1999 Volume 45 Issue 3 Pages 251-263
A study was conducted on 20 subjects with Japanese cedar pollinosis to confirm the safety of standardized Japanese cedar pollen extract (TO-194: 2,000 JAU/ml) in specific immunotherapy. None of the subjects exhibited any serious adverse side effects, however, mild adverse side effects, for which a causative relationship with TO-194 could not be ruled out, were observed in 2 of 20 subjects. The safety rete of TO-194 was therefore 90% (95% confidence limits: 68.3-98.8%). The 2 cases exhibiting adverse side effects comprised of 1 case with nasal secretion and 1 case with eye itching. Both symptoms disappeared before the treatment with maintenance dose, and the injectional dose could be increased without incident in both cases. As a result, specific immunotherapy using standardized Japanese cedar pollen extract (TO-194) is considered to be safe since it caused no signifficant problems in this study.
