丹参多酚酸盐联合前列地尔、谷胱甘肽延缓慢性肾脏病患者肾功能减退的小样本随机对照研究

背景：中药结合前列地尔等西药的中西医结合疗法在延缓急性肾损伤方面的作用已得到证实,但对慢性肾脏病（chronic kidney disease, CKD）肾功能减退进展的疗效尚无定论。目的：探讨规律地使用活血化瘀中药丹参多酚酸盐联合前列地尔、谷胱甘肽等西药是否具有延缓CKD患者肾功能减退的长期疗效。设计、场所、对象和干预措施：所有患者均为2004年8月~2010年10月在第二军医大学长海医院住院的符合CKD临床诊断标准的患者,共30例,肾功能分期为CKD 2~4期。采用随机、对照的试验设计方案,将30例患者分为试验组和对照组,每组15例。在常规治疗基础上,试验组每月1次静脉滴注丹参多酚酸盐、前列地尔、谷胱甘肽等中西药物治疗,每次7~10 d,1个月后重复下一疗程;对照组则采取和试验组同样的口服药物治疗,但不用丹参多酚酸盐以及前列地尔和谷胱甘肽的保守疗法。随访时间平均4年。主要结局指标：研究终点为血肌酐值较入组时增长一倍或患者进入替代治疗阶段。观察治疗前后患者血常规、电解质、血白蛋白以及血肌酐的变化以及1~4年末每组患者的留存数。结果：4年后两组患者血白细胞计数、白蛋白及电解质水平无明显变化（P〉0.05）,试验组患者血红蛋白较对照组明显升高（P〈0.01）;试验组进入研究终点的患者比例（40%,6/15）显著低于对照组（93%,14/15;P〈0.01）。结论：规律地使用丹参多酚酸盐联合前列地尔和还原性谷胱甘肽的中西医结合疗法可延缓CKD患者肾功能的恶化,阻止患者进入替代治疗阶段。

Effects of salvianolate combined with alprostadil and reduced glutathione on progression of chronic renal failure in patients with chronic kidney diseases: a long-term randomized controlled trial

BACKGROUND： Effects of traditional Chinese medicine salvianolate combined with alprostadil and reduced glutathione on delay of progression in patients with acute kidney injury has been confirmed, but the role of this combination therapy on the progression of chronic renal failure is uncertain.
OBJECTIVE： To investigate the long-term effects of regular administration of salvianolate combined with Western medicine on the progression of chronic renal failure in patients with chronic kidney diseases （CKDs）.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： The study was performed at the ward of the Nephrology Department, Changhai Hospital, Second Military Medical University from August 2004 to October 2010. Thirty patients with CKDs at stage 2 to 4 and impaired renal function were recruited and randomly assigned to a treatment group or a control group, which consisted of 15 patients in each. Based on conventional therapy with the same oral medicines in the control group, patients in the treatment group were treated with salvianolate combined with alprostadil and reduced glutathione liquid intravenously for 7 to 10 d. Patients in the control group did not receive this combination therapy. The therapy was repeated monthly in patients in the treatment group. The follow-up time was an average of four years.
MAIN OUTCOME MEASURES： Assessment of renal function, count of white blood cells, and test of serum hemoglobin, electrolytes and albumin were performed before and every year after treatment. Study endpoints were the serum creatinine level doubled from baseline or receiving replacement therapy. Number of remaining patients in each group was calculated at the end of every year.
RESULTS： White blood cell count, serum albumin and electrocyte levels changed little in two groups after four years （P〉0.05）. Average serum hemoglobin levels in patients in the treatment group was elevated markedly compared with that in the control group after being treated for two years （P〈0.01）. The percentage of patients reaching the study termination in the treatment group （40%） decreased significantly compared with that （93%） in the control group （P〈0.01）.
CONCLUSION： The regular integrated traditional Chinese and Western medicine can effectively delay the deterioration of renal function in patients with CKDs over a period of four years.