A Multicenter Prospective Randomized Controlled Study Of 5-fluorouracil In Different Concentrations Combined With Triamcinolone In The Treatment Of Keloid

Objective To evaluate the clinical efficacy of 5-fluorouracil(5-FU)combined with triamcinolone acetonide in the treatment of keloid and to explore the feasibility of adjusting the concentration of 5-fu according to the patient’s symptoms.Methods A total of 60 keloids were selected from 49 patients who visited the hospital from March 2018 to March 2019.Patients were randomly divided into three groups:Group A:5-FU concentration of 0.5mg/ml,Group B:5-FU concentration of5.0mg/ml,and Group C:5-FU concentration of 12.5mg/ml.10mg/ml triamcinolone acetonide injection was added.Patients were injected every 4 weeks for 3 months.In the3rd month after the treatment,the Vancouver Scar Scale(VSS)and the Visual Analogy Scale(VAS)were used to score the degree of improvement of keloid appearance and clinical symptoms.Results The VSS scores of the three groups before and after treatment passed the paired t-test and the differences were statistically significant(t value:18.222,44.272,22.523 respectively,P<0.001).After conducting variance analysis on the three groups of cases of the score difference before and after treatment,the differences was statistically significant(F=55.95,P<0.001).Further we notice that differences among group A,B and C were all statistically significant(P<0.001).Therefore,it is suggested that the improvement of keloid appearance in group C is better than that in group B,and group B is greater than that in group A.The VAS score of the three groups before and after treatment passed the paired Wilcoxon rank-sum test was no statistically significant difference in the group A(P>,0.05),but the differences was statistically significant in group B and group C(P<0.001).Then the difference of VAS score before and after treatment in group B and group C was statistically significant by rank-sum test(Z=-2.692,P=0.007),indicating that the improvement degree of pain symptoms in group C was better than that in group B.There was a statistically significant difference in patient satisfaction score between the three groups(F=56.691、P=0.001).There was no statistically significant difference in adverse reactions between the three groups(P>0.05).The recurrence rate of group A was 47.3%,group B 23.8%and group C 10%,which were significant by chi-square test(X~~2=7.092,P=0.029).Conclusion 12.5mg/ml 5-FU combined with triamcinolone acetonide in the treatment of keloid has the advantages of definite efficacy,obvious and lasting improvement of clinical symptoms,and high patient satisfaction.Furthermore,there is neither significant increase in the incidence of complications nor serious complications.Hence,our suggested treatment is especially suitable for patients with keloid who either have obvious symptoms of itching and pain or those who cannot stand to long-term treatment.