机构地区:[1]上海中医药大学附属市中医医院外三科,上海200071 [2]上海中医药大学附属龙华医院皮肤科,上海200032 [3]上海中医药大学附属市中西医结合医院皮肤科,上海200082
出 处:《世界临床药物》2019年第9期630-636,共7页World Clinical Drug
基 金:上海市科学技术委员会科研计划项目(16401931000)
摘 要:目的评价外涂大风子膏"异病同治"治疗慢性皮炎及湿疹的临床疗效及其安全性。方法将符合纳入标准的258例慢性皮炎及湿疹患者随机分为治疗组(84例)、对照组(88例)及安慰剂组(86例),治疗组外用大风子膏,对照组外用曲安奈德尿素乳膏,安慰剂组外用尿素乳膏,一日2次,连续使用4周为1个疗程,观察、记录三组患者治疗1个疗程前后的各症状积分及不良反应,评价外用药物的临床疗效及安全性。结果治疗组总有效率91.67%,对照组总有效率96.59%,安慰剂组总有效率31.40%。治疗组显效率39.29%,对照组显效率40.91%,安慰剂组显效率6.98%。治疗组总有效率和显效率均明显优于安慰剂组(P<0.01),且与对照组疗效相当。治疗组与对照组在瘙痒、结痂/鳞屑、浸润/苔藓样变等方面的改善效果均优于安慰剂组(P<0.05),且治疗组对瘙痒的改善优于对照组(P<0.05)。治疗组和对照组对症状总积分的改善明显优于安慰剂组(P<0.01),治疗组对症状总积分最终的改善与对照组相当,但在试验初期(第1、2周)治疗组对症状总积分的改善优于对照组(P<0.01)。治疗期间三组患者不良反应率无统计学差异(P>0.05)。安全性评估显示,三组患者相关安全性指标试验前后差异无统计学意义(P>0.05)。结论大风子膏外用"异病同治"治疗慢性皮炎及湿疹的疗效肯定、安全可靠,值得临床推广应用。Objective To evaluate the clinical efficacy and safety of Dafengzi ointment in treating chronic dermatitis and eczema with same treatment for different diseases. Methods A total of 258 patients meeting the selecting criteria of chronic dermatitis and eczema were randomly divided into the treatment group with 84 cases, the control group with 88 cases and the placebo group with 86 cases. The treatment group was given Dafengzi ointment, the control group was given triamcinolone acetonide urea cream, and the placebo group was given urea cream, 2 times per day, continuous treatment for 4 weeks as a course. The symptom integral of 3 groups of patients were recorded and compared before and after the treatment, and the clinical curative effect and safty were evaluated. Results The total effective rate was 91.67% in the treatment group, 96.59%in the control group and 31.40% in the placebo group. The apparent efficiency was 39.29% in the treatment group, 40.91% in the control group and 6.98% in the placebo group. The total effective rate and significant effective rate of the treatment group were significantly better than that of placebo group(P<0.01), and the efficacy was comparable with that of control group. Both the treatment group and the control group were superior to the placebo group in the improvement of pruritus, scab/scale, infiltration/mossy degeneration(P<0.05), and the treatment group was superior to the control group in the improvement of pruritus(P<0.05). The improvement of the total symptom score in the treatment group and the control group was significantly better than that in the placebo group(P<0.01). The final improvement of the total symptom score in the treatment group was similar to that in the control group, but the improvement of the total symptom score in the treatment group was better than that in the control group at the beginning of the experiment(1 st week and 2 rd week, P<0.01). There was no significant difference in adverse reaction events between the three groups during the treatment(P>0.05
分 类 号:R751.05[医药卫生—皮肤病学与性病学]
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