CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

Objective To explore the clinical value and typing characteristic of prenatal ultrasonography for fetal cystic adenomatoid malformation of the lung(CAML).Methods Ultrasonographic features and typing of fetal CAML in 41 cases detected by prenatal ultrasonography were analyzed retrospectively.All cases were followed up until to the induction of labor or birth.Results (1)Site of tumor: in the 41 cases,there were 22 cases on the left side,15 on the right side and 4 on bilateral.(2)Typing diagnosis of prenatal ultrasonography: three cases were CAML type Ⅰ,14 were type Ⅱ,and 24 cases were type Ⅲ.(3)Pathology diagnosis: thirty two cases were induced abortion.CAML was confirmed in 29 cases by autopsy and the classifications were consistent with the prenatal diagnosis of ultrasonography.Three pulmonary sequestration cases were prenatally misdiagnosed as CAML type Ⅲ by ultrasonography.(4)The other nine cases were followed up to birth.Three masses decreased gradually and then disappeared.Six newborns were confirmed as CAML by CT.Their typings were consistent with the postnatal diagnosis.(5)The diagnostic accuracy rate of prenatal ultrasonography for CAML was 92.7%(38/41).Its misdiagnostic rate was 7.3%(3/41).Conclusions Prenatal ultrasonography has a high accuracy rate for the diagnosis and classification of CAML and is the first choice to detect CAML early in pregnancy.It has an important clinical value.Pulmonary sequestration should be distinguished from CAML type Ⅲ because they tend to be confused.

Abstract: Objective　To understand the distribution and drug resistance of common pathogens of fungal bloodstream infection in Sichuan, and to provide reference for clinicians to empirically treat fungal bloodstream infection. Methods　From November 1, 2019 to December 31, 2020, fungal strains isolated from blood culture of patients diagnosed with bloodstream infection in 19 tertiary first-class general hospitals in Sichuan Province were collected for mass spectrometry identification and drug susceptibility, and the results were statistically analyzed, along with a retrospective analysis of clinical data. Results　A total of 255 fungal strains were received and identified by mass spectrometry, 215 strains of Candida spp (84.3%), 28 strains of Cryptococcus neoformans (11.0%), 4 strains of Talaromyces marneffei (1.6%) and 8 strains of others (3.1%). Among the Candida spp 90 strains of Candida albicans, 39 strains of Candida parapsilosis complex, 36 strains of Candida glabrata, 33 strains of Candida tropicalis, 8 strains of Candida guilliermondii, and 9 strains of other Candida. In the department, the ICU was predominant, accounting for 35.7%. The top four Candida (Candida albicans, Candida parapsilosis complex, Candida glabrata, Candida tropicalis) were analyzed for drug sensitivity, Candida albicans and Candida parapsilosis complex group were more sensitive to antifungal drugs, the sensitivity rates of Candida albicans to fluconazole, voriconazole, anidulafungin, caspofungin, micarafungin were 89.2%, 92.8%, 97.6%, 97.6%, 96.4%, respectively. The sensitivity rates of Candida parapsilosis to fluconazole and voriconazole were 89.7% and 94.9%, and to anidulafungin, caspofungin and micafungin were all 100%. Echinocandins had stronger antibacterial activity against Candida spp., Candida parapsilosis complex and Candida tropicalis had 100% sensitivity to echinocandins, Candida albicans had more than 95% sensitivity to echinocandins, and Candida glabrata had about 90% sensitivity to echinocandins. Candida tropicalis was less sensitive to fluconazole and voriconazole with 66.7% and 54.5%, and the sensitivity of Candida glabrata to fluconazole was mainly concentrated in susceptible dose dependent (SDD), accounting for 91.4%. The four Candida species did not show resistance to amphotericin B, all of them showed wild-type strains, Candida tropicalis showed the highest non-wild-type rate to posaconazole and itraconazole with 21.2% and 36.4%, and the drug sensitivity results of Cryptococcus neoformans showed that 4 out of 23 strains showed resistance to amphotericin B (non-wild-type) and 3 strains showed resistance to fluconazole (non-wild-type). Conclusions　The fungus of bloodstream infection is mainly Candida spp.. Among of them, Candida albicans accounts for the highest percentage, echinocandins have good antibacterial effect on Candida, Candida is sensitive to amphotericin B as wild type, but Candida tropicalis has slightly higher resistance rate to fluconazole and voriconazole, and the non-wild type rate of Cryptococcus neoformans to amphotericin B is increasing, and clinicians should pay high attention to the rational use of antifungal drugs.

