A double-blind,randomized controlled trial of 1%Bifonazole Cream combined with 40%Urea Ointment in the treatment of onychomycosis
LYU Pei-shan1 WANG Jian-song2 FANG Yue-li3
1.Department of Pharmacy,Puning Overseas Chinese Hospital,Guangdong Province,Puning 515300,China;2.Department of Dermatology,Puning Overseas Chinese Hospital,Guangdong Province,Puning 515300,China;3.Clinical Pharmaceutics Room,Puning Overseas Chinese Hospital,Guangdong Province,Puning 515300,China
Abstract:ObjectiveTo investigate the efficacy of 1%Bifonazole Cream combined with 40%Urea Ointment in the treatment of onychomycosis in a double-blind randomized controlled trial.MethodsIn 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.ResultsThe 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 differ-ence(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).ConclusionThe 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.
吕佩珊;王建松;方悦丽. 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[J]. 中国当代医药, 2018, 25(18): 83-86.
LYU Pei-shan;WANG Jian-song;FANG Yue-li. A double-blind,randomized controlled trial of 1%Bifonazole Cream combined with 40%Urea Ointment in the treatment of onychomycosis. 中国当代医药, 2018, 25(18): 83-86.