复方硝酸益康唑乳膏治疗足癣和体股癣随机双盲对照临床试验

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目的:评价复方硝酸益康唑乳膏治疗足癣和体股癣的疗效及安全性, 并与1%硝酸益康唑霜对比。方法:每天外用2次,疗程体股癣2周, 足癣 4周,随访2周。 足癣可疗效评价病例,试验组38例,对照组33例。体股癣试验组33例,对照组35例。结果:试验组对足癣,在第4周时脱屑症状的改善和临床的综合改善明显优于对照组(P<0.01); 在停药后2周, 角化、浸渍和瘙痒症状的改善和临床的综合改善优于对照组(P<0.05)。试验组对体股癣,在第1周时瘙痒症状的改善和临床的综合改善优于对照组(P<0.05); 在停药后2周, 丘疹症状的改善优于对照组(P<0.05)。试验组对足癣,在第2周时临床有效率57.89%(对照组51.52%),真菌学清除率71.05%(对照组72.73%);在第4周分别为94.74%(对照组81.82%)和94.74%(对照组100%);在停药后2周分别为100%(对照组81.82%,P<0.05)和100%(对照组93.94%)。试验组对体股癣, 在第1周的临床有效率87.88%(对照组60.00%,P<0.01),真菌学清除率90.91%(对照组88.57%);在第2周分别为96.97%(对照组91.43%)和100%(对照组97.14%);在停药后2周分别为100%(对照组100%)和100%(对照组100%)。试验组不良反应发生率2.74%(对照组2.86%),表现为局部轻度刺激。结论:复方硝酸益康唑乳膏治疗足癣和体股癣,可在短时间内抑? Objective: To evaluate the efficacy and safety of compound econazole nitrate cream in the treatment of tinea pedis and tinea corporis and compare with 1% econazole nitrate cream. Method: topical 2 times a day, treatment of body tinea cruris 2 weeks, tinea pedis 4 weeks, followed up for 2 weeks. Tinea pedis can evaluate the efficacy of cases, the experimental group of 38 cases, control group of 33 cases. Body tinea cruris test group 33 cases, control group 35 cases. Results: Tinea pedis was improved in the experimental group at 4 weeks and the overall clinical improvement was significantly better than that in the control group (P <0.01). The symptoms of keratosis, dipping and pruritus were improved 2 weeks after drug withdrawal And clinical comprehensive improvement than the control group (P <0.05). The improvement of the pruritus symptom and the clinical comprehensive improvement in the experimental group were better than that of the control group (P <0.05) at the first week; the improvement of the papula symptom was better than that of the control group (P <0.05) ). In the test group, the effective rate of tinea pedis was 57.89% (51.52% in the control group) and 71.05% in the control group (72.73% in the control group) at week 2, 94.74% in the fourth week (81.82% in the control group) And 94.74% respectively (100% in control group); 100% (control group, 81.82%, P <0.05) and 100% (control group, 93.94%) two weeks after drug withdrawal. The clinical effective rate was 87.88% in the first week (60.00% in the control group, P <0.01), mycological clearance rate was 90.91% (88.57% in the control group), 96.97% in the second week 91.43% in the control group) and 100% in the control group (97.14% in the control group), 100% in the control group (100%) and 100% in the control group (100% in the control group). The incidence of adverse reactions in the experimental group was 2.74% (control group 2.86%), showing mild local irritation. Conclusion: Compound Econazole nitrate cream for the treatment of tinea pedis and tinea corporis, can be suppressed in a short time?
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