复发性感染患者的健康相关生活质量
Health-related quality of life in patients with recurrent infections.
作者信息
Hammeken Lianna H, Baunwall Simon M D, Dahlerup Jens F, Hvas Christian L, Ehlers Lars H
机构信息
Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Fredrik Bajers Vej 5, DK-9220 Aalborg, Denmark.
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
出版信息
Therap Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.
BACKGROUND
The health-related quality of life (HrQoL) can be substantially affected in patients with recurrent infection (rCDI) but the impact of effective treatment of the infection remains unclear. This study aimed to evaluate the HrQoL in patients with rCDI and estimate the gain in HrQoL associated with effective treatment of rCDI.
METHODS
Patients' HrQoL was estimated based on EuroQol 5-Dimensions 3-Levels (EQ-5D-3L) questionnaires obtained from a Danish randomised controlled trial (RCT). In the RCT, 64 patients with rCDI were randomised to receive either vancomycin ( = 16), fidaxomicin ( = 24) or faecal microbiota transplantation (FMT) preceded by vancomycin ( = 24). The primary outcome in the RCT was rCDI resolution. Patients were closely monitored during the RCT, and rescue FMT was offered to those who failed their primary treatment. Patients' HrQoL was measured at baseline and at 8- and 26-weeks follow-up. Linear regression analyses conditional on the differences between baseline and follow-up measurements were used to assess statistical significance ( < 0.05).
RESULTS
Within 26 weeks of follow-up, 13 (81%) patients treated with vancomycin, 12 (50%) patients treated with fidaxomicin, and 3 (13%) patients treated with FMT had a subsequent recurrence and received a rescue FMT. The average HrQoL for untreated patients with rCDI was 0.675. After receiving effective treatment, this value increased by 0.139 to 0.813 (< 0.001) at week 8 and by 0.098 to 0.773 ( = 0.003) at week 26 of follow-up compared with baseline.
CONCLUSION
The HrQoL was adversely affected in patients with an active episode of rCDI but increased substantially after receiving an effective treatment algorithm in which rescue FMT was provided in case of a primary treatment failure.
TRIAL REGISTRATION
The RCT was preregistered at EudraCT (j.no. 2015-003004-24, https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003004-24/results) and at ClinicalTrials.gov (study identifier NCT02743234, https://clinicaltrials.gov/ct2/show/NCT02743234).
背景
复发性艰难梭菌感染（rCDI）患者的健康相关生活质量（HrQoL）可能受到严重影响，但感染有效治疗的影响尚不清楚。本研究旨在评估rCDI患者的HrQoL，并估计与rCDI有效治疗相关的HrQoL改善情况。
方法
基于从丹麦一项随机对照试验（RCT）中获得的欧洲五维健康量表3级（EQ-5D-3L）问卷对患者的HrQoL进行评估。在该RCT中，64例rCDI患者被随机分为接受万古霉素治疗（n = 16）、非达霉素治疗（n = 24）或先接受万古霉素治疗后再进行粪便微生物群移植（FMT）（n = 24）。RCT的主要结局是rCDI缓解。在RCT期间对患者进行密切监测，对初始治疗失败的患者提供挽救性FMT。在基线以及随访8周和26周时测量患者的HrQoL。采用基于基线和随访测量差异的线性回归分析来评估统计学显著性（P < 0.05）。
结果
在随访的26周内，接受万古霉素治疗的13例（81%）患者、接受非达霉素治疗的12例（50%）患者以及接受FMT治疗的3例（13%）患者出现了后续复发并接受了挽救性FMT。未治疗的rCDI患者的平均HrQoL为0.675。与基线相比，接受有效治疗后，该值在随访第8周时增加了0.139，达到0.813（P < 0.001），在随访第26周时增加了0.098，达到0.773（P = 0.003）。
结论
rCDI活动期患者的HrQoL受到不利影响，但在接受有效治疗方案（在初始治疗失败时提供挽救性FMT）后显著提高。
试验注册
该RCT已在欧盟临床试验注册数据库（EudraCT）（编号：2015-003004-24，https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003004-24/results）和美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）（研究标识符NCT02743234，https://clinicaltrials.gov/ct2/show/NCT02743234）进行了预注册。
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