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Objective:To collect the simple interventions in pediatric biomedical research and analyze the risk condition, to establish the minimal risk evaluation criteria, thus to provide the scientific method for the ethical re-view of pediatric biomedical research. Methods:The expert consultation was carried out on the minimal risk evalu-ation of the simple interventions for pediatric biomedical research, and 25 experts from 11 medical institutions car-rying out children' s clinical research were selected to conduct 2 rounds of expert consultation. Results:25 valid questionnaires were collected, and the positive coefficient of the respondents was 100％. The judgment and famili-arity or degree of attention on the related problems was 0 . 764 . The minimal risk evaluation criteria of 25 simple in-terventions in 4 dimensions were determined. Conclusion: We determine the minimal risk evaluation criteria for simple interventions in pediatric biomedical research using the Delphi method, and the research results were relia-ble and could provide a reference for the ethical review of pediatric biomedical research.
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Objective@#To explore age-based clinical and immune parameters in Henoch-Schönlein purpura (HSP) to determine clinically useful markers reflecting disease characteristic.@*Methods@#A cohort of 502 patients with HSP were enrolled into this retrospective study to evaluate their clinical and immune data.@*Results@#Majority HSP cases occurred at age ≤14 years and showed significant immune imbalances of ESR, CD3+ cells, CD4+ cells, CD3-CD16+CD56+ cells, CD4+/CD8+ cells, IgG, IgA, IgM, IgE, complements C3/C4 and ASO in the acute phase. Compared to patients aged >14 years, symptoms of joint were more frequent at disease onset in patients aged ≤14 years (20.8% vs 7.6%, χ2=13.547, P<0.001) , and involvement of digestive tract and joint were also more frequent (57.4% vs 33.8%, χ2=24.106, P<0.001; 55.9% vs 32.5%, χ2=23.768, P<0.001, respectively) , but not for involvement of kidney (21.4% vs 51.3%, χ2=42.440, P<0.001) . The patients aged ≤14 years had distinct immune state, reductions of CD3+ cells, CD4+ cells and IgG were more frequent than patients aged >14 years, also increase of ASO (33.1% vs 20.0%, χ2=6.656, P=0.010) , but not increase of IgA (2.6% vs 39.4%, χ2=15.582, P<0.001) . In addition, reduction of IgG and increase of IgE were positively associated with digestive tract involvement (P<0.001, P=0.001, respectively) , reduction of CD3+CD4+ cells and normal IgM were positively associated with joint involvement (P=0.004, P=0.003, respectively) , increase of CD3+CD8+ cells and normal CD3+ cells were positively associated with kidney involvement (P=0.032, P=0.014, respectively) .@*Conclusion@#HSP showed significant immune imbalance in the acute phase, patients between aged ≤14 and >14 years had distinct clinical and immune characteristic, and abnormal immune parameters were significantly associated with organ involvements.