沙环素评论,Annals of Pharmacotherapy

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沙环素评论
Annals of Pharmacotherapy ( IF 2.3 ) Pub Date : 2019-08-28 , DOI: 10.1177/1060028019873111
Wasim Haidari ₁ , Raquel Bruinsma ₁ , Jesus Alberto Cardenas-de la Garza ₁ , Steven R Feldman ₁

Affiliation

目的：Sarecycline 是美国食品和药物管理局最近批准的一种新型口服四环素抗生素。本文的目的是评估已发表的沙环素治疗痤疮的临床试验数据，回顾该药物的药理学，并了解这种新药如何应用于临床实践。数据来源：使用 MEDLINE 和 EMBASE 数据库中的术语 sarecycline (Seysara)、P005672 和 WC-3035 进行了系统文献综述。搜索 ClinicalTrials.gov 以确定正在进行或未发表的研究。研究选择和数据提取：评估了 2000 年 1 月至 2019 年 4 月期间与临床试验、药理学、安全性和微生物学特征相关的英文文章。数据合成：在 3 期临床试验 (SC1401) 中，第 12 周面部炎症病变计数相对于基线的绝对变化，沙环素组为 -15.3，安慰剂组为 -10.1（P < 0.01）。在另一项 3 期临床试验 (SC1402) 中，该类别的绝对变化对于沙利环素为 -15.7，对于安慰剂为 -10.7（P < 0.01）。在两项研究中，沙瑞环素组的面部炎症病变计数的平均百分比变化高于安慰剂组（P < 0.01）。与患者护理和临床实践的相关性：1.5-mg/kg 沙环素剂量可有效减少炎症病变，耐受性良好，并且具有更有针对性的抗菌活性，这可能有助于降低产生抗生素耐药性的风险。结论：这种新颖的、每日一次的治疗方法可能是对中重度痤疮患者有用的治疗方法。

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Sarecycline Review

Objective: Sarecycline is a new oral tetracycline antibiotic recently approved by the US Food and Drug Administration. The aim of this article was to evaluate the data from published clinical trials of sarecycline in the treatment of acne, review the drug’s pharmacology, and understand how this new medication may apply to clinical practice. Data Sources: A systematic literature review was performed using the terms sarecycline (Seysara), P005672, and WC-3035 in the MEDLINE and EMBASE databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles in English between January 2000 and April 2019 relating to clinical trials, pharmacology, safety, and microbiological profile were evaluated. Data Synthesis: In a phase 3 clinical trial (SC1401), absolute change from baseline in facial inflammatory lesion count at week 12 was −15.3 for the sarecycline arm and −10.1 for placebo (P < 0.01). In another phase 3 clinical trial (SC1402), the absolute change in this category was −15.7 for sarecycline and −10.7 for placebo (P < 0.01). Mean percentage change in facial inflammatory lesion count was higher in the sarecycline group than in the placebo group in both studies (P < 0.01). Relevance to Patient Care and Clinical Practice: The 1.5-mg/kg sarecycline dose has efficacy in reducing inflammatory lesions, is well tolerated, and has more targeted antimicrobial activity, which may help reduce the risk of developing antibiotic resistance. Conclusions: This novel, once-daily treatment may represent a useful treatment for patients with moderate to severe acne.

更新日期：2019-08-28

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