We evaluated the efficacy and safety of pocepullan, Japanese cedar pollen allergen-pullulan conjugate, against Japanese cedar pollinosis in a long-term trial. The participants who had been on medication but who were not undergoing immunotherapy were also enrolled as a reference group. Immunotherapy with pocepullan was started after the end of the pollen dispersion season in 1995 and was continued until the beginning of the season in 1999. The symptom-medication score as calculated from the data obtained from the patients' diaries was suppressed significantly more in the pocepullan group than in the reference group during the immunotherapeutic period from 1997 to 1999 (p<0.001). In particular, the decrease in medication score was significant in 2000, one year after the therapy had been completed. A survey was also conducted in the pollen dispersion season of 2000. The questionnaire mainly dealt with the quality of life of the patients, such as their impressions and subjective evaluation of their symptoms during the pollen dispersion season. The survey suggested that pocepullan continued to be efficacious even after the end of immunotherapy. The efficacy rate is the ratio of subjects in whom the effects of pocepullan were rated higher than “efficacious” and was 59/77 (76.7%, 1996), 40/59 (67.7%, 1997), 38/47 (80.9%, 1998), and 22/32 (68.8%, 1999) for each year. The degree of pollen dispersion, which varies each year, also has some influence on the efficacy rates. In 1996, 21 adverse events were reported in 13 subjects (14.8%). In 1997, 1998 and 1999, 1.5%, 1.7% and 8.8% of the subjects showed adverse events, respectively. However, no serious adverse events were reported during the study.
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