Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome:A randomized, double-blind, placebo controlled trial

HONG Yan; FENG Feng; DONG Qiu; SUN Ruitao

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Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome:A randomized, double-blind, placebo controlled trial

更新时间：2022-08-31

- Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome:A randomized, double-blind, placebo controlled trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 52, Issue 1, Pages: 43-47(2018)
- 作者机构：
  
  1. 上海市同济医院中医科,上海,200065
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HONG Yan, FENG Feng, DONG Qiu, et al. Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome:A randomized, double-blind, placebo controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 52(1):43-47(2018)
DOI：

HONG Yan, FENG Feng, DONG Qiu, et al. Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome:A randomized, double-blind, placebo controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 52(1):43-47(2018) DOI：

摘要

目的：观察加味补阳还五颗粒治疗难治性肾病综合征的临床疗效。方法：将80例难治性肾病综合征患者随机分为治疗组与对照组,每组40例。治疗组予西医基础治疗+加味补阳还五颗粒,对照组予西医基础治疗+安慰剂。两组疗程均为6个月,观察临床疗效及用药安全性,比较24 h尿蛋白定量、肾功能、血浆白蛋白、血脂、凝血指标、肝功能及中医证候积分的变化情况。结果：①治疗组、对照组临床总有效率分别为87.5%、77.5%；组间临床疗效比较,治疗组明显优于对照组(P＜0.05)。②组间治疗后比较,中医证候积分差异有统计学意义,治疗组积分明显低于对照组(P＜0.05)。③两组治疗期间各随访时间点与治疗前比较,24 h尿蛋白定量均差异有统计学意义(P＜0.05)；组间同期比较,治疗16周起,24 h尿蛋白定量差异开始有统计学意义(P＜0.05)。④治疗前后组内比较,两组BUN、Scr、ALB、TG、TC、LDL水平差异均有统计学意义(P＜0.05)。组间治疗后比较,治疗组较对照组的BUN、Scr、TG、TC、LDL下降更加明显(P＜0.05),血ALB提高更加明显(P＜0.05)。组间治疗后比较,FIB、D-D水平差异有统计学意义,治疗组明显低于对照组(P＜0.05)。⑤组间不良反应发生率比较,差异有统计学意义,治疗组明显低于对照组(P＜0.05)。结论：加味补阳还五颗粒治疗难治性肾病综合征,可明显减少蛋白尿,提高血浆白蛋白水平,纠正脂质代谢紊乱,改善血液高凝状态,保护肾功能。

Abstract

Objective:To observe the clinical efficacy of Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome(RNS). Methods80 RNS patients were randomly divided into the treatment group and control group, 40 cases in each group. The treatment group was treated with the basic therapy of western medicine and Modified Buyang Huanwu Granule,the control group was treated with the basic therapy of western medicine and placebo,with a course of 6 months. The clinical efficacy and medication safety were observed. The changes on the 24 hours urine protein quantitation,renal function indexes,plasma albumin,blood lipid indexes,coagulation indexes,liver function indexes and Chinese medical syndrome score were compared. Results:①The clinical total effective rates of the treatment and control group were 87.5% and 77.5% respectively,and the clinical efficacy of the treatment group was obviously better than that of the control group(P＜0.05). ②After treatment,there was statistically significant difference on Chinese medical syndrome score between the two groups,and the score of the treatment group was obviously lower than that of the control group(P＜0.05). ③Compared with treatment before,the level of 24 hours urine protein quantitation at each timepoint during treatment was obviously decreased in both groups,with statistically significant differences(P＜0.05). From the 16th week of treatment,there were statistically significant differences on the level of 24 hours urine protein quantitation at same timepoint between the control group and treatment group(P＜0.05). ④In both groups,there were statistically significant differences on the levels of BUN,Scr,ALB,TG,TC and LDL between treatment before and after(P＜0.05). After treatment,the levels of BUN,Scr,TG,TC and LDL in the treatment group were significantly lower than those in the control group(P＜0.05),and the level of ALB in the treatment group was significantly higher than that in the control group(P＜0.05). After treatment,there were statistically significant differences on the levels of FIB and D-D between the control group and treatment group,and the levels in the treatment group were obviously lower than those in the control group(P＜0.05). ⑤There was statistically significant difference on incidence rate of adverse reactions between the two groups,and the incidence rate of the treatment group was obviously lower than that of the control group(P＜0.05). Conclusion:Modified Buyang Huanwu Granule in the treatment of refractory nephropathy syndrome can significantly reduce the proteinuria,increase the plasma albumin level,alleviate the disorder of lipid metabolism,improve the blood hypercoagulability and protect the renal function.

关键词

难治性肾病综合征补阳还五汤随机对照试验安慰剂盲法

Keywords

refractory nephropathy syndromeBuyang Huanwu Decoctionrandomized controlled trialplaceboblind trial

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