Gettig Jacob P, Crank Christopher W, Philbrick Alexander H
Pharmacy Practice, Midwestern University Chicago College of Pharmacy, Downers Grove, IL 60515, USA.
Ann Pharmacother. 2008 Jan;42(1):80-90. doi: 10.1345/aph.1G232. Epub 2007 Dec 19.
To review the literature concerning the in vitro activity, pharmacokinetic properties, in vivo efficacy, and adverse events associated with a new penem antibiotic, faropenem medoxomil.
We conducted a search of MEDLINE/PubMed and International Pharmaceutical Abstracts databases for articles or abstracts using the terms faropenem, faropenem daloxate, faropenem medoxomil, SUN5555, SY5555, WY49605, RU67655, ALP201, BLA 857, and YM 044 and published through July 2007. Information on poster presentations was obtained from the drug's manufacturer. Additional articles were identified from citations in the bibliographies of review articles. Articles written in languages other than English were excluded.
All published reports that evaluated faropenem (or its chemical synonyms) and faropenem medoxomil were used in this review. Abstracts subsequently published as full reports were excluded, and only the resulting reports were included. Abstracts without subsequently published reports were included.
The in vitro activity of faropenem has been evaluated extensively against respiratory pathogens and less extensively against aerobic gram-positive, gram-negative, and anaerobic organisms. Prospective, randomized, multicenter clinical trials have demonstrated noninferiority of faropenem to comparators for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis, and uncomplicated skin and skin structure infections. Adverse events associated with faropenem appear to be minimal and include nausea, vomiting, and diarrhea.
Faropenem has demonstrated excellent in vitro activity against common respiratory pathogens, many aerobic gram-positive organisms, and anaerobes. Activity against gram-negative organisms is more reserved. In vivo data suggest that faropenem is efficacious in treating community-acquired infections including uncomplicated skin and skin structure infections; however, more data may help to characterize faropenem's place in antimicrobial therapy. Replidyne, Inc., the manufacturer of faropenem, is conducting studies to address the Food and Drug Administration's concerns that resulted in a nonapprovable letter in October 2006.
综述有关新型青霉烯类抗生素法罗培南钠的体外活性、药代动力学特性、体内疗效及不良事件的文献。
我们在MEDLINE/PubMed和国际药学文摘数据库中检索了截至2007年7月发表的文章或摘要，检索词包括法罗培南、法罗培南氢钠、法罗培南钠、SUN5555、SY5555、WY49605、RU67655、ALP201、BLA 857和YM 044。有关壁报展示的信息来自该药物的制造商。通过综述文章的参考文献又识别出了其他文章。排除了非英文撰写的文章。
本综述使用了所有评估法罗培南（或其化学同义词）和法罗培南钠的已发表报告。随后作为完整报告发表的摘要被排除，仅纳入最终报告。未随后发表报告的摘要也被纳入。
法罗培南对呼吸道病原体的体外活性已得到广泛评估，对需氧革兰氏阳性菌、革兰氏阴性菌和厌氧菌的评估则较少。前瞻性、随机、多中心临床试验表明，在治疗急性细菌性鼻窦炎、社区获得性肺炎、慢性支气管炎急性加重以及单纯性皮肤及皮肤结构感染方面，法罗培南不劣于对照药物。与法罗培南相关的不良事件似乎很少，包括恶心、呕吐和腹泻。
法罗培南对常见呼吸道病原体、许多需氧革兰氏阳性菌和厌氧菌具有出色的体外活性。对革兰氏阴性菌的活性则相对较弱。体内数据表明，法罗培南在治疗包括单纯性皮肤及皮肤结构感染在内的社区获得性感染方面有效；然而，更多数据可能有助于明确法罗培南在抗菌治疗中的地位。法罗培南的制造商Replidyne公司正在开展研究，以回应美国食品药品监督管理局在2006年10月发出的一封不批准函中所提出的担忧。
