Clinical data management,a critical part of clinical trials,plays a decisive role in assuring the accuracy and reliability of the trail results.This article discusses the quality standards of clinical data,introduces the important rules and principles for standardized clinical data management,and reviews the development and current status of clinical data management home and abroad.It is proposed that we should learn the advanced clinical data management modes from international partners and introduce standardized clinical management software from abroad,so as to improve the clinical data management in China.

Aim To develop a sensitive, rapid and ac-curate LC-MSn method for determination of midazolam/1′-hydroxymidazolam and their pharmacokinetic char-acteristics in rat brain. Methods SD rats received in-travenous injection of midazolam ( 5 mg · kg-1 ) via femoral vein, a probe drug of cytochrome P450 3A. The microdialysis ( MD ) samples in situ brain were collected every 8 mins at 2. 0μl·min-1 in 2. 4 hours. Analytes in brain dialysate were quantified by the pro-posed LC-MSn method. Gradient elution was performed on an Agilent Eclipse Plus-C18 column ( 2 . 1 × 50 mm, 3. 5 μm). The mobile phase consisted of 2 mmol ·L-1 ammonium acetate and acetonitrile. The analyte was detected using electrospray ionization ( ESI ) in multiple reaction monitoring ( MRM) modes. The reac-tion selected ions were 326 . 1/291 . 1 m/z for midazo-lam, 342. 1/324. 1 m/z for 1′-hydroxymidazolam and 285. 1/154. 0 m/z for diazepam as internal standard. Result The linear ranges of midazolam and 1′-hydroxymidazolam were 0 . 78~100 and 0 . 195 ~12 . 5μg·L-1 respectively. The lower limit of quantification was 0 . 2 μg · L-1 . The RSD of intra- and inter-batch precisions was less than 7 %. The RSD of accuracy was from -1 . 34 to -8 %. Conclusion This sensi-tive and rapid LC-MSn method is suitable for determi-nation of midazolam/1′-hydroxymidazolam in rat brain dialysate. MD combined with LC-MSn method may give assistance to deep and further studies of drug metabo-lism and CYP3A enzyme in brain.

Objective To investigate the personality patterns, coping styles and social support statue of the patients with stroke.Methods 68 patients of stroke and 68 normal controls were measured with Eysenck Personality Questionnaire (EPQ)、Coping Style Questionnaire (CSQ) and Social Support Scale (SSS).Results The scores of E and N(11.98?4.79,12.98?4.73) were very higher in stroke group than those of in normal control group(9.46?4.18,9.60?4.70)(all P

Objective To investigate the relationship between polymorphisms of angiotensinogen(AGT) gene T704C and cerebrovascular disease(CVD).Methods AGT T704C genotype and allele were examined by PCR-RLFP in 82 patients with cerebral infarction(CI group),70 patients with intracerebral hemorrhage(ICH group) and 89 age-matched normal controls(NC group).The AGT T704C genotype and allele frequencies among the 3 groups were compared and analyzed.The effectes of AGT T704C genotype and the risk factors of stroke to induce CI snd ICH were analyzed by Logistic regression. Results The frequencies of AGT 704CC genotype and C allelic in CI group(63.4%,79.9%) were significantly higher than those in NC group(34.8%,61.2%)(allP

Objective To explore whether the patients aged over 65 years with obstructive sleep apnea hypopnea syndrome (OSAHS) are able to tolerate continuous positive airway pressure (CPAP)while compared with patients aged less than 65 years.And to investigate the factors that affect compliance to CPAP in OSAHS patients.Methods A total of 147 OSAHS patients diagnosed with overnight polysomnography (PSG) were divided into two groups:≥65 years old group (n=46),<65 years old group (n = 101 ).Clinical data and PSG parameters were included in a computerized database.The pressure level of CPAP,the duration of respirator use were followed up.Results Compared with <65 years old group,there were higher prevalences of COPD (16% vs.4%,P=0.02),cardiovascular disease (23% vs.10%,P=0.04),apnea (43% vs.26%,P=0.03),regular alcohol consumption (61% vs.38%,P=0.007) and lower incidence of snoring (31% vs.54%,P= 0.03),shorter total sleeping time (378 min vs.423 min,P=0.001),longer wake after sleep onset periods (162 min vs.115 min,P=0.004),lower sleep efficiency (69% vs.77%,P<0.001),higher percentage of stage 1 sleep (29% vs.20%,P=0.001),lower percentage of stage 3-4 sleep (6% vs.9%,P=0.016) and rapid eye movement (REM) sleep (12% vs.15%,P=0.001) in ≥65 years old group.The percentages of acceptance to CPAP at 3 months,6 months,1 year,2 years and 3 years were 91%,89%,84%,82% and 82% respectively in ≥65 years old group,and were 92%,86%,81%,72% and 67% in <65 years old group.Average use time of CPAP were (5.1±1.5) h/night in ≥65 years old group,and were (3.9±1.2) h/night in <65 years old group (P=0.022).By analysis of multivariate logistic regression,a high pressure CPAP was associated with higher objective CPAP compliance in OSAHS patients.Conclusions Compliance to CPAP in older OSAHS patients is not decreased when compared to younger adults.A high CPAP pressure is the only significant independent predictor of better CPAP compliance.

