Ocampo-Candiani Jorge, Vázquez-Martínez Osvaldo T, Iglesias Benavides José Luis, Buske Kristin, Lehn Annette, Acker Clemens
J Drugs Dermatol. 2014 Feb;13(2):176-82.
Abdominal Cesarean sections (C-sections) are frequently associated with an increased risk of excessive or unpleasant scarring. A topical scar gel containing extract of Allium cepae, allantoin and heparin (Contractubex®; Merz Pharmaceuticals GmbH, Germany), has shown efficacy in improving the appearance of various scar types.
To investigate the efficacy of the topical scar gel, Contractubex, in the early treatment of C-section scars.
MATERIALS & METHODS: A total of 61 females, aged ≥18 years, who had given birth by elective C-section for the first time within the last 5-10 days, were included in this prospective, randomized, single-center study. Patients were advised to apply the topical scar gel twice daily (treatment group), or received no treatment (control group). Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment tool comprised of a Patient Scale and an Observer Scale.
Analysis revealed a significant change in the POSAS Patient Scale total score, with a 14.2% improvement in the treatment group compared with a decline of similar magnitude (-14.8%) in the control group at week 6. Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color (13.6% vs -18.5%, respectively, P=0.0284), stiffness (12.5% vs -34.6%, respectively, P=0.0029), and irregularity (29.4% vs -46.2%, respectively, P=0.0140) after 6 weeks of treatment. No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel, although there was a strong overall trend in favor of the treatment group. No significant adverse events were observed during the study.
Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color, stiffness and irregularity of C-section scars.
腹部剖宫产术(剖腹产)常伴有过度或难看疤痕风险增加的情况。一种含有洋葱提取物、尿囊素和肝素的外用疤痕凝胶(康瑞保®;德国默克制药有限公司),已显示出对改善各种疤痕类型外观的功效。
研究外用疤痕凝胶康瑞保在剖腹产疤痕早期治疗中的疗效。
本前瞻性、随机、单中心研究纳入了61名年龄≥18岁的女性,她们在过去5 - 10天内首次接受择期剖腹产分娩。建议患者每天两次涂抹外用疤痕凝胶(治疗组),或不接受治疗(对照组)。在基线访视后的第6周和第12周,使用患者和观察者疤痕评估量表(POSAS)评估疗效,POSAS是一种经过验证的疤痕评估工具,由患者量表和观察者量表组成。
分析显示,POSAS患者量表总分有显著变化,治疗组在第6周时改善了14.2%,而对照组下降了类似幅度(-14.8%)。与对照组相比,治疗组在疤痕颜色(分别为13.6%对 - 18.5%,P = 0.0284)、硬度(分别为12.5%对 - 34.6%,P = 0.0029)和不规则度(分别为29.4%对 - 46.2%,P = 0.0140)方面,在治疗6周后的POSAS患者量表子项目上也有显著改善。外用疤痕凝胶治疗后,POSAS观察者量表总分及其子项目未观察到显著变化,尽管总体上有强烈趋势支持治疗组。研究期间未观察到显著不良事件。
康瑞保是一种有效且耐受性良好的预防性治疗方法,能迅速且显著改善剖腹产疤痕的颜色、硬度和不规则度。