地氯雷他定联合烟酰胺治疗多形性日光疹

Desloratadine combined with nicotinamide for the treatment of polymorphous light eruption

目的 探讨地氯雷他定联合烟酰胺治疗多形性日光疹的临床疗效.方法 137例多形性日光疹患者随机分为2组：试验组69例,给予地氯雷他定分散片5 mg,每天1次,烟酰胺片200 mg,每天3次;对照组68例,给予沙利度胺片50 mg,每天2次,烟酰胺片200 mg,每天3次.两组患者同时给予复方硼酸软膏外用,每天2次,4周为1个疗程.要求所有患者试验期间防晒.分别于治疗开始前（D0）、治疗开始后每2周（D14、D28）评定患者的症状积分下降指数（SSRI）、痊愈率及总有效率.治疗过程中记录不良反应以评估安全性.结果 共有119例完成试验,其中试验组61例,对照组58例.在D14、D28,试验组SSRI分别为0.81±0.23与0.92±0.11,痊愈率分别为47.54％与70.49％,总有效率分别为80.33％与93.44％;与对照组（SSRI分别为0.87±0.17与0.97±0.23,痊愈率分别为48.28％与72.41％;总有效率分别为84.48％与91.38％）比较,差异无统计学意义（均P＞0.05）.部分患者发生不良反应但可耐受,试验组不良反应发生率显著低于对照组（P＜0.01）.结论 地氯雷他定分散片与烟酰胺片治疗多形性日光疹临床疗效确切,与沙利度胺疗效相当,不良反应发生率显著减少.

Objective To estimate the efficacy of desloratadine combined with nicotinamide for the treatment of polymorphous light eruption （PLE）.Methods One hundred and thirty-seven patients with PLE were enrolled in this study,and randomly divided into two groups：test group （n =69） treated with oral desloratadine dispersible tablets （5 mg once daily） and nicotinamide tablets （200 mg thrice daily）,control group （n =68） treated with thalidomide tablets （50 mg twice daily） and nicotinamide tablets （200 mg thrice daily）.All the patients topically applied compound boric acid ointment twice daily,and were requested to adopt sun-protection measures during the treatment.All the treatments lasted 4 weeks.Symptom score was estimated for the patients before treatment and on day 14 and 28 after the start of treatment.The efficacy was evaluated according to symptom score reduction index（SSRI）,cure rate and total response rate,and safety was assessed based on adverse reactions during the treatment.Results One hundred and nineteen patients （61 in the test group and 58 in the control group） completed the trial.No significant differences were observed between the test group and control group in SSRI （day 14：0.81 ＆#177; 0.23 vs.0.87 ＆#177; 0.17; day 28：0.92 ＆#177; 0.11 vs.0.97 ＆#177; 0.23,both P 〉 0.05）,cure rate （day 14：47.54% vs.48.28%; day 28：70.49% vs.72.41%,both P 〉 0.05） or total response rate （day 14：80.33% vs.84.48%; day 28：93.44% vs.91.38%,both P 〉 0.05）.Adverse reactions were observed in some patients,but were tolerable,and their incidence rate was significantly lower in the test group than in the control group （P 〈 0.01）.Conclusion Compared with thalidomide plus nicotinamide,desloratadine combined with nicotinamide show equivalent efficacy in the treatment of PLE with reduced incidence of adverse reactions.