[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.