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优化的中医药治疗慢性肾脏病 3 期方案:一项多中心、双盲、随机对照临床试验。

Optimized project of traditional Chinese medicine in treating chronic kidney disease stage 3: a multicenter double-blinded randomized controlled trial.

机构信息

Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Chinese Medicine, Hangzhou, Zhejiang Province, China.

出版信息

J Ethnopharmacol. 2012 Feb 15;139(3):757-64. doi: 10.1016/j.jep.2011.12.009. Epub 2011 Dec 13.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Stage 3 is the key phase of chronic kidney disease. Traditional Chinese medicine (TCM) has been used for the treatment of chronic kidney disease. But a large sample trial is desirable.

MATERIALS AND METHODS

A total of 578 Chinese patients with primary glomerulonephritis in CKD stage 3 were randomly assigned to three groups: patients received TCM (TCM group), benazepril (Ben group), TCM combined with benazepril (TCM+Ben group). Patients were followed up for 24 weeks. The primary endpoint was the time to the composite of 50% increased of serum creatinine, end stage renal disease or death.

RESULTS

eGFR in the TCM and the TCM+Ben group were improved (week 24 vs. baseline, P<0.05) while eGFR in the Ben group was decreased (week 24 vs. baseline, P>0.05). 24h urinary protein excretion (UP) and urinary albumin/creatinine (UAlb/Cr) were decreased in the TCM+Ben (week 24 vs. baseline, P<0.05) and the Ben group (week 24 vs. baseline, P>0.05). UP and UAlb/Cr were increased in the TCM group to week 12, then were stable (week 24 vs. baseline, P<0.05). The hemoglobin in the TCM group was also improved (week 24 vs. baseline, P<0.05). The accumulative survival rate in the TCM+Ben group was higher than that in the TCM group and the Ben group (P=0.044). Side effects in the TCM group were the lowest in these groups (P<0.05). The patients with dry cough in the TCM+Ben group and the Ben group were increased as compared with the TCM group (P<0.05). Hyperkalemia happened less frequently in the TCM group as compared with the other two groups (P=0.052).

CONCLUSIONS

For the patients with CKD stage 3, TCM can improve eGFR and hemoglobin with lower side effects. Benazepril significantly decreased the proteinuria. Chinese medicine integrated with benazepril can ameliorate renal function and decrease proteinuria synergistically.

摘要

民族药理学相关性

第 3 期是慢性肾脏病的关键阶段。中药(TCM)已用于治疗慢性肾脏病。但需要进行大样本试验。

材料和方法

共有 578 例中国原发性肾小球肾炎慢性肾脏病 3 期患者随机分为三组:患者接受 TCM(TCM 组)、贝那普利(Ben 组)、TCM 联合贝那普利(TCM+Ben 组)。患者随访 24 周。主要终点是血清肌酐、终末期肾病或死亡的复合终点的时间。

结果

TCM 组和 TCM+Ben 组的 eGFR 得到改善(与基线相比,第 24 周,P<0.05),而 Ben 组的 eGFR 降低(与基线相比,第 24 周,P>0.05)。TCM+Ben(第 24 周与基线相比,P<0.05)和 Ben 组(第 24 周与基线相比,P>0.05)的 24 小时尿蛋白排泄量(UP)和尿白蛋白/肌酐(UAlb/Cr)降低。TCM 组的 UP 和 UAlb/Cr 在第 12 周增加,然后稳定(与基线相比,第 24 周,P<0.05)。TCM 组的血红蛋白也得到改善(与基线相比,第 24 周,P<0.05)。TCM+Ben 组的累积生存率高于 TCM 组和 Ben 组(P=0.044)。TCM 组的副作用最低(P<0.05)。TCM+Ben 组和 Ben 组的干咳患者比 TCM 组增加(P<0.05)。与其他两组相比,TCM 组低钾血症的发生频率较低(P=0.052)。

结论

对于慢性肾脏病 3 期患者,TCM 可改善肾功能,副作用较低。贝那普利可显著减少蛋白尿。中药与贝那普利联合使用可协同改善肾功能和减少蛋白尿。

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