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2015 年至 2019 年艰难梭菌感染和复发的流行病学和临床负担:德国 RECUR 研究。

Epidemiological and clinical burden of Clostridioides difficile infections and recurrences between 2015 - 2019: the RECUR Germany study.

机构信息

IQVIA, Real World Solutions, Paris, France.

IQVIA, Global Database Studies, Real World Solutions, Lisbon, Portugal.

出版信息

BMC Infect Dis. 2024 Mar 27;24(1):357. doi: 10.1186/s12879-024-09218-y.

Abstract

BACKGROUND

This real-world study assessed the epidemiology and clinical complications of Clostridioides difficile infections (CDIs) and recurrences (rCDIs) in hospital and community settings in Germany from 2015 - 2019.

METHODS

An observational retrospective cohort study was conducted among adult patients diagnosed with CDI in hospital and community settings using statutory health insurance claims data from the BKK database. A cross-sectional approach was used to estimate the annual incidence rate of CDI and rCDI episodes per 100,000 insurants. Patients' demographic and clinical characteristics were described at the time of first CDI episode. Kaplan-Meier method was used to estimate the time to rCDIs and time to complications (colonic perforation, colectomy, loop ileostomy, toxic megacolon, ulcerative colitis, peritonitis, and sepsis). A Cox model was used to assess the risk of developing complications, with the number of rCDIs as a time-dependent covariate.

RESULTS

A total of 15,402 CDI episodes were recorded among 11,884 patients. The overall incidence of CDI episodes declined by 38% from 2015 to 2019. Most patients (77%) were aged ≥ 65 years. Around 19% of CDI patients experienced at least one rCDI. The median time between index CDI episode to a rCDI was 20 days. The most frequent complication within 12-months of follow-up after the index CDI episode was sepsis (7.57%), followed by colectomy (3.20%). The rate of complications increased with the number of rCDIs. The risk of any complication increased by 31% with each subsequent rCDI (adjusted hazard ratio [HR]: 1.31, 95% confidence interval: 1.17;1.46).

CONCLUSIONS

CDI remains a public health concern in Germany despite a decline in the incidence over recent years. A substantial proportion of CDI patients experience rCDIs, which increase the risk of severe clinical complications. The results highlight an increasing need of improved therapeutic management of CDI, particularly efforts to prevent rCDI.

摘要

背景

本真实世界研究评估了 2015 年至 2019 年德国医院和社区环境中艰难梭菌感染(CDI)和复发(rCDI)的流行病学和临床并发症。

方法

使用 BKK 数据库的法定健康保险索赔数据,对医院和社区环境中诊断为 CDI 的成年患者进行了一项观察性回顾性队列研究。采用横断面方法估计每 10 万保险人数中 CDI 和 rCDI 发作的年发生率。描述了首次 CDI 发作时患者的人口统计学和临床特征。Kaplan-Meier 法估计 rCDI 和并发症(结肠穿孔、结肠切除术、回肠造口术、中毒性巨结肠、溃疡性结肠炎、腹膜炎和败血症)的时间。使用 Cox 模型评估发生并发症的风险,将 rCDI 的数量作为时间依赖性协变量。

结果

共记录了 11884 例患者的 15402 例 CDI 发作。2015 年至 2019 年,CDI 发作的总体发生率下降了 38%。大多数患者(77%)年龄≥65 岁。约 19%的 CDI 患者经历过至少一次 rCDI。从指数 CDI 发作到 rCDI 的中位时间为 20 天。指数 CDI 发作后 12 个月内随访期间最常见的并发症是败血症(7.57%),其次是结肠切除术(3.20%)。并发症的发生率随 rCDI 的数量而增加。随着 rCDI 的增加,任何并发症的风险增加 31%(调整后的危险比 [HR]:1.31,95%置信区间:1.17;1.46)。

结论

尽管近年来发病率有所下降,但 CDI 仍是德国的公共卫生关注点。相当一部分 CDI 患者经历 rCDI,这增加了严重临床并发症的风险。结果强调了对 CDI 治疗管理的需求不断增加,特别是预防 rCDI 的努力。

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