克林霉素磷酸酯凝胶联合光动力疗法治疗玫瑰痤疮患者的临床研究

Clinical trial of clindamycin phosphate gel combined with photodynamic therapy in the treatment of patients with acne rosacea

目的观察克林霉素磷酸酯凝胶联合光动力疗法治疗玫瑰痤疮的疗效及安全性。方法将玫瑰痤疮患者按随机数字表法分为试验组和对照组。对照组给予外用克林霉素磷酸酯凝胶治疗,每天2次,共4周;试验组在此基础上给予5-氨酮戊酸光动力治疗,每周1次,共4周。评估2组患者的临床疗效,比较2组治疗2周、4周的红斑、丘疹脓疱、毛囊蠕形螨情况、生活质量[皮肤病生活质量指数量表(DLQI)],随访复发情况,评价治疗方案安全性。结果对照组和试验组各入组70例。治疗4周后,试验组的总有效率为87.14%,高于对照组的72.86%,在统计学上差异有统计学意义(P<0.05)。治疗2周后,试验组和对照组的红斑评分分别为(2.14±0.57)和(2.63±0.52)分,丘疹脓疱评分为(2.28±0.46)和(2.56±0.49)分,2 mm×2 mm毛囊蠕形螨总数为(10.12±3.55)和(11.74±4.31)条,DLQI评分分别为(11.27±2.49)和(12.57±2.28)分;治疗4周后,试验组和对照组的红斑评分分别为(1.16±0.32)和(1.59±0.38)分,丘疹脓疱评分为(0.92±0.27)和(1.37±0.41)分,2 mm×2 mm毛囊蠕形螨总数为(6.08±2.39)和(8.69±2.47)条,DLQI评分分别为(5.09±1.22)和(6.88±2.16)分,在统计学上差异均有统计学意义(均P<0.05)。治疗期间,试验组和对照组的药物不良反应发生率分别为28.57%和18.57%,在统计学上差异无统计学意义(P>0.05)。试验组和对照组随访至治疗结束后3个月的复发率分别为4.29%和14.29%,在统计学上差异有统计学意义(P<0.05)。结论克林霉素磷酸酯凝胶联合光动力疗法治疗玫瑰痤疮疗效确切,在缓解患者症状、改善毛囊蠕形螨感染、提高患者生活质量方面具有明显优势,且不增加药物不良反应发生率。

Objective To observe the effect and safety of clindamycin phosphate gel combined with photodynamic therapy in the treatment of acne rosacea.Methods Patients with acne rosacea were divided into treatment group and control group by random number table method.The control group was treated with external application of clindamycin phosphate gel twice a day for 4 weeks.The treatment group was given 5-aminolevulinic acid photodynamic therapy on this basis,once a week for 4 weeks.The clinical efficacy of the two groups was evaluated.The erythema,papulopustule,demodex folliculorum and quality of life[dermatology life quality index(DLQI)]of the two groups were compared after 2 weeks and 4 weeks of treatment.The recurrence status was followed up and the safety of the treatment regimen was evaluated.Results There were 70 cases in treatment group and 70 cases in control group.The total clinical effective rate after 4 weeks of treatment in treatment group was87.14%,which was higher than 72.86%in control group(P<0.05).After 2 weeks of treatment,the erythema scores in treatment group and control group were(2.14±0.57)and(2.63±0.52)points;the papulopustule scores were(2.28±0.46)and(2.56±0.49)points;the total counts of demodex folliculorum of(2 mm×2 mm)were10.12±3.55 and 11.74±4.31;DLQI scores were(11.27±2.49)and(12.57±2.28)points.After 4 weeks of treatment,the erythema scores in treatment group and control group were(1.16±0.32)and(1.59±0.38)points;the papulopustule scores were(0.92±0.27)and(1.37±0.41)points;the total counts of demodex folliculorum of(2 mm×2 mm)were 6.08±2.39 and 8.69±2.47;and the DLQI scores were(5.09±1.22)and(6.88±2.16)points,all with significant difference(all P<0.05).During treatment,there was no statistical significance in the incidence of adverse drug reactions between treatment group and control group(28.57%vs 18.57%,P>0.05).Follow-up to 3 months after the end of treatment,the recurrence rates in treatment group and control group were4.29%and 14.29%,with statistical difference(P<0.05).Conclusion Clindamycin phosphate gel combined with photodynamic therapy has an exact efficacy in the treatment of acne rosacea,and it has obvious advantages in relieving symptoms,improving demodex folliculorum infection and enhancing quality of life of patients,and it does not increase the incidence of adverse drug reactions.