AlM: To investigate the association between the degree of anterioruveitis and related factors including inflammatory markers as well as sacroiliac joint imaging in patients with ankylosing spondylitis ( AS) .
METHODS: Anterior changes evaluated by slit lamp, erythrocyte sedimentation rate ( ESR ) , C - reactive protein ( CRP ) and magnetic resonance imaging of 55 cases with AS associateduveitis were retrospectively analyzed. A modified endotoxin-induced uveitis ( ElU ) clinical standard was used for uveitis grading. SPARCC sacroiliac scoring was used to evaluate bone edema of sacroiliac joint. The correlation between the degree of uveitis and sacroiliitis was assessed.
RESULTS: ln the 55 patients with AS, ElU grading scored 2-10, and SPARCC index scored 0-22. Further analysis showed that the severity of uveitis was significantly correlated with ESR (r=0. 869, P<0. 001) and CRP (r=0. 485, P<0. 001). The degree of anterior uveitis in AS patients was not correlated with inflammation of sacroiliac joint (r=0. 237, P=0. 081).
CONCLUSlON: Local autoimmunity of uveitis and sacroiliac joint inflammation with subsequent bone formation in AS might be mutually independent processes.

OBJECTIVE: To study changes of DNA content in the kidney cellule of rats and relationship with the postmortem interval. METHODS: This experiment chose seven parameter of cell nuclear, including the area and integral optical density, determined the changes of DNA content in the kidney cellule of 15 rats at different intervals between 0 and 48 h postmortem with auto-TV-image system. RESULTS: The degradation rate of DNA in nuclear has a certainty relationship to early PMI(in 48 h) of rat, and get binomial regress equation. CONCLUSION Determining the quantity of DNA in nuclear should be an objective and exact way to estimate the PMI.
Animals ; Cell Nucleus/metabolism* ; DNA/metabolism* ; Image Processing, Computer-Assisted ; Kidney/cytology* ; Male ; Postmortem Changes ; Rats ; Time Factors

OBJECTIVETo evaluate the creativity of medical students and study their personality characteristics using personality questionnaires.

METHODSThis investigation was conducted among 310 medical students using 16 Personality Factor Questionnaire (16PF) and Eysenck Personality Questionnaire (EPQ).

RESULTSA total of 302 students completed the questionnaires. The male and female students showed significant differences in two sub-factors with similar creativity. Four subfactors were identified to positively or inversely correlate to the creativity. The number of male students without either high or low scores was greater than that of female students. The incidences of abnormal scores in 16PF showed significant difference between students with typical EPQ scores and those with atypical scores for introversion-extroversion.

CONCLUSIONSThese medical students do not show high creativity in this study. Compared with the male medical students, the female students are more likely to have extroverted personality, and their scores for 16 basic personality factors easily exceed the normal ranges, suggesting the necessity of mental health education. The students with at least 5 abnormal scores in 16PF may show a typical introversion-extroversion personality, and individual psychological counseling can be considered when necessary.

China ; Creativity ; Female ; Humans ; Male ; Personality ; Students, Medical ; psychology ; Surveys and Questionnaires ; Young Adult

OBJECTIVETo elucidate the relative factors and prognostic impact for angiographic no-reflow phenomenon during primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

METHODSA total of 930 patients with AMI who underwent primary PCI were divided into no-reflow group and normal-reflow group. Factors related to no-reflow were analyzed by logistic regression model and major adverse cardiac events (MACE) in-hospital as well as during long-term follow-up was also observed.

RESULTSNo-reflow occurred in 82 out of 930 patients. Admission glucose level (9.8 +/- 4.3 mmol/L vs. 8.5 +/- 3.5 mmol/L, P = 0.001), peak CK-MB value (369.4 +/- 167.8 U/L vs. 282.3 +/- 161.7 U/L, P < 0.01) and percentage of TIMI flow grade 0 on initial angiogram (69.5% vs. 54.5%, P = 0.009) were significantly higher and pre-infarction angina (19.5% vs. 48.1%, P < 0.01) was significantly lower in no-flow patients than normal flow patients. Logistic regression analyses showed that admission glucose level, absence of pre-infarction angina, TIMI flow grade 0 on initial angiogram and pump failure were independent predictors of no reflow. In-hospital MACE (37.8% vs. 11.3%, P < 0.01) and follow-up MACE (37.5% vs. 17.4%, P < 0.01) were also significantly higher in no-flow patients than normal flow patients. Multivariate Cox regression analysis revealed that no-reflow was an independent predictor of long-term cardiac death (relative risk 3.83, 95% confidence interval 1.71 to 5.57).

CONCLUSIONAdmission glucose level, absence of pre-infarction angina, TIMI flow grade 0 on initial angiogram and pump failure were independent risk factors for no-reflow and no-flow is an independent predictor for increased in-hospital and follow-up MACE.

