今日の臨床サポート

中耳炎(小児科)

著者: 中村豊 ゆたかこどもクリニック

監修: 渡辺博 帝京大学老人保健センター

著者校正済:2021/12/22
現在監修レビュー中
参考ガイドライン:
  1. 日本耳科学会など:小児急性中耳炎診療ガイドライン
  1. 小児外来診療における抗菌薬適正使用のためのワーキンググループ:小児上気道炎に対する抗菌薬適正使用のすすめ 
  1. 厚生労働省:抗微生物薬適正使用の手引き 第二版 
患者向け説明資料

概要・推奨   

  1. 中耳炎の診断は臨床所見と鼓膜所見を組み合わせて行う(推奨度1)。
  1. 年齢・臨床症状・鼓膜所見より重症度の判定を行う(推奨度2)。 
  1. 重症度に基づき初期治療方針を決定する(推奨度1)。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となりま
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
中村豊 : 特に申告事項無し[2021年]
監修:渡辺博 : 特に申告事項無し[2021年]

改訂のポイント:
  1. 「抗微生物薬適正使用の手引き 第二版」を参考ガイドラインに追記し、内容の見直しを行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. わが国の小児急性中耳炎の診療のためのガイドラインとして、日本耳科学会などによる「小児急性中耳炎診療ガイドライン」(ガイドライン1)と、小児外来診療における抗菌薬適正使用のためのワーキンググループ作成の「小児上気道炎および関連疾患に対する抗菌薬使用ガイドライン」(ガイドライン2)、厚生労働省が出した、抗微生物薬適正使用の手引き 第二版(ガイドライン3)の3つがある。それぞれにおける中耳炎の定義は次のとおりである。
  1. ガイドライン1[1]
  1. 急性に発症した中耳の感染症で、耳痛、発熱、耳漏を伴うことがある。『急性に発症』とは、本人の訴えあるいは両親や保護者に急性症状が発見され、急性症状が持続する間に受診した場合としている。持続については3週間を超えない。
  1. ガイドライン2[2]
  1. 急性の耳漏がみられるかあるいは中耳に貯留液を認め、かつ耳痛などの感染症状と鼓膜の明らかな発赤・強い腫脹・水疱形成などの感染所見を1つ以上認めるものとしている。
  1. ガイドライン3[3]
  1. 耳痛、発熱、耳漏を伴うことがある急性に発症した中耳の感染症。耳管経由で中耳腔まで炎症、感染が波及して生じる。
  1. ガイドライン1は2013年版までは正確な鼓膜所見の評価や鼓膜切開などの耳処置を施行できる耳鼻科医を対象としていたが、2018年版では小児急性中耳炎の診療に携わるすべての医師を対象と変更して小児科医も対象に含めた。ガイドライン2と3はすべての一般診療医を対象としている。
  1. 中耳炎は、ウイルスが呼吸器粘膜に感染することにより、粘膜浮腫が起こり耳管機能障害をきたすため、上気道に存在する病原菌が中耳に侵入し炎症を生じると考えられる。穿孔がなければ外耳からの感染は考えられない。
  1. 肺炎球菌、インフルエンザ菌ならびにモラクセラ・カタラーリスが起炎菌の多くをしめる。以前は薬剤耐性化が問題となっていたが、抗菌薬適正使用の普及や肺炎球菌ワクチンの定期接種化を受けて耐性化はいくぶん改善傾向にある。
  1. 1歳までに75%が罹患、7歳までに40%が4回以上罹患する頻度の高い感染症である。[4][5]
 
  1. 海外のガイドライン
  1. 小児の急性中耳炎に関するガイドラインは諸外国からも公刊されている。ガイドライン1で触れられているのは、米国、カナダ、イタリアのガイドラインである。ガイドライン2ではオランダのガイドラインに触れている。このほかにもSuzukiらはヨーロッパのガイドラインを17編集めて比較している。[6] 
  1. 多くの国のガイドラインで共通している診断の決め手は
  1. 急性発症である(耳痛や発熱など)。
  1. 中耳腔に液貯留が証明されている。
  1. 鼓膜の炎症が確認できること。
  1. この点は、わが国のガイドラインも同様で、重要なことは鼓膜の正確な観察である。
 
問診・診察のポイント  
  1. 耳痛の有無を聞くこと(夜間の不機嫌は重要なサインである。乳児では耳を引っ張る、こする、触る)。

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最新のエビデンスに基づいた二次文献データベース「今日の臨床サポート」。
常時アップデートされており、最新のエビデンスを各分野のエキスパートが豊富な図表や処方・検査例を交えて分かりやすく解説。日常臨床で遭遇するほぼ全ての症状・疾患から薬剤・検査情報まで瞬時に検索可能です。

