PLoS One. 2015 Sep 8;10(9):e0137546. doi: 10.1371/journal.pone.0137546.

Influence of Pneumococcal Conjugate Vaccine on Acute Otitis Media with Severe Middle Ear Inflammation: A Retrospective Multicenter Study.

 

Sugino H1, Tsumura S2, Kunimoto M3, Noda M4, Chikuie D5, Noda C4, Yamashita M6, Watanabe H7, Ishii H8, Tashiro T9, Iwata K8, Kono T10, Tsumura K8, Sumiya T11, Takeno S12, Hirakawa K12.
  • 1Asa Medical Association, Hiroshima City, Japan; Sugino Pediatric Clinic, Hiroshima City, Japan.
  • 2Asa Medical Association, Hiroshima City, Japan; Tsumura ENT Clinic, Hiroshima City, Japan.
  • 3Asa Medical Association, Hiroshima City, Japan; Department of Otolaryngology, Head and Neck Surgery, Graduate School of Biomedical & Health Sciences, Applied Life Sciences, Hiroshima University, Hiroshima City, Japan; Kunimoto ENT Clinic, Hiroshima City, Japan.
  • 4Asa Medical Association, Hiroshima City, Japan; Noda ENT Clinic, Hiroshima City, Japan.
  • 5Asa Medical Association, Hiroshima City, Japan; Hiroshima Kyouritsu Hospital, Hiroshima City, Japan.
  • 6Asa Medical Association, Hiroshima City, Japan; Yamashita Clinic, Hiroshima City, Japan.
  • 7Asa Medical Association, Hiroshima City, Japan; Watanabe ENT Clinic, Hiroshima City, Japan.
  • 8Asa Medical Association, Hiroshima City, Japan; Hiroshima City Asa Hospital, Hiroshima City, Japan.
  • 9Asa Medical Association, Hiroshima City, Japan; Tashiro ENT Clinic, Hiroshima City, Japan.
  • 10Asa Medical Association, Hiroshima City, Japan; Department of Otolaryngology, Head and Neck Surgery, Graduate School of Biomedical & Health Sciences, Applied Life Sciences, Hiroshima University, Hiroshima City, Japan; Hiroshima City Asa Hospital, Hiroshima City, Japan.
  • 11Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima City, Japan.
  • 12Department of Otolaryngology, Head and Neck Surgery, Graduate School of Biomedical & Health Sciences, Applied Life Sciences, Hiroshima University, Hiroshima City, Japan.

 

Abstract

The Japanese guidelines for acute otitis media in children recommend classifying acute otitis media by age, manifestations and local findings, and also recommend myringotomy for moderate-grade cases with severe local findings, severe-grade cases, and treatment-resistant cases. The heptavalent pneumococcal conjugate vaccine was released in Japan in February 2010. In Hiroshima City, public funding allowing free inoculation with this vaccine was initiated from January 2011, and the number of vaccinated individuals has since increased dramatically. This study investigated changes in the number of myringotomies performed to treat acute otitis media during the 5-year period from January 2008 to December 2012 at two hospitals and five clinics in the Asa Area of Hiroshima City, Japan. A total of 3,165 myringotomies for acute otitis media were performed. The rate of procedures per child-year performed in <5-year-old children decreased by 29.1% in 2011 and by 25.2% in 2012 compared to the mean rate performed in the 3 years prior to the introduction of public funding. A total of 895 myringotomies were performed for 1-year-old infants. The rate of myringotomies per child-year performed for acute otitis media in 1-year-old infants decreased significantly in the 2 years after the introduction of public funding for heptavalent pneumococcal conjugate vaccine compared to all years before introduction (p<0.000001). Our results suggest a benefit of heptavalent pneumococcal conjugate vaccine for acute otitis media in reducing the financial burden of myringotomy. In addition, this vaccine may help prevent acute otitis media with severe middle ear inflammation in 1-year-old infants.

PMID: 26348230

 

Supplements:

Streptococcus pneumoniae is one of the major causative bacteria for acute otitis media (AOM). Previous studies have investigated the effectiveness of the heptavalent pneumococcal conjugate vaccine (PCV7) against AOM in terms of changes in AOM episodes and total number of visits to medical institutions made by children. In 2014, an update to a meta-analysis of PCV effects on AOM was reported in the Cochrane collection and one of the authors concluded the PCV7 had modest beneficial effects on healthy infants with a low baseline risk of AOM (1).

In Japan, the PCV7 was launched in February 2010 as a vaccination paid out of private expenses. In November 2010, the Japanese government announced an official program recommending PCV7 immunization for <5-year-old children. Yamanaka reported the 7-year study between 2007 and 2013 was based on the Japan Medical Data Center Claims Database of neonates to children less than 15 years old and the number of AOM patients did not change significantly during the study period (2).

The Japanese clinical practice guidelines for the diagnosis and management of AOM in children provide criteria for evaluating the degree of AOM and recommend myringotomy for AOM accompanied by severe otoscopic findings and for treatment-resistant cases.

We present the rate of myringotomies per child-year performed for acute otitis media in 1-year-old infants decreased significantly in the 2 years after the introduction of public funding for PCV7 compared to all years before introduction (p<0.000001). And Yamanaka also present the myringotomy rate showed a significant decline over time after 2010 based on the Japan Medical Data Center Claims Database of neonates to children less than 15 years old (2). Those data suggested that in Japan the number of AOM patients did not changed before and after introduction of free PCV7 and myringotomy decreased after 2011.

Yamanaka considered that 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 (2). But we think it seems natural to reason that PCV7 represents an extremely important factor in the decreased incidence of middle ear inflammation among <5-year-old children. We show the change of the rate of myringotomy before and after introduction of PCV7in each age (Figure 1). We consider that the changes of the rate of myringotomy in each age and year is similar to the changes of the rate of invasive pneumococcal disease among children under five years old (3).

 

Figure jpeg

Figure: Rate of myringotomy for all cause acute otitis media under five years old, according to age and year.

The rate of myringotomies per child-year performed for acute otitis media in 1-year-old infants decreased significantly in the 2 years after the introduction of public funding for PCV7 compared to all years before introduction ( *, p<0.000001).

 

References

1) Fortanier AC, Venekamp RP, Boonacker CWB, Hak E, Schilder AGM, Sanders EA, Damoiseaux RA. 2014 Pneumococcal conjugate vaccines for preventing otitis media. The Cochrane Collaboration Issue 4.2014;doi:10.1002/14651858.CD001480.pub4.

2) Yamanaka N. 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. Practica Oto-Rhino-Laryngologica 108:177-186 [Article in Japanese]

3) Whitney CG1, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, Reingold A, Cieslak PR, Pilishvili T, Jackson D, Facklam RR, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance of the Emerging Infections Program Network 2003 Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 1; 348:1737-46.

 

 

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