0.75%甲硝唑凝胶和安慰剂治疗酒渣鼻临床疗效及安全性评估

Clinical Efficacy and Safety Evaluation of Metronidazole 0.75% Gel versus Vehicle in the Treatment of Rosacea

目的:观察0.75％甲硝唑凝胶治疗酒渣鼻临床疗效和安全性。方法: 采用随机双盲、安慰剂对照、平行分组、多中心临床试验,每天外用2次,疗 程12周。在治疗前,治疗第4,8和12周进行观察。结果:共156例患者入选, 甲硝唑组和安慰剂组各78例。在治疗的第4,8,12周,甲硝唑组对炎性损害（丘 疹和脓疱的总和）计数减少均明显优于安慰剂组（P<0.001）。对炎性损害较治疗 前减少百分数,在治疗的第4周甲硝唑组为40.9％,安慰剂组为10.7％;在第8周分别为61.0％和32.7％;在第12周分别为65.4％和40.5％。在治疗的第4,8,12周,对红斑严重性程度改善甲硝唑组与安慰剂组比较统计学上均无显著性差异（P>0.05）。在治疗的第12周,总体疗效评估甲硝唑组有效率为56.1％,优于安慰剂组37.9％（P<0.05）。甲硝唑组不良反应发生率为17.9％,安慰剂组为19.2％,均表现为皮肤局部刺激性皮炎,以轻中度为主。结论:0.75％甲硝哇凝胶治疗酒渣鼻疗效肯定,安全性高,是治疗酒渣鼻的良好选择。

OBJECTIVE:This study was to assess the efficacy and safety of metronidazole 0.75% gel versus vehicle in the treatment of rosacea. METHODS: This study is a randomized, double-blind, vehicle-controlled, parallel group and multicentre trial, applied either metronidazole 0.75% gel or its vehicle twice daily for 12 weeks. Study visits took place at baseline and week 4, 8 and 12. RESULTS: 156 subjects were included, 78 subjects in the metronidazole group and 78 in the vehicle group. The metronidazole group had significantly superior to the vehicl group in the reduction of inflammatory lesions (sum of papules and pustules) at each visit (P<0.001). Percent reduction from baseline of inflammatory lesions at week 4 were 40.9% in the metronidazole group and 10.7% in the vehicle group;61.0% versus 32.7% at week 8 respectively ; and 65.4% versus 40.5% at week 12 respectively. The change of severity score for erythema in the metronidazole group compared with the vehicle group were not statistically significant at each visit(P>0.05).Global assessment of improvement at week 12 were 56.1% in the metronidazole group and 37.9% in the vehicle group (P<0.05). Mild and moderate local irritation occurred equally in both treatment groups, adverse reaction rate were 17.9% in the metronidazole group and 19.2% in the vehicle group(P>0.05).CONCLUSION: Metronidazole 0.75% gel is a effective and safety drug in the treatment of rosacea.