Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes
Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes
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DOI：
10.3310/hta18630
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发表时间：
2014-10-01
影响因子：
3.6
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中科院分区：
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背景：护理院的抗生素处方率高于一般人群。抗生素破坏正常的肠道菌群，有时引起抗生素相关性腹泻（AAD）。艰难梭菌（Hall and O’toole 1935）是1938年普氏病最常见的引起AAD的原因。人们对养老院开抗生素的频率和种类知之甚少，也不知道这种情况下AAD的发病率和病因。目的：益生菌治疗抗生素相关性腹泻（PAAD）研究设计为两阶段研究。PAAD阶段1旨在(1)前瞻性地描述养老院的抗生素处方；(2)确定艰难梭菌携带和AAD的发生率（包括艰难梭菌相关腹泻）；(3)考虑实施方面的挑战，并为一项随机对照试验（RCT）的样本量估计奠定基础，该试验将益生菌与抗生素结合使用，以预防养老院中的AAD。如果经过第1阶段的验证，RCT将在第2阶段实施。然而，由于有关益生菌对AAD发病率的临床有效性的新证据，决定不进行PAAD 2期治疗。设计：PAAD阶段1是一项前瞻性观察队列研究，在南威尔士的养老院对每位居民进行了长达12个月的随访。设置：招募的养老院有管理层和业主同意参与，并且有三个或更多的工作人员愿意承担实施研究的责任。参与者：招募了11家养老院，但在招募任何居民之前就有一家退出了。共有279名护理院居民被招募到观察性研究中，其中19人退出，16人（84%）因为搬到非参与的护理院。主要结局指标：主要结局指标为抗生素处方率、AAD发生率(定义为24小时内三次或更多稀便（布里斯托大便表5-7型），以及粪便培养证实携带艰难梭菌。结果：81%的居民在研究开始时获得了粪便样本。超过一半的样本含有耐抗生素分离株，其中47%的肠杆菌科对环丙沙星耐药。居民平均每年获得2.16张抗生素处方[95%置信区间（CI） 1.90至2.46]。来自双重登记家庭的居民不太可能开抗生素。在处方抗生素的居民中，AAD的发生率为每年0.57次（95% CI 0.41 - 0.81）。与其他抗生素相比，服用复方阿莫昔拉的居民和常规使用尿失禁垫的居民更容易发生AAD。AAD在居住家庭的居民中不太常见。结论：护理院居民，特别是在养老院，经常开抗生素，经常经历AAD。抗生素耐药性，包括环丙沙星耐药性，在从养老院居民的粪便中分离的肠杆菌科细菌中很常见。与其他常用抗生素相比，共阿莫昔拉夫与AAD的风险更大有关。
Background: Antibiotic prescribing rates in care homes are higher than in the general population. Antibiotics disrupt the normal gut flora, sometimes causing antibiotic-associated diarrhoea (AAD). Clostridium difficile (Hall and O'Toole 1935) Prevot 1938 is the most commonly identified cause of AAD. Little is known either about the frequency or type of antibiotics prescribed in care homes or about the incidence and aetiology of AAD in this setting.Objectives: The Probiotics for Antibiotic-Associated Diarrhoea (PAAD) study was designed as a two-stage study. PAAD stage 1 aimed to (1) prospectively describe antibiotic prescribing in care homes; (2) determine the incidence of C. difficile carriage and AAD (including C. difficile-associated diarrhoea); and (3) to consider implementation challenges and establish the basis for a sample size estimation for a randomised controlled trial (RCT) of probiotic administration with antibiotics to prevent AAD in care homes. If justified by PAAD stage 1, the RCT would be implemented in PAAD stage 2. However, as a result of new evidence regarding the clinical effectiveness of probiotics on the incidence of AAD, a decision was taken not to proceed with PAAD stage 2.Design: PAAD stage 1 was a prospective observational cohort study in care homes in South Wales with up to 12 months' follow-up for each resident.Setting: Recruited care homes had management and owner's agreement to participate and three or more staff willing to take responsibility for implementing the study.Participants: Eleven care homes were recruited, but one withdrew before any residents were recruited. A total of 279 care home residents were recruited to the observational study and 19 withdrew, 16 (84%) because of moving to a non-participating care home.Main outcome measures: The primary outcomes were the rate of antibiotic prescribing, incidence of AAD, defined as three or more loose stools (type 5-7 on the Bristol Stool Chart) in a 24-hour period, and C. difficile carriage confirmed on stool culture.Results: Stool samples were obtained at study entry from 81% of participating residents. Over half of the samples contained antibiotic-resistant isolates, with Enterobacteriaceae resistant to ciprofloxacin in 47%. Residents were prescribed an average of 2.16 antibiotic prescriptions per year [95% confidence interval (CI) 1.90 to 2.46]. Antibiotics were less likely to be prescribed to residents from dual-registered homes. The incidence of AAD was 0.57 (95% CI 0.41 to 0.81) episodes per year among those residents who were prescribed antibiotics. AAD was more likely in residents who were prescribed co-amoxiclav than other antibiotics and in those residents who routinely used incontinence pads. AAD was less common in residents from residential homes.Conclusions: Care home residents, particularly in nursing homes, are frequently prescribed antibiotics and often experience AAD. Antibiotic resistance, including ciprofloxacin resistance, is common in Enterobacteriaceae isolated from the stool of care home residents. Co-amoxiclav is associated with greater risk of AAD than other commonly prescribed antibiotics.