Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Clin Drug Investig. 2011;31(8):599-604. doi: 10.2165/11539570-000000000-00000.
The conventionally used dose of isotretinoin in acne causes significant dose-related adverse effects. Low-dose isotretinoin has been used successfully in mild to moderate papulopustular acne. Although isotretinoin acts against all mechanisms of acne formation, it has no significant direct antimicrobial effect.
To test whether the addition of an antibacterial enables use of isotretinoin in low doses even in moderate to severe acne.
This was a preliminary open-label, prospective, non-comparative, single-centre study carried out in a tertiary-care referral hospital. Seventy patients with grade 3 and 4 acne according to the US FDA global score were included in the study between October 2005 and December 2007. These patients were treated with a combination of low-dose isotretinoin (0.3 mg/kg/day) and pulsed oral azithromycin (500 mg/day over three consecutive days every 2 weeks). Response to treatment was assessed at monthly intervals and was recorded as a percentage decrease in overall severity of disease. Treatment was continued to complete clearance of lesions or to 16 weeks, whichever came later.
Sixty-two (93.9%) of 66 eligible patients had complete clearance of disease activity after a mean treatment duration of 21 weeks. The mean total cumulative dose of isotretinoin was 49.6 mg/kg. Seven (11.3%) patients had a relapse of disease during the post-treatment follow-up period. Fifty-three adverse effects were observed. Three patients had initial aggravation of disease that was managed with prednisolone and disappeared with continuation of treatment.
A combination of low-dose isotretinoin and oral azithromycin pulse is effective in severe acne and has a reasonably acceptable adverse-effect profile and low post-treatment relapse rates.
痤疮常规使用的异维 A 酸剂量会引起明显的剂量相关不良反应。低剂量异维 A 酸已成功用于轻度至中度丘疹脓疱性痤疮。虽然异维 A 酸针对痤疮形成的所有机制，但它没有明显的直接抗菌作用。
测试在中重度痤疮中添加一种抗菌药物是否能使低剂量异维 A 酸得以使用。
这是一项初步的、开放性、前瞻性、非对照、单中心研究，在一家三级转诊医院进行。2005 年 10 月至 2007 年 12 月期间，共有 70 名美国食品和药物管理局全球评分 3 级和 4 级痤疮患者纳入该研究。这些患者接受低剂量异维 A 酸（0.3mg/kg/天）联合脉冲口服阿奇霉素（500mg/天，连续 3 天，每 2 周一次）治疗。每月评估一次治疗反应，以疾病总体严重程度的百分比下降来记录。治疗持续至皮损完全清除或达到 16 周，以先到者为准。
在平均治疗 21 周后，66 名符合条件的患者中有 62 名（93.9%）完全清除了疾病活动。异维 A 酸的总累积剂量平均为 49.6mg/kg。7 名（11.3%）患者在治疗后随访期间疾病复发。观察到 53 种不良事件。3 名患者出现疾病初始加重，用泼尼松龙治疗后消失，并继续治疗。
低剂量异维 A 酸联合口服阿奇霉素脉冲治疗重度痤疮有效，具有相当可接受的不良事件谱和较低的治疗后复发率。
