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Cochrane Database of Systematic Reviews

Tratamiento médico y quirúrgico de la miastenia ocular

Información

DOI:
https://doi.org/10.1002/14651858.CD005081.pub3Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 12 diciembre 2012see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Neuromuscular

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Michael Benatar

    Correspondencia a: Department of Neurology, University of Miami, Miami, USA

    [email protected]

  • Henry Kaminski

    Department of Neurology, George Washington University, Washington, USA

Contributions of authors

Michael Benatar and Henry Kaminski both evaluated each paper and extracted the relevant data. Michael Benatar wrote the first draft of the review. Henry Kaminski commented on and edited the draft to produce a final review. In 2010 both authors assessed 'Risk of bias' in the included studies. Both authors reviewed searches for updates and approved the text.

Declarations of interest

Dr Michael Benatar is the principal investigator on a RCT designed to compare the efficacy of prednisone plus pyridostigmine versus placebo plus pyridostigmine for the treatment of ocular myasthenia. He receives research funding from both the US National Institutes of Health (NIH) and the Food and Drug Administration for clinical trials in the field of MG.

Henry Kaminski is co‐investigator of the NIH‐sponsored trial of thymectomy for treatment of non‐thymomatous MG. He serves as consultant for Varleigh Limited, which is developing a drug for treatment of MG. He has served as a consultant for GlaxoSmithKline and serves on the Data and Safety Monitoring Board for a clinical trial sponsored by Cytokinetics. He receives royalties from Springer Publishing. He has performed legal consultations in cases related to MG.

Acknowledgements

The authors are grateful to Kate Jewitt and Richard Hughes at the Cochrane Neuromuscular Disease Group for their advice during the preparation of this review. We are also grateful to the late John Newsom‐Davis, Tony Swan, Philippe Gajdos and Sumit Singh for their helpful comments on an earlier draft of this review.

The editorial base of the Cochrane Neuromuscular Disease Group is supported by the MRC Centre for Neuromuscular Diseases and the Muscular Dystrophy Campaign.

Version history

Published

Title

Stage

Authors

Version

2012 Dec 12

Medical and surgical treatment for ocular myasthenia

Review

Michael Benatar, Henry Kaminski

https://doi.org/10.1002/14651858.CD005081.pub3

2006 Apr 19

Medical and surgical treatment for ocular myasthenia

Review

Michael Benatar, Henry Kaminski

https://doi.org/10.1002/14651858.CD005081.pub2

2005 Jan 24

Medical and surgical treatment for ocular myasthenia

Protocol

Michael Benatar, Henry Kaminski

https://doi.org/10.1002/14651858.CD005081

Differences between protocol and review

For the 2010 update we revised the 'Risk of bias' methodology and stated outcomes that would be included in a 'Summary of findings' table. At the 2012 update, the RevMan categories for review authors 'Risk of bias' judgements changed (Higgins 2011).

The protocol gives details of methodology that the review authors would have followed had more data been available (Benatar 2006).

Notes

A published, completed study (Benatar 2016) has been added to Characteristics of studies awaiting classification, pending a planned full update of the review.

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.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Table 1. Observational studies with outcome of progression to generalized MG

Author (year)

n

Study Design

Demographics

Treatment

Treatment Schedule

Confounding

Follow‐up

Blinding

OR (95% CI)

Papapetropoulos (2003)

28
7 steroids
21 no steroids

Case‐control

Mean age 48.6
Range: 15 to 80
61% male

Steroids

Gradual titration to 60 mg every other day and then tapered to lowest dose required (5 to 10 mg every other day)

Adequate
Logistic regression to control for differences in age and antibody titer between the two treatment groups

Adequate
Follow‐up in 100%
Duration of follow‐up at least 8 years

Not done

4.3 (0.6 to 25.9)

Mee (2003)

34
11 steroids
23 no steroids

Case‐control

Mean age 55
Range: 18 to 87
56% male

Steroids

25 mg per day (mean duration of therapy 33.5 months)

Adequate
Duration of ocular symptoms, duration of follow‐up and antibody titers similar between the two treatment groups

Adequate
Follow‐up in 100%.
Mean duration of follow‐up 50.5 months

Not done

0.02 (0.001 to 0.16)

Kupersmith (2003)

147
58 steroids
36 no steroids

Cohort

Mean age 50
Range 2 to 80
57% male

Steroids

10 mg per day for 2 days, 20 mg per day for 2 days, dose increased to 50 to 60 mg per day for 4 to 5 days, 40 mg per day for 1 week, 30 mg per day for 1 week, 20 mg per day for 1 week, 10 mg/20 mg every alternate day for 1 week, dose further reduced by 2.5 mg per day each week

Adequate
Age and proportion of participants with elevated antibody titers similar between the two treatment groups

Inadequate
Follow‐up in 64%.
Mean duration of follow‐up 3.6 years (range 0.5 to 16 years)