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文献 

著者: Hijiri G Suzuki, Juan Emmanuel Dewez, Ruud G Nijman, Shunmay Yeung
雑誌名: BMJ Open. 2020 May 5;10(5):e035343. doi: 10.1136/bmjopen-2019-035343. Epub 2020 May 5.
Abstract/Text OBJECTIVES: To appraise European guidelines for acute otitis media (AOM) in children, including methodological quality, level of evidence (LoE), astrength of recommendations (SoR), and consideration of antibiotic stewardship.
DESIGN: Systematic review of the literature.
DATA SOURCES: Three-pronged search of (1) databases: Medline, Embase, Cochrane library, Guidelines International Network and Trip Medical Database; (2) websites of European national paediatric associations and (3) contact of European experts. Data were collected between January 2017 and February 2018.
ELIGIBILITY CRITERIA: National guidelines of European countries for the clinical management of AOM in children aged <16 years.
DATA EXTRACTION AND SYNTHESIS: Data were extracted using tables constructed by the research team. Guidelines were graded using AGREE II criteria. LoE and SoR were compared. Guidelines were assessed for principles of antibiotic stewardship.
RESULTS: AOM guidelines were obtained from 17 or the 32 countries in the European Union or European Free Trade Area. The mean AGREE II score was ≤41% across most domains. Diagnosis of AOM was based on similar signs and symptoms. The most common indication for antibiotics was tympanic membrane perforation/otorrhoea (14/15; 93%). The majority (15/17; 88%) recommended a watchful waiting approach to antibiotics. Amoxicillin was the most common first-line antibiotic (14/17; 82%). Recommended treatment duration varied from 5 to 10 days. Seven countries advocated high-dose (75-90 mg/kg/day) and five low-dose (30-60 mg/kg/day) amoxicillin. Less than 60% of guidelines used a national or international scale system to rate level of evidence to support recommendations. Under half of the guidelines (7/17; 41%) referred to country-specific microbiological and antibiotic resistance data.
CONCLUSIONS: Guidelines for managing AOM were similar across European countries. Guideline quality was mostly weak, and it often did not refer to country-specific antibiotic resistance patterns. Coordinating efforts to produce a core guideline which can then be adapted by each country may help improve overall quality and contribute to tackling antibiotic resistance.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
PMID 32371515  BMJ Open. 2020 May 5;10(5):e035343. doi: 10.1136/bmjope・・・
著者: Allan S Lieberthal, Aaron E Carroll, Tasnee Chonmaitree, Theodore G Ganiats, Alejandro Hoberman, Mary Anne Jackson, Mark D Joffe, Donald T Miller, Richard M Rosenfeld, Xavier D Sevilla, Richard H Schwartz, Pauline A Thomas, David E Tunkel
雑誌名: Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25.
Abstract/Text This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM. In 2009, the AAP convened a committee composed of primary care physicians and experts in the fields of pediatrics, family practice, otolaryngology, epidemiology, infectious disease, emergency medicine, and guideline methodology. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the new literature related to AOM since the initial evidence report of 2000. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific, stringent definition of AOM. It addresses pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotic agents, and preventive measures. It also addresses recurrent AOM, which was not included in the 2004 guideline. Decisions were made on the basis of a systematic grading of the quality of evidence and benefit-harm relationships. The practice guideline underwent comprehensive peer review before formal approval by the AAP. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.

PMID 23439909  Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.・・・
著者: L Bertin, G Pons, P d'Athis, J F Duhamel, C Maudelonde, G Lasfargues, M Guillot, A Marsac, B Debregeas, G Olive
雑誌名: Fundam Clin Pharmacol. 1996;10(4):387-92.
Abstract/Text Two hundred and nineteen children (boys: 56%, girls: 44%) were included in a randomized, double-blind, multicentre (4 centres) controlled trial designed to assess the efficacy and safety of ibuprofen (IBU) in the treatment of 1 to 6 year-old children with otoscopically proven acute otitis media (AOM), either unilateral or bilateral. They randomly received 10 mg/kg IBU (n = 71), or acetaminophen (PARA) (n = 73) or placebo (PLA) (n = 75), orally, tid, for 48 hours. All received oral cefaclor (Alfatil, Lilly, France) for seven days. They were evaluated before (D0) and at the end of treatment (D2). The main criterion of response was the aspect (landmarks and color) of the tympanic membrane assessed on a semi-quantitative scale from 0 to 6. Other criteria, assessed on semi-quantitative scales, included relief of pain (0 or 1), rectal temperature (0 to 2), and overall evaluation by parents of the improvement of quality of life on three items: appetite (0 to 2), sleep (0 to 2), and playing activity (0 to 2). The results at D2 were as follows: there was no significant difference between treatment groups as to the main criterion, but only a trend for IBU and PARA to do better than PLA but not for IBU to do better than PARA. From these data there is no argument to emphasize the utility of non-steroidal anti-inflammatory drugs (NSAIDs) in treating the inflammatory signs of the tympanic membrane in otitis. There was a statistically significant difference between treatment groups at D2 for pain, IBU being superior to PLA (P < 0.01): 7%, 10% and 25% of the children were still suffering at D2 in the IBU, PARA and PLA treatment groups, respectively. The difference between PARA and PLA for pain was not statistically significant. There was no significant difference between treatment groups for the other criteria. All treatments were well and equally tolerated. Although no significant difference was found between the treatment groups on the aspect of the tympanic membrane, the efficacy of IBU was evidenced on the relief of pain, the symptom that most disturbs the child.

