Objective:To evaluate the simulation effect of the placebo in a clinical trial of whole nutrition formula, and to inform the preparation of placebo in the clinical trial of foods for special medical purposes.Methods:Evaluators assessed the appearance, color, smell, and taste, and made the distinction between the placebo and the experimental product independently. The similarity and consistency between the placebo and experimental product were also assessed using a manual scoring method.Results:In the group assessing experimental product, 40% evaluators made the correct judgment while 50% did not. In the group assessing placebo, 10% evaluators made the correct judgment while 70% did not. Compared with the reference product, the experimental product and placebo were scored 9.75±0.79 vs. 6.63±3.73 for appearance, 9.75±0.79 vs. 7.25±3.99 for color, 8.75±3.17 vs. 8.50±3.16 for smell, and 9.00±1.29 vs. 7.75±2.99 for taste. The intra-evaluator consistency rate for the appearance, color, smell and taste of different products was 80%, 80%, 90%, and 90%, respectively. Conclusions:The blinding effect of placebo was relatively satisfactory in the trial we assessed. The placebo was comparable with the experimental product in terms of color, smell, and taste, but not appearance. The approaches for preparing and evaluating placebo in this clinical trial could give some clues for similar trials involving foods for special medical purposes.

Objective:To investigate the clinical value of serum cystatin C(Cys C) and neutrophil gelatinase associated lipocalin(NGAL) combined with cardiac biomarkers in the evaluation of sepsis with renal injury in children.Methods:The clinical data of 130 children with sepsis(67 cases in sepsis non AKI group and 63 cases in septic AKI group)admitted to pediatric intensive care unit(PICU) at Hunan Children′s Hospital from May 2018 to December 2019 were retrospectively analyzed.The differences of serum Cys C, NGAL and cardiac related biomarkers between sepsis and septic kidney injury were analyzed and compared.Results:The levels of serum Cys C, NGAL and amino-terminal pro-brain natriuretic peptide(NT-proBNP) in children with septic AKI were significantly higher than those in children of sepsis non AKI group(all P<0.01). There were no significant differences in creatine kinase isoenzyme(CK-MB)and high-sensitivity troponin T(cTnT-hs) between two groups (all P>0.05). The levels of CK-MB, cTnT-hs, NT-proBNP, Cys C and NGAL in the dead children were significantly higher than those in the surviving children ( P<0.05). In terms of predicting of AKI, the area under the ROC curve of NGAL, Cys C and NT proBNP were 0.724, 0.759 and 0.747, respectively.Regarding predicting the survival and death of sepsis, the area under the ROC curve of NGAL, Cys C and NT proBNP were 0.719, 0.722 and 0.769, respectively.In predicting the prognosis of children with sepsis and kidney injury, the area under the ROC curve of NGAL, Cys C and NT proBNP were 0.683, 0.651 and 0.682, respectively.The binary Logistic regression equation was established by Cys C, NGAL and NT-proBNP, Y=0.970 NGAL+ 0.9441 BNP+ 1.815 Cys C-2.944.In predicting kidney injury, evaluating prognosis of sepsis and predicting prognosis of sepsis with kidney injury, the area under ROC curve of new variable Y were 0.882, 0.802 and 0.808, respectively. Conclusion:NGAL, Cys C and NT-proBNP can be used to judge sepsis and sepsis with kidney injury alone.The evaluation value of combined detection of three indexes is better than that of single index.Therefore, the combined use of the three indicators may be better to judge the condition of children with sepsis and kidney injury.

DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials, report the details of blinding, conduct a blinding survey and calculate Jame's BI and Bang's BI. Jame's BI was 0.683 (95% CI: 0.593~0.772). The Bang's BI for the intervention group was 0.340 (95% CI: 0.199~0.481), and for the control group was 0.086 (95% CI: -0.060~0.231). The blinding of the DECIDE)-Diet was generally successful, but the intervention group may infer their group to a certain extent. Feeding trials should report the details of blinding and consider blinding assessment.

