Abstract
Argatroban is a direct antithrombin agent developed for the first time by Okamoto
et al in 1978. Unlike heparin, it manifests its anticoagulant effect by binding directly
to the active site of thrombin. A phase II double-blind comparative study was conducted
in 52 facilities with a placebo control. The drug was administered by a slow intravenous
infusion at 60 mg/d for the first 2 days and then at 10 mg twice daily for the subsequent
5 days. Glycerol was used concomitantly as a basic therapy for both the argatroban
and placebo groups.
The results demonstrated superior improvements, particularly in neurological symptoms
(motor paralysis) and daily living activities (walking, standing up, continuous sitting,
and eating), in the argatroban group compared with the placebo group. These improvements
were observed from the early stage of administration.
It was also found that administration of the drug in the early stage of the disease
gave better results. In the present study, although a hemorrhagic cerebral infarct
occurred in one case in the argatroban group, this seemed to be no different from
a spontaneous incidence, as it also occurred in two cases in the placebo group. Symptoms
were not aggravated in any of the cases. These results indicate that argatroban is
an effective and safe drug for the treatment of acute cerebral thrombosis.
Keywords:
Argatroban - direct thrombin inhibitor - acute cerebral thrombosis - double-blind
controlled study - activity of daily living (ADL)