RESUMO
ObjectiveTo investigate the clinical efficacy of Niaoxue No.1 Prescription in treating Henoch-Schönlein purpura （HSP） nephritis with blood heat and stasis syndrome and its effect on urine erythrocyte， urine protein， blood neutrophils， and blood routine-derived indicators. MethodA multicenter， randomized controlled trial （RCT） was conducted involving 108 HSP nephritis patients from three hospitals. The patients were randomly divided into a control group （54 cases） and a treatment group （54 cases）. The treatment group received Niaoxue No.1 prescription once daily， while the control group was treated with captopril and ferulic acid tablets. Both groups underwent a 4-week course of treatment. The urine erythrocyte， urine microalbumin （mAlb）， urine sediment red blood cell count， traditional Chinese medicine （TCM） syndrome score， 24-hour urine protein， blood neutrophil count， neutrophil to lymphocyte ratio （NLR）， platelet to lymphocyte ratio （PLR）， lymphocyte to monocyte ratio （LMR）， D-dimer， and immunoglobulin A were detected. The recurrence rate of HSP nephritis was followed up for 6 months. ResultThe total effective rates were 88.9% （48/54） in the treatment group and 70.4% （38/54） in the control group， and the treatment group was superior to the control group （χ2=5.708， P<0.05）. Compared with the results before treatment， after 14 days of treatment， the TCM syndrome total score， urine erythrocyte， urine mAlb， and 24-hour urine protein in both groups significantly decreased （P<0.05，P<0.01）， and the improvement was more significant in the treatment group than the control group （P<0.05）. After 28 days of treatment， compared with the results before treatment， the TCM syndrome total score， urine erythrocyte， urine mAlb， urine sediment red blood cell count， D-dimer， and 24-hour urine protein in both groups significantly decreased （P<0.05，P<0.01）， with the treatment group showing a more significant reduction in urine mAlb than the control group （P<0.05）. On the 14th and 28th days of treatment， the neutrophil percentage and NLR were lower in the treatment group than in the control group （P<0.05）， while there was no statistically significant difference in PLR and LMR. The recurrence rate of nephritis in both groups showed no statistically significant difference after a 6-month follow-up. ConclusionNiaoxue No.1 Prescription in the treatment of HSP nephritis with blood heat and stasis syndrome can significantly improve clinical symptoms， shorten the course of the disease， and reduce urine erythrocyte， urine mAlb， 24-hour urine protein， blood neutrophils， and NLR， thereby effectively alleviating the inflammatory state and reducing kidney damage in children with HSP nephritis.
RESUMO
Objective:To study on the correlation between integrated pharmacokinetics and pharmacodynamic effects of five active components(oxidized paeoniflorin,paeoniflorin,quercetin,gallic acid, paeonol) in Moutan Cortex. Method:Rats were divided into blank group,model group(syndrome of blood-heat and blood stasis) and drug-administered group.The concentration of five active components in serum were detected with UPLC-MS at different time points after being administrated ethanol extract of Moutan Cortex.The integrated concentrations were calculated according to area under the curve(AUC) self-defined weighting coefficiency.At the same time,the enzyme-linked immunosorbent assay(ELISA) was used to determine the contents of thromboxane B2(TXB2) and 6-keto-prostaglandin F1α(6-keto-PGF1α) in serum at different time points,and then correlation between pharmacodynamics and integrated pharmacokinetics of these five active ingredients was analyzed. Result:At different time points(0.083,0.25,0.5,0.75,1,2,3,4,6,8,10,12 h),the integrated plasma concentrations of these five active ingredients in Moutan Cortex(158.65,174.60,220.13,227.23,244.31,251.51,404.28,654.39,472.62,355.04, 231.56,199.40 mg·L-1) had a good correlation with concentration of TXB2(264.44,261.03,284.93,273.30,264.04, 278.90,274.83,303.58,260.03,264.78,264.40,256.62 μg·L-1) and value of TXB2/6-keto-PGFlα(4.50,4.47,3.66,3.37, 3.29,3.66,3.71,4.30,3.63,3.65,3.75,3.66). Conclusion:There is a good correlation between the dynamic changes in vivo of active components from Moutan Cortex and pharmacodynamic effects of activating blood circulation of this herb.