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2008-2017 年日本医院艰难梭菌(梭状芽孢杆菌)感染:基于实际情况的全国范围内治疗模式、发病率和检测密度分析。

Clostridioides (Clostridium) difficile infection in Japanese hospitals 2008-2017: A real-world nationwide analysis of treatment pattern, incidence and testing density.

机构信息

Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.

Astellas Pharma US LLC, 1 Astellas Way, Northbrook, IL, 60062, USA.

出版信息

J Infect Chemother. 2020 May;26(5):438-443. doi: 10.1016/j.jiac.2019.11.005. Epub 2020 Feb 17.

DOI:10.1016/j.jiac.2019.11.005
PMID:32081648
Abstract

OBJECTIVE

To characterize treatment pattern, incidence and diagnosis of hospital-onset Clostridioides difficile infection (CDI) in Japan, cases were studied over a 9-year period using a large, administrative database.

METHODS

This was a retrospective, cross-sectional analysis of inpatients at 320 Japanese Diagnosis-Procedure Combination (DPC) hospitals. Hospitalizations between April 2008 and March 2017 were extracted for patients aged ≥18 years. CDI was defined as CDI treatment plus CDI diagnosis or positive enzyme immunoassay (EIA) result. Endpoints included treatment (type, route, daily dose, duration), time to CDI onset from admission, and time to recurrence (rCDI) from the end of treatment. Chronological changes were reported for treatment pattern, CDI incidence and EIA testing.

RESULTS

The analysis included 11,823 CDI hospitalizations, 1359 with rCDI. Overall, oral metronidazole (MNZ), oral vancomycin (VCM), and intravenous MNZ were used in 50.2%, 42.1% and 1.2% of CDI hospitalizations, respectively. From 2009 to 2017, CDI hospitalizations treated with MNZ more than doubled and VCM more than halved. Median (Q1-Q3) time to CDI and rCDI onset was 25 (11-52) days and 10 (6-17.5) days, respectively. Median treatment duration ranged from 8 to 10 days and median dose was 1 g/day for both MNZ and VCM. CDI incidence remained steady from 2010 until 2017 (0.99/10,000 patient-days) and EIA testing density doubled from 2008 to 2017 (24.46/10,000 patient-days).

CONCLUSION

Oral MNZ has become the primary CDI treatment in Japanese DPC hospitals. The treatment duration and dose were aligned to the package insert. CDI diagnostic testing density increased over time, CDI incidence did not.

CLINICAL TRIAL REGISTRATION NUMBER

N/A.

摘要

目的

利用大型行政数据库,对日本 9 年来的医院获得性艰难梭菌感染(CDI)的治疗模式、发生率和诊断进行描述,对患者进行了回顾性、横断面分析。

方法

这是对 320 家日本诊断-程序组合(DPC)医院≥18 岁住院患者的一项回顾性、横断面分析。提取 2008 年 4 月至 2017 年 3 月期间的住院记录。CDI 被定义为 CDI 治疗加 CDI 诊断或酶联免疫吸附试验(EIA)阳性结果。终点包括治疗(类型、途径、日剂量、持续时间)、入院后 CDI 发病时间和治疗结束后复发(rCDI)时间。报告了治疗模式、CDI 发生率和 EIA 检测的时间变化。

结果

分析包括 11823 例 CDI 住院患者,其中 1359 例有 rCDI。总的来说,口服甲硝唑(MNZ)、口服万古霉素(VCM)和静脉内 MNZ 分别用于 50.2%、42.1%和 1.2%的 CDI 住院患者。从 2009 年到 2017 年,MNZ 治疗的 CDI 住院患者增加了一倍以上,而 VCM 则减少了一半以上。CDI 和 rCDI 发病的中位数(Q1-Q3)时间分别为 25(11-52)天和 10(6-17.5)天。治疗持续时间中位数为 8-10 天,MNZ 和 VCM 的日剂量中位数均为 1 克。2010 年至 2017 年,CDI 发病率保持稳定(0.99/10000 患者日),EIA 检测密度从 2008 年到 2017 年翻了一番(24.46/10000 患者日)。

结论

口服 MNZ 已成为日本 DPC 医院治疗 CDI 的主要方法。治疗持续时间和剂量与说明书一致。随着时间的推移,CDI 诊断检测密度增加,但 CDI 发病率没有增加。

临床试验注册号

无。

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