五苓散合玉屏风散加减治疗儿童过敏性紫癜肾炎肾病型随机对照研究

Randomized Controlled Trial of Modified Wuling Powder and Yupingfeng Powder on the Treatment of Henoch Schönlein Purpura Nephritis with Nephrotic Syndrome in Children

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DOI：10.7661/j.cjim.20220805. 059

中文关键词: 儿童过敏性紫癜肾炎肺脾气虚五苓散玉屏风散疗效观察

英文关键词:children Henoch Schönlein purpura nephritis Fei and Pi qi deficiency syndrome Wuling Powder Yupingfeng Powder efficacy observation

基金项目:北京市属医院科研培育计划项目（No. PZ2019029）

作者	单位
杨阳，陈芳，刘畅，舒静	国家儿童医学中心，首都医科大学附属北京儿童医院中医科（北京 100045）

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中文摘要:

目的评价中药五苓散合玉屏风散加减联合西药治疗儿童过敏性紫癜肾炎肾病型（肺脾气虚证）的有效性与安全性。方法纳入88例过敏性紫癜肾炎肾病型（肺脾气虚证）患儿，按1：1比例随机分为对照组和治疗组，每组44例。对照组采用糖皮质激素联合环磷酰胺等西医常规治疗，治疗组在西医常规治疗基础上给予中药五苓散合玉屏风散加减治疗，疗程12周。评价两组中医证候疗效、24 h尿蛋白定量、尿红细胞计数、肾小管功能、血脂改善情况及安全性。结果治疗过程中脱落5例（治疗组3例，对照组2例），共完成观察83例，治疗组41例，对照组42例。治疗组第4、8周尿蛋白有效率分别为87.80%（36/41）、95.12%（39/41），高于同期对照组的64.29%（27/42）、80.95%（34/42）（U分别为2.16、2.51，P分别为0.034，0.014）；治疗组第8周尿红细胞有效率75.61%（31/41），高于对照组59.52%（25/42）（U=2.30，P=0.024）；治疗组第4、8、12周中医证候疗效有效率分别为80.49%（33/41）、92.68%（38/41）、95.12%（39/41），均高于同期对照组的66.67%（28/42）、73.81%（31/42）、83.33%（35/42）（U分别为2.17、3.07、2.73，P分别为0.033、0.003、0.008）。与本组治疗前比较，两组治疗后4、8、12周24 h尿蛋白定量、尿红细胞计数、尿肾小管标志蛋白[N-乙酰-β-D-氨基葡糖酶（NAG）、尿α1-微球蛋白（α1-MG）]均降低（P<0.05），血白蛋白升高（P<0.05）。与对照组同期比较，治疗组第12周24 h尿蛋白定量降低（P<0.01），第8周尿红细胞计数降低（P<0.05），第4、8周NAG降低，12周尿α1-MG降低（P<0.05），第8周甘油三酯降低（P<0.05）。结论中药五苓散合玉屏风散加减联合西药治疗儿童过敏性紫癜肾炎肾病型（肺脾气虚证）能改善临床症状，降低蛋白尿及血尿，改善肾小管功能及高脂血症。

英文摘要:

Objective To evaluate the clinical efficacy and safety of modified Wuling Powder and Yupingfeng Powder combined with Western medicine in the treatment of Henoch Sch?nlein purpura nephritis with nephrotic syndrome（Fei and Pi qi deficiency syndrome）in children. Methods Totally 88 children with Henoch Sch?nlein purpura nephritis with nephrotic syndrome（Fei and Pi qi deficiency syndrome）were randomly assigned to the treatment group（44 cases）and the control group（44 cases） in the ratio of 1： 1. All patients received glucocorticoids and cyclophosphamide as the conventional treatment， while those in the treatment group took Chinese medicine（CM）modified Wuling Powder and Yupingfeng Powder additionally. The course of treatment was 12 weeks. The effectiveness of CM syndromes， 24 h urine protein， urinary erythrocyte count， renal tubular function and blood lipid as well as the safety were evaluated in the two groups. Results Five cases dropped out （3 cases in the treatment group and 2 cases in the control group）and 83 cases were available，41 cases in the treatment group and 42 cases in the control group. In the 4th and 8th week， the effective rate of proteinuria in the treatment group were 87.80%（36/41） and 95.12% （39/41）， higher than those of 64.29% （27/42） and 80.95%（34/42） in the control group（U=2.16，2.51，P=0.034， 0.014）. In the 8th week， the effective rate of urinary erythrocyte count was 75.61%（31/41）in the treatment group， higher than that in the control group [59.52% （25/42），U=2.30，P=0.024]. The effective rate of CM syndromes in the 4th， 8th，and 12th week were 80.49%（33/41）， 92.68%（38/41），and 95.12%（39/41） in the treatment group，respectively. There are 66.67%（28/42）， 73.81%（31/42）， and 83.33%（35/42）in the control group，respectively. All were superior in the treatment group（U=2.17，3.07，2.73，P=0.033， 0.003， 0.008）. Compared with the same group before treatment， 24 h urine protein， urinary erythrocyte count and renal tubular marker protein（NAG， α1-MG）decreased （P<0.05）， and serum albumin increased（P<0.05）in the two groups. Compared with the control group in the same period， 24 h urine protein in the treatment group decreased in the 12th week （P<0.01），urinary erythrocyte count decreased in the 8th week（P<0.05），NAG decreased in the 4th and 8th week，α1-MG decreased in the 12th week（P<0.05）， and triglyceride decreased in the 8th week（P<0.05）. Conclusion Modified Wuling Powder and Yupingfeng Powder combined with Western medicine were effective for the treatment of Henoch Sch?nlein purpura nephritis with nephrotic syndrome（Fei and Pi qi deficiency syndrome）in children， which could improve the clinical symptoms， reduce proteinuria and hematuria， and regulate renal tubular function and lipid profiles.

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