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.

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 explore the association between the intake and changes in various types of food and the changes in blood pressure in patients with mild to moderate hypertension.Methods:Mild to moderate hypertension participants with complete baseline and outcome data were included from DECIDE-Diet study, a multicenter, randomized controlled trial. Dietary records and blood pressure measurements at both 7-day run-in (baseline) and 28-day intervention phases were collected for enrolled participants. Blood pressure change was defined as the difference between blood pressure at the end of trial and the baseline blood pressure. Baseline intake of food was the average daily intake during the run-in period, and the intake increment was defined as the difference between the average intake during the trial period and the average intake during the run-in period. After adjusting for age, sex, study center, intervention groups, baseline body mass index (kg/m 2), antihypertension medication use, and baseline total calorie intake, a linear regression model was used to analyze the associations of the before-after-intervention change in blood pressure with baseline intake and intake increment of foods. Results:A total of 258 patients with mild to moderate hypertension were included, including 133 males, aged (56.5±9.9) years. (1) After adjusting for confounding factors, there was no significant association between baseline intake of food and baseline blood pressure (all P>0.05). The blood pressure change was negatively associated with baseline intakes of tubers, vegetables, and vegetable oils but positively with baseline intake of meats; and was negatively associated with intake increment of whole grains and fish (all P<0.05). (2) The multiple linear regression analysis showed that baseline intake of vegetables ( β=-0.021, P=0.004), vegetable oils ( β=-0.260, P=0.002), and increment in intake of fish ( β=-0.128, P=0.026) were all significantly associated with changes in systolic blood pressure; baseline intake of vegetables ( β=-0.017, P=0.002), vegetable oils ( β=-0.182, P=0.001), dairy products ( β=0.021, P=0.022), and increment in intake of fish ( β=-0.092, P=0.010) were all significantly associated with changes in diastolic blood pressure. Conclusion:Increasing the intake of whole grains, vegetables, vegetable oils, and fish and decreasing the intake of meat may be beneficial for blood pressure control in patients with mild to moderate hypertension.

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.

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 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