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Cochrane Database of Systematic Reviews

Sulodeksid za liječenje venskih ulkusa nogu

Información

DOI:
https://doi.org/10.1002/14651858.CD010694.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 02 junio 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Heridas

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Bin Wu

    Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China

  • Jing Lu

    Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China

  • Ming Yang

    Center of Geriatrics and Gerontology, West China Hospital, Sichuan University, Chengdu, China

  • Ting Xu

    Correspondencia a: Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China

    [email protected]

    [email protected]

Contributions of authors

Bin Wu: conceived the review question, developed the protocol and full review, completed the first draft, performed part of the writing and editing of the review, advised on the review and approved final version prior to submission.
Jing Lu: developed the protocol, selected studies and extracted data, performed part of the writing and editing of the review, advised on the review and approved the final version prior to submission.
Ming Yang: developed the protocol, participated in study selection and data extraction, assessed risk of bias, made an intellectual contribution, advised on part of the review and approved the final version prior to submission.
Ting Xu: conceived the review question, made an intellectual contribution, advised on the review and approved the final version prior to submission.

Contributions of editorial base:

Nicky Cullum (Editor): edited the protocol and the review; advised on methodology, interpretation and protocol content. Approved the final protocol and review prior to submission.
Joan Webster (Editor): edited the review; advised on methodology, interpretation and review content. Approved the final review prior to submission.
Sally Bell‐Syer and Gill Rizzello: co‐ordinated the editorial process. Advised on interpretation and content.
Ruth Foxlee: designed the search strategy and edited the search methods section. Reetu Child updated the search and edited the search methods section.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • This project was supported by the National Institute for Health Research via Cochrane Infrastructure funding to Cochrane Wounds. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health, UK.

Declarations of interest

Bin Wu: none known
Jing Lu: none known
Ming Yang: none known
Ting Xu: none known.

Acknowledgements

We are grateful to Rachel Richardson for her comments on the protocol. We would also like to acknowledge the contribution of peer referees Susan O' Meara, Gill Norman, Gill Worthy, Audrey Demetriouk Janet Whale, Morag Heirs, Giovanni Casazza, Patricia Davies, Madhu Periasamy and Shirley Manknell and copy editors Elizabeth Royle and Denise Mitchell. 

Version history

Published

Title

Stage

Authors

Version

2016 Jun 02

Sulodexide for treating venous leg ulcers

Review

Bin Wu, Jing Lu, Ming Yang, Ting Xu

https://doi.org/10.1002/14651858.CD010694.pub2

2013 Aug 10

Sulodexide for treating venous leg ulcers

Protocol

Bin Wu, Jing Lu, Ming Yang, Ting Xu

https://doi.org/10.1002/14651858.CD010694

Differences between protocol and review

  • EndNote X3 was updated to EndNote X7.

  • RevMan 5.1 software was updated to RevMan 5.3.

  • We decided to add a 'Summary of findings' table to evaluate the overall quality of evidence for each outcome.

  • For assessing reporting biases, we added comparison between the study protocols and the final study reports, or between 'Methods' section of the published studies and the 'Results' section.

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.

PRISMA flow diagram of literature screening
Figuras y tablas -
Figure 1

PRISMA flow diagram of literature screening

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.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

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

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 1 Proportion of ulcers completely healed (overall).
Figuras y tablas -
Analysis 1.1

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 1 Proportion of ulcers completely healed (overall).

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 2 Proportion of ulcers completely healed (sensitivity analysis).
Figuras y tablas -
Analysis 1.2

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 2 Proportion of ulcers completely healed (sensitivity analysis).

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 3 Proportion of ulcers completely healed at 30 days.
Figuras y tablas -
Analysis 1.3

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 3 Proportion of ulcers completely healed at 30 days.

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 4 Proportion of ulcers completely healed at 60 days.
Figuras y tablas -
Analysis 1.4

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 4 Proportion of ulcers completely healed at 60 days.

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 5 Proportion of ulcers completely healed at 90 days.
Figuras y tablas -
Analysis 1.5

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 5 Proportion of ulcers completely healed at 90 days.

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 6 Adverse effects.
Figuras y tablas -
Analysis 1.6

Comparison 1 Sulodexide + local treatment vs. local treatment, Outcome 6 Adverse effects.

Summary of findings for the main comparison. Sulodexide + local treatment compared to local treatment for treating venous leg ulcers

Sulodexide + local treatment compared to local treatment for treating venous leg ulcers

Patient or population: patients with venous leg ulcers
Settings: Italy and China
Intervention: Sulodexide + local treatment
Comparison: local treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

local treatment

Sulodexide + local treatment

Proportion of ulcers completely healed (overall)
Follow‐up: 30 to 90 days

298 per 1000

494 per 1000
(387 to 631)

RR 1.66
(1.3 to 2.12)

438
(3 studies)

⊕⊕⊝⊝
low1

Proportion of ulcers completely healed at 30 days
Follow‐up: mean 30 days

189 per 1000

360 per 1000
(189 to 691)

RR 1.91
(1 to 3.66)

114
(1 study)

⊕⊝⊝⊝
very low2

Proportion of ulcers completely healed at 60 days
Follow‐up: mean 60 days

250 per 1000

412 per 1000
(300 to 570)

RR 1.65
(1.2 to 2.28)

324
(2 studies)

⊕⊕⊝⊝
low1

Proportion of ulcers completely healed at 90 days
Follow‐up: mean 90 days

327 per 1000

524 per 1000
(383 to 720)

RR 1.6
(1.17 to 2.2)

230
(1 study)

⊕⊕⊝⊝
low3

Time to complete ulcer healing

Available data were limited and not analysed

Change in absolute ulcer size

Available data were limited and not analysed

Ulcer recurrence

Not reported

Adverse effects
Follow‐up: 30 to 90 days

31 per 1000

44 per 1000
(15 to 133)

RR 1.44
(0.48 to 4.34)

344
(2 studies)

⊕⊝⊝⊝
very low4

Health‐related quality of life

Not reported

Direct costs

Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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.

1 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors).

2 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors) and one level for imprecision (single study with very wide confidence intervals).

3 Downgraded one level for risk of bias (lack of allocation concealment) and one level for imprecision (single study with very wide confidence intervals).

4 Downgraded two levels for risk of bias (risk of selection bias due to lack of allocation concealment; risk of performance bias due to lack of blinding of participants, personnel and outcome assessors) and one level for imprecision (wide confidence intervals).

Figuras y tablas -
Summary of findings for the main comparison. Sulodexide + local treatment compared to local treatment for treating venous leg ulcers
Comparison 1. Sulodexide + local treatment vs. local treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of ulcers completely healed (overall) Show forest plot

3

438

Risk Ratio (M‐H, Fixed, 95% CI)

1.66 [1.30, 2.12]

2 Proportion of ulcers completely healed (sensitivity analysis) Show forest plot

3

438

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [1.27, 1.83]

3 Proportion of ulcers completely healed at 30 days Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4 Proportion of ulcers completely healed at 60 days Show forest plot

2

324

Risk Ratio (M‐H, Fixed, 95% CI)

1.65 [1.20, 2.28]

5 Proportion of ulcers completely healed at 90 days Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6 Adverse effects Show forest plot

2

344

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [0.48, 4.34]

Figuras y tablas -
Comparison 1. Sulodexide + local treatment vs. local treatment