じん臓培養組織由来ウロキナーゼ（ＴＣＵＫ）による脳血せん症治療効果の評価に関する二重盲検試験

Abstract

A multi-center double blind study for the clinical evaluation of TCUK was carried out on 115 patients with cerebral thrombosis.The administration of TCUK was done continuously in doses of 60, 000 I. U. for 7 days under comparison with negative placebo.The study was performed according to the protocol, shown in Table 1-6 and the effects of TCUK were judged by the grade of improvement of apparent subjective complaints, disturbances of consciousness, motorius and sensorial disorders of extremities and comprehensive daily life activities. The total scoring of improvements in individual disorders and their comprehensive evaluation were made for judgement of the global improvement and availability of the drugs, obtaining the following conclusions:(1) The availability, particularly the global improvement of TCUK were better than those of placebo in their statistical significance (Table 10).(2) In the serial evaluations, the clinical effects were more significant in patient groups of mild or moderate grades in the severity of disorders, of ages between 40-69, without histories of brain damages and without simultaneous infusions of large amount of solutions.(3) The side effects of TCUK were rare (Table 11) with only two exceptional cases with disturbance of liver functions (Table 18), but the relationship between this liver function disturbance and administration of TCUK was obscure and no cases of hemorrhagic infarction were found in connection with TCUK administration in this study.