摘要
目的:观察扶正祛浊口服液对慢性肾脏病3期(CKD3期)患者肾功能减退的影响。方法:采用随机前瞻、单盲、安慰剂对照、双中心的试验,治疗组和对照组按1∶1分配。共纳入120例患者,均予优质低蛋白饮食、控制血压、保持电解质及酸碱平衡、纠正贫血等合并症的基础治疗,治疗组加服扶正祛浊口服液20ml,每日3次,对照组予安慰剂20ml/次,每日3次;疗程为6个月。比较两组患者观察期内中医证侯积分、血清肌酐(Scr)、估算的肾小球滤过率(eGFR)、b值、尿蛋白排泄量变化、进入CKD4期比例、与CKD相关住院次数及血红蛋白、血清白蛋白、谷丙转氨酶变化。结果:3例排除,观察期内脱落17例(其中治疗组4例,安慰剂对照组13例);符合并完成试验病例100例(治疗组55例,对照组45例)。与安慰剂组比较,治疗组进入CKD4期及与CKD相关住院风险明显降低,eGFR、Scr、蛋白尿量、中医证侯积分均有改善(P<0.05),且无严重不良反应。结论:扶正祛浊口服液可以有效的延缓CKD3期患者肾功能减退速度,改善患者临床症状,且安全可靠。
To evaluate the efficacy of Fu - zheng - qu - zhuo （FZQZ） Oral liquid on renal function decline in patients of Chronic Kidney Disease （CKD） stage 3. Methods：one hundred and twenty patients were recruited, which were dived into 2 groups （ FZQZ and placebo Group, 60 respectivly） in a randomized, single blind, placebo - control, two -centre clinical design, FZQZ Oral liquid or placebo 20 ml erery time, three times a clay for different Group. Meanwhile, patients accept basic treatment pro tocols as low protein diet, blood control, electrolytes and acid -base balance and anemia ameliorated, 6 months therapeutic period. TCM syndrome scores, serum creatinine, eGFR, b value, Urine protein （UTP）, hemoglobin, serum albumin and glutamate pyruvate transaminase were compared between the Groups and before and after treatment, cases progressed to CKD stage 4 and hospitalization times related to CKD were compared between the Groups too. Results ：Three patients evacuated, seventeen patients fall off, four from FZQZ Group and thirteen from Placebo Group. One hundred patients consistent with inclusion Criteria and accomplish the trial, fifty - five of FZQZ Group and forty - five of Placebo Group. Compared to Placebo Group, the risk of progressed to CKD stage 4 and hos- pitalization related to CKD were decrease in FZQZ Group, eGFR, Scr, UTP and TCM syndrome scores were improved too （P 〈 0.05 ）, furthermore, no severer adverse reaction reported. Conclusion： FZQZ Oral liquid has effect in delay the progress of renal func- tion decline in patients of CKD stage 3, and the medicine is safety.
出处
《中国中西医结合肾病杂志》
2013年第8期677-681,共5页
Chinese Journal of Integrated Traditional and Western Nephrology
基金
首都医学发展基金(中医药类)自主创新项目(No.SF-2009-Ⅲ-01)
关键词
慢性肾脏病3期
扶正祛浊口服液
随机对照试验
Chronic kidney disease （CKD） stage 3 Fuzhengquzhuo oral liquid Randomized control trail
