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Objective: To observe the clinical efficacy of combined therapy of Shehuang Paste (SHP) with colonic dialysis in treating patients with refractory cirrhotic ascites complicated with azotemia., Methods: Adopting a multi-centered, randomized, double blinded and 1:1 parallel controlled trial, 120 patients were equally randomized into 2 groups, the control group was treated by conventional basic therapy (umbilical application of placebo paste and colonic dialysis with normal saline), and the treatment group by, besides the same basic therapy, umbilical application of SHP once a day and colonic dialysis with herbal medicine once every other day. The course was 1 month for both groups. Changes of ascites volume, renal function, serum and urinary levels of Na+ and K+, blood vasoactive substance, and portal dynamics in patients before and after treatment were observed., Results: The total effective rate for ascites was 71.7% (43/60 cases) in the treatment group and 18.3% (11/60 cases) in the control group, showing significant difference between groups (P < 0.01). Significant difference of blood creatinine, urea nitrogen, serum Na+ levels, and urinary Na+/K+ ratio were shown in the treatment group (P < 0.01) before and after treatment, and between groups after treatment (P < 0.05, P < 0.01). Portal vein blood flow was significantly lowered in the treatment group after treatment (P < 0.01), which showed significant difference as compared with that in the control group (P < 0.01). Besides, levels of atrial natriuretic peptide, renin, angiotensin, nitric oxide, and aldosterone decreased and endotoxemia improved remarkably in the treatment group (P < 0.01). One-year follow-up showed that the ascites eliminating rate and the incidence of hepato-renal syndrome in the treatment group was 38.3% (23/60 cases) and 23.3% (14/60 cases) respectively, while in the control group 0 and 41.7% (25/60 cases) respectively, all showed statistical difference between groups (all P < 0.05)., Conclusion: Combined therapy of SHP and colonic dialysis with herbal medicine could effectively eliminate the ascites, improve the hemodynamic condition of portal and splenic veins, reduce the content of vasoactive substance and noxious substances like ammonia and endotoxin in blood, and lower the incidence of hepato-renal syndrome.

Aim: To explore the efficacy and mechanism of a novel therapeutic method of traditional Chinese medicine in patients with refractory cirrhotic ascites complicated with azotemia., Methods: Seventy-five cases of refractory cirrhotic ascites complicated with azotemia were randomly divided into 3 groups: comprehensive treatment (n = 29), simple treatment (n = 24), and control (n = 22). The basic treatment methods were the same in all groups, including liver protecting medicines, diuretics and supportive drugs. The control group underwent only the basic treatment. Shehuang Paste (SHP) was applied to the navels of the two treatment groups once a day for 30 d. Colon dialysis with Chinese herbs was administered to the comprehensive treatment group once every two days. Before and after treatment, we measured abdominal circumference, BUN, Cr, serum Na+, urine Na+/K+, liver function, endotoxin content, NO, and ET-1. Color Doppler ultrasonography was conducted to measure the portal vein blood flow., Results: The total effective rate for ascites was 72.4% in the comprehensive treatment group, 45.8% in the simple treatment, contrasting with 18.2% in the controls. Between the two treatment groups and the controls, there were significant differences in the effective rates (P < 0.01, and P < 0.05). There was also a significant difference (P < 0.05) between the two treatment groups. Measurements of Cr and BUN showed higher values for the treatment groups, with the comprehensive better than the simple group (P < 0.05). Sera Na, urine Na/K were different, P < 0.01 between pre- and post-treatment in the comprehensive group, and P < 0.05 in the simple group. The treatment groups' endotoxin content was also significantly reduced (P < 0.01, and P < 0.05), with the comprehensive group better than the simple group (P < 0.05). Portal vein blood flow and NO content significantly reduced (P < 0.05), as did ET-1 content (P < 0.01). There were no significant changes in the control group (P > 0.05). The comprehensive treatment group's pre- and post-treatment portal vein and splenic vein blood flows showed a positive correlation to NO, ET-1 and endotoxin contents., Conclusion: When treating refractory cirrhotic ascites complicated with azotemia, Shehuang Paste combined with Chinese herbal dialysis is better than Shehuang Paste alone for ascites resolution, azotemia, and endotoxin elimination. However, both methods on their own were also effective for reducing portal and splenic vein blood flow, and lowering the contents of NO, ET-1 in the two treatment groups.