12 Pract. Otol. (Kyoto) Suppl.

144：12 ～ 13，2015

Influence of the Protein-conjugated Pneumococcal

Vaccine (PCV7) and the Newly Developed
Antimicrobials on the Incidence of Acute Otitis
Media and the Frequency of Myringotomy

Noboru Yamanaka

We conducted an epidemiological survey of patients with acute otitis media (AOM) and evaluated the
effects of use of the protein-conjugated pneumococcal vaccine (PCV7) and of the newly developed antimi-
crobials tosufloxacin (TFLX) and tebipenem pivoxil (TBPM-PI) on the incidence of AOM and the frequency
of myringotomy in Japan. The 7-year study between 2007 and 2013 was based on the Japan Medical Data
Center (JMDC) Claims Database of neonates to children less than 15 years old. The number of AOM
patients did not change significantly during the study period. On the other hand, the myringotomy rate
showed a significant decline over time after 2010. In Japan, large-scale PCV7 vaccination was started in 2011
under public assistance, and the newly developed antimicrobials TFLX and TBPM-PI were introduced in the
market in 2009 and 2010, respectively, before the large-scale PCV7 vaccination initiative was launched. The
major antimicrobial agents used for AOM are amoxicillin, cefditoren pivoxil, and amoxicillin clavulanate, and
rate of use these drugs did not change during study period. On the other hand, the number of prescriptions
for TFLX and TBPM-PI increased over time, and also, the number of prescriptions for these drugs showed
a significant negative correlation with the myringotomy rate. Based on this evaluation, while adoption of
PCV7 vaccination may not have had a strong influence on the incidence of AOM or the myringotomy rate in
Japan, wider use of the newly developed antimicrobials TFLX and TBPM-PI appears to have played an
important role in the decline of the myringotomy rate over time.
Keywords : PCV7, acute otitis media, TFLX, TBPM-PI, myringotomy

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Department of Otolaryngology-Head and Neck Surgery, Corresponding Author Address : Noboru Yamanaka
Wakayama Medical University ynobi@wakayama-med.ac.jp
Pract. Otol. (Kyoto) Suppl. 144 13

Number of patients with acute otitis media (AOM) by age bracket Prevalence of acute otitis media (AOM) and the myringotomy rate
The number of patients with AOM was the largest in the children in children under 2 years of age
aged 4 years, and the number of AOM patients was larger in *** P<0.001 by chi-square test based on the myringotomy rate in
preschool children aged 1 to 6 years than in school children.  2010
PCV7: 7-valent protein-conjugated pneumococcal vaccine
TFLX: tosufloxacin
TBPM-PI: tebipenem pivoxil
The myringotomy rate has remained significantly decreased since
2011.

Incidence of acute otitis media (AOM) from 2007 to 2013 in three
age groups
*** P<0.001 by chi-square test based on the incidence of AOM in
 2007
###
 P<0.001 by chi-square test based on the incidence of AOM in
 2011
PCV7: 7-valent protein-conjugated pneumococcal vaccine
The incidence of AOM was higher in the children that were over 2
years but under 7 years of age than in the other age groups. The
incidence of AOM in children under 7 years of age was significantly
higher in 2013 than that in 2007.
Prevalence of acute otitis media (AOM) and the myringotomy rate
in children over 2 years and under 7 years of age
*** P<0.001 by chi-square test based on the myringotomy rate in
 2010
PCV7: 7-valent protein-conjugated pneumococcal vaccine
TFLX: tosufloxacin
TBPM-PI: tebipenem pivoxil
The myringotomy rate decreased over time and has remained sig­
nificantly decreased since 2011.