نقش آسپرین خوراکی برای درمان زخمهای وریدی پا
Información
- DOI:
- https://doi.org/10.1002/14651858.CD009432.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 18 febrero 2016see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Heridas
- Copyright:
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- Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
Paulo de Oliveira Carvalho: conceived the review; designed the review; coordinated the review; extracted data; checked the quality of data extraction; undertook and checked quality assessment; analysed or interpreted data; performed statistical analysis; checked the quality of the statistical analysis; produced the first draft of the review; contributed to writing or editing the review; made an intellectual contribution to the review; approved the final review prior to submission; secured funding; performed previous work that was the foundation of the current review; performed translations; and is a guarantor of the review.
Natiara Magolbo: conceived the review; designed the review; extracted data; undertook quality assessment; produced the first draft of the review; performed previous work that was the foundation of the current review; wrote to study author / experts / companies; and provided data.
Rebeca De Aquino: conceived the review; designed the review; extracted data; undertook quality assessment; produced the first draft of the review; performed previous work that was the foundation of the current review; wrote to study author / experts / companies; and provided data.
Carolina Weller: extracted data; analysed or interpreted data; contributed to writing or editing the review; made an intellectual contribution to the review; approved the final review prior to submission; advised on the review; and provided data.
Contributions of editorial base:
Editors: Nicky Cullum edited the protocol; advised on methodology, interpretation and protocol content; approved the final protocol prior to submission.
Joan Webster: edited the protocol; advised on methodology, interpretation and protocol content; approved the final protocol prior to submission.
Managing Editors: Sally Bell‐Syer and Gill Rizzello, coordinated the editorial process; advised on interpretation and content. Edited the review.
Ruth Foxlee: designed the search strategy, Rocio Rodriguez Lopez ran the searches.
Sources of support
Internal sources
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Evidence Based Actions Department From Marília Medical School ‐ FAMEMA, Brazil.
External sources
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FAPESP‐ Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil.
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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
Paolo Eduardo de Oliveira Carvalho: none known.
Natiara Magolbo: none known.
Rebeca De Aquino: none known.
Carolina Weller: none known.
Acknowledgements
We would like to thank:
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Peer referees: Susan O' Meara, Liz McInnes, Duncan Chambers, Gill Worthy, Mike Clark, Una Adderley and Jane Nadel, for their valuable and constructive feedback.
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FAPESP (Fundaçao de Amparo à Pesquisa do Estado de São Paulo) for the support granted.
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Copy editors, Jenny Bellorini and Elizabeth Royle.
Version history
| Published | Title | Stage | Authors | Version |
| 2016 Feb 18 | Oral aspirin for treating venous leg ulcers | Review | Paulo Eduardo de Oliveira Carvalho, Natiara G Magolbo, Rebeca F De Aquino, Carolina D Weller | |
| 2011 Nov 09 | Oral aspirin for treating venous leg ulcers | Protocol | Natiara G Magolbo, Rebeca F De Aquino, Paulo Eduardo de Oliveira Carvalho | |
Differences between protocol and review
Proportion of ulcer recurrence and mean time until recurrence were not specified in the protocol, but these outcomes appeared in the del Río Solá 2012 trial and were considered important by the review team, so they were included in the review.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Adult; Humans;
PICO
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Flow diagram of included and excluded studies
Comparison 1 Oral aspirin versus control, Outcome 1 Number of people with healed ulcer.
Comparison 1 Oral aspirin versus control, Outcome 2 Time to recurrence (days).
| Oral aspirin for venous leg ulcers | ||||||
| Patient or population: patients with venous leg ulcers | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Oral aspirin | |||||
| Average time for ulcer healing | 22 weeks | 12 weeks | Not estimable | 51 (1 study) | ⊕⊕⊝⊝ | P values and confidence intervals were not reported |
| Reduction of ulcer area (median) | 0 cm² | 6.5cm² | Not estimable | 20 | ⊕⊕⊝⊝ | P value < 0.002 Follow‐up: 4 months |
| Proportion of healed ulcers in the trial period | No healed ulcers | 38% of healed ulcers | Not estimable | 20 | ⊕⊕⊝⊝ | P value < 0.007 Follow‐up: 4 months |
| Major bleeding | See comment | See comment | Not estimable | 20 | ⊕⊕⊝⊝ | No events were observed in either group, follow‐up: 4 months Another study reported 2 hospitalisations for unknown reasons, intervention group not specified |
| Average time of ulcer recurrence | 16.33 days SD: 7.5 | 39 days SD: 6.0 | Not estimable | 51 | ⊕⊕⊝⊝ | P value = 0.007 Post hoc assessment not pre‐specified in protocol |
| Mortality | See comment | See comment | Not estimable | See comment | See comment | Mortality not reported |
| Other adverse events | See comment | See comment | Not estimable | 71 | See comment | No events were observed in either group. del Río Solá reported 2 hospitalisations for unknown reasons, the group of these patients were not specified and they were removed from the study |
