维胺酯和异维A酸治疗寻常痤疮随机双盲研究

Comparison of isotretinoin and viaminate in the treatment of moderate to severe acne vulgaris:a multiple-centre,randomized,double-blind,comparative clinical trial

目的评价维胺酯胶囊和异维A酸胶丸治疗中重度寻常痤疮的疗效和安全性。方法采用多中心、随机、双肓双模拟、对照临床研究,按痤疮综合分析系统(GAGS)评价痤疮的严重程度,将评分确定为中重度痤疮的患者随机分为维胺酯组(50mg,每日3次)和异维A酸组(10mg,每日2次),于服药前、服药后2、4、6周计数皮损,观察疗效和不良反应。结果共入组227例,计入全分析集(FAS)分析213例,符合方案集(PPS)分析200例。PPS分析治疗后2、4、6周异维A酸组有效率分别为6．0%、29．0%、57．0%；维胺酯组分别为5．0%、20．0%、51．00%,两组比较差异无统计学意义(P＞0．05)。各随访期皮损数下降值比较,除异维A酸组炎性丘疹和脓疱数下降值高于维胺酯组(P＜0．05)外,粉刺、结节类皮损数两组差异无统计学意义。FAS分析不良反应发生率异维A酸组(68．81%)显著高于维胺酯组(36．53%)(P＜0．001),常见不良反应如口干、口唇脱屑异维A酸组发生率显著高于维胺酯组(P＜0．001),不良反应的程度也明显重于维胺酯组(P＜0．05)。结论异维A酸和维胺酯治疗中重度痤疮疗效较为一致,但异维A酸治疗炎性皮疹起效较快,同时其常见不良反应也多于维胺酯。

Objective To evaluate the efficacy and safety of isotretinoin and viaminate for the treatment of moderate to severe acne vulgaris. Methods A multiple-centre, double-blind, double-analog comparative clinical trial was conducted. Patients diagnosed with moderate to severe acne by GAGS （ global acne grading system ） were randomly divided into isotretinoin group （ 10 mg, bid ） and viaminate group （ 50 mg, tid ） ; treatment was done for a total of 6 weeks. All subjects were evaluated before treatment, and at 2, 4, 6 weeks after the initiation of treatment, for evaluation of lesion count, and for observation of therapeutic effects and side effects. Results A total of 217 patients were enrolled this trial, of which, 213 could be evaluated in a FAS （ Full Analysis Set ） analysis and 200 in a PPS （ per protocol ） analysis. There was no significant difference in the efficacy at 2, 4, 6 weeks after the initiation of treatment between the isotretinoin group and viaminate group （6.0% vs 5.0%, 29.0% vs 20.0%, 57.0 % vs 51.0 %, respectively ）. However, the inflammatory papules and pustules decreased more rapidly in the isotretinoin group than in the viaminate group at each of the follow up evaluations （ all P 〈 0.05 ）. There was no obvious difference in the rate of clearance of comedones and nodules between the two groups. Both the occurrence rate （68.81% vs 36.53%, P〈 0.001 ） and severity （P 〈 0.05 ） of side effects were higher in the isotretinoin group than in the viaminate group. The main adverse events included mouth dryness, dizziness, etc, occurred more frequently in the isotretinoin group than in the viaminate group. Conclusion For the treatment of moderate to severe acne, the efficacy of isotretinoin is similar to that of viaminate; however, isotretinoin has more immediate effect with more side effects than viaminate.