Lin N, Li M, Guo Z H, Wu M Q, Zhou Y K, Zhang L X, Yu H, Zhong Y, Huang C S
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.
Zhonghua Shao Shang Za Zhi. 2021 May 20;37(5):437-445. doi: 10.3760/cma.j.cn501120-20200315-00168.
To evaluate the clinical effects of 5-fluorouracil in different mass concentrations combined with triamcinolone in the treatment of keloids. 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 test, least significant difference test, Wilcoxon rank sum test, Kruskal-Wallis rank sum test, or Fisher's exact probability test. Before the first treatment, the appearance VSS scores of appearance of keloids in the three groups were similar (0.039, >0.05). In 3 months after the last treatment, the appearance VSS scores of keloids in low mass concentration group were significantly higher than those in medium mass concentration group and high mass concentration group (=2.267, 4.086, <0.05 or <0.01). In 3 months after the last treatment, the appearance VSS scores of keloids in low mass concentration group, medium mass concentration group, and high mass concentration group were significantly decreased compared with those before the first treatment (=18.222, 44.272, 22.523, <0.01). The differences of appearance VSS scores of keloids in low mass concentration group before and after treatment were significantly lower than those in medium mass concentration group and high mass concentration group (=-4.096, -6.357, <0.01), and the differences of appearance VSS scores of keloids in medium mass concentration group before and after treatment were significantly lower than those in high mass concentration group (=-2.368, <0.05). Before the first treatment, the pain and pruritus VAS scores of keloids in the three groups were similar (=0.149, >0.05). In 3 months after the last treatment, the pain and pruritus VAS scores of keloids in low mass concentration group were significantly higher than those in medium mass concentration group and high mass concentration group (=2.191, 4.386, <0.05 or <0.01), and the pain and pruritus VAS scores of keloids in medium mass concentration group were significantly higher than those in high mass concentration group (=2.276, <0.05). In 3 months after the last treatment, the pain and pruritus VAS scores of keloids in medium mass concentration group and high mass concentration group were significantly decreased compared with those before the first treatment (-3.904, -3.844, <0.01). The differences of pain and pruritus VAS scores of keloids in low mass concentration group before and after treatment were significantly lower than those in medium mass concentration group and high mass concentration group (-4.265, -6.104, <0.01). In 6 months after the last treatment, the efficacy satisfaction scores of the corresponding patients of keloids were (88±8) points in high mass concentration group, which were significantly higher than (76±8) points in medium mass concentration group and (60±8) points in low mass concentration group (=-3.820, -6.675, <0.01), and the efficacy satisfaction scores of the corresponding patients of keloids in medium mass concentration group were significantly higher than those in high mass concentration group (=-2.984, <0.05). There was only statistically significant difference in pain within the 3 groups (<0.01). In the follow-up of one year after the last treatment, the recurrence rate of keloids in high mass concentration group was significantly lower than that in low mass concentration group (=8.313, <0.01), and the recurrence rate of keloids in medium mass concentration group was similar to the recurrence rates in low mass concentration group and high mass concentration group (>0.05). After treating keloids with high mass concentration of 5-fluorouracil combined with triamcinolone acetonide, the symptoms were significantly improved, the efficacy satisfaction of patients was increased, with no obvious adverse reactions but long lasting efficacy. Their overall effects are better than treatment using medium and low mass concentrations of 5-fluorouracil, which is worthy of clinical promotion.
评估不同质量浓度的5-氟尿嘧啶联合曲安奈德治疗瘢痕疙瘩的临床效果。2018年3月至2019年3月，福建医科大学附属协和医院整形外科收治的29例患者共31个瘢痕疙瘩、平潭综合实验区医院皮肤科收治的11例患者共20个瘢痕疙瘩、福州海西迪娅医疗美容门诊部收治的9例患者共9个瘢痕疙瘩纳入本前瞻性随机对照研究，其中男性27例，女性22例，年龄（30±9）岁。根据随机数字表，将瘢痕疙瘩分为低质量浓度组（19个瘢痕疙瘩，17例患者）、中等质量浓度组（21个瘢痕疙瘩，19例患者）和高质量浓度组（20个瘢痕疙瘩，17例患者）。然后分别注射质量浓度为0.5、5.0和12.5mg/mL的5-氟尿嘧啶联合曲安奈德，每4周注射1次，共注射3次。在首次治疗前及末次治疗后3个月，采用温哥华瘢痕量表（VSS）评估瘢痕疙瘩外观，采用视觉模拟评分法（VAS）评估瘢痕疙瘩的疼痛和瘙痒情况。然后计算治疗前后的评分差异。在末次治疗后6个月，采用疗效满意度量表评估患者的疗效满意度。记录治疗期间的不良反应。在末次治疗后1年的随访中，统计瘢痕疙瘩的复发率。数据采用卡方检验、单因素方差分析、配对样本t检验、最小显著差检验、Wilcoxon秩和检验、Kruskal-Wallis秩和检验或Fisher确切概率检验进行统计学分析。首次治疗前，三组瘢痕疙瘩外观VSS评分相似（P=0.039，>0.05）。末次治疗后3个月，低质量浓度组瘢痕疙瘩外观VSS评分显著高于中等质量浓度组和高质量浓度组（P=2.267、4.086，<0.05或<0.01）。末次治疗后3个月时，低质量浓度组、中等质量浓度组和高质量浓度组瘢痕疙瘩外观VSS评分与首次治疗前相比均显著降低（P=18.222、44.272、22.523，<0.01）。低质量浓度组瘢痕疙瘩治疗前后外观VSS评分差值显著低于中等质量浓度组和高质量浓度组（P=-4.096、-6.357，<0.01），中等质量浓度组瘢痕疙瘩治疗前后外观VSS评分差值显著低于高质量浓度组（P=-2.368，<0.05）。首次治疗前，三组瘢痕疙瘩疼痛和瘙痒VAS评分相似（P=0.149，>0.05）。末次治疗后3个月时，低质量浓度组瘢痕疙瘩疼痛和瘙痒VAS评分显著高于中等质量浓度组和高质量浓度组（P=2.191、4.386，<0.05或<0.01），中等质量浓度组瘢痕疙瘩疼痛和瘙痒VAS评分显著高于高质量浓度组（P=2.276，<0.05）。末次治疗后3个月时，中等质量浓度组和高质量浓度组瘢痕疙瘩疼痛和瘙痒VAS评分与首次治疗前相比均显著降低（P=-3.904、-3.844，<0.01）。低质量浓度组瘢痕疙瘩治疗前后疼痛和瘙痒VAS评分差值显著低于中等质量浓度组和高质量浓度组（P=-4.265、-6.104，<0.01）。末次治疗后6个月时，高质量浓度组瘢痕疙瘩相应患者的疗效满意度评分为（88±8）分，显著高于中等质量浓度组的（76±8）分和低质量浓度组的（60±8）分（P=-3.820、-6.675，<0.01），中等质量浓度组瘢痕疙瘩相应患者的疗效满意度评分显著高于低质量浓度组（P=-2.984，<0.05）。三组间仅疼痛差异有统计学意义（P<0.01）。在末次治疗后1年的随访中，高质量浓度组瘢痕疙瘩复发率显著低于低质量浓度组（P=8.313，<0.01），中等质量浓度组瘢痕疙瘩复发率与低质量浓度组和高质量浓度组相似（P>0.05）。采用高质量浓度5-氟尿嘧啶联合曲安奈德治疗瘢痕疙瘩后，症状明显改善，患者疗效满意度提高，无明显不良反应且疗效持久。其总体效果优于中等和低质量浓度5-氟尿嘧啶治疗，值得临床推广。
