Objective: To observe the curative effect of Gandouling tablet in the treatment of Wilson's disease (WD) with intermin-gled phlegm and blood stasis syndrome. Method: Totally 76 WD patients with intermin-gled phlegm and blood stasis syndrome were randomly divided into the control group (38 cases) and the observation group (38 cases). The control group was given routine western medicine therapy

including dimercaptopropansulfonate sodium (DMPS) and zinc sulfate tablets. The observation group was given Gandouling tablet in addition to the therapy of control group. The curative effect was observed after 6 treatment courses. indexes such as traditional Chinese medicine (TCM) syndrome score

improved Goldstein classification

24-hour urine copper (u-Cu)

ceruloplasmin (CP) and plasma copper (p-Cu) were recorded

the level of non-ceruloplasmin plasma copper (nCP-Cu) were calculated

and the blood cell counts

liver function and blood coagulation were detected before treatment and after treatment. Result: The TCM syndrome effective rates of control group and observation group were 60.53%and 81.58%

respectively

with a significant difference between two groups (P<0.01). The clinical effective rates of the control group and the observation group were 73.68% and 84.21%

respectively

with a significant difference between two groups (P<0.05). The nCP-Cu decreased in both groups (P<0.05)

while the u-Cu increased in both groups (P<0.01)

but there was no significant difference between two groups. After treatment

total bilirubin (TBIL)

aspartate aminotransferase (AST) and alanine aminotransferase (ALT) decreased in both groups (P<0.01)

particularly in observation group (P<0.05). Conclusion: Gandouling tablet can significantly regulate TCM syndrome

clinical efficacy and liver function in patients with WD with intermin-gled phlegm and blood stasis syndrome.