Not done

0.13 (0.04 to 0.45)

Monsul (2004)

56
27 steroids
29 no steroids

Cohort

Mean age 53

Steroids

40 to 60 mg per day tapered to 2.5 to 10 mg per day over 3 to 6 months

Adequate
Age and proportion of participants with elevated antibody titers similar between the two groups

Adequate
Follow‐up in 100%.
Minimum duration of follow‐up 24 months

Not done

0.24 (0.06 to 0.99)

Sommer (1997)

78
45 steroids
33 no steroids

Cohort

Mean age 50.6
Range 10 to 84
49% male

Steroids

Maximum dose 52 mg per day (mean duration of therapy 32 months)

Inadequate
Age similar between two groups, but proportion with elevated antibody titers and with abnormal repetitive nerve stimulation different between the treatment groups

Adequate
Follow‐up in 100%.
Duration of follow‐up not specified.

Not done

0.09 (0.03 to 0.29)

Kupersmith (2009)

87

55 prednisone

32 no prednisone

Cohort

Mean age
Range 4 to 87 years
63% male

Steroids

10 mg per day for 2 days, 20 mg per day for 2 days, dose increased to 50 to 60 mg per day for 7 days, dose decreased by 10mg per week to 10 mg per day, dose further reduced by 2.5 mg per day each week

Inadequate. Prednisone treated patients were those who did not refuse or had no contra‐indication to prednisone treatment.

Gender distribution, age and frequency of elevated AChR antibodies were comparable between the two treatment groups.

Adequate
Follow‐up in 100%, but follow‐up duration not explicitly reported.

Not done

0.15 (0.05 to 0.4)

Ortiz (2008)

21

6 prednisone

15 no prednisone

Cohort

Median age 2.6
Range 1.2 ‐ 4.9

Steroids

Not specified

Inadequate. No discussion of whether the two treatment groups were comparable with respect to important potential confounding variables.

Adequate
Follow‐up in 100%; mean duration 6.5 (range 2‐15.6)

Not done

1.3 (0.09 to 17.7)

Sommer (1997)

78
27 azathioprine
51 no azathioprine

Cohort

Mean age 50.6
Range 10 to 84
49% male

Azathioprine

Maximum dose 145 mg per day (mean duration of therapy 44 months)

Inadequate
Age similar between two groups, but proportion with elevated antibody titers and with abnormal repetitive nerve stimulation different between the treatment groups

Adequate
Follow‐up in 100%.
Duration of follow‐up not specified.

Not done

0.18 (0.05 to 0.67)

Kawaguchi (2005)

75
17 thymectomy
58 no thymectomy

Cohort

Mean age 41
Range 1 to 76
35% male

Thymectomy

Adequate
Age, the use of concurrent immunosuppressive therapy and duration of follow‐up were similar in the two treatment groups

Adequate
Follow‐up in 100%
Duration of follow‐up ranges from 58 to 86 months

Not done

0.23 (0.012 to 4.31)

OR: odds ratios of development of generalized MG amongst those receiving active treatment compared to those receiving control treatment.

Figuras y tablas -
Table 1. Observational studies with outcome of progression to generalized MG
Table 2. Observational studies with outcome of improvement in ocular symptoms

Author (year)

n

Study Design

Demographics

Treatment

Confounding

Follow‐up

Blinding

OR (95% CI)

Bhanushali (2008)

16

Cohort

Median age 53.5

Range 30‐77

Steroids

Inadequate. No discussion of whether the two treatment groups were comparable with respect to important potential confounding variables.

Adequate

Follow‐up in 100%

Not done

6.75 (0.93 to 49.2)

Ortiz (2008)

21

Cohort

Median age 2.6

Range 1.2 ‐ 4.9

Steroids

Inadequate. No discussion of whether the two treatment groups were comparable with respect to important potential confounding variables.

Adequate

Follow‐up in 100%; mean duration 6.5 (range 2‐15.6)

Not done

0.8 (0.07 to 9.67)

Papatestas (1987)

313
12 thymectomy
301 no thymectomy

Cohort

Not reported

Thymectomy

Not done

Adequate
Follow‐up in 100%
Duration of follow‐up not specified

Not done

0.82 (0.18 to 3.8)

Kawaguchi (2005)

75

17 thymectomy 58 no thymectomy

Cohort

Mean age 41 Range 1‐76 35% male

Thymectomy

Adequate
Age, the use of concurrent immunosuppressive therapy and duration of follow‐up were similar in the two treatment groups

Adequate
Follow‐up in 100%
Duration of follow‐up ranges from 58 to 86 months

Not done

0.97 (0.27 to 3.45)

CI: confidence interval

OR: odds ratios of improvement in ocular symptoms amongst those receiving active treatment compared to those receiving control treatment.

Figuras y tablas -
Table 2. Observational studies with outcome of improvement in ocular symptoms