Objective To understand the compliance of highly active anti-retroviral therapy (HAART) and influencing factors in people living with HIV/AIDS (PLWHA) in Nanjing. Methods PLWHA receiving HAART in No. 2 Hospital of Nanjing during May-June 2014 were recruited in this study. Self-administrated questionnaire was used to collect the data about HAART compliance and socio-demographic characteristics of PLWHA surveyed. Descriptive and multivariate statistical analysis were conducted to examine the effects of the factors on self-reported HAART adherence. Results A total of 276 PLWHA were surveyed,According to the evaluation criterion of Center for Adherence Support Evaluation (CASE),252 cases showed good compliance (91.3%). logistic regression analysis revealed that smoking,progress of the disease and side effects,reminding of taking drug and age were correlated with self-reported HAART adherence. Conclusion It is suggested to strengthen the education about antiviral therapy compliance in PLWHA with mild infection and those who are smokers and young,suffer from side effects,have no reminding methods for taking drug.

OBJECTIVETo understand the incidence of drop out of antiretroviral therapy (ART) in people living with AIDS/HIV and related factors in Nanjing, Jiangsu province, and Yuncheng, Shanxi province.

METHODSRetrospective cohort analysis was conducted. The cumulative incidence curves of drop out of ART, mortality and drug withdrawal were drawn with Kaplan-Meier method. The related factors were identified with Cox proportional hazards regression model.

RESULTSA total of 1 006 patients were included in Yuncheng, the median length of ART follow-up was 49.59 months (QR: 20.02-92.84), and 976 patients were included in Nanjing, the median length of ART follow-up was 19.93 months (QR: 11.48-34.07). The cumulative incidence of drop out of ART at 3 months, 6 months, 1 year, 2 years, 4 years, 8 years after ART was 8.19%, 9.23%, 11.08%, 13.75%, 17.74%, 27.66% in Yuncheng, and 3.01%, 5.17%, 7.47%, 10.97%, 17.45%, 28.72% in Nanjing respectively. Age, marital status, infection route, baseline CD4 cell count, the clinical stage classified by WHO at the end of the observation were correlated with the drop out of ART.

CONCLUSIONIn order to reduce the drop out of ART among people living with AIDS/HIV, it is necessary to conduct effective interventions targeting the patients with young age, the patients who divorced/widowed, the patients who were intravenous drug users, the patients with higher CD4 cell count at the beginning of ART and clinical stage III or IV at the end of the follow-up and increase the coverage of HIV test.

Acquired Immunodeficiency Syndrome ; drug therapy ; Anti-Retroviral Agents ; administration & dosage ; CD4 Lymphocyte Count ; China ; Communicable Diseases ; Humans ; Incidence ; Medication Adherence ; Proportional Hazards Models ; Retrospective Studies

OBJECTIVETo understand the economic burden caused by antiretroviral treatment for people living with HIV/AIDS and influencing factors in Nanjing.

METHODSPeople living with HIV/AIDS were divided into two groups, HIV infected patients and AIDS patients. The data about their direct medical expenditure, direct non-medical expenditure and indirect economic loss in the past year were collected. Univariate and multivariate analysis were conducted to identify the potential influencing factors.

RESULTSThe median of direct medical expenditure and total costs for 133 HIV infected patients were 1,200 yuan RMB and 1,972 yuan RMB respectively. The median of direct medical expenditure and total costs for 145 AIDS patients were 1 060 yuan RMB and 2 826 yuan RMB respectively. The differences in direct medical expenditure and total costs between HIV infected patients and AIDS patients showed no statistical significance. The results from univariate analysis indicated that the sample source influenced total costs significantly. Multivariate analysis showed that onset time and CD level were negatively correlated with direct medical expenditure. The patients infected through heterosexual contact had more direct medical expenditure than those infected through homosexual contact. The patients receiving HIV test in hospitals had more direct medical expenditure than those receiving volunteer counseling and testing.

CONCLUSIONFurther efforts should be made to expand HIV testing and treatment coverage in order to detect HIV infections as early as possible. Early antiretroviral treatment should be given to HIV infected patients to maintain their immunity and reduce their medical expenditure.

Acquired Immunodeficiency Syndrome ; drug therapy ; economics ; Anti-Retroviral Agents ; economics ; therapeutic use ; China ; Cost of Illness ; Counseling ; HIV Infections ; drug therapy ; economics ; Health Expenditures ; statistics & numerical data ; Heterosexuality ; Humans ; Mass Screening ; Voluntary Programs

OBJECTIVETo understand the compliance of highly active anti-retroviral therapy (HAART) and influencing factors in people living with HIV/AIDS (PLWHA) in Nanjing.

