in the third trimester were signiifcantly higher than those in the second trimester (P??0 . 05 ). The intake of DHA ( 64 . 43 mg/d) in the second trimester was lower than that in the third trimester 75 . 12 mg/d, (P??0 . 05 ).The dietary intakes of n-3 PUFA, n-6 PUFA and n-6/n-3 ratio in the second trimester were positively correlated with neonatal BMI r=0 . 142~0 . 189 , P??0 . 05 ). Conclusions The dietary ratio of n-6/n-3 PUFA in the second trimester was positively correlated with neonatal BMI, suggesting that moderately increasing the intake of n-3 PUFA may play a positive role in reducing childhood obesity.

Global views on clinical trials and data quality / 药学学报

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.

Clinical trial data validation and user acceptance testing / 药学学报

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.

Key issues on the clinical trial data management / 药学学报

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.

Key issues on the clinical trial data management / 药学学报

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.