Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: a randomized, double-blind, placebo-controlled trial.

IF 3.7 4区 医学 Q1 DERMATOLOGY Clinical and Experimental Dermatology Pub Date : 2024-11-22 DOI:10.1093/ced/llae254
Vazula Z Bekkers, Katarzyna M Zdunczyk, Liora Bik, Wouter Ten Voorde, Pim Aarts, Femke Oerlemans, Roman Bohoslavsky, Merete Haedersdal, Errol P Prens, Robert Rissmann, Martijn B A van Doorn
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Abstract

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 4 weeks in the intervention and control sides. Outcome measures were change in scar volume assessed by three-dimensional 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 (nine female, five male) were included. The estimated mean keloid volume was significantly reduced by 20% after EPI-assisted bleomycin, compared with a slight increase of 3% in the control side (P < 0.01). The estimated mean POSAS patient and observer scores decreased by respectively 28% and 20% (P = 0.03 and P = 0.001). 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 numerical rating scale pain scores were moderate. Adverse events included bruising, hyperpigmentation and transient superficial necrosis.

Conclusions: A course of three EPI-assisted bleomycin injections is efficacious and well tolerated in severe keloids. Moreover, EPI was preferred by most patients and may serve as a patient-friendly alternative treatment.

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用博莱霉素进行无针喷射治疗对严重瘢痕疙瘩患者有效:一项随机、双盲、安慰剂对照试验。
背景:严重的瘢痕疙瘩很难治疗。用针头注射皮质类固醇激素不仅痛苦,而且经常复发。因此,迫切需要更有效、更安全、更方便患者的替代治疗方法:评估使用无针电子气动喷射注射器(EPI)对严重瘢痕疙瘩进行局部博莱霉素治疗的疗效、耐受性和患者满意度:方法:重度瘢痕疙瘩患者被纳入这项双盲、随机安慰剂对照试验,采用分割瘢痕设计。在干预侧和对照侧分别使用博莱霉素或生理盐水进行三次EPI治疗,每四周一次。结果指标包括三维成像评估的疤痕体积变化、患者和观察者疤痕评估量表(POSAS)、激光斑点对比成像(LSCI)的皮肤灌注、溢出量、手术相关疼痛、不良事件和患者满意度:共纳入 14 名患者(9 名女性,5 名男性)。结果:共纳入14名患者(9名女性,5名男性),经EPI辅助博莱霉素治疗后,瘢痕疙瘩的估计平均体积明显缩小了20%,而对照组则略微增加了3%(p结论:EPI辅助博莱霉素治疗后,瘢痕疙瘩的估计平均体积明显缩小了20%:三种EPI辅助博莱霉素疗法对严重瘢痕疙瘩具有良好的疗效和耐受性。此外,EPI疗法受到大多数患者的青睐,可作为一种对患者友好的替代治疗方法。
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来源期刊
CiteScore
3.20
自引率
2.40%
发文量
389
审稿时长
3-8 weeks
期刊介绍: Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.
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