甲硝唑凝胶治疗中、重度酒渣鼻随机双盲、安慰剂对照临床试验  

Metronidazole gel in treatment of moderate to severe rosacea: a randomized, double-blind,placebo-controlled clinical trial

作　　者：蔡林[1] 李文海[1] 徐前喜[1] 杜鹃[1] 陈周[1] 王玲霞 张建中[1] 朱铁君[1] 

机构地区：[1]北京大学人民医院皮肤科

出　　处：《中国新药与临床杂志》2002年第11期657-660,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :评价 0 .75 %甲硝唑凝胶治疗中、重度酒渣鼻的临床疗效和安全性。方法 :采用随机、双盲、安慰剂对照方法 ;病人在皮损区域局部外用0 .75 %甲硝唑凝胶或安慰剂 ,每日 2次 ,疗程 12wk。结果 :可分析病例 6 2例 ,其中甲硝唑组 31例 ,安慰剂组 31例。治疗后炎性损害百分数 ,甲硝唑组与安慰剂组在wk 4时分别为 (2 9± 38) %vs (1±83) % (P >0 .0 5 ) ,wk 8时为 (49± 5 1) %vs (3±83) % (P <0 .0 5 ) ,wk 12时为 (5 6± 4 2 ) %vs (2 1± 4 8) % (P <0 .0 1)。wk 12时红斑消失甲硝唑组和安慰剂组分别为 8%和 4 % ,2组比较差异无显著意义 (P >0 .0 5 )。用药后局部刺激反应 ,甲硝唑组为 2 9% ,安慰剂组为 2 3% ,均为轻、中度 ,2组比较差异无显著意义 (P >0 .0 5 )。结论 :0 .75 %甲硝唑凝胶治疗中、重度酒渣鼻的疗效肯定 。AIM: To evaluate the efficacy and safety of 0.75 % metronidazole gel in the treatment of moderate to severe rosacea. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted. Patients applied topically either 0.75 % metronidazole gel or placebo twice daily for 12 wk. RESULTS: Totally sixty-two patients with rosacea were enrolled, thirty-one patients in metronidazole group and thirty-one in placebo group. At wk 4, the number of inflammatory lesions decreased by (29± s 38) % in metronidazole group, (1±83) % in placebo group. No statistical difference was found (P>0.05). At wk 8, the number of inflammatory lesions decreased by (49±51) % in metronidazole group and (3±83) % in placebo group with significant difference(P<0.05).At wk 12, the number of inflammatory lesions decreased by (56±42) % in metronidazole group and (21±48) % in placebo group (P<0.01). The erythema clearace rate at wk 12 was 8 % in metronidazole group and 4 % in placebo group (P>0.05). Adverse reaction rates were 29 % in metronidazole group and 23 % in placebo group. They were all mild and moderate local irritations. No statistical difference was found between two groups (P>0.05). CONCLUSION: 0.75 % metronidazole gel is both effective and safe in the treatment of moderate to severe rosacea.

关 键 词：甲硝唑凝胶 治疗 酒渣鼻 随机双盲 安慰剂 对照 临床试验 

分 类 号：R758.734[医药卫生—皮肤病学与性病学]