SH/TA-508臨床第二相試験

―脳血管領域における成績―

抄録

This phase-two clinical trial was designed to investigate the effectiveness, safety, and usefulness of galactose microparticles (SH/TA-508) as a new ultrasound transpulmonary contrast-enhancing agent for transcranial color flow imaging.
Seventy-six patients with clinical indications for transcranial Doppler investigation were entered in this frial. Thirty-eight patients were given an intravenous injection of 8 ml at the concentration of 200 mg/ml, 5 ml at 300 mg/ml, and 4 ml at 400 mg/ml and the other 38 received a two-fold higher volume of the agent at each different concentration. We evaluated the adequacy of signal enhancement and the duration of appropriate signal enhancement on transcranial color-coded flow image after each injection. Safety was determined by clinical and laboratory monitoring for 24 hours.
The concentrations of 300 mg/ml and 400 mg/ml were more effective in providing signal enhancement and a long duration of enhancement than 200 mg/ml, and there was no difference in effectiveness between the concentrations of 300 mg/ml and 400 mg/ml. No significant difference in effectiveness was shown between different volumes at the same concentration. Pain at the injection site as an adverse effect was observed in only one patient at injection of 8 ml of 400 mg/ml of the agent.
SH/TA-508 was found to be a very useful ultrasound contrast-enhancing agent for transcranial color flow imaging. A suspension of 5 ml of 300 mg/ml seemed to be the optimum volume and concentration for intravenous administration.