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Terapia de compresión para el tratamiento del síndrome postrombótico en etapas I y II (Widmer)

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Referencias

Referencias de los estudios incluidos en esta revisión

Ginsberg 1999 {published data only}

Ginsberg JS, Magier D, Mackinnon B, Gent M, Hirsh J. Intermittent compression units for severe post‐phlebitic syndrome: a randomized crossover study. Canadian Medical Association Journal 1999;160(9):1303‐6.

Ginsberg 2001 {published data only}

Ginsberg JS, Hirsh J, Julian J, Vander LaandeVries M, Magier D, MacKinnon B, et al. Prevention and treatment of postphlebitic syndrome: results of a 3‐part study. Archives of Internal Medicine 2001;161(17):2105‐9.

Referencias de los estudios excluidos de esta revisión

Kahn 2003 {published data only}

Kahn SR, Azoulay L, Hirsch A, Haber M, Strulovitch, Shrier I. Effect of graduated elastic compression stockings on leg symptoms and signs during exercise in patients with deep venous thrombosis: a randomized cross‐over trial. Journal of Thrombosis and Haemostasis 2003;1(3):494‐9.

Kakkos 2001 {published data only}

Kakkos SK, Szendro G, Griffin M, Sabetai MM, Nicolaides AN. Improved hemodynamic effectiveness and associated clinical correlations of a new intermittent pneumatic compression system in patients with chronic venous insufficiency. Journal of Vascular Surgery 2001;34(5):915‐22.

Referencias adicionales

Brakkee 1988

Brakkee AJM, Kuiper JP. The influence of compressive stockings on the haemodynamics in the lower extremities. Phlebologie 1988;3:147‐53.

Brandjes 1997

Brandjes DP, Büller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal‐vein thrombosis. Lancet 1997;349(9054):759‐62.

Comp. Bulletin 2002

Partsch H, Rabe E, editors. Subbandage pressure of different stocking sizes. Compression Bulletin, 2, 2002. Robert Stemmer Library. http://www.sigvaris.com/PROD_Web/GlobalDB.nsf/filecontainers/CompressionBulletin/$FILE/CompressionBulletinNo2.pdf (accessed 1 Aug 2003).

Cullum 2003

Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database of Systematic Reviews 2001, Issue 2. [Art. No.: CD000265. DOI: 10.1002/14651858.CD000265.]

Mantel 1959

Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. Journal of the National Cancer Institute 1959;22(4):719‐48.

Partsch 1984

Partsch H. Do we need firm compression stockings exerting high pressure?. Vasa 1984;13(1):52‐7.

Partsch 1991

Partsch H. Compression therapy of the legs. A review. Journal of Dermatologic Surgery & Oncology 1991;17(10):799‐805.

Porter 1995

Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. Journal of Vascular Surgery 1995;21(4):635‐45.

Prandoni 1996

Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, et al. The long‐term clinical course of acute deep venous thrombosis. Annals of Internal Medicine 1996;125(1):1‐7.

Widmer 1985

Widmer LK, Zemp E, Widmer TM, Schmitt HE, Brandenberg HE, Voelin R, et al. Late results in deep vein thrombosis of the lower extremity. Vasa 1985;14(3):264‐8.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ginsberg 1999

Methods

Randomised, crossover design with independent blinded assessment of the outcome events.

Method of randomisation: Computer generated randomisation schedule.

Exclusions post‐randomisation: none.

Losses to follow up: none.

Study duration: 2 months.

Participants

Country: Canada.

Setting: Ontario teaching hospital.

No. of participants: 15.

Gender: 12 women and 3 men.

Age: mean age 60 (range 38 to 81.

Inclusion criteria: documented DVT and intractable symptoms of PPS causing significant limitation of lifestyle, significant morbidity or both, as indicated by any of the following: loss of job or absenteeism from work because of PPS; interference with day‐to day activities, e.g. housework, sports; frequent loss of sleep; failure of condition to improve with use of graduated compression stockings; or person's intolerance of, or refusal to use such stockings.

Exclusion criteria: DVT within the past 3 months or if they were unable to travel to the clinic.

Interventions

Extremity pump twice daily (20 minutes per session) randomly assigned to use either 50 mm Hg pressure or 15 mm Hg pressure for the first month, the other pressure was used the second month.

Outcomes

Successful treatment: defined as preferring the high pressure, and continuing the use of the extremity pump and difference between the two pressures of at least slight importance.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Ginsberg 2001

Methods

Randomised, double blind study. Participant and outcome assessor blinded.

Method of randomisation: Not stated.

Exclusions post‐randomisation: none described.

Losses to follow up: one in treatment group due to death.

Follow up was done every 3 months.

Participants

Country: Canada.

Setting: affiliated hospitals, Hamilton University, Ontario Canada.

No. of participants: 35.
18 compression stockings (14 CLCS, 4 TLCS); 17 placebo stockings (13 CLCS, 4 TLCS)

Age: mean (range) years:
46.0 (18‐79) CLCS;
51.6 (28‐74) TLCS;
54.6 (22‐75) CLPS;
39.5 (25‐64) TLPS.

Gender: (% women):
(50%) CLCS;
(50%) TLCS;
(62%) CLPS;
(100%) TLPS.

Inclusion criteria: symptomatic DVT. Evaluation was done one year after proximal DVT. PPS was defined as chronic pain and swelling as scored on a standardized questionnaire.

Exclusion criteria: previous graduated compression stockings, geographic inaccessibility and failure to provide informed consent.

Interventions

Comparison was done with compression stockings (30‐40 mm Hg) or placebo stockings (one to two sizes too large). Calf length or thigh length compression stockings were administered depending on the localisation of complaints.

Outcomes

Treatment failure: defined as pain and swelling that did not improve, or worsened after the first three months, or if these symptoms worsened during further follow up, or if a patient could not perform his daily activities for five or more days in any three‐month period, or developed a leg ulcer.

Mean follow up: treatment group =25.6 months,
placebo group = 25.4 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

CLCS calf length compression stockings
CLPS calf length placebo stockings
DVT deep vein thrombosis
PPS post‐phlebitic syndrome
TLCS thigh length compression stockings
TLPS thigh length placebo stockings

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Kahn 2003

Crossover study to evaluate the effect of graduated elastic compression stockings on leg symptoms and signs during exercise in patients who had had a deep vein thrombosis one year previously. Artificial situation with treadmill exercise session with and without stockings.

Kakkos 2001

Study was not a treatment for post‐thrombotic syndrome but designed to test the effectiveness of a new intermittent pneumatic compression system.

Data and analyses

Open in table viewer
Comparison 1. Treatment failure

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 No improvement or deterioration of post‐thrombotic syndrome Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Treatment failure, Outcome 1 No improvement or deterioration of post‐thrombotic syndrome.

Comparison 1 Treatment failure, Outcome 1 No improvement or deterioration of post‐thrombotic syndrome.

Comparison 1 Treatment failure, Outcome 1 No improvement or deterioration of post‐thrombotic syndrome.
Figuras y tablas -
Analysis 1.1

Comparison 1 Treatment failure, Outcome 1 No improvement or deterioration of post‐thrombotic syndrome.

Comparison 1. Treatment failure

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 No improvement or deterioration of post‐thrombotic syndrome Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 1. Treatment failure