METHODSPLWHA receiving HAART in No. 2 Hospital of Nanjing during May-June 2014 were recruited in this study. Self-administrated questionnaire was used to collect the data about HAART compliance and socio-demographic characteristics of PLWHA surveyed. Descriptive and multivariate statistical analysis were conducted to examine the effects of the factors on self-reported HAART adherence.

RESULTSA total of 276 PLWHA were surveyed, According to the evaluation criterion of Center for Adherence Support Evaluation (CASE), 252 cases showed good compliance (91.3%). logistic regression analysis revealed that smoking, progress of the disease and side effects, reminding of taking drug and age were correlated with self-reported HAART adherence.

CONCLUSIONIt is suggested to strengthen the education about antiviral therapy compliance in PLWHA with mild infection and those who are smokers and young, suffer from side effects, have no reminding methods for taking drug.

Acquired Immunodeficiency Syndrome ; drug therapy ; Age Factors ; Antiretroviral Therapy, Highly Active ; Antiviral Agents ; adverse effects ; therapeutic use ; China ; Disease Progression ; HIV Infections ; drug therapy ; Humans ; Medication Adherence ; statistics & numerical data ; Reminder Systems ; Smoking ; Surveys and Questionnaires

OBJECTIVETo evaluate relevant prognostic factors of unrelated single unit umbilical cord blood hematopoietic stem cell transplantation (sUCBT), and to explore the correlation between cryopreservation time of cord blood and cell viability and outcome of sUCBT.

METHODSRetrospective analysis of 137 patients undergoing sUCBT with cord blood provided by Shanghai Cord Blood Bank from Mar. 15, 2007 to Dec. 26, 2013 were performed in this study. The mean cryopreservation time of 137 units cord blood was 698(96-1968) days, with mean cell viability of 87.4% after thawing.

RESULTSNo statistical difference on cell viability, hematopoietic reconstitution, graft failure, acute graft versus host disease (GVHD) and overall survival (OS) was found between patients transfused with cord blood preserved below and above 2 years. The 5-year OS of patients transfused with cord blood preserved below and above 2 years were 55.6% and 67.9%, respectively (P=0.124). OS of the UCBT at 2011 and before, and after 2011 was 48.7% and 79.6%, respectively (P=0.001). Age above 16-year-old (RR=2.830, P=0.027) and UCBT at 2011 and before (RR=0.203, P<0.001) were two risk factors of treatment related mortality.

CONCLUSIONOutcome of sUCBT in China had significant improvement in recent 2 years. Cryopreservation time of cord blood had no statistical correlation to cell viability after thawing and clinical outcome.

Cell Survival ; China ; Cord Blood Stem Cell Transplantation ; Fetal Blood ; Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Retrospective Studies

OBJECTIVETo investigate the impact of cryopreservation duration of umbilical cord blood (UCB) on quality of hematopoietic stem cell and outcome of clinical transplantation.

METHODS605 units of UCB which had been used in clinical transplantation were previously cryopreserved for 820 (88-2651) days in average. UCB was detected for total nucleated cell count, CD34+ cells count, cell recovery rate, cell viability and CFU-GM after thawing.

RESULTSNo statistical correlation was found between cryopreservation duration and cell recovery rate, cell viability. CFU-GM decreased along with the extension of cryopreservation duration (P=0.011), ranging between 109.6 and 105.7/1 × 10⁵. There was no significant difference on hematopoietic reconstitution time, graft failure, acute GVHD and overall survival among groups with different cryopreservation duration.

CONCLUSIONCryopreservation duration has no significant effect on cell recovery rate, cell viability and clinical transplantation outcome. Extension of cryopreservation duration may reduce CFU-GM of stem cells with fluctaion still in normal range. UCB could maintain cell viability and function to achieve satisfactory clinical transplantation outcome even when thawed after 3 to 7 years' cryopreservation.

Cell Count ; Cell Survival ; Cryopreservation ; Fetal Blood ; Graft vs Host Disease ; Granulocyte-Macrophage Progenitor Cells ; Hematopoietic Stem Cell Transplantation ; Hematopoietic Stem Cells ; Humans ; Treatment Outcome