中药配方颗粒与传统汤剂用于重度糖尿病肾病的疗效及安全性综合分析

Effect of Traditional Decoction and Chinese Medicine Granule for Severe Diabetic Nephropathy and Its Security

目的:探讨中药配方颗粒与传统汤剂用于重度糖尿病肾病的疗效,并分析其安全性。方法:收集2012年2月—2015年1月来本院就诊的重度糖尿病肾病患者104例,随机分为试验组和对照组,每组52例,两组患者统一给予常规西医对症治疗、针灸疗法和中医辨证论治方,试验组额外给予中药配方颗粒口服治疗,对照组给予传统汤剂治疗,观察两组患者治疗后疗效及安全性差异。结果:两组患者治疗前中医证候积分、血糖、肾功能、血清相关因子水平均相近,差异无统计学意义(P>0.05);试验组治疗后中医证候积分、血糖、血肌酐、血尿素氮、血清25(OH)D3和IGF-1水平及不良反应发生率均低于对照组,而GFR和治疗有效率均高于对照组,分别经卡方检验或t检验比较,差异均有统计学意义(P<0.05)。结论:中药配方颗粒治疗重度糖尿病肾病具有更好的疗效和安全性。

Objective：To explore the traditional decoction and Chinese medicine granule for treatment of severe diabetic nephropathy and analyze its security.Methods：From February 2012 to January 2015 in our hospital,104 cases of severe diabetic nephropathy patients were randomly divided into experimental group and control group,52 cases in each group.Two groups were given conventional western medicine symptomatic treatment,acupuncture and TCM.The experimental group was given the Chinese medicine granule orally and the control group was given traditional decoction.We observed the safety and efficacy between two groups after treatment.Results：Two groups＇ symptom scores,blood glucose,renal function,serum levels of cytokines were similar before treatment（P〈0.05）.The experimental group＇s TCM syndrome integral,blood glucose,serum creatinine,blood urea nitrogen,serum 25-（OH）-D3 and IGF-1 levels and adverse reaction rate after treatment were lower than those of the control group,while the GFR and the effective rate of treatment was higher than that of control group.Respectively by chi square test or t test,the differences were statistically significant（P〈0.05）.Conclusion：The traditional Chinese medicine granule has better efficacy and safety in the treatment of severe diabetic nephropathy.