益气养阴法治疗慢性肾炎的临床研究

【作者】 李小军；

【导师】 李明权；

【作者基本信息】 成都中医药大学 ， 中西医结合临床， 2008， 硕士

【摘要】 目的:初步研究益气养阴法治疗慢性肾炎气阴两虚证的有效性及安全性。方法:根据本研究的诊断纳入与排除标准,选取慢性肾炎气阴两虚证患者48例,按1:1随机分为肾康胶囊组(治疗组)和肾炎康胶囊组(对照组),进行随机、双盲、对照试验。治疗组口服肾康胶囊,每日2次,每次2粒;对照组口服肾炎康,每日2次,每次2粒,疗程均为8周。结果:慢性肾炎的疗效比较,全分析数据集(FAS)分析结果显示,治疗组的临床控制率为9.1%(2/22),显效率为27.3%(6/22),总有效率为59.1%(13/22);对照组分别为8.3%(2/24)、4.2%(1/24)和45.8%(11/24);符合方案集(PP)数据分析结果显示,治疗组的临床控制率为11.1%(2/18),显效率为33.3%(6/18),总有效率为72.2%(13/18);对照组分别为10.0%(2/20)、5.0%(1/20)和55.0%(11/20),两组间差异均无统计学意义(P＞0.05)。气阴两虚中医证候疗效比较,FAS分析结果显示,治疗组对气阴两虚证的愈显率为22.7%(5/22),总有效率为59.1%(13/22),对照组分别为20.8%(5/24)和45.8%(11/24);PP结果显示,治疗组对气阴两虚证的愈显率为31.3%(5/16),总有效率为81.3%(13/16),对照组分别为26.3%(5/19)和57.9%(11/19),两组间差异无统计学意义(P＞0.05)。结论:肾康胶囊的疗效与肾炎康相比,其差异无统计学意义,未发现其明显的毒副作用。更多还原

【Abstract】 Objective:To research primarily the effectivess and safety of profit Qi raises the Yin method in treat chronic glomerulonephrit for Qiyinliangxu syndrome.Methods:A double blind,double dummy and randomized controlled method was adopted.A total of 48 patients were randomized to the treatment group(Shenkang capsule,2 capsules, twice a day) and the control group(Shenyankang capsule,2 capsules,twice a day).The therapeutic course for both groups was 8 weeks.Results:All the results were analyzed on the basis of full analysis sets(FAS) and per-protocol-population(PP).For effect of chronic glomerulonephrit is in the treatment group, the clinical control rates were 9.1%(2/22) with FAS analysis and 11.1%(2/18) with PP analysis;good mi provement rates were 27.3%(6/22) with FAS analysis and 33.3%(6/18) with PP analysis;the total effective rates were 59.1%(13/22) and 72.2%(13/18).In the control group,the clinical control rates were 8.3%(2/24) with FAS analysis and 10.0%(2/20) with PP analysis respectively;the good mi provement rates were 4.2%(1/24) with FAS analysis and 5.0%(1/20) with PP analysis respectively;the total effective rates were 45.8%(11/24) with FAS analysis and 55.0%(11/20) with PP analysis.There was no statistical difference between the two groups(P＞0.05).For Qiyinliangxu syndrome mi provement in the treatment group,the clinical control rate and good mi provement rate were 22.7%(5/22) with FAS analysis and 31.3%(5/16) with PP analysis respectively;the total effective rates were 59.1%(13/22) with FAS analysis and 81.3%(13/16) with PP analysis respectively;In the control group,the clinical control rate and good mi provement rate were 20.8%(5/24) with FAS analysis and 26.3%(5/19) with PP analysis respectively;the total effective rates were 45.8%(11/24) with FAS analysis and 57.9%(11/19) with PP analysis respectively.The results showed no statistical difference between the two groups(P＞0.05).No adverse effects were found.Conclusions:No statistical difference was detected between Shengkang capsule and Shenyan capsule groups.No obvious toxic adverse effects were found.更多还原