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Recombinant human granulocyte-macrophage colony-stimulating factor applied locally in low doses enhances healing and prevents recurrence of chronic venous ulcers.

Abstract

BACKGROUND

Chronic venous leg ulcers have a major medical and economic impact on the elderly worldwide. Healing of the large ulcers (>10 cm2) occurs only in two-thirds of the patients and reulceration of healed ulcers recurs in one-third within 1 year. Because both healing and relapse rate influence greatly a patient's quality of life and the overall cost of treatment, every effort should be made to improve these two parameters.

OBJECTIVE

To determine the safety and efficacy of topical low-dose recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) for the treatment of venous ulcers, and to document any improvement in healing rates.

METHODS

Thirty-eight patients (29 women, 9 men; median age, 74 years) with chronic venous insufficiency were treated with topical rhu GM-CSF (5 microg/mL 0.9% sodium chloride solution), followed by application of a compression dressing. All subjects were treated as outpatients.

RESULTS

Complete healing was observed in 47 of the 52 ulcers (90.4%). The average healing time was 19 weeks. No systemic or local side-effects from the therapy were observed. Nine chronic ulcers, previously refractory to conventional treatment (pretreatment for more than 46 weeks), showed the same response rate (9/8, or 88.9%) and healing time (mean, 19 weeks). After 40 months, no reulceration of the healed ulcers was observed, but two patients developed new ulcers on the same leg. Healing remained stable, with excellent cosmetic results.

CONCLUSIONS

In this first study, topically applied low-dose rhu GM-CSF was a safe treatment for chronic venous leg ulcers. Healing rates were significantly increased and relapse rates were minimal.

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  • Authors+Show Affiliations

    ,

    Department of Internal Medicine, General Hospital, Kufstein, Austria.

    ,

    Source

    MeSH

    Administration, Cutaneous
    Adult
    Aged
    Aged, 80 and over
    Bandages
    Chronic Disease
    Dose-Response Relationship, Drug
    Female
    Granulocyte-Macrophage Colony-Stimulating Factor
    Humans
    Male
    Middle Aged
    Patch Tests
    Recombinant Proteins
    Secondary Prevention
    Skin
    Varicose Ulcer
    Wound Healing

    Pub Type(s)

    Clinical Trial
    Journal Article

    Language

    eng

    PubMed ID

    10369552

    Citation

    Jaschke, E, et al. "Recombinant Human Granulocyte-macrophage Colony-stimulating Factor Applied Locally in Low Doses Enhances Healing and Prevents Recurrence of Chronic Venous Ulcers." International Journal of Dermatology, vol. 38, no. 5, 1999, pp. 380-6.
    Jaschke E, Zabernigg A, Gattringer C. Recombinant human granulocyte-macrophage colony-stimulating factor applied locally in low doses enhances healing and prevents recurrence of chronic venous ulcers. Int J Dermatol. 1999;38(5):380-6.
    Jaschke, E., Zabernigg, A., & Gattringer, C. (1999). Recombinant human granulocyte-macrophage colony-stimulating factor applied locally in low doses enhances healing and prevents recurrence of chronic venous ulcers. International Journal of Dermatology, 38(5), pp. 380-6.
    Jaschke E, Zabernigg A, Gattringer C. Recombinant Human Granulocyte-macrophage Colony-stimulating Factor Applied Locally in Low Doses Enhances Healing and Prevents Recurrence of Chronic Venous Ulcers. Int J Dermatol. 1999;38(5):380-6. PubMed PMID: 10369552.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Recombinant human granulocyte-macrophage colony-stimulating factor applied locally in low doses enhances healing and prevents recurrence of chronic venous ulcers. AU - Jaschke,E, AU - Zabernigg,A, AU - Gattringer,C, PY - 1999/6/16/pubmed PY - 1999/6/16/medline PY - 1999/6/16/entrez SP - 380 EP - 6 JF - International journal of dermatology JO - Int. J. Dermatol. VL - 38 IS - 5 N2 - BACKGROUND: Chronic venous leg ulcers have a major medical and economic impact on the elderly worldwide. Healing of the large ulcers (>10 cm2) occurs only in two-thirds of the patients and reulceration of healed ulcers recurs in one-third within 1 year. Because both healing and relapse rate influence greatly a patient's quality of life and the overall cost of treatment, every effort should be made to improve these two parameters. OBJECTIVE: To determine the safety and efficacy of topical low-dose recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) for the treatment of venous ulcers, and to document any improvement in healing rates. METHODS: Thirty-eight patients (29 women, 9 men; median age, 74 years) with chronic venous insufficiency were treated with topical rhu GM-CSF (5 microg/mL 0.9% sodium chloride solution), followed by application of a compression dressing. All subjects were treated as outpatients. RESULTS: Complete healing was observed in 47 of the 52 ulcers (90.4%). The average healing time was 19 weeks. No systemic or local side-effects from the therapy were observed. Nine chronic ulcers, previously refractory to conventional treatment (pretreatment for more than 46 weeks), showed the same response rate (9/8, or 88.9%) and healing time (mean, 19 weeks). After 40 months, no reulceration of the healed ulcers was observed, but two patients developed new ulcers on the same leg. Healing remained stable, with excellent cosmetic results. CONCLUSIONS: In this first study, topically applied low-dose rhu GM-CSF was a safe treatment for chronic venous leg ulcers. Healing rates were significantly increased and relapse rates were minimal. SN - 0011-9059 UR - https://www.unboundmedicine.com/medline/citation/10369552/Recombinant_human_granulocyte_macrophage_colony_stimulating_factor_applied_locally_in_low_doses_enhances_healing_and_prevents_recurrence_of_chronic_venous_ulcers_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0011-9059&date=1999&volume=38&issue=5&spage=380 DB - PRIME DP - Unbound Medicine ER -