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]