Granata Guido, Schiavone Francesco, Pipitone Giuseppe
Clinical and Research Department for Infectious Diseases, National Institute for Infectious Diseases L. Spallanzani, IRCCS, 00149 Rome, Italy.
Divers and Raiders Group Command "Teseo Tesei" COMSUBIN, Medical Service, Italian Navy, 19025 Portovenere, Italy.
Antibiotics (Basel). 2022 Oct 28;11(11):1495. doi: 10.3390/antibiotics11111495.
Nowadays, one of the main issues in the management of infection (CDI) is the high rate of recurrences (rCDI), causing increased mortality and higher health care costs.
To assess the available evidence on the use of bezlotoxumab for the prevention of rCDI during a first CDI episode.
Published articles on bezlotoxumab during a primary CDI episode were identified through computerized literature searches with the search terms [(bezlotoxumab) AND (CDI) OR ( infection)] using PubMed and by reviewing the references of retrieved articles. PubMed was searched until 31 August 2022.
Eighty-eight studies were identified as published from December 2014 to June 2022. Five studies were included in this study, one was a phase III clinical trial and four were sub-analyses or extensions of the previous phase III clinical trial. In the phase III clinical trial, the subgroup analysis on the included primary CDI patients showed that 13.5% of patients receiving bezlotoxumab had an rCDI, whilst 20.9% of patients in the placebo group had an rCDI at the twelve weeks follow-up (absolute difference: -7.4).
Bezlotoxumab administration during the standard of care antibiotic therapy is effective and safe in reducing the rate of rCDI. Despite its high cost, evidence suggests considering bezlotoxumab in patients with a primary CDI episode. Further studies are needed to assess the benefit in specific subgroups of primary CDI patients and to define the risk factors to guide bezlotoxumab use.
如今,艰难梭菌感染(CDI)管理中的主要问题之一是复发率(rCDI)高,这导致死亡率增加和医疗保健成本上升。
评估在首次CDI发作期间使用贝佐妥单抗预防rCDI的现有证据。
通过使用PubMed进行计算机文献检索,搜索词为[(贝佐妥单抗) AND (CDI) OR (艰难梭菌感染)],并查阅检索文章的参考文献,确定在原发性CDI发作期间关于贝佐妥单抗的已发表文章。检索PubMed直至2022年8月31日。
确定了88项从2014年12月至2022年6月发表的研究。本研究纳入了5项研究,1项为III期临床试验,4项为先前III期临床试验的亚分析或扩展研究。在III期临床试验中,对纳入的原发性CDI患者进行的亚组分析显示,接受贝佐妥单抗治疗的患者中有13.5%发生rCDI,而安慰剂组在12周随访时有20.9%的患者发生rCDI(绝对差异:-7.4)。
在标准护理抗生素治疗期间给予贝佐妥单抗在降低rCDI发生率方面是有效且安全的。尽管成本高昂,但有证据表明在原发性CDI发作的患者中可考虑使用贝佐妥单抗。需要进一步研究以评估原发性CDI患者特定亚组的获益情况,并确定指导贝佐妥单抗使用的风险因素。