دورية أكاديمية
Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: a randomized, double-blind, placebo-controlled trial.
| العنوان: | Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: a randomized, double-blind, placebo-controlled trial. |
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| المؤلفون: | Bekkers VZ; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Zdunczyk KM; Department of Dermatology, Center for Human Drug Research, Leiden, the Netherlands.; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden, The Netherlands., Bik L; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Ten Voorde W; Department of Dermatology, Center for Human Drug Research, Leiden, the Netherlands., Aarts P; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Oerlemans F; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Bohoslavsky R; Department of Dermatology, Center for Human Drug Research, Leiden, the Netherlands., Haedersdal M; Department of Dermatology, University Hospital Bispebjerg, Copenhagen, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark., Prens EP; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands., Rissmann R; Department of Dermatology, Center for Human Drug Research, Leiden, the Netherlands.; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden, The Netherlands.; Department of Dermatology, Leiden University Medical Center, University Medical Center Leiden, Leiden, The Netherlands., van Doorn MBA; Department of Dermatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.; Department of Dermatology, Center for Human Drug Research, Leiden, the Netherlands. |
| المصدر: | Clinical and experimental dermatology [Clin Exp Dermatol] 2024 Jul 20. Date of Electronic Publication: 2024 Jul 20. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 7606847 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2230 (Electronic) Linking ISSN: 03076938 NLM ISO Abbreviation: Clin Exp Dermatol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2023- : Oxford : Oxford University Press Original Publication: Oxford : Blackwell Scientific Publications. |
| مستخلص: | Background: Severe keloids are difficult to treat. Corticosteroid injections with needles are painful and associated with frequent recurrences. Therefore, more effective, safe and patient friendly alternative treatments are urgently needed. Objectives: To assess the efficacy, tolerability, and patient satisfaction of intralesional bleomycin treatment using a needle-free electronic pneumatic jet injector (EPI) in severe keloids. Methods: Patients with severe keloids were included in this double-blind, randomized placebo-controlled trial with split-lesion design. Three EPI treatments with bleomycin or saline, were administered every four weeks in respectively the intervention and control side. Outcome measures were change in scar volume assessed by 3D-imaging, Patient and Observer Scar Assessment Scale (POSAS), skin perfusion with laser speckle contrast imaging (LSCI), spilled volume, procedure related pain, adverse events, and patient satisfaction. Results: Fourteen patients (9 female, 5 men) were included. The estimated mean keloid volume was significantly reduced with 20% after EPI-assisted bleomycin, compared to a slight increase of 3% in the control side (p<0.01). The estimated mean POSAS patient and observer scores decreased with respectively 26% and 28% (p = 0.02; p = 0.03). LSCI showed no significant change in perfusion. EPI treatment was preferred over previous needle injections in 85% of patients. The estimated mean spilled volume after EPI was around 50%, and NRS pain scores were moderate. Adverse events included bruising, hyperpigmentation, and transient superficial necrosis. Conclusion: Three EPI-assisted bleomycin treatments are efficacious and well-tolerated in severe keloids. Moreover, EPI treatment was preferred by most patients and may serve as a patient-friendly alternative treatment. (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.) |
| تواريخ الأحداث: | Date Created: 20240720 Latest Revision: 20240720 |
| رمز التحديث: | 20240720 |
| DOI: | 10.1093/ced/llae254 |
| PMID: | 39030712 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1365-2230 |
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| DOI: | 10.1093/ced/llae254 |