中医阶梯方案治疗儿童过敏性紫癜性肾炎的多中心临床研究

丁樱; 翟文生; 任献青; 张霞; 刘建平; 何丽云; 徐虹; 黄文彦; 俞建; 张颖; 孙利; 吴滢; 吕晓颖; 肖慧捷; 孙香娟; 何平; 韩姗姗; 王龙; 代彦林

doi:10.3969/j.issn.1006-2157.2023.04.003

您当前的位置：

首页 >

文章列表页 >

中医阶梯方案治疗儿童过敏性紫癜性肾炎的多中心临床研究

“有故无殒”专题 | 更新时间：2023-05-09

- 中医阶梯方案治疗儿童过敏性紫癜性肾炎的多中心临床研究
- Treatment of pediatric Henoch-Schönlein purpura nephritis by a stepwise Chinese medicine scheme: a multicenter clinical study
- 北京中医药大学学报 2023年46卷第4期页码：456-466
- 作者机构：
  
  1.河南中医药大学儿科医学院　郑州　450046
  2.河南中医药大学第一附属医院
  3.北京中医药大学循证医学中心
  4.中国中医科学院中医临床基础医学研究所
  5.复旦大学附属儿科医院
  6.上海市儿童医院
  7.北京大学第一医院
  8.成都中医药大学
  9.云南中医药大学第一附属医院
- 作者简介：
  
  Prof.DING Ying, Master of Chinese Medicine, Chief Physician, Doctoral Supervisor.School of Pediatrics, Henan University of Chinese Medicine, No.1, Jinshui Road, Jinshui District, Zhengzhou 450046.E-mail: dingying3236@ sina.com
- 基金信息：
  
  “十二五”国家科技支撑计划项目(2013BAI02B07)
- DOI：10.3969/j.issn.1006-2157.2023.04.003
  中图分类号： R272.6
- 收稿日期：2022-12-23，
  
  纸质出版日期：2023-04-30
- 稿件说明：
移动端阅览
丁樱, 翟文生, 任献青, 等. 中医阶梯方案治疗儿童过敏性紫癜性肾炎的多中心临床研究[J]. 北京中医药大学学报, 2023,46(4):456-466.

DING Ying, ZHAI Wensheng, REN Xianqing, et al. Treatment of pediatric Henoch-Schönlein purpura nephritis by a stepwise Chinese medicine scheme: a multicenter clinical study[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(4): 456-466.
丁樱, 翟文生, 任献青, 等. 中医阶梯方案治疗儿童过敏性紫癜性肾炎的多中心临床研究[J]. 北京中医药大学学报, 2023,46(4):456-466. DOI： 10.3969/j.issn.1006-2157.2023.04.003.

DING Ying, ZHAI Wensheng, REN Xianqing, et al. Treatment of pediatric Henoch-Schönlein purpura nephritis by a stepwise Chinese medicine scheme: a multicenter clinical study[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(4): 456-466. DOI： 10.3969/j.issn.1006-2157.2023.04.003.

摘要

目的

探寻儿童过敏性紫癜性肾炎(HSPN)(非肾病水平的蛋白尿)疗效明显且安全性较高的中医治疗方案。

方法

采用前瞻性多中心的分层随机对照试验方案，将诊断为HSPN的316例患儿分为中医组(轻型132例、重型83例)和西医组(轻型60例、重型41例)。中医组的治疗方案为雷公藤多苷＋丹参酮ⅡA磺酸钠注射液＋清热止血方，中医轻型组的雷公藤多苷起始剂量为1.5 mg/(kg·d)，中医重型组的雷公藤多苷起始剂量为2 mg/(kg·d)。西医轻型组的治疗方案为低分子肝素钙＋贝那普利＋双嘧达莫＋中药模拟剂，西医重型组在西医轻型组的基础上加用泼尼松。治疗12周，随访36周，比较4周、12周2个治疗节点的尿蛋白、尿红细胞疗效；此外，在随访结束48周时统计复发率，12周治疗期结束后统计不良反应发生率。

结果

尿蛋白疗效方面，4周和12周时，中医组较西医组、中医轻型组较西医轻型组、中医重型组较西医重型组可降低尿蛋白(

0.01)。尿红细胞疗效方面，4周和12周时，中医组较西医组、中医轻型组较西医轻型组、中医重型组较西医重型组可降低尿红细胞(

0.01)。复发率方面，中医组与西医组、中医轻型组与西医轻型组、中医重型组与西医重型组比较，差异无统计学意义。不良反应发生率方面，中医组低于西医组、中医重型组低于西医重型组(

0.01)，中医轻型组与西医轻型组比较，差异无统计学意义。

结论

不论是轻型还是重型HSPN均可单独使用中医综合方案以减轻蛋白尿和血尿，且中医综合方案起效更早，不良反应也少于西医组。中医以雷公藤多苷为主配合中药清热止血方辨证用药的阶梯治疗方案疗效肯定，不良反应少，值得临床推广。

Abstract

Objective

To investigate the safety and efficacy of a traditional Chinese medicine (TCM) treatment of pediatric Henoch-Schönlein purpura nephritis (HSPN) (proteinuria below the nephrotic level).

