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小兒急性中耳炎之抗生素治療

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DOI:
https://doi.org/10.1002/14651858.CD000219.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 23 junio 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Infecciones respiratorias agudas

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Roderick P Venekamp

    Correspondencia a: Department of Otorhinolaryngology & Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands

    [email protected]

  • Sharon L Sanders

    Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

  • Paul P Glasziou

    Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

  • Chris B Del Mar

    Centre for Research in Evidence‐Based Practice (CREBP), Bond University, Gold Coast, Australia

  • Maroeska M Rovers

    Department of Operating Rooms, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Contributions of authors

Chris Del Mar (CDM) and Paul P Glasziou (PPG) prepared the original version of the review.
Sharon L. Sanders (SLS) conducted searches, identified studies, extracted data and prepared the manuscript for the updated reviews in 2003, 2007 and 2008.
Maroeska M. Rovers (MMR) participated in the 2007 update by providing data and information from the individual patient data meta‐analysis that has been included in this update.
Roderick P. Venekamp (RPV) conducted searches, identified studies, extracted data and prepared the manuscript for the updated review in 2012 and 2015.
PPG, CDM, MMR, SLS and RPV have reviewed and provided comments on the updated version of the review.

Declarations of interest

Chris Del Mar (CDM) declares no conflicts of interests in the current work.
Maroeska M. Rovers (MMR) has participated in workshops and educational activities on otitis media organised by GlaxoSmithKline and received a grant from GlaxoSmithKline for a study on the microbiology of otitis media in 2009.
Roderick P. Venekamp (RPV) is an Editor of the Cochrane Acute Respiratory Infections Group.
Sharon L Sanders (SLS) declares no conflicts of interests in the current work.
Paul P Glasziou (PPG) is co‐investigator on NHMRC funded grant Antibiotic Resistance.

Acknowledgements

We would like to thank Professor Charles Bridges‐Webb (deceased) for stimulating initial discussions and for constructive advice on the protocol for this review and Professor Steve Berman for helpful comments on the draft review. We would like to thank Bruce Arroll and Tom Fahey for peer refereeing the 2005 updated review and Dilip Raghavan, Brian Westerberg, Mark Jones and Peter Morris for peer refereeing the 2009 updated review. We also thank Dilip Raghavan, Brian Westerberg, Teresa Neeman and Peter Morris for commenting on the 2012 updated review and Ann Fonfa, Julie Gildie, Conor Teljeur, Bruce Arroll, Brian Westerberg and Peter Morris for peer refereeing the 2015 updated review.

Thank you to David McCormick and his colleagues for allowing us to access raw study data from the trial comparing immediate antibiotics and expectant observation (McCormick 2005).

Thank you to Chris Cates for noticing and advising us of an error in the confidence intervals presented in the review.

We gratefully thank Sarah Thorning for her support with the search strategy and searches.

Version history

Published

Title

Stage

Authors

Version

2023 Nov 15

Antibiotics for acute otitis media in children

Review

Roderick P Venekamp, Sharon L Sanders, Paul P Glasziou, Maroeska M Rovers

https://doi.org/10.1002/14651858.CD000219.pub5

2015 Jun 23

Antibiotics for acute otitis media in children

Review

Roderick P Venekamp, Sharon L Sanders, Paul P Glasziou, Chris B Del Mar, Maroeska M Rovers

https://doi.org/10.1002/14651858.CD000219.pub4

2013 Jan 31

Antibiotics for acute otitis media in children

Review

Roderick P Venekamp, Sharon Sanders, Paul P Glasziou, Chris B Del Mar, Maroeska M Rovers

https://doi.org/10.1002/14651858.CD000219.pub3

2004 Jan 26

Antibiotics for acute otitis media in children

Review

Sharon Sanders, Paul P Glasziou, Chris B Del Mar, Maroeska M Rovers

https://doi.org/10.1002/14651858.CD000219.pub2

2000 Apr 28

Antibiotics for acute otitis media in children

Review

Paul Glasziou, M Hayem, B Del Mar C

https://doi.org/10.1002/14651858.CD000219

Differences between protocol and review

In this 2015 updated review, we now provide outcome data on:

  • pain at 24 hours, two to three days, four to seven days and 10 to 14 days (in earlier versions outcome data on pain were presented at 24 hours, two to three days and four to seven days);

  • abnormal tympanometry findings at two to four weeks, six to eight weeks and three months (in earlier versions outcome data on abnormal tympanometry findings were presented at four to six weeks and three months);

  • long‐term effects including number of parent‐reported AOM‐symptom episodes, antibiotic prescriptions and health care utilisation as assessed at least one year after randomisation (in earlier versions no data on long‐term effects were presented).