Aged ; Angina Pectoris ; Angioplasty, Balloon, Coronary ; Blood Glucose ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; diagnosis ; therapy ; Prognosis ; Treatment Outcome

AIMTo establish chromatographic fingerprint of Carthamus tinctorius L. by RP-HPLC in order to control the quality of Carthamus tinctorius L.

METHODSThe gradient elution mode was applied in chromatographic separation, and data were analysed by "Computer Aided Similarity Evaluation" software to compare the quality of Carthamus tinctorius L. samples from different habitats.

RESULTSSamples from different habitats were of high similarity, though a few samples showed evident difference in fingerprint graphics.

CONCLUSIONThe RP-HPLC fingerprint method is repeatable, feasible in analysis of Carthamus tinctorius L. and can be used in quality assessment of Carthamus tinctorius L. Chemical components in Carthamus tinctorius L. samples from various habitats are similar, and their ratios between each other are stable.

Carthamus tinctorius ; chemistry ; Chalcone ; analogs & derivatives ; chemistry ; isolation & purification ; China ; Chromatography, High Pressure Liquid ; methods ; Ecosystem ; Flowers ; chemistry ; Plants, Medicinal ; chemistry ; Quality Control ; Quinones ; chemistry ; isolation & purification

OBJECTIVETo explore the biological and clinical significance of the double mutations of C1673T/C1799G in HBV C promoter (CP).

METHODSTotally 136 patients were enrolled, including 25 asymptomatic carriers (AsC), 38 patients with chronic hepatitis B (CHB), 24 patients with chronic severe hepatitis B (CSHB), 36 cases with liver cirrhosis (LC) and 13 cases with hepatocellular carcinoma (HCC). HBV subgenotypes and mutations in CP of all samples were determined by nested-PCR and direct nucleotide sequence analysis. The C to T mutation at nucleotide 1673 and C to G at nucleotide 1799 were analyzed in different subgenotypes, and the relationships of C1673T/C1799G double mutations with HBV replication, the expression of HBeAg, and with the severity of liver disease after chronic HBV infection were studied.

RESULTSOf the 136 patients, 110 were subgenotype Ba, 1 was Bj, 7 were C1, and 18 were C2. C1673T/C1799G double mutations in Ba were determined in 106 (96. 4%) samples, which was significantly higher than in C1 (14.3%) and C2 (12.5%) subgenotype (P < 0.0001). In contrast to non-mutation group, HBV DNA content in mutation group had no significant difference (P > 0.05). The prevalence of the mutation was lower in HBeAg positive patients (71.4%) than in HBeAg negative patients (87.5%) (P < 0.05). The frequencies of the double mutations were not significantly different among ASC, CHB, CSHB, LC and HCC groups (P > 0.05).

CONCLUSIONIn Ba subgenotype, double mutations of C1673T/C1799G is much popular than in C1 and C2; the mutation has no effect on HBV replication, and may not be associated with the outcome of chronic HBV infection.

Adolescent ; Adult ; Aged ; Female ; Genotype ; Hepatitis B e Antigens ; analysis ; Hepatitis B virus ; genetics ; Hepatitis B, Chronic ; virology ; Humans ; Male ; Middle Aged ; Mutation ; Promoter Regions, Genetic

Objective To observe the efficacy and safety of fusidic acid cream and halometasone cream in the treatment of psoriasis vulgaris.Methods Fifty-four patients with psoriasis vulgaris were enrolled in this study and were divided into observation group and control group.26 patients in observation group were treated with halometasone cream,28 patients in control group were treated with fusidic acid cream combined with halometasone cream.The psoriasis area and severity index (PASI) and abverse events of treatment were recorded.At the same time,34 normal people taking physical examination were selected as health group,the infections of pathogenic microorganism were compared between psoriasis vulgaris patients and normal people.Results The pathogenic infection rate of patients with psoriasis vulgaris was 72.22％,the infection rate was 75.00％ in observation group and 69.23％ in control group.The infection rate in health group was 38.24％,the difference in the pathogenic infection rate was statistically significant between paitents with psoriasis vulgaris and normal people (P ＜0.05).After treatment,the rate of negative infections was 95.24％ in observation group and 72.22％ in control group,there was significant difference between two groups (P＜0.05).The PASI scores and VAS scores of observation group were significantly lower than those of control group (P＜0.05).The total effective rate of treatment was 71.43％ in observation group and 34.62％ in control group,the difference was statistically significant (P＜0.05).There was no significant difference in rate of adverse events between observation group and control group (P ＞0.05)Conclusion The pathogenic infection is closely correlated with psoriasis vulgaris,fusidic acid cream combined with halometasone cream has good efficacy and safety in treatment of psoriasis vulgaris and worth of popularization and application.