Abstract:

ABSTRACT   Objective: By a prospective randomized controlled study, to compare the efficacy of low protein diet supplemented with two kinds of ketoanalogues tablets in treatment of patients with chronic renal failure.    Methodology: From May, 2010 to Oct,2010, patients diagnosed as chronic renal failure who regularly visiting the outpatient department of Jinling hospital were screened for enrolment. The major inclusion criteria were as following: serum creatinine(SCr) 132.6~265.2?mol/L; stable renal function status without active disease; primary glomerular disease was supposed to be the primary diagnosis. All enrolled patients were recommended to adhere to a diet with protein intake less than 0.6g/(kg.d) and received the same routine renal protective therapy before being randomly allocated into Keluodi and Ketosteril group supplemented with ketoanalogues tablets Keluodi or Ketosteril, respectively. They were followed at timepoint 0, 2, 4,6th month, for recording of main complains, weight, height and blood and urine tests, as well as body fat and lean weight using bioimpedance analysis method.   Results: Each group enrolled 32 patients, with 2 dropouts in Keluodi(KLD) group and 1 dropout in Ketosteril(KT) group. Finally 61 patients were entered into data analysis. There was no difference in baseline values between two groups in regards of age, sex, body mass index, blood hemoglobin, SCr, cystatin C(Cys C), endogenous creatinine clearance(CCr), estimated glomerular filtration rate(eGFR), urine protein and drugs intake, diet protein intake(DPI). No obvious side effects were recorded during the follow up period. At the endpoint, compared with baseline, following parameters had significant decline in both group: weight [0 vs. 6th month：KLD group (59.0±8.9) kg vs (57.8 ±8.4) kg; KT group (61.8±11.7 )kg vs (60.6±11.3)kg; P<0.05], serum urate[0 vs. 6th month：KLD group (483.0 ±84.1)??mol/L vs (439.4 ±80.1)?mol/L; KT group (484.9 ± 96.1)??mol/L vs (426.1 ±61.2) ?mol/L; P<0.01]; following parameters had significant rise in both group: serum calcium [0 vs. 6th month：KLD group (2.3 ±0.1)mmol/L vs (2.4±0.1)mmol/L; KT group (2.3 ±0.2) mmol/L vs (2.4 ±0.2) mmol/L; P<0.01], serum immunoglobulin G (IgG)[0 vs. 6th month：KLD group (13.8 ±2.6) g/L vs (15.1 ±3.2) g/L; KT group (14.3 ± 2.9) g/L vs (15.1 ±3.7) g/L;P<0.05]，urine protein(0 vs. 6th month：KLD group (0.41±0.33) g/24h vs (0.79±0.78)g/24h; KT group (0.61±0.53) g/24h vs (0.77±0.59)g/24h; P<0.01]; following parameter had significant decline only in KT group but not in KLD group: serum pre-albumin [0 vs. 6th month：KT group (376.5 ± 89.5)mg/L vs (318.3 ±77.0)mg/L, P<0.001; KLD group (393.0±103.6) mg/L vs (349.4 ±72.0)mg/L, P>0.05]; following parameter had significant rise only in KLD group but not in KT group: CCr [0 vs. 6th month：KLD group (36.5±13.5) ml/min vs (40.1±14.5)ml/min, P<0.05; KT group (37.3±17.8) ml/min vs (39.5±17.7) ml/min, P>0.05]; other parameters including  body lean weight, serum albumin, serum transferrin, lipids, hemoglobin, SCr, Cys C, serum phosphorus and eGFR had no significant changes. There was no significant difference between two groups in regards of all above-mentioned parameters.   Conclusions: Low-protein diet supplemented with two kinds of ketoanalogues tablets has no significant different effect in treatment of patients with chronic renal failure, in regarding nutrition status and renal function preservation, as well as side effects.

Key words: chronic renal failure , low-protein diet , ketoanalogues  , nutrition