Tone Rubak, Simon Mark Dahl Baunwall, Merete Gregersen, Sara Ellegaard Paaske, Malene Asferg, Ishay Barat, Joanna Secher-Johnsen, Mikael Groth Riis, Jeppe Bakkestrøm Rosenbæk, Troels Kjærskov Hansen, Marianne Ørum, Claire J Steves, Hanne Veilbæk, Christian Lodberg Hvas, Else Marie Skjøde Damsgaard
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引用次数: 0
摘要
背景：艰难梭菌感染会导致腹泻和结肠炎：艰难梭菌感染会导致腹泻和结肠炎。感染艰难梭菌的老年患者通常体弱多病，死亡率很高。老年人的虚弱负担可能会限制艰难梭菌感染特异性抗生素和粪便微生物群移植等治疗方法的使用。我们旨在研究早期老年综合评估（CGA）和虚弱评估（包括家访和粪便微生物群移植评估）对艰难梭菌感染老年患者的临床效果：在这项采用实用设计的随机质量改进试验中，丹麦中部地区 70 岁或以上、艰难梭菌毒素 PCR 检测呈阳性的患者被随机分配（1:1）接受 CGA 或标准护理，两者均可接受粪便微生物群移植。患者和研究人员在接受治疗时均未蒙面。主要结果是90天死亡率，根据意向治疗原则对研究组进行比较。该研究已在ClinicalTrials.gov注册，编号为NCT05447533.研究结果：2022年9月1日至2023年5月3日期间，我们将217名患者随机分配至CGA（109人）或标准护理（108人）。患者年龄中位数为 78 岁（IQR 74-84）。217 名患者中有 116 名（53%）女性，101 名（47%）男性。CGA组109名患者中有16人（15%；95% CI 9-23）在90天内死亡，标准护理组108名患者中有22人（20%；14-29）在90天内死亡（几率比0-66，95% CI 0-32-1-38）。两组患者均未发生与患者评估或粪便微生物群移植相关的严重不良事件或死亡。CGA组直接因艰难梭菌感染导致的死亡人数较少（16例死亡中的7例[44%]与标准护理组22例死亡中的18例[82%]；P=0-020）：接受CGA治疗的老年患者的90天死亡率与接受标准治疗的患者相似，但因艰难梭菌感染直接导致的死亡人数较少：资金来源：丹麦创新基金、诺和诺德基金会和Helsefonden。
Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial.
Background: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.
Methods: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.
Findings: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).
Interpretation: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.
Funding: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.
期刊介绍：
The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.
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