Gabriel A. Mecott, MMS, is Professor; Iván González-Cantú, MD, is a resident; and Edgar Gerardo Dorsey-Treviño, MD, is Research Fellow, all at the Universidad Autónoma de Nuevo León, Department of Plastic, Aesthetic, and Reconstructive Surgery, University Hospital Dr José E. González, in Monterrey, Mexico. Daniel Matta-Yee-Chig, MSc, is a master's student; Odila Saucedo-Cárdenas, PhD, is Professor; and Roberto Montes de Oca-Luna, PhD, is Professor, at the Department of Histology, Faculty of Medicine, Universidad Autónoma de Nuevo León. Sergio Pérez-Porras, MD, is Professor; and Mauricio M. García-Pérez, PhD, is Professor, at the Universidad Autónoma de Nuevo León, Department of Plastic, Aesthetic, and Reconstructive Surgery, University Hospital Dr José E. González. Acknowledgments: The authors thank Dr Sergio Lozano for his kind assistance with English language revision. They also disclose that this article discusses the off-label use of pirfenidone. The authors have disclosed no financial relationships related to this article. Submitted April 24, 2019; accepted in revised form August 29, 2019.
Adv Skin Wound Care. 2020 Apr;33(4):1-7. doi: 10.1097/01.ASW.0000655484.95155.f7.
Several studies suggest that pirfenidone may have a potential off-label use for wound healing. However, the effectiveness of this medication in patients with burns remains uncertain. Accordingly, investigators sought to assess wound re-epithelialization in patients with second-degree burns after adding pirfenidone to usual care.
Single-center pilot, proof-of-concept, single-blind randomized controlled trial.
Eight patients with second-degree burns were treated with occlusive hydrocolloid dressings and were randomly allocated to receive either no additional treatment or pirfenidone.
The primary outcome of the study was to evaluate wound healing between groups based on the thickness of the re-epithelialized epidermis at day 7. Secondary outcomes were to qualitatively assess the development of fibrotic tissue in the dermis, anomalies in the basal membrane, and the development of collagen fibers by histologic analysis. Liver and renal functions were measured daily to assess the overall safety of oral pirfenidone.
Patients treated with pirfenidone showed a remarkable improvement in wound re-epithelialization at day 7 (148.98 ± 13.64 vs 119.27 ± 15.55 μm; P = .029; 95% confidence interval, 4.14-55.29). Histologic evaluations showed less wound fibrosis in the pirfenidone group.
A decrease in wound healing time by enhancing wound re-epithelialization was observed with pirfenidone. Larger clinical trials are needed to reach more reliable conclusions.
几项研究表明，吡非尼酮可能具有治疗伤口愈合的潜在非适应证用途。然而，该药在烧伤患者中的疗效尚不确定。因此，研究人员试图评估在常规治疗的基础上加用吡非尼酮对二度烧伤患者的伤口再上皮化的影响。
单中心试点、概念验证、单盲随机对照试验。
8 例二度烧伤患者接受封闭性水胶体敷料治疗，并随机分为不接受额外治疗或接受吡非尼酮治疗。
该研究的主要结局是根据第 7 天再上皮化的表皮厚度评估两组之间的伤口愈合情况。次要结局是通过组织学分析定性评估真皮纤维化组织、基底膜异常和胶原纤维的发育情况。每天测量肝肾功能以评估口服吡非尼酮的整体安全性。
接受吡非尼酮治疗的患者在第 7 天（148.98 ± 13.64 比 119.27 ± 15.55 μm；P =.029；95%置信区间，4.14-55.29）的伤口再上皮化明显改善。组织学评估显示吡非尼酮组的伤口纤维化程度较低。
通过增强伤口再上皮化，吡非尼酮可缩短伤口愈合时间。需要更大的临床试验来得出更可靠的结论。
