复方联苯苄唑液治疗浅部真菌病双盲对照研究

目的 为了研究复方联苯苄唑液对浅部真菌病的疗效。方法 采用双盲对照的方法。试验组为复方联苯苄唑液,对照组为克霉唑癣药水。均每日涂患部1次,疗程体股癣为2周,手足癣为4周,停药后随访2周,主要观察红斑、丘疹、水疱、鳞屑、角化和瘙痒,评价治疗后每周的皮损情况。每例患者于疗前、疗中及疗后,停药后2周作真菌学检查。结果 观察434例患者,复方联苯苄唑液临床治愈率体股癣为82.25%,手足癣为68.75%,总有效率体股癣为95.85%,手足癣为92.5%;对照组治疗体股癣痊愈率为58.6%,手足癣为44.7%,有效率体股癣为83.0%,手足癣为87.2%。临床350株常见致病菌,复方联苯苄唑液的MIC为1.6~12.5mg/L,克霉唑药水的MIC为3.125~25mg/L。结论 复方联苯苄唑液是高效、广谱的抗真菌药物。本药能溶解、松解角质,渗透性好,可长期应用。

Treatment of Superficial Mycosis with Compound Bifonazole Solution: A Double-blind Controlled Clinical Trial

Objective To investigate the effects of compound bifonazole solution for the treatment of superficial mycosis.Methods The study groups were treated with compound bifonazole solution and the control group with clotrimazole solution in a double-blind controlled clinical trial.The solutions were applied to skin lesions once a day.The course of treatment was two weeks for tinea corporis and tinea cruris and four weeks for tinea manus and tinea pedis.The patients were followed up weekly for two weeks after cessation of treatment and evaluated with regard to erythema,papule,blister,scale,keratinization and pruritus.Mycologic examinations were performed before,during and right after treatment and two weeks after treatment.Results A total of434patients participated into the study.The clinical cure rates of study group were82.25%in tinea corporis and tinea cruris,and68.75%tinea manus and tinea pedis,with a total response rates of95.85%and92.5%in tinea corporis and tinea cruris,and92.5%in tinea manus and tinea pedis,respectively.The clinical cure rates of control group were58.6%in tinea corporis and tinea cruris,and44.7%in tinea manus and tinea pedis,with a total response rates of83.0%and87.2%in tinea corporis and tinea cruris,and in tinea manus and tinea pedis,respectively.The MICs to350clinical isolates of pathogenic fungi were1.6~2.5mg/L for compound bifonazole solution,and3.125~25mg/L for clotrimazole solution.Conclusions Compound bifonazole solution is a high-effective,broad-spectrum anti-fungal agent.It is keratolytic,well permeable and safe for relatively long term application.