BACKGROUND Patients with lupus nephritis(LN)typically undergo long-term treatment with glucocorticoids(GCs)and immunosuppressants.There is a growing demand for optimal therapy with better remission results and fewer s...BACKGROUND Patients with lupus nephritis(LN)typically undergo long-term treatment with glucocorticoids(GCs)and immunosuppressants.There is a growing demand for optimal therapy with better remission results and fewer side effects.Sustained traditional Chinese medicine(TCM)might be quite valuable for multitarget therapy,reducing the total dosage of GCs and minimizing the side effects of immunosuppressants.AIM To evaluate whether Dan Bai Xiao Formula(DBXF)can reduce the exposure to GCs and cyclophosphamide(CYC)and to assess the efficacy and safety of DBXF for the resolution of proteinuria and hematuria in children with LN.METHODS A 24-wk pilot study was conducted at Beijing Children’s Hospital.Children with active LN were divided into either a TCM group or a control group.Children in the TCM group received DBXF combined with GCs and CYC,and the ones in the control group received GCs and CYC every 4 wk for 24 wk.The primary endpoints of this trial were urinary protein excretion of<150 mg/d and normal serum albumin concentration and renal function.RESULTS The trial included 78 children,of whom 38 received GCs and CYC treatment(control group)and the remaining 40 received DBXF combined with GCs and CYC treatment(TCM group).At week 24,the TCM group showed a better rate of complete remission(42.5%);however,there was no significant difference compared with the control group(31.5%,P>0.05).The urine red blood cell count and urine protein level were significantly lower in the TCM group than in the control group at weeks 4,12,and 24(P<0.05).Furthermore,patients in the TCM group had a lower proportion of methylprednisolone pulses than those in the control group(1.30±1.41 vs 3.05±2.02,P<0.0001).The ending GC dose was significantly lower in the TCM group than in the control group(P<0.001).Moreover,more hepatic function damage,gastrointestinal adverse effects,and hypertension were observed in the control group than in the TCM group(P<0.05).CONCLUSION The findings suggest that DBXF treatment is effective and safe as a supplementary therapy for LN and is superior to routine GC and CYC therapy.DBXF containing combination treatment possibly results in a faster resolution of proteinuria and hematuria,smoother GC reduction,fewer methylprednisolone pulses,and fewer adverse events.展开更多
目的建立RP-HPLC双波长法同时测定活络效灵丹中3种丹参酮和6种乳香酸的含量。方法采用RP-HPLC法,色谱柱为Waters x BridgeTmC18柱（150 mm×4.6 mm,3.5μm）,流动相为体积分数为0.01%的磷酸水溶液-乙腈,梯度洗脱,流速为1.0 m L·...目的建立RP-HPLC双波长法同时测定活络效灵丹中3种丹参酮和6种乳香酸的含量。方法采用RP-HPLC法,色谱柱为Waters x BridgeTmC18柱（150 mm×4.6 mm,3.5μm）,流动相为体积分数为0.01%的磷酸水溶液-乙腈,梯度洗脱,流速为1.0 m L·min^-1,检测波长为210 nm和254 nm,柱温为30℃。结果隐丹参酮、丹参酮I、丹参酮IIA、11-羰基-β-乳香酸（KBA）、11-羰基-β-乙酰乳香酸（AKBA）、α-乳香酸（α-BA）、β-乳香酸（β-BA）、乙酰基-α-乳香酸（A-α-BA）和乙酰基-β-乳香酸（A-β-BA）的质量浓度分别在0.252 0~8.064、0.157 2~5.030、0.937 5~30.00、3.156~101.0、25.10~803.2、6.250~200.0、6.813~218.0、13.50~432.0、12.50~400.0 mg·L-1内与峰面积呈良好的线性关系（r≥0.999 3,n=6）,提取回收率均在97.2%~101.2%内。结论该方法可做为活络效灵丹中丹参酮类和乳香酸类化学成分的含量测定方法,为其质量控制提供参考依据。展开更多
基金Supported by the Capital Health Research and Development of Special,No.CH2018-2-2092.
文摘BACKGROUND Patients with lupus nephritis(LN)typically undergo long-term treatment with glucocorticoids(GCs)and immunosuppressants.There is a growing demand for optimal therapy with better remission results and fewer side effects.Sustained traditional Chinese medicine(TCM)might be quite valuable for multitarget therapy,reducing the total dosage of GCs and minimizing the side effects of immunosuppressants.AIM To evaluate whether Dan Bai Xiao Formula(DBXF)can reduce the exposure to GCs and cyclophosphamide(CYC)and to assess the efficacy and safety of DBXF for the resolution of proteinuria and hematuria in children with LN.METHODS A 24-wk pilot study was conducted at Beijing Children’s Hospital.Children with active LN were divided into either a TCM group or a control group.Children in the TCM group received DBXF combined with GCs and CYC,and the ones in the control group received GCs and CYC every 4 wk for 24 wk.The primary endpoints of this trial were urinary protein excretion of<150 mg/d and normal serum albumin concentration and renal function.RESULTS The trial included 78 children,of whom 38 received GCs and CYC treatment(control group)and the remaining 40 received DBXF combined with GCs and CYC treatment(TCM group).At week 24,the TCM group showed a better rate of complete remission(42.5%);however,there was no significant difference compared with the control group(31.5%,P>0.05).The urine red blood cell count and urine protein level were significantly lower in the TCM group than in the control group at weeks 4,12,and 24(P<0.05).Furthermore,patients in the TCM group had a lower proportion of methylprednisolone pulses than those in the control group(1.30±1.41 vs 3.05±2.02,P<0.0001).The ending GC dose was significantly lower in the TCM group than in the control group(P<0.001).Moreover,more hepatic function damage,gastrointestinal adverse effects,and hypertension were observed in the control group than in the TCM group(P<0.05).CONCLUSION The findings suggest that DBXF treatment is effective and safe as a supplementary therapy for LN and is superior to routine GC and CYC therapy.DBXF containing combination treatment possibly results in a faster resolution of proteinuria and hematuria,smoother GC reduction,fewer methylprednisolone pulses,and fewer adverse events.
