曲安奈德皮损内注射单药及其联合5-氟尿嘧啶治疗瘢痕疙瘩和增生性瘢痕的疗效及安全性：随机、平行组、双盲试验
Efficacy and safety of intralesional triamcinolone acetonide alone and its combination with 5- fluorouracil in keloids and hypertrophic scars: Randomized, parallel group, and double blinded trial.
作者信息
Acharya Ripala, Agrawal Sudha, Khadka Dhan Keshar, Pant Aashish Raj
机构信息
Department of Dermatology and Venereology B.P Koirala Institute of Health Sciences Dharan Nepal.
Department of Ophthalmology Maharajgunj Medical Campus Tribhuwan University Kathmandu Nepal.
出版信息
Skin Health Dis. 2024 Aug 24;4(5):e450. doi: 10.1002/ski2.450. eCollection 2024 Oct.
BACKGROUND
Treatment of keloids and hypertrophic scars is challenging. The current first-line treatment is a steroid which has high resistance and recurrence rate along with unacceptable adverse effects. Different studies involving the combination of TAC and 5-FU that have been done so far showed better treatment outcomes in terms of efficacy and safety.
OBJECTIVE
The objective of this study was to compare the efficacy and safety of intralesional triamcinolone acetonide alone and its combination with 5-fluorouracil in patients with keloids and hypertrophic scars at 12 weeks follow-up.
METHODS
In this randomized parallel group double-blinded clinical trial, we enroled 66 cases of keloids and hypertrophic scars randomly allocated into two treatment groups. Patients received an intralesional injection of triamcinolone acetonide (20 mg/mL) in Group A and an intralesional injection of a combination of triamcinolone acetonide (20 mg/mL) and 5-fluorouracil (25 mg/mL) in Group B for every 2 weeks until 10 weeks and the final evaluation was done at 12 weeks follow-up.
RESULTS
There was a reduction in all the parameters at every follow-up visit in both groups. The ≥50% reduction in height, reduction in the VSS and POSAS scores, and good to excellent subjective improvement reported by both the patients and the observer were significantly greater in the combination group compared to TAC alone group. The response rate was faster and complications were lesser in the combination group as compared to TAC alone group.
LIMITATION
Single-centred, no long-term follow-up, and recurrence could not be assessed.
CONCLUSION
TAC alone and its combination with the 5-FU both were effective in keloids and hypertrophic scars. Yet, the TAC and 5-FU combination treatment was more efficacious with a faster response rate and safer than the TAC alone treatment.
背景
瘢痕疙瘩和增生性瘢痕的治疗具有挑战性。目前的一线治疗药物是类固醇，其耐药性高、复发率高，且有不可接受的不良反应。迄今为止，不同的关于曲安奈德（TAC）与5-氟尿嘧啶（5-FU）联合使用的研究在疗效和安全性方面显示出更好的治疗效果。
目的
本研究的目的是比较曲安奈德皮损内注射单用及其与5-氟尿嘧啶联合使用在瘢痕疙瘩和增生性瘢痕患者12周随访时的疗效和安全性。
方法
在这项随机平行组双盲临床试验中，我们纳入了66例瘢痕疙瘩和增生性瘢痕患者，随机分为两个治疗组。A组患者接受曲安奈德（20mg/mL）皮损内注射，B组患者接受曲安奈德（20mg/mL）和5-氟尿嘧啶（25mg/mL）联合皮损内注射，每2周一次，共10周，最终评估在12周随访时进行。
结果
两组在每次随访时所有参数均有降低。联合治疗组在高度降低≥50%、温哥华瘢痕量表（VSS）和患者与观察者瘢痕评估量表（POSAS）评分降低以及患者和观察者报告的主观改善为良好至优秀方面，均显著高于单用曲安奈德组。与单用曲安奈德组相比，联合治疗组的反应率更快，并发症更少。
局限性
单中心研究，无长期随访，无法评估复发情况。
结论
单用曲安奈德及其与5-氟尿嘧啶联合使用对瘢痕疙瘩和增生性瘢痕均有效。然而，曲安奈德与5-氟尿嘧啶联合治疗比单用曲安奈德治疗更有效，反应率更快且更安全。
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