Alekseev Andrey A, Malyutina Natalia B, Bobrovnikov Alexander E, Shoham Yaron
National Medical Research Center of Surgery Named after A. Vishnevsky of the Ministry of Health of the Russian Federation, 115093 Moscow, Russia.
Russian Medical Academy for Continuing Professional Education of the Ministry of Health of the Russian Federation, 123995 Moscow, Russia.
Life (Basel). 2023 Feb 10;13(2):488. doi: 10.3390/life13020488.
Since its approval in Europe a decade ago, NexoBrid enzymatic debridement of deep thermal burns has been gaining acceptance as standard practice around the world. The purpose of this study is to report the first experience with NexoBrid in the Russian Federation. During 2019-2020, we conducted a post-registration clinical study assessing the safety and treatment results of NexoBrid enzymatic debridement. The study involved 15 adult patients suffering from deep thermal burns over an area ≤15% of their total body surface area. Patients were treated with NexoBrid within 3 days of injury, followed by spontaneous or surgical wound closure. Complete eschar removal was achieved in twelve patients, 80% eschar removal in two patients, and 70% in one patient. Complete spontaneous epithelialization of wounds was achieved in 12 patients (80%) within 18 ± 1.9 days after the start of treatment. We did not witness pathological scarring during follow-up, and there were no significant safety issues throughout the study. Early use of NexoBrid resulted in rapid, effective, and safe eschar removal with good results and sufficient preservation of viable dermis to allow for spontaneous healing in 80% of patients. These results demonstrate the ability to minimize surgical intervention and hopefully lead to better long-term scarring results.
自十年前在欧洲获批以来,NexoBrid酶促清创治疗深度热烧伤已在全球范围内逐渐被接受为标准治疗方法。本研究的目的是报告俄罗斯联邦首次使用NexoBrid的经验。在2019年至2020年期间,我们开展了一项上市后临床研究,评估NexoBrid酶促清创的安全性和治疗效果。该研究纳入了15例成年深度热烧伤患者,烧伤面积≤体表面积的15%。患者在受伤后3天内接受NexoBrid治疗,随后进行创面自然愈合或手术闭合。12例患者实现了焦痂完全清除,2例患者焦痂清除率达80%,1例患者焦痂清除率达70%。12例患者(80%)在治疗开始后18±1.9天内实现了创面完全自然上皮化。在随访期间,我们未观察到病理性瘢痕形成,且在整个研究过程中未出现重大安全问题。早期使用NexoBrid可快速、有效且安全地清除焦痂,效果良好,并能充分保留存活的真皮组织,使80%的患者实现自然愈合。这些结果表明,NexoBrid能够将手术干预降至最低,并有望带来更好的长期瘢痕形成效果。