The outcome 'Adverse effects likely to be related to the use of antibiotics such as vomiting, diarrhoea or rash' has been added to primary outcomes (in earlier versions this outcome was listed as a secondary outcome) according to the recommendations described in Chapter 5.4.2 of the Cochrane Handbook for Systematic Reviews of Interventions ("the primary outcomes should include at least one desirable and at least one undesirable outcome") (Higgins 2011).

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 1

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

L'Abbé plot of the rates of pain at 24 hours for the placebo (control) versus antibiotic (experimental) group.
Figuras y tablas -
Figure 3

L'Abbé plot of the rates of pain at 24 hours for the placebo (control) versus antibiotic (experimental) group.

L'Abbé plot of the rates of pain at two to three days for the placebo (control) versus antibiotic (experimental) group.
Figuras y tablas -
Figure 4

L'Abbé plot of the rates of pain at two to three days for the placebo (control) versus antibiotic (experimental) group.

Funnel plot of comparison: 1 Antibiotic versus placebo, outcome: 1.1 Pain.
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 Antibiotic versus placebo, outcome: 1.1 Pain.

Percentage with pain based on the subset of six studies included in the IPD meta‐analysis (Rovers 2006).
Figuras y tablas -
Figure 6

Percentage with pain based on the subset of six studies included in the IPD meta‐analysis (Rovers 2006).

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.
Figuras y tablas -
Analysis 1.1

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.

Comparison 1 Antibiotics versus placebo, Outcome 2 Vomiting, diarrhoea or rash.
Figuras y tablas -
Analysis 1.2

Comparison 1 Antibiotics versus placebo, Outcome 2 Vomiting, diarrhoea or rash.

Comparison 1 Antibiotics versus placebo, Outcome 3 Abnormal tympanometry.
Figuras y tablas -
Analysis 1.3

Comparison 1 Antibiotics versus placebo, Outcome 3 Abnormal tympanometry.

Comparison 1 Antibiotics versus placebo, Outcome 4 Tympanic membrane perforation.
Figuras y tablas -
Analysis 1.4

Comparison 1 Antibiotics versus placebo, Outcome 4 Tympanic membrane perforation.

Comparison 1 Antibiotics versus placebo, Outcome 5 Contralateral otitis (in unilateral cases).
Figuras y tablas -
Analysis 1.5

Comparison 1 Antibiotics versus placebo, Outcome 5 Contralateral otitis (in unilateral cases).

Comparison 1 Antibiotics versus placebo, Outcome 6 Late AOM recurrences.
Figuras y tablas -
Analysis 1.6

Comparison 1 Antibiotics versus placebo, Outcome 6 Late AOM recurrences.

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain.
Figuras y tablas -
Analysis 2.1

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain.

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 2 Vomiting, diarrhoea or rash.
Figuras y tablas -
Analysis 2.2

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 2 Vomiting, diarrhoea or rash.

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 Abnormal tympanometry at 4 weeks.
Figuras y tablas -
Analysis 2.3

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 Abnormal tympanometry at 4 weeks.

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Tympanic membrane perforation.
Figuras y tablas -
Analysis 2.4

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Tympanic membrane perforation.

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 5 AOM recurrences.
Figuras y tablas -
Analysis 2.5

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 5 AOM recurrences.

Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children

Antibiotics versus placebo for acute otitis media in children

Patient or population: children with acute otitis media
Settings: primary care and secondary care
Intervention: antibiotics versus placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Antibiotics versus placebo

Pain ‐ pain at 24 hours

Study population

RR 0.89
(0.78 to 1.01)

1394
(5 studies)1

⊕⊕⊕⊕
high

426 per 1000

379 per 1000
(332 to 431)

Pain ‐ pain at 2 to 3 days

Study population

RR 0.70
(0.57 to 0.86)

2320
(7 studies)

⊕⊕⊕⊕
high

159 per 1000

111 per 1000
(90 to 137)

Pain ‐ pain at 4 to 7 days

Study population

RR 0.76
(0.63 to 0.91)

1347
(7 studies)1

⊕⊕⊕⊕
high

241 per 1000

183 per 1000
(152 to 220)

Pain ‐ pain at 10 to 12 days

Study population

RR 0.33
(0.17 to 0.66)

278
(1 study)

⊕⊕⊕⊝
moderate2

216 per 1000

71 per 1000
(37 to 142)

Abnormal tympanometry ‐ 2 to 4 weeks

Study population

RR 0.82
(0.74 to 0.90)

2138
(7 studies)

⊕⊕⊕⊕
high

481 per 1000

395 per 1000
(356 to 433)

Abnormal tympanometry ‐ 3 months

Study population

RR 0.97
(0.76 to 1.24)

809
(3 studies)

⊕⊕⊕⊕
high

241 per 1000

234 per 1000
(183 to 299)

Vomiting, diarrhoea or rash

Study population

RR 1.38
(1.19 to 1.59)

2107
(8 studies)

⊕⊕⊕⊕
high

196 per 1000

270 per 1000
(233 to 311)

*The basis for the assumed risk for ‘Study population’ was the average risk in the control groups (i.e. total number of participants with events divided by total number of participants included in the meta‐analysis). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1The number of studies reported in the 'Summary of findings' table for the outcomes 'Pain at 24 hours' and 'Pain at 4 to 7 days' differ slightly from those reported in the Data Analysis Table 1 ‐ Antibiotics versus placebo (five versus six studies and seven versus eight studies, respectively). This is due to the van Buchem trial. This trial is included as one study in our review (and in the 'Summary of findings' table), but we included data from two different comparisons from this 2 x 2 factorial design trial in our analyses (van Buchem 1981a; van Buchem 1981b).

2We downgraded the evidence for pain at days 10 to 12 from high quality as this outcome was not specified a priori in this trial (secondary analysis).

Figuras y tablas -
Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children
Comparison 1. Antibiotics versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain Show forest plot

13

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Pain at 24 hours

6

1394

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.78, 1.01]

1.2 Pain at 2 to 3 days

7

2320

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.57, 0.86]

1.3 Pain at 4 to 7 days

8

1347

Risk Ratio (M‐H, Fixed, 95% CI)

0.76 [0.63, 0.91]

1.4 Pain at 10 to 12 days

1

278

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.17, 0.66]

2 Vomiting, diarrhoea or rash Show forest plot

8

2107

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [1.19, 1.59]

3 Abnormal tympanometry Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 2 to 4 weeks

7

2138

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.74, 0.90]

3.2 6 to 8 weeks

3

953

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.78, 1.00]

3.3 3 months

3

809

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.76, 1.24]

4 Tympanic membrane perforation Show forest plot

5

1075

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.76]

5 Contralateral otitis (in unilateral cases) Show forest plot

4

906

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.25, 0.95]

6 Late AOM recurrences Show forest plot

6

2200

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.78, 1.10]

Figuras y tablas -
Comparison 1. Antibiotics versus placebo
Comparison 2. Immediate antibiotics versus expectant observation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Pain at 3 to 7 days

4

959

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.50, 1.12]

1.2 Pain at 11 to 14 days

1

247

Risk Ratio (M‐H, Random, 95% CI)

0.91 [0.75, 1.10]

2 Vomiting, diarrhoea or rash Show forest plot

2

550

Risk Ratio (M‐H, Fixed, 95% CI)

1.71 [1.24, 2.36]

3 Abnormal tympanometry at 4 weeks Show forest plot

1

207

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.78, 1.35]

4 Tympanic membrane perforation Show forest plot

1

179

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 AOM recurrences Show forest plot

1

209

Risk Ratio (M‐H, Fixed, 95% CI)

1.41 [0.74, 2.69]

Figuras y tablas -
Comparison 2. Immediate antibiotics versus expectant observation