1%联苯苄唑乳膏联合40%尿素软膏治疗甲真菌病的双盲随机对照实验研究

A double-blind,randomized controlled trial of 1% Bifonazole Cream combined with 40% Urea Ointment in the treatment of onychomycosis

目的应用双盲随机对照实验探讨1%联苯苄唑乳膏联合40%尿素软膏治疗甲真菌病的效果。方法选取2016年9月~2017年10月于我院门诊确诊的120例甲真菌病患者作为研究对象,采用随机数字表法将患者分为综合治疗组和对照组,再直接编盲置于密封信封中并由不直接参与实验的人员进行控制和分配,医患双方均对药物保持盲态直至实验结束且数据输入锁定后揭盲,每组各60例。综合治疗组患者采用1%联苯苄唑乳膏联合40%尿素软膏封包治疗,对照组患者采用1%联苯苄唑乳膏封包治疗。根据疗效评价标准进行两组治疗效果的评价,采用生活质量简表(SF-36)评价两组患者治疗前后的生存质量,统计患者对医嘱和治疗的遵从情况并计算治疗依从性,同时统计两组患者治疗期间的恶心、呕吐、头晕、肝肾损伤等不良反应发生情况。结果综合治疗组患者的治疗总有效率高于对照组,差异有统计学意义(P<0.05)。综合治疗组患者的治疗依从性评分高于对照组,差异有统计学意义(P<0.05)。治疗前,两组患者的SF-36评分比较,差异无统计学意义(P>0.05)。治疗后,综合治疗组患者的SF-36评分高于对照组,差异有统计学意义(P<0.05)。两组患者的不良反应发生率比较,差异无统计学意义(P>0.05)。结论 1%联苯苄唑乳膏联合40%尿素软膏治疗甲真菌病的效果确切,可有效改善患者的临床症状,提高患者治疗的依从性,减少不良反应发生率,促进患者生存质量的提高。

Objective To investigate the efficacy of 1%Bifonazole Cream combined with 40%Urea Ointment in the treatment of onychomycosis in a double-blind randomized controlled trial.Methods In this study,120 patients diagnosed as onychomycosis in the outpatient department of our hospital from September 2016 to October 2017 were selected as subjects.The patients were divided into comprehensive treatment group and control group by a random number table method,and then directly blinded and sealed in envelop.The envelopes were kept and allocated by those who were not directly involved in the experiment.Both doctors and patients were blinded until the end of the experiment.Unblinding was after the datas were entered and locked.Each group had 60 cases.Patients in the comprehensive treatment group was treated with 1%Bifonazole Cream combined with 40%Urea Ointment in envelops,and in the control group,pariticipants were treated with 1%Bifonazole Cream alone in envelops.The efficacy of the two groups was evaluated according to the efficacy evaluation criteria.The quality of life before and after treatment was evaluated by SF-36 in the two groups.The treatment compliance including following doctor′s advice and treatment was calculated.The potential side effects of nausea,vomiting,dizziness and liver and kidney function damage during the treatment were counted.Results The total effective rate of the comprehensive treatment group was higher than that in the control group,the difference was statistically significant(P<0.05).The score of treatment compliance in the comprehensive treatment group was higher than that in the control group with a statistical difference(P<0.05).Before treatment,there was no statistical difference in the scores of SF-36 in the two groups(P>0.05).After treatment,the SF-36 score of the comprehensive treatment group was significantly higher compared with that in the control group,the difference was statistically significant(P<0.05).The incidence of adverse reactions in the comprehensive treatment group was not significantly different from that in the control group(P>0.05).Conclusion The combination of 1%Bifonazole Cream and 40%Urea Ointment in the treatment of onychomycosis can obtain a definite effect,which can effectively improve the clinical symptoms,enhance patients′treatment compliance,reduce the occurrence of adverse reactions,and promote the amelioration of quality of life.