PMID 8871138  Fundam Clin Pharmacol. 1996;10(4):387-92.
著者: Maroeska M Rovers, Paul Glasziou, Cees L Appelman, Peter Burke, David P McCormick, Roger A Damoiseaux, Isabelle Gaboury, Paul Little, Arno W Hoes
雑誌名: Lancet. 2006 Oct 21;368(9545):1429-35. doi: 10.1016/S0140-6736(06)69606-2.
Abstract/Text BACKGROUND: Individual trials to test effectiveness of antibiotics in children with acute otitis media have been too small for valid subgroup analyses. We aimed to identify subgroups of children who would and would not benefit more than others from treatment with antibiotics.
METHODS: We did a meta-analysis of data from six randomised trials of the effects of antibiotics in children with acute otitis media. Individual patient data from 1643 children aged from 6 months to 12 years were validated and re-analysed. We defined the primary outcome as an extended course of acute otitis media, consisting of pain, fever, or both at 3-7 days.
FINDINGS: Significant effect modifications were noted for otorrhoea, and for age and bilateral acute otitis media. In children younger than 2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3-7 days, with a rate difference between these groups of -25% (95% CI -36% to -14%), resulting in a number-needed-to-treat (NNT) of four children. We identified no significant differences for age alone. In children with otorrhoea the rate difference and NNT, respectively, were -36% (-53% to -19%) and three, whereas in children without otorrhoea the equivalent values were -14% (-23% to -5%) and eight.
INTERPRETATION: Antibiotics seem to be most beneficial in children younger than 2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhoea. For most other children with mild disease an observational policy seems justified.

PMID 17055944  Lancet. 2006 Oct 21;368(9545):1429-35. doi: 10.1016/S01・・・
著者: P H Kaleida, M L Casselbrant, H E Rockette, J L Paradise, C D Bluestone, M M Blatter, K S Reisinger, E R Wald, J S Supance
雑誌名: Pediatrics. 1991 Apr;87(4):466-74.
Abstract/Text A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.

PMID 2011422  Pediatrics. 1991 Apr;87(4):466-74.
著者: C A Flynn, G H Griffin, J K Schultz
雑誌名: Cochrane Database Syst Rev. 2004;(3):CD001727. doi: 10.1002/14651858.CD001727.pub2.
Abstract/Text BACKGROUND: Acute otitis media (AOM) is a common and important source of morbidity in children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit.
OBJECTIVES: To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, symptom resolution, medication side effects, and complications of AOM.
SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2003); MEDLINE (January 1966 to December 2003), EMBASE (January 1990 to July 2003) and reference lists of articles for this updated review. We also contacted study authors and pharmaceutical companies.
SELECTION CRITERIA: Randomized controlled trials evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. There were no quality or language restrictions.
DATA COLLECTION AND ANALYSIS: Investigators independently evaluated studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate relative risks; homogeneity was assessed using approximate chi-square tests.
MAIN RESULTS: Fifteen trials involving 2695 people were included. Only the combined decongestant-antihistamine group demonstrated statistically lower rates of persistent AOM at the two week period (fixed relative risk (RR) 0.76; 95% confidence interval (CI) 0.60 to 0.96; number needed to treat (NNT) 10). No benefit was found for early cure rates, symptom resolution, prevention of surgery or other complications. There was a five to eight -fold increased risk of side effects for those receiving an intervention, which reached statistical significance for all decongestant groupings. Validity sub analyses demonstrated that lower quality studies found benefit, while analysis of those studies with higher validity scores found no benefit of treatment.
REVIEWERS' CONCLUSIONS: Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM. There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results. Thus, the routine use of antihistamines for treating AOM in children cannot be recommended.

