Puget Sound VA HealthCare System, Department of Health Services Research and Development, Seattle, WA 98101, USA.
Expert Opin Emerg Drugs. 2011 Sep;16(3):425-39. doi: 10.1517/14728214.2011.571204. Epub 2011 Mar 28.
Clostridium difficile infection (CDI) is the leading identifiable gastrointestinal disease in healthcare institutions, but the response rates to the two standard therapies for CDI are declining and so innovative therapies are being developed for CDI. The purpose of this paper is to review the data on the efficacy and safety of emerging therapies for CDI and assess their potential for effectiveness based on the clinical phase of development and marketing challenges.
Emerging therapies for CDI are reviewed including new antibiotics, peptides, immune regulators, probiotics and toxin binders. PubMed, Medline and Google Scholar and online clinical trial registers are searched from 1976 to 2010 for articles unrestricted by language. Secondary searches by author, manufacturing companies and FDA websites are also performed.
Of the emerging therapies for CDI, several may ultimately reduce the incidence of CDI and the economic burden of this disease on the healthcare system. Several emerging treatments (fidaxomicin, rifaximin and mAbs) show the most promise, although only one is currently being actively developed. Use of other clostridial strains, probiotic strains and immune enhancers have great potential as therapies, but require further development.
艰难梭菌感染(CDI)是医疗机构中可识别的主要胃肠道疾病,但针对 CDI 的两种标准疗法的响应率正在下降,因此正在为 CDI 开发创新疗法。本文的目的是回顾新兴 CDI 疗法的疗效和安全性数据,并根据临床开发阶段和营销挑战评估其有效性的潜力。
对包括新型抗生素、肽类、免疫调节剂、益生菌和毒素结合物在内的 CDI 新兴疗法进行了回顾。从 1976 年到 2010 年,在不受语言限制的情况下,通过 PubMed、Medline 和 Google Scholar 以及在线临床试验登记处进行了搜索。还通过作者、制造公司和 FDA 网站进行了二次搜索。
对于 CDI 的新兴疗法,其中一些可能最终会降低 CDI 的发病率和这种疾病给医疗保健系统带来的经济负担。一些新兴疗法(非达霉素、利福昔明和单抗)显示出最大的前景,尽管目前只有一种正在积极开发。其他梭状芽孢杆菌株、益生菌株和免疫增强剂作为疗法具有很大的潜力,但需要进一步开发。