Methods

This study was a prospective multicenter stratified randomized controlled trial. In total

316 children diagnosed with HSPN were divided into the Chinese medicine group (mild:

=132; severe:

=83) and the Western medicine group (mild:

=60; severe:

=41). Patients in the Chinese medicine group were treated with tripterygium wilfordii multiglucoside + sulfotanshinone sodium injection+

Qingre Zhixue

Formula

the starting dose of tripterygium wilfordii multiglucoside for the Chinese medicine mild group was 1.5 mg/(kg·d)

while that for the Chinese medicine severe group was 2 mg/(kg·d). Patients in the Western medicine mild group were treated with low-molecular-weight heparin calcium + benazepril + dipyridamole + a TCM simulator. In addition

patients in the Western medicine severe group received prednisone. The patients were treated for 12 weeks and followed up for 36 weeks. The urinary protein levels and urinary red blood cell (RBC) count were investigated in the 4th week and the 12th week. In addition

the recurrence rate at the end of 48 weeks of follow-up was calculated

and the incidence of adverse events at the end of 12 weeks of treatment was calculated.

Results

The urinary protein levels in the Chinese medicine group

the Chinese medicine mild group and the Chinese medicine severe group at the 4th week and the 12th week were significantly lower than in the Western medicine group

the Western medicine mild group and the Western medicine severe group (

0.01). The urinary RBC counts in the Chinese medicine group

the Chinese medicine mild group and the Chinese medicine severe group at the 4th week and the 12th week were significantly lower than in the Western medicine group

the Western medicine mild group and the Western medicine severe group (

0.01). No significant difference in recurrence rate was found between the Chinese medicine group and the Western medicine group

between the Chinese medicine mild group and the Western medicine mild group

or between the Chinese medicine severe group and the Western medicine severe group. The incidence of adverse events was lower in the Chinese medicine group than in the Western medicine group

and it was lower in the Chinese medicine severe group than in the Western medicine severe group (

0.01)

but there was no significant difference between the Chinese and Western medicine mild groups.

Conclusion

Chinese medicine alone can be used to reduce urinary protein levels and urinary RBC counts in both mild and severe HSPN. The effect of Chinese medicine on proteinuria was quicker than that of Western medicine

and the incidence of adverse events was significantly lower in the Chinese medicine group than in the Western medicine group. The stepwise Chinese medicine scheme

which is mainly based on tripterygium wilfordii multiglucoside combined with

Qingre Zhixue

Formula

shows an excellent curative effect and fewer adverse events

indicating it is worthy of clinical promotion.

关键词

Keywords

references

JENNETTE JC , FALK RJ , BACON PA , et al . 2012 revised international chapel hill consensus conference nomenclature of vasculitides [J]. Arthritis Rheum , 2013 , 65 ( 1 ): 1 － 11 .

RUPERTO N , OZEN S , PISTORIO A , et al . EULAR/PRINTO/PRES criteria for Henoch-Schonlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part Ⅰ：Overall methodology and clinical characterisation [J]. Ann Rheum Dis , 2010 , 69 ( 5 ): 790 － 797 .

PIRAM M , MALDINI C , BISCARDI S , et al . Incidence of IgA vasculitis in children estimated by four-source capture-recapture analysis: a population-based study [J]. Rheumatology (Oxford) , 2017 ， 56 ( 8 ): 1358 － 1366 .

GARDNER-MEDWIN JM , DOLEZALOVA P , CUMMINS C , et al . Incidence of Henoch-Schönlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins [J]. Lancet , 2002 , 360 ( 9341 )： 1197 － 1202 .

STEWART M , SAVAGE JM , BELL B , et al . Long term renal prognosis of Henoch-Schönlein purpura in an unselected childhood population [J]. Eur J Pediatr , 1988 , 147 ( 2 )： 113 － 115 .

RONKAINEN J , NUUTINEN M , KOSKIMIES O . The adult kidney 24 years after childhood Henoch-Schönlein purpura: a retrospective cohort study [J]. Lancet , 2002 , 360 ( 9334 ): 666 － 670 .

KAWASAKI Y , SUYAMA K , HASHIMOTO K , et al . Methylprednisolone pulse plus mizoribine in children with Henoch-Schoenlein purpura nephritis [J]. Clin Rheumatol , 2011 ( 30 )： 529 － 535 .

HAYCOCK GB . The treatment of glomerulonephritis in children [J]. Pediatr Nephrol , 1988 , 2 ( 2 )： 247 － 255 .

