RESUMO
Objective@#To observe the therapeutic effect of terlipressin on refractory ascites (RA) in cirrhosis, and its role and impact on acute kidney injury (AKI).@*Methods@#A non-randomized controlled clinical trial data of 111 hospitalized cases of liver cirrhosis accompanied with RA was collected from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Zhongshan Hospital of Hubei Province, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Medical School of Zhejiang University, and People's Hospital of Pudong New Area of Shanghai between March 2015 and March 2017. 26 cases of conventional treatment group (control group) were divided into two subgroups: RA without AKI (RA-NAKI) and RA with AKI (RA-AKI), and each subgroup consisted 13 cases. Patients with bacterial infection were treated with diuretics, albumin supplementation and antibiotics. 85 cases were presented in terlipressin combined treatment group, of which 27 cases were of RA-NAKI and 58 cases were of RA-AKI. Control group was injected terlipressin 1mg of intravenous drip or static push (once q6 h ~ 12 h) for more than 5 days. The treatment duration lasted for 2 weeks with 4 weeks of follow-up. Body weight, 24-hour urine volume, abdominal circumference, mean arterial pressure (MAP), liver and kidney function, anterior hepatic ascites, deepest point of ascites, and ultrasonographic detection of ascites in supine position before treatment, one and two weeks after treatment and 4 weeks after follow-up were compared. Count data were tested by χ 2. Samples of four groups at baseline were compared. One-way analysis of variance was used for normal distribution data and Kruskal-Wallis H test for non-normal distribution data. Repeated measures analysis of variance was used to compare the difference in efficacy between different time points before and after treatment in the group. The LSD method of one-way ANOVA was used to compare the two groups. A t-test of independent samples was used to compare the efficacy of different time series between the two groups. Mann-Whitney rank- sum test was used to compare the data of non-normal distribution between the two groups.@*Results@#(1) Baseline data were compared among 4 subgroups of terlipressin RA-NAKI and control RA-AKI. Control group age was higher than that of terlipressin group, and the serum creatinine (SCr) of the RA-AKI group was higher than RA-NAKI group, and there was no significant difference in the rest of the baseline data and the combined medication (P > 0.05). (2) An intra-group comparison between control and trelipressin before and after treatment showed that all patients had lower body mass, abdominal circumference and deepest ascites, and higher serum albumin (P < 0.05). 24-hour urine volume and MAP was significantly increased in the terlipressin group, while the pre-ascites, SCr and child Turcotte Pugh (CTP) scores were decreased. Body weight, abdominal circumference, pre-ascites, and deepest ascites of the terlipressin group were decreased, while MAP was increased during the treatment and follow-up periods. The differences were statistically significant when compared with the control group at the same time (P < 0.05). There was a statistically significant difference in the increase of 24-h urine volume in the terlipressin group compared with the control group (P < 0.05). The decrease in SCr and CTP in the terlipressin group after 2 weeks of treatment and 4 weeks of follow-up was statistically significant compared with the control group (P < 0.05). (3) Among the two subgroups of RA-AKI and RA-NAKI in the terlipressin group, the baseline SCr value of the former was higher than that of the latter. After treatment, the body weight, abdominal circumference, pre-ascites, deepest ascites and CTP scores were decreased. In the RA-AKI group, 24-hour urine volume, MAP, SCr and serum albumin concentration were significantly increased. The difference between the two subgroups before and after treatment was compared, and the body weight of RA-AKI group at 1, 2 weeks of treatment and 4 weeks of follow-up was significantly lower than RA-NAKI group, which were (- 2.3 ± 0.2 vs. - 1.5 ± 0.2) kg, (- 4.1 ± 0.2 vs. - 2.6 ± 0.2) kg, (- 4.2 ± 0.3 vs. - 2.4 ± 0.3) kg, respectively. RA-NAKI group urine volume was significantly increased at 2 weeks of treatment and 4 weeks of follow-up, which was (468 ± 42 vs. 110 ± 131) ml, (272 ± 34 ml vs. 11 ± 112) ml, respectively. SCr reduction (18.3 ± 4.7 vs. 0.9 ± 2.4) µmol/l at 4 weeks of follow-up was apparent in RA-NAKI group, and the difference was statistically significant (P < 0.05).@*Conclusion@#Addition of terlipressin to conventional treatment may significantly increase MAP, 24-h urine volume, improve renal function and promote ascites resolution in patients with refractory cirrhotic ascites. Moreover, its combination effect is more obvious in AKI patients, and adverse reactions are mild.