2023 年第 10 期 第 18 卷

德莫林皮肤创面无机诱导活性敷料联合重组牛碱性成纤维细胞生长因子治疗放射性皮肤损伤的临床效果分析

Clinical effect analysis of Dermlin inorganic induced active dressing for skin wound combined with recombinant bovine basic fibroblast growth factor on radiation-induced skin injury

作者：李凤菊朱玉霞侯堆鹏张凯张明

英文作者：Li Fengju Zhu Yuxia Hou Duipeng Zhang Kai Zhang Ming

单位：甘肃省肿瘤医院放疗科，兰州730050

英文单位：Department of Radiotherapy Gansu Provincial Cancer Hospital Lanzhou 730050 China

关键词：放射性皮肤损伤；德莫林皮肤创面无机诱导活性敷料；重组牛碱性成纤维细胞生长因子

英文关键词：Radiation-inducedskininjury;Dermlininorganicinducedactivedressingforskinwound; Recombinantbovinebasicfibroblastgrowthfactor

• 摘要：

• 目的  探讨德莫林皮肤创面无机诱导活性敷料联合重组牛碱性成纤维细胞生长因子(rb-bFGF)治疗放射性皮肤损伤的临床效果。方法  选取2019年1月至2021年12月于甘肃省肿瘤医院行放疗期间发生放射性皮肤损伤的126例头颈部肿瘤患者作为研究对象，根据美国肿瘤放疗协作组织急性放射性皮肤损伤标准将患者分为Ⅱ期（51例）、Ⅲ期（45例）、Ⅳ期（30例），将各分期患者完全随机分为N组、FGF组和FGF+D组，各42例（包括Ⅱ期17例、Ⅲ期15例、Ⅳ期10例）。N组在常规护理基础上予碘伏喷擦创面，FGF组在常规护理基础外予rb-bFGF外用溶液喷涂创面，FGF+D组在常规护理基础上使用德莫林皮肤创面无机诱导活性敷料（粉剂）溶解于rb-bFGF外用溶液涂抹于创面，均为3次/d。最长观察期为28 d，记录放射性皮肤损伤的愈合情况，比较3组总有效率、创面感染、住院费用、生活质量等临床资料。结果  治疗第14、28天，在Ⅲ期患者中，FGF+D组、FGF组总有效率均高于N组；在Ⅳ期患者中，FGF+D组和FGF组总有效率均高于N组，且FGF+D组均高于FGF组（均P＜0.05）。FGF+D组总换药次数少于FGF组和N组，FGF+D组和FGF组住院天数、有效时间、显效时间、创面感染率均短于/低于N组［（14±6）、（18±7）d比（26±10）d，（4.2±0.9）、（5.9±1.0）d比（10.0±1.7）d，（9.9±1.0）、（13.9±1.4）d比（20.6±2.2）d，2.4%（1/42）、11.9%（5/42）比28.6%（12/42）］，且FGF+D组均短于/低于FGF组（均P＜0.05）。FGF+D组和FGF组创面愈合率、欧洲癌症质量与研究组织生活质量问卷评分均高于N组，且FGF+D组均高于FGF组（均P＜0.05）。结论  德莫林皮肤创面无机诱导活性敷料联合rb-bFGF对放射性皮肤损伤的治疗效果优于单独使用rb-bFGF，可为放疗的顺利进行提供保障。

• Objective  To investigate the clinical effect of Dermlin inorganic induced active dressing for skin wound combined with recombinant bovine basic fibroblast growth factor (rb-bFGF) on radiation-induced skin injury. Methods  From January 2019 to December 2021, 126 patients with head and neck tumors who developed radiation-induced skin injury during radiation therapy admitted to Gansu Provincial Cancer Hospital were selected as the study subjects. According to the acute radiation skin injury standard of the Radiation Therapy Oncology Group, patients were divided into stage Ⅱ (51 cases), stage Ⅲ (45 cases) and stage Ⅳ (30 cases), and patients of each stage were randomly divided into N group, FGF group and FGF+D group, with 42 cases in each group (including 17 cases with stage Ⅱ, 15 cases with stage Ⅲ and 10 cases with stage Ⅳ).The N Group was treated with iodophor spray on the wound surface on the basis of routine care, the FGF group was treated with rb-bFGF external solution spray on the wound surface on the basis of routine care, and the FGF+D group was treated with Dermlin inorganic induced active dressing for skin wound (powder) dissolved in rb-bFGF external solution spray on the wound surface on the basis of routine care, all for 3 times/d. The longest observation period was 28 d, and the healing of radiation-induced skin injury was recorded. The clinical date such as total effective rate, wound infection, hospitalization expenses and quality of life were compared among the three groups. Results  On 14th and 28th d of treatment, the total effective rates in FGF+D group and FGF group were higher than that in N group in patients with stage Ⅲ, the total effective rates in FGF+D group and FGF group were higher than that in N group in patients with stage Ⅳ, and FGF+D group was higher than FGF group (all P<0.05). The total number of dressing changes in FGF+D group was less than those in FGF group and N group, and days of hospitalization, effective times, onset times and wound infection rates in the FGF+D group and FGF group were shorter/lower than those in the N group［（14±6）,（18±7）d vs （26±10）d;（4.2±0.9）,（5.9±1.0）d vs （10.0±1.7）d;（9.9±1.0）,（13.9±1.4）d vs （20.6±2.2）d; 2.4%（1/42）, 11.9%（5/42） vs 28.6%（12/42）］, and FGF+D group were shorter/lower than FGF group (all P<0.05). The wound healing rates and scores of The Europe Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 in FGF+D group and FGF group were higher than those in N group, and FGF+D group were higher than FGF group(all P<0.05). Conclusion  Effect of Dermlin inorganic induced active dressing for skin wound combined with rb-bFGF on radiation-induced skin injury is better than that of rb-bFGF alone. It can provide guarantee for the smooth progress of radiotherapy.