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非达霉素与口服万古霉素治疗复发性艰难梭菌感染的疗效比较

Effectiveness of fidaxomicin versus oral vancomycin in the treatment of recurrent clostridioides difficile.

作者信息

Rinaldi Alyssa, Reed Erica E, Stevenson Kurt B, Coe Kelci, Smith Jessica M

机构信息

Department of Pharmacy, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Department of Internal Medicine, Division of Infectious Diseases, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

出版信息

J Clin Pharm Ther. 2021 Aug;46(4):993-998. doi: 10.1111/jcpt.13387. Epub 2021 Feb 20.

Abstract

WHAT IS KNOWN AND OBJECTIVE

The 2017 IDSA/SHEA Clinical Practice Guidelines for Clostridioides difficile infection (CDI) recommend treating recurrent episodes with fidaxomicin or oral vancomycin, but there is little evidence to support one strategy over another, particularly beyond the first recurrence. The aim of this study was to compare clinical outcomes in patients with recurrent CDI treated with vancomycin vs. fidaxomicin.

METHODS

This retrospective study evaluated inpatients with recurrent CDI treated with vancomycin or fidaxomicin between 1 January 2013 and 1 May 2019. The primary outcome was CDI recurrence. Secondary outcomes included re-infection, treatment failure, infection-related length of stay (IRLOS) and in-hospital all-cause mortality (IHACM). The Wilcoxon rank-sum test, Pearson's chi-square test or Fisher's exact test was utilized, as appropriate. A multivariable logistic regression (MLR) model was used to estimate the adjusted odds ratio and 95% confidence interval assessing recurrence while adjusting for confounding variables. A survival analysis was also conducted.

RESULTS

135 patients met the inclusion criteria (35 fidaxomicin vs. 100 vancomycin). There was no difference in CDI recurrence [7 (20%) fidaxomicin vs. 11 (11%) vancomycin, p = 0.18]; this persisted in the MLR model (OR: 0.85 [95% CI 0.27-2.7]) and survival analysis (p = 0.1954). Additionally, there was no difference in re-infection rate (p = 0.73), treatment failure (p = 0.13), IRLOS (p = 0.19) or IHACM (p = 0.65).

WHAT IS NEW AND CONCLUSION

This represents the first analysis of CDI recurrence that included patients with >2 prior episodes of CDI. The study found no difference in additional recurrences when patients were treated with oral vancomycin vs fidaxomicin for recurrent CDI. However, the current study is limited by the small sample size available for inclusion. Prospective randomized studies with larger sample sizes are needed to confirm this study's conclusions.

摘要

已知信息与研究目的

2017年美国感染病学会(IDSA)/美国医疗保健流行病学学会(SHEA)发布的艰难梭菌感染(CDI)临床实践指南推荐使用非达霉素或口服万古霉素治疗复发性CDI,但几乎没有证据支持一种策略优于另一种,尤其是在首次复发之后。本研究的目的是比较接受万古霉素与非达霉素治疗的复发性CDI患者的临床结局。

方法

这项回顾性研究评估了2013年1月1日至2019年5月1日期间接受万古霉素或非达霉素治疗的复发性CDI住院患者。主要结局是CDI复发。次要结局包括再次感染、治疗失败、感染相关住院时间(IRLOS)和院内全因死亡率(IHACM)。根据情况使用Wilcoxon秩和检验、Pearson卡方检验或Fisher精确检验。使用多变量逻辑回归(MLR)模型估计调整后的优势比和95%置信区间,在调整混杂变量的同时评估复发情况。还进行了生存分析。

结果

135例患者符合纳入标准(35例接受非达霉素治疗,100例接受万古霉素治疗)。CDI复发情况无差异[非达霉素组7例(20%),万古霉素组11例(11%),p = 0.18];在MLR模型(OR:0.85[95%CI 0.27 - 2.7])和生存分析中(p = 0.1954)这一情况持续存在。此外,再次感染率(p = 0.73)、治疗失败(p = 0.13)、IRLOS(p = 0.19)或IHACM(p = 0.65)均无差异。

新发现与结论

这是首次对包括既往有>2次CDI发作患者的CDI复发情况进行分析。该研究发现,复发性CDI患者接受口服万古霉素与非达霉素治疗时,再次复发情况无差异。然而,本研究受纳入样本量较小的限制。需要开展样本量更大的前瞻性随机研究来证实本研究的结论。

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