Philadelphia College of Pharmacy, University of the Sciences, PA, USA.
Ann Pharmacother. 2012 Feb;46(2):219-28. doi: 10.1345/aph.1Q481. Epub 2012 Feb 7.
To evaluate the pharmacology, microbiology, safety, and efficacy of fidaxomicin for treatment of Clostridium difficile infections (CDI).
Literature was identified through Ovid MEDLINE (1948-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) using the search terms fidaxomicin, OPT-80, PAR-101, OP-118, difimicin, tiacumicin, lipiarmycin, Clostridium difficile, Clostridium difficile infection, Clostridium difficile-associated diarrhea, and cost. Drug monographs were retrieved from manufacturers' Web pages, and the Red Book component of Micromedex was used for cost information.
All pertinent Phase 1, 2, and 3 studies published in English were included.
Fidaxomicin is a macrocyclic compound bactericidal against C. difficile and inhibits toxin and spore production. It has poor oral absorption with high fecal concentrations. Available Phase 2 and 3 data with fidaxomicin 200 mg orally every 12 hours demonstrate similar effectiveness in treating CDI compared to oral vancomycin. Fidaxomicin was shown to have less frequency of recurrent infections. Adverse effects are uncommon and occur at similar rates as with oral vancomycin. The most frequently reported adverse effects are gastrointestinal, hematologic, and electrolyte disorders. Available data are lacking in several areas, including the efficacy and safety of fidaxomicin compared to established regimens for mild-to-moderate, life-threatening, and recurrent CDIs. The cost of a 10-day course of fidaxomicin is significantly more than that of metronidazole and vancomycin for treatment of mild-to-moderate CDI.
Fidaxomicin appears to be an effective and safe alternative to oral vancomycin for treatment of mild-to-moderate and severe CDI. Data on its use compared to guideline-recommended therapies for mild-to-moderate and life-threatening CDI are needed. Further data assessing the cost-effectiveness of fidaxomicin are needed. Currently, it cannot be recommended over vancomycin for treatment of CDI. However, it may be considered for treatment of recurrent infections.
评估 fidaxomicin 治疗艰难梭菌感染（CDI）的药理学、微生物学、安全性和疗效。
通过 Ovid MEDLINE（1948 年-2011 年 12 月）和 International Pharmaceutical Abstracts（1970 年-2011 年 12 月），使用 fidaxomicin、OPT-80、PAR-101、OP-118、difimicin、tiacumicin、lipiarmycin、Clostridium difficile、Clostridium difficile infection、Clostridium difficile-associated diarrhea 和 cost 等检索词进行检索。从制造商的网页上检索药物专论，并使用 Micromedex 的 Red Book 组件获取成本信息。
纳入所有发表于英文文献的相关 1 期、2 期和 3 期研究。
fidaxomicin 是一种对艰难梭菌具有杀菌作用的大环化合物，可抑制毒素和孢子的产生。它口服吸收差，粪便浓度高。已有的 fidaxomicin 200mg 口服、每 12 小时 1 次的 2 期和 3 期数据表明，与口服万古霉素相比，其治疗 CDI 的效果相似。fidaxomicin 显示出较低的复发感染频率。不良反应不常见，且与口服万古霉素的发生率相似。最常报告的不良反应是胃肠道、血液学和电解质紊乱。在几个方面缺乏现有数据，包括 fidaxomicin 与用于轻至中度、危及生命和复发性 CDI 的既定方案相比的疗效和安全性。fidaxomicin 治疗 10 天的费用明显高于甲硝唑和万古霉素治疗轻至中度 CDI。
fidaxomicin 似乎是治疗轻至中度和重度 CDI 的一种有效、安全的口服万古霉素替代药物。需要有关其与轻至中度和危及生命的 CDI 的指南推荐疗法比较的数据。需要进一步评估 fidaxomicin 的成本效益数据。目前，它不能被推荐用于治疗 CDI，但对于治疗复发性感染，可能会被考虑。
