Abstract
A multi-center open trial was conducted to evaluate the efficacy and safety of pocepullan against Japanese cedar pollinosis on a larger scale. The participants were confirmed to be allergic to pollen based on an interview in which the participants indicated that symptoms appeared or were exacerbated in the dispersion season of Japanese cedar pollen. The subjects ranged from 15 to 64 years of age and scored more than class II in RAST (radioallergosorbent test) or tested positive on the skin test. A total of 140 subjects participated in the trial with 83 after the season of 1997 and 57 after that of 1998. Pocepullan was graded as effective in 68.4% of the subjects in 1998 and in 71.1% of the subjects in 1999. The results were comparable to those of a pollen extract used previously for immunotherapy trials. On the other hand, a causative relationship with pocepullan could not be denied in 15 of the 137 cases of adverse events (10.9%). One case experienced an adverse effect which was considered to possibly be due to an anaphylactic reaction. As a result, precautions should be taken (e. g. dose reduction) when patients are not in good health. The results obtained so far show that pocepullan, Japanese cedar allergen conjugated with pullulan, is potentially useful as a specific immunotherapeutic agent with a superior safety and a comparable efficacy when compared with the current allergen ex- tract presently in widespread use.
