丹参川芎嗪治疗原发性肾病综合征的随机对照实验

Salviae Miltiorrhizae Ligustrazine Hydrochloride Injection in Treating Primary Nephrotic Syndrome: A Randomized Controlled Trial

目的:观察应用丹参川芎嗪联合泼尼松治疗原发性肾病综合征的疗效。方法:160例肾病综合征病人随机分成两组,每组80例,试验组给予丹参川芎嗪联合泼尼松治疗,对照组单用泼尼松治疗,观察12周,观察治疗后两组疗效与不良反应,并于治疗后4,8和12周检查血清白蛋白,尿蛋白定量,肾小球滤过率等指标。结果:两组治疗12周后,24 h尿蛋白定量均下降,其中试验组在治疗后尿蛋白定量与对照组有显著性差异(P<0.05),而血清白蛋白与肾小球滤过率均有不同程度升高。试验组治疗有效率86%(69/80),对照组为74%(59/80),两组差异有统计学意义(P<0.05),且试验组药物副作用小于对照组。结论:丹参川芎嗪联合泼尼松能够有效缓解肾病综合征。

Objective ：To investigate the efficacy of Salviae Mihiorrhizae Ligustrazine Hydrochloride Injection with prednisone in the treatment of primary nephritic syndrome. Methods ： One hundred and sixty primary nephrotic patients were divided into two groups randomly with 80 for each. The patients in trial group accepted Salviae Miltiorrhizae Ligustrazine Hydrochloride Injection and prednisone while those in the control group accepted prednisone isolone with a same course of 12 weeks observation. The ad- verse reactions and the concerned efficacies including serum albumin, proteinuria and glomercular filtration rate and so on were observed in the period of 4,8,12 weeks after the treatment. Results：After 12 weeks therapy, proteinuria of 24 h in both groups both decreased, and that in the trial group was much lower than that in control group （P 〈 0.05 ）. The serum albumin and glomercular filtration rate improved more or less. The efficacy rates of trial and control groups were 86% （69/80） and 74% （59/80）, showing remarkable difference clinically between them （P 〈 0.05 ）. The side effect of trial group was less than that of the control group. Conclusion：Salviae Miltiorrhizae Ligustrazine Hydrochloride Injection combined with prednisone possesses effective relief in trea- ting primary nephritic syndrome.