肾康胶囊治疗慢性肾炎气阴两虚的随机双盲阳性药对照试验

目的评价肾康胶囊治疗慢性肾炎气阴两虚证的有效性和安全性.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96例,按3:1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,意向性分析(ITT)结果显示,治疗组的临床控制率为12.86%(9/70),显效率为12.86%(9/70),总有效率为 48.58%(34/70);对照组分别为4.17%(1/24)、4.17%(1/24)和45.83%(11/24);符合方案数据分析(PP)结果显示,治疗组的临床控制率为14.75%(9/61),显效率为14.75%(9/61),总有效率为 55.73%(34/61);对照组分别为5.00%(1/20)、5.00%(1/20)和55.00%(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, ITT分析结果显示,治疗组对气阴两虚证的控显率为18.57%(13/70),总有效率为81.43%(57/70),对照组分别为20.85%(5/24)和75.00%(18/24);PP结果显示,治疗组对气阴两虚证的控显率为21.31%(13/61),总有效率为93.44%(57/61),对照组分别为25.00%(5/20)和85.00%(17/20),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.

Shenkang Capsule in the Treatment of Chronic Glomerulonephritis (Qiyinliangxu Syndrome): A Double Blind, Randomized Controlled Trial

Objective To assess the effectivess and safety of Shenkang capsule in the treatment of chronic glomerulonephritis (Qiyinliangxu Syndrome). Methods A double blind, double dummy and randomized controlled method was adopted. A total of 96 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 2 months. Results All the results were analyzed on the basis of intention-to-treat(ITT) and per-protocol-population(PP). For effect of chronic glomerulonephritis in the treatment group, the clinical control rates were 12.86% (9/70) with ITT analysis and 14.75% (9/61) with PP analysis; the good improvement rates were 12.86% (9/70) with ITT analysis and 14.75% (9/61) with PP analysis; the total effective rates were 48.58% (34/70) and 55.73% (34/61). In the control group, the clinical control rates were 4.17% (1/24) with ITT analysis and 5.00% (1/20) with PP analysis respectively; the good improvement rates were 4.17% (1/24) with ITT analysis and 5.00% (1/20) with PP analysis respectively; the total effective rates were 45.83% (11/24) with ITT analysis and 55.00% (11/20) with PP analysis. There was no statistical difference between the two groups (P>0.05). For Qiyinliangxu syndrome improvement, in the treatment group, the clinical control rate and good improvement rate were 18.57% (13/70) with ITT analysis and 21.31% (13/61) with PP analysis respectively; the total effective rates were 81.43% (57/70) with ITT analysis and 93.44% (57/61) with PP analysis respectively; In the control group, the clinical control rate and good improvement rate were 20.84% (5/24) with ITT analysis and 25.00% (5/20) with PP analysis respectively; the total effective rates were 75.00% (18/24) with ITT analysis and 85.00% (17/20) 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.