过敏煎加减治疗紫癜性肾炎的随机对照多中心临床研究  

Randomized controlled multicenter clinical study of allergic decoction in the treatment of Henoch-Schonlein Purpura Nephritis

作　　者：王贺勇[1] 陈扬[1] 杨兰[1] 周靖颖 黄尚文 何剑川 何倩 蒋廷 何小平[1] WANG Heyong;CHEN Yang;YANG Lan(Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine,Chengdu 610042,China)

机构地区：[1]四川省中西医结合医院,四川成都610041

出　　处：《四川中医》2025年第2期118-122,共5页Journal of Sichuan of Traditional Chinese Medicine

基　　金：四川省中医药管理局科研专项项目(编号:2020LC0191)。

摘　　要：目的:评价过敏煎加减对紫癜性肾炎(气虚热毒血瘀证)患者的临床疗效及安全性。方法:采用随机对照多中心临床试验的设计方法,将3家医院气虚热毒血瘀证的紫癜性肾炎患者256例,按照1∶1比例随机分为治疗组128例,对照组128例。两组均给予西医基础治疗,治疗组在西医治疗基础上联合应用过敏煎加减,疗程3个月。结果:两组患者在基线病情等指标均具有可比性,治疗随访期间因患者依从性差等原因脱落24例,最终完成232例,对照组120例,治疗组112例。治疗组总有效率明显高于对照组(P<0.05)。与治疗前比较,两组治疗后中医证候积分、尿红细胞计数、尿蛋白定量、IgA、IgG、IgM、补体C3、补体C4、IL-4、IL-21水平均明显降低(P<0.05);治疗后,治疗组中医证候积分及相关实验室指标均明显低于对照组(P<0.05);两组安全性比较,差异无统计学意义(P>0.05)。结论:过敏煎加减治疗紫癜性肾炎(气虚热毒血瘀证)能提高临床疗效、改善临床症状、纠正机体免疫功能紊乱,安全性良好。Objective:To evaluate the clinical efficacy and safety of allergic decoction in the treatment of patients with Henoch-Schonlein purpura nephritis(Qi deficiency and heat toxin blood stasis syndrome).Methods:A randomized controlled multi-center clinical trial design method was used to randomly divide 256 patients with purpura nephritis of qi deficiency,heat toxin and blood stasis syndrome in 3hospitals into 128 patients in the treatment group and 128patients in the control group according to the 1∶1 ratio.Both groups were given basic treatment of western medicine,and the treatment group was treated with modified Guominjian on the basis of western medicine,with a course of 3months.Results:The two groups of patients were comparable in baseline conditions and other indicators.During the follow-up period,24 cases were lost due to poor patient compliance,and 232cases were finally completed,120 cases in the control group and 112 cases in the treatment group.The total effective rate of the treatment group was significantly higher than that of the control group(P<0.05).Compared with before treatment,the levels of TCM syndrome score,urinary red blood cell count,urinary protein quantification,IgA,IgG,IgM,complement C3,complement C4,IL-4 and IL-21 in the two groups were significantly decreased after treatment(P<0.05).After treatment,the TCM syndrome scores and related laboratory indexes in the treatment group were significantly lower than those in the control group(P<0.05).There was no significant difference in safety between the two groups(P>0.05).Conclusion:Modified Guomin Decoction in the treatment of Henoch-Schonlein purpura nephritis(qi deficiency,heat toxin and blood stasis syndrome)can improve clinical efficacy,improve clinical symptoms,correct immune dysfunction,and has good safety.

关 键 词：过敏煎 紫癜性肾炎 中医 随机 气虚热毒血瘀 对照 多中心 临床研究 

分 类 号：R256.5[医药卫生—中医内科学]