Objective:To study the predictive value of the amplitude-integrated electroencephalography (aEEG) within 6 hours and 3 days after birth and magnetic resonance imaging(MRI) on the adverse neurobehavioral development of asphyxiated preterm infants at the correction age of 6 months.Methods:From December 2017 to June 2019, 50 asphyxiated preterm infants who were delivered at the obstetrical department transferred to the division of neonatology in the Third Affiliated Hospital of Anhui Medical University were monitored by aEEG within 6 hours after birth, then once a day for at least 4 h. MRI was administered at 40 weeks of corrected age, neuromotor developmental function of the infants was assessed by the Geisel developmental diagnostic scale at 6 months of corrected age, then the infants were divided into good prognosis group and poor prognosis group according to the assessment results. SPSS 19.0 software was used for statistical analysis.The software of SPSS 19.0 was used to analyze the data.Independent sample t-test and χ 2 test were used to analyze the difference between the two groups.The relationship between aEEG grading and MRI, and their predictive value for adverse neurobehavioral development were analyzed at 6 months of corrected age. Results:The degree of white matter damage( H=24.896) and intracranical hemorrhage( H=29.245) of premature infants with different aEEG clinical grades were different (both P<0.01) on MRI. The sensitivity of aEEG within 6 hours and 3 days after birth on predicting poor prognosis was 96.2% and 97.8%, the specificity was 56.2% and 62.5%, the negative predictive value was 98.2% and 99.0%, the positive predictive value was 37.8% and 52.3%, the correct index was 52.4% and 60.3%, respectively. The aEEG was combined with MRI, the sensitivity (90.0%, 97.0%), specificity (89.0%, 99.0%), negative predictive value (99.2%, 99.5%), positive predictive value (80.6%, 88.5%), and correct index (79%, 96%) were all improved. Conclusion:The combination of aEEG grading and MRI can improve the prognostic value on neurodevelopmental prognosis, and provide a better evaluation basis for clinical follow-up and intervention of asphyxiated premature infants with brain injury.

Objective:Constructing a physical fitness test index system for pregnant women to fully understand their physical fitness level and provide a reference for exercise prescription for this population.Methods:The system was established by way of literature review and Delphi survey, which was further validated on 60 pregnant women undergoing prenatal examination at Maternal and Child Health Hospital of Beijing Haidian District from November 7, 2019, to January 7, 2020. A questionnaire was used to evaluate the satisfaction of pregnant women with the process and results of the physical fitness test. The test and survey data adopted the descriptive analysis. Paired sample t test was used for statistical analysis. Results:The index system of maternal physical fitness test during pregnancy was established through three rounds of expert discussion, and consists of three first-level indexes, 11 second-level indexes, and 23 third-level indexes. All 60 subjects completed the test successfully and no complaints or discomfort were reported. There was no significant difference in the fetal heart rate before and after the test [(142.1±3.8) vs (142.1±4.5) bpm; t=－0.025, P=0.980]. The average test duration was (32.6±3.4) min, and the average load consumption was (300.1±41.2) kcal (1 kcal=4.184 kJ). The questionnaire showed that all subjects were satisfied with the test process and results. Conclusions:The index system of physical fitness test for pregnant women established in this study is scientific, practical, and safe, which is a potential evaluation tool of the physical fitness level for pregnant women.

【Objective】 To develop a mobile software application named " Component Assistant" and test for its performance in practical work, so as to address the difficulties and problems encountered during the management process of blood component preparation, such as communication and coordination in the workflow, personnel scheduling and workload arrangements. 【Methods】 The software was developed based on the daily work requirements and processes using Java language, and foreground-background separation technologies were employed to provide secure and reliable data support. 【Results】 The results of practical work verification showed that through this software, component preparation managers were able to real-time monitor blood collection situations, blood transfusion details, manage inventory levels, and summarize and review the details of the preparation process. Comparison of the usage sequence of this software, the average amount of blood prepared of employees has increased(198 bloodbag, /M), the workload of employees has increased(3.5, /M) and the rest time has been shortened(1 h, /M). 【Conclusion】 The innovation of this software lies in providing effective data support for matching the workload and personnel in component preparation operations, meeting the needs of blood component preparation management, and greatly improving work efficiency in this field.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.