PMID 15266451  Cochrane Database Syst Rev. 2004;(3):CD001727. doi: 10.・・・
著者: Kenji Suzuki, Yuichi Kurono, Katsuhisa Ikeda, Akira Watanabe, Aikichi Iwamoto, Kyoichi Totsuka, Mitsuo Kaku, Satoshi Iwata, Jun-ichi Kadota, Hideaki Hanaki
雑誌名: J Infect Chemother. 2015 Jul;21(7):483-91. doi: 10.1016/j.jiac.2015.03.005. Epub 2015 Mar 24.
Abstract/Text The Japanese Three Academic Societies Joint Antimicrobial Susceptibility Surveillance Committee has conducted a nationwide surveillance on antimicrobial susceptibility patterns and rates of isolation in 6 otolaryngological diseases. The surveillance program was conducted in the otorhinolaryngological departments of 29 universities, and their 26 affiliated hospitals. Patients suffering from acute otitis media, chronic otitis media, acute nasal sinusitis, chronic nasal sinusitis, acute tonsillitis, and peritonsillar abscess between January 2011 and June 2012 were investigated. The collected swab or incision samples were cultivated for microbial identification, and the drug susceptibility of detected bacteria was measured at the Kitasato University Research Center for Infections and Antimicrobials. The surveillance focused on three gram-positive bacteria (Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus), three gram-negative bacteria (Haemophilus influenzae, Moraxella Catarrhalis, and Pseudomonas aeruginosa), and three anaerobic bacteria (Peptostreptococcus spp., Prevotella spp., and Fusobacterium spp.). Bacterial susceptibility to 39 antimicrobial drugs was investigated. We compared bacterial isolation ratio of each disease in this surveillance from those of past 4 times surveillance which we performed formerly, and we also compared percentage of main drug resistant strains from those of past 4 times surveillance. The age composition between this time and former surveillances was not statistically significant by student-t test. We were unable to completely resolve the rise in resistant bacteria, such as methicillin-resistant S. aureus, penicillin-resistant S. pneumoniae, penicillin-intermediate resistant S. pneumoniae, beta-lactamase non-producing ampicillin-resistant H. influenzae, beta-lactamase producing ampicillin-resistant H. influenzae, and beta-lactamase producing amoxicillin clavulanic acid-resistant H. influenzae. We suggest promoting the proper usage of antimicrobial drugs in order to avoid the spread of these bacteria.

Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
PMID 26004175  J Infect Chemother. 2015 Jul;21(7):483-91. doi: 10.1016・・・
著者: Kenji Suzuki, Yuichi Kurono, Katsuhisa Ikeda, Muneki Hotomi, Hisakazu Yano, Akira Watanabe, Tetsuya Matsumoto, Yoshisaburo Takahashi, Hideaki Hanaki
雑誌名: J Infect Chemother. 2020 Sep;26(9):890-899. doi: 10.1016/j.jiac.2020.05.020. Epub 2020 Jul 1.
Abstract/Text The Japanese Three Academic Societies Joint Antimicrobial Susceptibility Surveillance Committee conducted a nationwide surveillance on six otorhinolaryngological diseases and investigated the antimicrobial susceptibility patterns and isolation rates of the causative pathogens. The surveillance program was conducted in the otorhinolaryngological departments of 12 universities, and 36 affiliated hospitals and clinics. Patients with acute otitis media (children under six years old), chronic otitis media, acute nasal sinusitis, chronic nasal sinusitis, acute tonsillitis, and peritonsillar abscess (over 20 years old) between December 2015 and June 2017 were investigated. The collected swab or incision samples were cultivated for microbial identification, and the antimicrobial susceptibility of the detected bacteria was measured at the Kitasato University Research Center for Infections and Antimicrobials. The surveillance focused on three gram-positive bacteria (Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus), three gram-negative bacteria (Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa), and three anaerobic bacteria (anaerobic gram-positive cocci, Prevotella spp., Porphyromonas spp., and Fusobacterium spp.). Bacterial susceptibility to 40 antimicrobial agents was investigated. We were unable to completely mitigate the rise in the occurrence of resistant bacteria, such as methicillin-resistant S. aureus, penicillin-resistant S. pneumoniae, penicillin-intermediate resistant S. pneumoniae, beta-lactamase non-producing ampicillin-resistant H. influenzae, and beta-lactamase producing ampicillin-resistant H. influenzae. We suggest promoting the proper usage of antimicrobial agents to prevent the spread of these bacteria. We also suggested that immunization with pneumococcal vaccines is useful for decreasing the occurrence of otorhinolaryngological infectious diseases caused by pneumococci.

Copyright © 2020 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
PMID 32622623  J Infect Chemother. 2020 Sep;26(9):890-899. doi: 10.101・・・

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契約期間が通常12ヵ月のところ、14ヵ月ご利用いただけます。

優待コード: (利用期限:まで)

ご契約はこちらから