Subjects & study design
This study was conducted with an open-label and parallel-study design.
Clinical trials were conducted in Hanyang University Medical Center and
the Institutional Review Board (IRB) of Hanyang University Medical
Center approved the study protocol (IRB No. HYI-13-042-1). Informed
consents were obtained from all subjects prior to study enrollment. All
procedures were performed in accordance with the recommendations of the
Declaration of Helsinki and the study was conducted in compliance with
the current Good Clinical Practice.
A total of 102 subjects were included in this prospective study. Thirty
subjects were normal subjects who did not have any marked medical
history including liver cirrhosis. Eighteen subjects were patients with
chronic active hepatitis (CAH) and fifty-four subjects were patients
with cirrhosis.
All the study subjects were administered 40 mg of propranolol in fasting
state. Blood samples (8 mL) for pharmacokinetic analysis were taken at
pre-dose and 0.5, 1, 2, 3, 5 and 8 hours post-dose.
201TI per rectal scintigraphy and laboratory blood
test were performed on separate days of pharmacokinetic study.
Heart-to-liver radioactivity uptake ratio (H/L ratio)
Portal hypertension was evaluated by H/L ratio using201TI per rectal scintigraphy. The measurement of H/L
ratio has been extensively described in previous papers [9, 10].
Briefly, intrarectal administration of 18.5 MBq of201Tl was followed by acquisition of twenty-five
1-minute images of the cardiac and hepatic areas. When radioisotope
activity showed a plateau, the ratio of radiation activity between the
heart and liver area was acquired. The H/L ratio was used as an
indicator for the magnitude of portal hypertension.[11]