Objective To compare the clinical efficacy of clopidogrel and clopidogrel in the treatment of myocardial ischemia in patients with coronary heart disease (CHD).Methods86 patients with myocardial ischemia of coronary heart disease from January 2016 to January 2017 in our hospital, were randomly divided into group A (n=43) and group B (n=43), group A was treated with ticagrelor treatment, group B was treated with clopidogrel treatment, clinical curative effect were compared between the two groups.ResultsThe total effective rate in group A was 86.04% was significantly higher than 72.09% in group B, the difference was statistically significant (P<0.05);The number of ST segment descent in group A was (36.17±4.22) times,ST segment continuous decline time (120.29 ±13.53) s ST continued to decline time (120.29±13.53) s, heart rate (65.27±3.18) times/min, systolic blood pressure (105.44±2.17) mmHg, diastolic blood pressure (63.11±3.14) mmHg were significantly lower than the control group (P<0.05);group A patients with triglyceride,total cholesterol,plasma viscosity trimming rate, whole blood viscosity at low shear rate, and whole blood high shear rate were significantly lower than those in group B (P<0.05).ConclusionCompared with clopidogrel, Grillo can effectively improve the blood microcirculation of myocardial ischemia in patients with coronary heart disease, coronary heart disease,relieve myocardial ischemia caused by coronary heart disease The clinical efficacy is remarkable, and it has the value of popularization and Application.

Attentions have been paid to teaching Nepal students in English in our university,and many problems need to be analyzed and solved.Selection and application of appropriate teaching material,sufficient preparation before class and applying nimble teaching style have received satisfactory results.

A poly( GMA-EGDMA) coated SPME fiber was prepared using an in-situ polymerization by direct bonding to the surface of a polydopamine-modified stainless steel wire. Then the fiber was modified by sulfuric acid. A novel solid phase microextraction coating coupled to high performance liquid chromatography ( HPLC) method based on the as-prepared fiber was developed for the determination of four pharmaceuticals and personal care products ( PPCPs) in water samples. The influences of extraction parameters, including pH, extraction time, extraction temperature and salt addition were investigated. 3 mL water sample was extracted by the as-prepared fiber for 60 min at 30 ℃, and then desorbed with mobile phase for 30 min, respectively. Desorption solution was analyzed by HPLC-DAD ( diode array detection ) . The results indicated that the extraction yield of the fiber was good for four PPCPs. The linear correlation coefficients were>0. 997 with the linear range of 2-200 μg/L. The limits of detection (S/N=3) were 0. 5-5 μg/L with RSD (n=5) of 4. 1%-11. 9%. The recoveries of four PPCPs at spiked level of 20, 50, 100 μg/L were within the range of 70. 6%-105. 5%. The results showed that this method was easy, green, accurate and precise, and could be used to assay the four PPCPs in real water samples.

Background and purpose:Hepatitis B virus X protein (HBx) and hypoxia inducible factor-1α(HIF-1α) play key roles in hepatocarcinogenesis and the development of hepatocellular carcinoma. Positive correlation on the expression of these 2 proteins in hepatocellular carcinoma tissues has been found, whereas the underlying mechanisms have not been fully elucidated. This study focused on the role of HBx in regulating HIF-1α and the underlying mechanisms in hepatocellular carcinoma cells. Methods:The expression plasmids were transfected into Huh7 cells with LipofectemineTM 2000. Western blot analysis was applied to detect the expressions of HIF-1αand HIF-1β protein. The transcriptional activity of HIF-1α was detected by the commercial analysis kits. The mRNA levels of HIF-1αand its target genes, including vascular endothelial growth factor (VEGF) and multi-drug resistance gene 1 (MDR1), were detected by quantitative real-time PCR (qRT-PCR). Immunoprecipitation analysis was applied to detect the interaction of HIF-1α, HBx and protein von Hippel-Lindau (pVHL). Results:Huh7 cells transfected with HBx plasmid led to sharp increase of HIF-1αprotein and transcriptional activity, as well as the mRNA of VEGF and MDR1 (P<0.05). However, the mRNA level of HIF-1αwas not obviously changed after HBx transfection (P>0.05). Meanwhile, HBx also signiifcantly impaired the function of pVHL in mediating the degradation of HIF-1αby ubiquitin hydrolase. This finding was further confirmed by the immunoprecipitation analysis, which showed that HBx could directly bind to pVHL, but not to HIF-1α. Conclusion:HBx may inhibit the inter-activation between pVHL and HIF-1αthrough directly binding to pVHL, and thus enhance the stability and transcriptional activity of HIF-1α.

Objective To access the left internal thoracic artery (LITA) graft late postoperative patency after coronary artery bypass grafting (CABG) by peripheral blood vessel ultrasound combined with color Doppler coronary flow imaging (CDCFI).In contrast with angiography,try to find available flow parameter to access graft patency.MethodsForty-six patients with CABG more than 1 year postoperatively followed-by angiography were detected by ultrasound.The LITA graft and left anterior descending artery were examined.Systolic and diastolic peak velocity(Smax,Dmax),velocity time integral(VTIs,VTId)of each segment were measured separately.The ratio of diastolic and systolic peak velocity (D/S),and diastolic velocity time integral fraction(DVTIF) were calculated.All patients were divided into groups according to angiography results.ResultsThirty -one LITA grafts were patent,11 were dysfunctional,4 were occlusive.According to the angiography results,the flow parameters of the proximal segment of LITA graft were significant.The D/S and DVTIF of patent group was higher than that of dysfunctional group.The diastolic peak velocity of distal segment of LAD of patent group was higher than that of dysfunctional group.ConclusionsPeripheral blood vessel ultrasound combined with CDCFI could provide the evidence to access the patency of the graft.It was an effective method for the clinical follow-up.