OBJECTIVETo perform an analysis and comparative study of the clinical data for patients with cirrhosis and type 1 hepatorenal syndrome (HRS) who received treatment with terlipressin using high-or low-dose regimens.

METHODSA total of 56 patients with cirrhosis and type 1 HRS who presented for treatment to the Wuhan Medical Treatment Center and Taizhou Central Hospital between March 2010 and October 2012 were enrolled in the study. The patients were randomly assigned to the terlipressin treatment groups for receipt of the high-dose regimen (1 mg/6-8 h;n =27) or low-dose regimen (1 mg/12 h;n =29). All patients were assessed for 24-hour urine volume, serum blood urea nitrogen (BUN) and creatinine (Cr) levels, therapeutic effect and prognosis, and adverse reactions. Measurements were made before and after the treatment, and on post-treatment days 3, 7 and 14. Inter-group differences were assessed by statistical analyses.

RESULTSThe high-dose group showed an increase in 24-hour urine volumes from post-treatment day 3 (1112 ± 262 ml) to day 7 (1938 ± 312 ml), and the volumes on both days were significantly better than those of the low-dose group (day 3:986 ± 162 ml and day 7:1760 ± 300 ml, t =1.500, 1.830, P=0.038, 0.041). The high-dose group also showed a significantly better decreases in serum BUN levels (35.1 ± 8.6 to 30.2 ± 6.3 mmol/L vs.low-dose group: 43.2 ± 10.9 to 35.1 ± 7.6 mmol/L, t =3.200, 5.901, P =0.043, 0.047) and in serum Cr values (219.0 ± 35.1 to 128.2 ± 41.6 vs.low-dose group: 230.3 ± 82.1 to 151.5 ± 38.7, t =2.997, 5.765, P =0.036, 0.046).On post-treatment day 14 the 24-hour urine volume of patients in the high-dose group decreased (to 720+/-136 ml), but the difference from that of the low-dose group was not significant (vs. 620 ± 164 ml, t =1.855, P =0.069). The serum BUN level increased in the high-dose group (to 54.4 ± 15.0 mmol/L), which was statistically different from that in the low-dose group (vs .57.7 ± 17.3 mmol/L, t=5.166, P =0.022); the same trend was seen for the serum Cr value (397.8 ± 127.4 mumol/L vs. 480.3 ± 179.8 mumol/L, t =5.638, P =0.047). No statistically significant differences were observed for the groups in regard to significant efficiency, efficiency or 2-week survival rate (x2 =2.314, 1.767, 0.678, P =0.128, 0.128, 0.410 respectively), but the total efficiency was significantly different between the two groups (x² =5.793, P =0.016). In addition, no serious adverse reactions (including precordial pain, myocardial infarction or intestinal necrosis) were observed in either group.

CONCLUSIONTerlipressin therapy at both high and low dosages can lead to significant beneficial effects within as little as 3 days after the treatment; however, the high-dose appears to produce a better lasting efficacy (at day 14 after the treatment). The difference in doses does not appear to markedly affect significant efficiency, efficiency, nor the 2-week survival rate.