Del Rosso James Q, Preston Norman J, Caveney Scott W, Gottschalk Ronald W
Valley Hospital Medical Center, Las Vegas, NV, USA.
J Drugs Dermatol. 2012 Jun;11(6):703-7.
This article is a prospective planned analysis of data evaluating the effectiveness and safety of modified-release doxycycline capsules (30 mg immediate-release and 10 mg delayed-release beads) used once daily for up to 12 weeks in subgroups of males and females with papulopustular (subtype 2) rosacea from a large, open-label, multicenter, community-based study. A total of 1421 patients participated in the study. The per-protocol population comprised 826 patients on monotherapy, with 28.5% male participants (n=235) and 71.5% female participants (n=591). Rosacea was assessed on a 5-point investigator's global assessment (IGA) scale (0=clear, 1=near clear, 2=mild, 3=moderate, 4=severe). Erythema was also assessed on a 5-point clinician's erythema assessment (CEA) scale (0=none, 1=mild, 2=moderate, 3=significant, 4=severe). At baseline, males had a higher percentage of IGA scores of 3 (116 per 235; 49.4% versus 273 per 591; 46.2% in females) and 4 (32 per 235; 13.6% versus 35 per 591; 5.9% in females). Significant improvements in severity rating and erythema were observed in males and females as demonstrated by shifts in the distribution of IGA and CEA scores between baseline and week 12 (P<.001). Treatment success (IGA score of 0 or 1) at week 12 was achieved in 172 per 235 (73.2%) of males and in 444 per 591 (75.2%) of females. Adverse events (primarily mild or moderate gastrointestinal events) were reported in 9.9% of males and 12.8% of females. Anti-inflammatory dose doxycycline, which is administered as a 40 mg modified-release capsule once daily was effective and safe as monotherapy for papulopustular rosacea in both the female (n=591) and male (n=235) study groups. This specific 40 mg capsule delivers 30 mg immediate-release and 10 mg as delayed release using specially designed beads, and is subantimicrobial with both single and repeated dosing.
本文是一项前瞻性计划数据分析，评估了在一项大型、开放标签、多中心、基于社区的研究中，用于丘疹脓疱型（2型）酒渣鼻的男性和女性亚组中，每日一次服用长达12周的缓释强力霉素胶囊（30毫克速释和10毫克缓释微丸）的有效性和安全性。共有1421名患者参与了该研究。符合方案人群包括826名单药治疗患者，其中男性参与者占28.5%（n = 235），女性参与者占71.5%（n = 591）。酒渣鼻通过5分的研究者整体评估（IGA）量表进行评估（0 = 清除，1 = 接近清除，2 = 轻度，3 = 中度，4 = 重度）。红斑也通过5分的临床医生红斑评估（CEA）量表进行评估（0 = 无，1 = 轻度，2 = 中度，3 = 显著，4 = 重度）。在基线时，男性IGA评分为3的比例更高（235人中116人；49.4%，而女性591人中273人；46.2%）以及评分为4的比例更高（235人中32人；13.6%，而女性591人中35人；5.9%）。在男性和女性中均观察到严重程度评级和红斑有显著改善，这通过基线和第12周之间IGA和CEA评分分布的变化得以证明（P <.001）。在第12周时，235名男性中有172人（73.2%）和591名女性中有444人（75.2%）实现了治疗成功（IGA评分为0或1）。9.9%的男性和12.8%的女性报告了不良事件（主要是轻度或中度胃肠道事件）。作为40毫克缓释胶囊每日一次给药的抗炎剂量强力霉素，在女性（n = 591）和男性（n = 235）研究组中作为丘疹脓疱型酒渣鼻的单药治疗是有效且安全的。这种特定的40毫克胶囊使用特殊设计的微丸提供30毫克速释和10毫克缓释，并且单次和重复给药均为亚抗菌剂量。