NIAUDET P , HABIB R . Methylprednisolone pulse therapy in the treatment of severe forms of Schönlein-Henoch purpura nephritis [J]. Pediatr Nephrol , 1998 ， 12 ( 3 ): 238 － 243 .

COPPO R , MAZZUCCO G , CAGNOLI L , et al . Long-term prognosis of Henoch-Schönlein nephritis in adults and children. Italian Group of Renal Immunopathology Collaborative Study on Henoch-Schönlein purpura [J]. Nephrol Dial Transplant , 1997 , 12 ( 11 ): 2277 － 2283 .

COUNAHAN R , WINTERBORN MH , WHITE RH , et al . Prognosis of Henoch-Schönlein nephritis in children [J]. Br Med J , 1977 , 2 : 11 － 14 .

韩姗姗，丁樱，代彦林，等．脂质代谢异常对儿童过敏性紫癜肾损伤预测价值的Meta分析 [J]. 中国全科医学， 2021 ， 24 ( 32 )： 4137 － 4144 .

刘睿，马路，李长春 . 儿童紫癜性肾炎临床与病理分析 [J]. 临床儿科杂志， 2015 ， 33 ( 6 )： 515 － 519 .

樊忠民，刘光陵，夏正坤，等．儿童紫癜性肾炎的临床病理分析 [J]. 中国全科医学， 2009 ， 12 ( 11 )： 966 － 968 .

丁樱，翟文生，任献青，等 . 雷公藤多苷联合清热止血方、香丹注射液治疗小儿紫癜性肾炎疗效观察 [J]. 中国中西医结合杂志， 2012 ， 32 ( 9 )： 1290 － 1292 .

中华医学会儿科学分会肾脏学组 . 紫癜性肾炎诊治循证指南(2016) [J]. 中华儿科杂志， 2017 ， 55 ( 9 )： 647 － 651 .

NARCHI H . Risk of long term renal impairment and duration of follow up recommended for Henoch-Schonlein purpura with normal or minimal urinary findings: a systematic review [J]. Arch Dis Child , 2005 , 90 ( 9 ): 916 － 920 .

李欣航，赵墨，冒慧敏，等．雷公藤多苷联用泼尼松治疗特发性膜性肾病临床疗效及安全性的Meta分析 [J]. 世界中西医结合杂志， 2020 ， 15 ( 5 )： 815 － 820 .

秦卫松，刘志红，曾彩虹，等．雷公藤甲素对Heymann肾炎模型足细胞病变的影响 [J]. 肾脏病与透析肾移植杂志， 2007 , 16 ( 2 )： 101 － 109 .

陈朝红，刘志红，洪亦眉，等．雷公藤甲素干预C5b－9诱导足细胞损伤的体外研究 [J]. 肾脏病与透析肾移植杂志， 2009 ， 18 ( 4 )： 310 － 317 .

王俊宏，丁樱，任献青，等．中医综合方案治疗小儿紫癜性肾炎40例对照研究 [J]. 北京中医药大学学报， 2010 ， 33 ( 9 )： 641 － 645 .

崔雅璠，丁樱，杨晓青，等 . 过敏性紫癜性肾炎患儿血清IgA1对肾小球系膜细胞增殖及TNF－α分泌的影响 [J]. 中国医药导报， 2014 , 11 ( 18 ): 17 － 21 .

崔雅璠，丁樱，杨晓青，等 . 紫癜性肾炎患儿血清IgA1通过系膜细胞－足细胞轴对足细胞增殖及TNF－α分泌的影响 [J]. 中国医药导报， 2014 , 11 ( 19 ): 7 － 11 .

朱廷富，褚祝飞，李精华 . 雷公藤多苷联合丹参注射液对过敏性紫癜性肾炎患儿凝血机制的影响 [J]. 中国中药杂志， 2016 , 41 ( 11 )： 2162 － 2167 .

蒲海波 . 雷公藤多苷联合丹参注射液治疗过敏性紫癜性肾炎患儿对凝血机制的影响及疗效评价 [J]. 中华中医药学刊， 2017 ， 35 ( 11 )： 2946 － 2950 .

姜淼，韩珊珊，张霞，等 . 雷公藤多苷片联合中药对儿童成年后生育能力影响的远期随访 [J]. 中国中药杂志， 2019 ， 44 ( 16 )： 3558 － 3561 .

浏览量

125

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

清热止血方联合雷公藤多苷对过敏性紫癜性肾炎血清源性多聚IgA诱导内皮损伤的保护作用及对NF-κB通路的影响

基于TXNIP/NLRP3/Caspase-1通路探讨清热止血方联合雷公藤多苷治疗过敏性紫癜性肾炎模型大鼠的作用机制

从“机态辨识”立论的乳腺癌中医平衡调治理念与策略

基于临界慢化理论的中医“未病”状态识别建模研究初探

儿童过敏性紫癜性肾炎中西医结合诊疗指南(2023)