Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European
drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves
serum liver biochemistries and survival free of liver transplantation However, about 40% of
patients do not respond to UDCA optimally as assessed by known criteria for biochemical
response. Those patients represent the group in need for additional therapies, having
increased risk of disease progression and decreased survival free of liver transplantation.
And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might
jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis
and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could
significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we
start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu
combined with UDCA in the PBC treatment.