| *The basis for the assumed risk (for example, 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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Allocation concealment and blinding of outcome assessment were not described. Participants and personnel were not blinded. There was a high risk of bias from incomplete outcome data.There were some inconsistencies in the reporting of the data | ||||||
| Study identification | Layton | del Río Solá | ||||
| Country | United Kingdom | Spain | ||||
| Period | Not reported | 2001 to 2005 | ||||
| Centres | Academic Unit of Dermatology, General Infirmary at Leeds, West Yorkshire | University Hospital of Valladolid | ||||
| Source of funding | Not specified | Not specified | ||||
| Method | ||||||
| Study design | Prospective randomized, double‐blind | Prospective randomized trial | ||||
| Power calculation | Not described | Yes | ||||
| Method of randomisation | Not described | Generated by computer program | ||||
| Concealment of allocation | Not described | Not described | ||||
| Number of participants randomized | 20 | 51 | ||||
| Number of participants analyzed | 20 | 47 | ||||
| Number of participants excluded after randomizations | 0 | 0 | ||||
| Number of participant withdrawals and reasons | 0 | 4 people; 2 people needed hospitalisation and left the study and 2 people opted for treatment in another service | ||||
| Intention‐to‐treat analysis | Yes | Yes | ||||
| Participants | ||||||
| Inclusion criteria | People with chronic venous leg ulcer | Venous leg ulcer ≥ 2 cm Ankle‐brachial rate < 0.9 No contraindication to taking aspirin | ||||
| Exclusion criteria | Ulcer diameter < 2 cm Already taking aspirin, anticoagulants or non‐steroidal anti‐inflammatory Doppler flowmetry ankle‐brachial rate < 0.9 | People with diabetes mellitus, rheumatoid arthritis, peripheral arterial disease and neurologic disease Previous or concomitant therapy with aspirin | ||||
| Aspirin | Control | P value | Aspirin | Control | P value | |
| Number of participants | 10 | 10 |
| 23 | 28 |
|
| Age (years) | 62.2 years (mean) (48‐81) | 66 years (mean) (46 ‐ 85) |
| 60.50 years (SD:12.07) | 58.59 years (SD:16.55) | reported as non significant |
| Sex | 3 female, 7 male | 5 female, 5 male |
| 10 female, 13 male | 19 female, 9 male | reported as non significant |
| Ulcer duration before the study | 11.4 years (mean) (1‐24) | 10.5 years (mean) (2‐22) |
| 6‐12 months | > 12 months |
|
| 1 Number of ulcers | Not reported | Not reported | Not reported | Not reported | reported as non significant | |
| Initial ulcer surface area (cm²) | 16.5 cm² (mean) (2.5‐39.5) | 14.25 cm² (mean) (1.5‐48.5) | 25.15 cm² | 24.87 cm² | P=0.944 | |
| Signs of ulcer infection | Not reported | Not reported | Yes, 20 patients | Yes, 22 patients | P=0.094 | |
| Any comorbidity | Not reported | Not reported | 9 patients | 10 patients | ||
| Previously treated | \not reported | Not reported | 10 patients | 20 patients | ||
| Interventions | Aspirin 300 mg/day | Placebo | Aspirin 300 mg/day | No drug treatment | ||
| Outcomes | ||||||
| Follow‐up (months) | 4 months | 4 months | 42 months mean (24‐61) | 42 months mean (24‐61) | ||
| 2 Withdrawals | 0 | 0 | 2 people | 2 people | ||
| Duration of the study to complete ulcer healing | Not reported | Not reported | Not reported | 12.4 weeks | 16.5 weeks | P=0.07 Mann‐Whitney |
| Healing period | Not reported | Not reported | Not reported | Reported as short in the aspirin group | Reported as short in the aspirin group | P=0.04 log‐rank test = 3.90 OR = 0.93 95% CI 0.25‐3.5 |
| Average time to complete ulcer healing (weeks) | Not reported | Not reported | Not reported | 12 | 22 | Not reported |
| Number of participants with complete ulcer healing in the trial period | Not reported | Not reported | Not reported | 17 (74%) | 21 (75%) | reported as non significant |
| Proportion of ulcers healed in the trial period | 38% of the ulcers | 0% of the ulcers | < 0.007 (x² test) | Not reported | Not reported | Not reported |
| Change in ulcer areas in the trial period (second month; ulcer area cm²) | 15.5 cm² (median) 1 cm² of reduction (6.07% of reduction) | No reduction | < 0.01 (x² test) | Not reported | Not reported | Not reported |
| Reduction in ulcer size in the trial period (fourth month; ulcer area cm²) | 10.0 cm² (median) 6.5 cm² of reduction (39.4% of reduction) | No reduction | < 0.002 (x² test) | Not reported | Not reported | Not reported |
| Improvement assessed by reduction in ulcer size | 52% of the ulcers | 26% of the ulcers | < 0.007 (x² test) | Not reported | Not reported | Not reported |
| Increase in ulcer size in the trial period | 10% of the ulcers | 26% of the ulcers | < 0.004 (x² test) | Not reported | Not reported | Not reported |
| Ulcers size unchanged in the trial period | 0% of the ulcers | 48% of the ulcers | < 0.001 (x2 test) | Not reported | Not reported | Not reported |
| Proportion of participants with ulcers healed in the trial period | Not reported | Not reported | Not reported | 17 (74%) | 21 (75%) | reported as non significant |
| Proportion of participants with ulcer recurrence | Not reported | Not reported | Not reported | 25% | 33.33% | 0.74 |
| Average time for ulcer recurrence (days) | Not reported | Not reported | Not reported | 39 (SD 6) | 16.33 (SD 7.5) | P=0.007 Kaplan‐Meier |
| adverse effects | 0 | 0 | 0 | 0 | Not reported | |
|
| ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Number of people with healed ulcer Show forest plot | 1 | 51 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.99 [0.71, 1.36] |
| 2 Time to recurrence (days) Show forest plot | 1 | 51 | Mean Difference (IV, Fixed, 95% CI) | 22.67 [18.96, 26.38] |
