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

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(P<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(P<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(P<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。

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:n=132;severe:n=83)and the Western medicine group(mild:n=60;severe:n=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(P<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(P<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(P<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.