不同质量浓度5-氟尿嘧啶联合曲安奈德治疗瘢痕疙瘩的多中心前瞻性随机对照临床研究  

A multicenter prospective randomized controlled clinical study of 5-fluorouracil in different mass concentrations combined with triamcinolone in the treatment of keloids

作　　者：林楠[1] 李铭[1] 郭志辉[1] 吴敏强 周亚宽[1] 张履兴 俞瀚 钟奕 黄楚珊[1] Lin Nan;Li Ming;Guo Zhihui;Wu Minqiang;Zhou Yakuan;Zhang Lyvxing;Yu Han;Zhong Yi;Huang Chushan(Department of Plastic Surgery,Fujian Medical University Union Hospital,Institute of Plastic Surgery and Regenerative Medicine,Fujian Medical University,Fuzhou 350001,China;Department of Dermatology,Pingtan Comprehensive Experimental Area Hospital,Fuzhou 350400,China;Fuzhou Heisey-Dea Aesthetic Clinic,Fuzhou 350028,China)

机构地区：[1]福建医科大学附属协和医院整形外科,福建医科大学整形外科与再生医学研究所,福州350001 [2]平潭综合实验区医院皮肤科,福州350400 [3]福州市仓山迪娅医疗美容门诊部,350028

出　　处：《中华烧伤杂志》2021年第5期437-445,共9页Chinese Journal of Burns

基　　金：福建省科技创新联合资金项目(2018Y9051)。

摘　　要：目的评价不同质量浓度的5-氟尿嘧啶联合曲安奈德治疗瘢痕疙瘩的临床效果。方法2018年3月—2019年3月,将福建医科大学附属协和医院整形外科接诊的29例患者31个瘢痕疙瘩、平潭综合实验区医院皮肤科接诊的11例患者20个瘢痕疙瘩、福州市仓山迪娅医疗美容门诊部接诊的9例患者9个瘢痕疙瘩纳入此前瞻性随机对照研究,其中男27例、女22例,年龄(30±9)岁。将瘢痕疙瘩按随机数字表法分为低质量浓度组(19个瘢痕疙瘩,17例患者)、中质量浓度组(21个瘢痕疙瘩,19例患者)、高质量浓度组(20个瘢痕疙瘩,17例患者),分别采用质量浓度为0.5、5.0、12.5 mg/mL的5-氟尿嘧啶联合曲安奈德注射治疗,每4周注射1次,共3次。首次治疗前及末次治疗后3个月,采用温哥华瘢痕量表(VSS)评价瘢痕疙瘩外观、采用视觉模拟评分法(VAS)评定瘢痕疙瘩疼痛和瘙痒程度,并计算治疗前后的评分差值。末次治疗后6个月,采用疗效满意度评价量表行患者疗效满意度评分。记录治疗期间不良反应。末次治疗后1年随访,统计瘢痕疙瘩复发率。对数据行χ^(2)检验、单因素方差分析、配对样本t检验、LSD-t检验、Wilcoxon秩和检验、Kruskal-Wallis秩和检验、Fisher确切概率法检验。结果首次治疗前,3组瘢痕疙瘩外观VSS评分相近(F=0.039,P>0.05);末次治疗后3个月,低质量浓度组瘢痕疙瘩外观VSS评分明显高于中质量浓度组及高质量浓度组(t=2.267、4.086,P<0.05或P<0.01)。末次治疗后3个月,低质量浓度组、中质量浓度组、高质量浓度组瘢痕疙瘩外观VSS评分均较首次治疗前明显降低(t=18.222、44.272、22.523,P<0.01)。低质量浓度组瘢痕疙瘩治疗前后外观VSS评分差值明显低于中质量浓度组与高质量浓度组(t=-4.096、-6.357,P<0.01),中质量浓度组瘢痕疙瘩治疗前后外观VSS评分差值明显低于高质量浓度组(t=-2.368,P<0.05)。首次治疗前,3组瘢痕疙瘩疼痛和瘙Objective To evaluate the clinical effects of 5-fluorouracil in different mass concentrations combined with triamcinolone in the treatment of keloids.Methods From March 2018 to March 2019,29 patients with 31 keloids receipted in the Department of Plastic Surgery of Fujian Medical University Union Hospital,11 patients with 20 keloids receipted in the Department of Dermatology of Pingtan Comprehensive Experimental Area Hospital,and 9 patients with 9 keloids receipted in the Fuzhou Heisey-Dea Aesthetic Clinic were included in this prospectively randomized control study,with 27 males and 22 females,aged(30±9)years.According to the random number table,the keloids were divided into low mass concentration group(19 keloids,17 patients),medium mass concentration group(21 keloids,19 patients),and high mass concentration group(20 keloids,17 patients).Then 5-fluorouracil at mass concentrations of 0.5,5.0,and 12.5 mg/mL combined with triamcinolone acetonide were injected respectively,once every 4 weeks,for a total of 3 times.Before the first treatment and in 3 months after the last treatment,the appearance of keloids was evaluated by Vancouver Scar Scale(VSS)and pain and pruritus of keloids were evaluated by Visual Analogue Scale(VAS).Then the score differences before and after the treatment were calculated.In 6 months after the last treatment,the patients'efficacy satisfaction was evaluated by efficacy satisfaction rating scale.Adverse reactions during the treatment were recorded.In the follow-up of one year after the last treatment,the recurrence rates of keloids were counted.Data were statistically analyzed with chi-square test,one-way analysis of variance,paired sample t test,least significant difference t test,Wilcoxon rank sum test,Kruskal-Wallis rank sum test,or Fisher′s exact probability test.Results Before the first treatment,the appearance VSS scores of appearance of keloids in the three groups were similar(F=0.039,P>0.05).In 3 months after the last treatment,the appearance VSS scores of keloids in low mass conce

关 键 词：瘢痕疙瘩 氟尿嘧啶 曲安奈德 多中心 前瞻性随机对照研究 

分 类 号：R605[医药卫生—外科学] R632.1[医药卫生—临床医学]