Antibiotic prophylaxis

抗生素预防
  • 文章类型: Journal Article
    背景:尽管手术和患者依赖因素对手术部位感染(SSIs)的影响已得到广泛研究,它们对SSI微生物组成的影响仍未被探索。这项研究的目的是确定不同类型手术中SSI微生物组成的患者依赖性预测因子。
    方法:这项回顾性队列研究包括来自瑞士国家感染监测计划的538893名患者。多标签分类方法,使用自适应增强和高斯朴素贝叶斯来识别使用20个特征的SSIs的微生物组成的预测因子,包括性,年龄,BMI,手术持续时间,手术类型,和外科抗菌药物预防。
    结果:总体而言,SSIs记录了18642例患者(3.8%),其中,10632具有可用的微生物伤口拭子。SSIs中最常见的病原体是肠杆菌(57%),葡萄球菌属。(31%),和肠球菌属。(28%)。年龄(平均特征重要性0.260,95%c.i.0.209至0.309),BMI(0.224,0.177至0.271),和手术时间(0.221,0.180至0.269)是SSIs微生物组成的强大且独立的预测因子。年龄和手术时间的增加以及BMI的降低与葡萄球菌属的转变有关。肠杆菌和肠球菌属。机器学习模型的在线应用程序可用于其他医疗保健系统中的验证。
    结论:年龄,BMI,手术时间和手术时间是SSI微生物组成的关键预测因素,不管手术类型如何,证明患者依赖性因素与SSIs发病机制的相关性。
    局部感染是手术后常见的问题。已经确定了手术感染的危险因素,但是尚不清楚哪些因素可以预测此类感染中发现的微生物类型。本研究的目的是评估影响手术感染中微生物组成的患者因素。使用标准统计学和机器学习方法分析了538893名患者的数据。结果表明,年龄,BMI,手术时间对确定手术部位感染中的细菌很重要。随着年龄的增长,更长的操作,较低的BMI,在手术部位发现了更多来自肠道的细菌,与来自皮肤的细菌相反。这些知识可能有助于为将来接受手术的患者开发更个性化的治疗方法。
    BACKGROUND: Although the impact of surgery- and patient-dependent factors on surgical-site infections (SSIs) have been studied extensively, their influence on the microbial composition of SSI remains unexplored. The aim of this study was to identify patient-dependent predictors of the microbial composition of SSIs across different types of surgery.
    METHODS: This retrospective cohort study included 538 893 patients from the Swiss national infection surveillance programme. Multilabel classification methods, adaptive boosting and Gaussian Naive Bayes were employed to identify predictors of the microbial composition of SSIs using 20 features, including sex, age, BMI, duration of surgery, type of surgery, and surgical antimicrobial prophylaxis.
    RESULTS: Overall, SSIs were recorded in 18 642 patients (3.8%) and, of these, 10 632 had microbiological wound swabs available. The most common pathogens identified in SSIs were Enterobacterales (57%), Staphylococcus spp. (31%), and Enterococcus spp. (28%). Age (mean feature importance 0.260, 95% c.i. 0.209 to 0.309), BMI (0.224, 0.177 to 0.271), and duration of surgery (0.221, 0.180 to 0.269) were strong and independent predictors of the microbial composition of SSIs. Increasing age and duration of surgical procedure as well as decreasing BMI were associated with a shift from Staphylococcus spp. to Enterobacterales and Enterococcus spp. An online application of the machine learning model is available for validation in other healthcare systems.
    CONCLUSIONS: Age, BMI, and duration of surgery were key predictors of the microbial composition of SSI, irrespective of the type of surgery, demonstrating the relevance of patient-dependent factors to the pathogenesis of SSIs.
    Local infections are a frequent problem after surgery. The risk factors for surgical infections have been identified, but it is unclear which factors predict the type of microorganisms found in such infections. The aim of the present study was to assess patient factors affecting the composition of microorganisms in surgical infections. Data from 538 893 patients were analysed using standard statistics and machine learning methods. The results showed that age, BMI, and the duration of surgery were important in determining the bacteria found in the surgical-site infections. With increasing age, longer operations, and lower BMI, more bacteria stemming from the intestine were found in the surgical site, as opposed to bacteria from the skin. This knowledge may help in developing more personalized treatments for patients undergoing surgery in the future.
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  • 文章类型: Journal Article
    背景:手术部位感染(SSI)的特征是发生在手术切口部位的感染,器官或腔在术后期间。坚持外科抗菌药物预防(SAP)对于减轻SSIs的发生至关重要。在这项研究中,我们的目的是根据美国卫生系统药剂师协会(ASHP)指南,评估在普外科领域接受外科手术的患者中使用SAP的适当性,并确定培训前(TP前)和根据该指南组织的培训后(TP后)之间的差异.
    方法:这是2022年1月至2023年5月在普外科病房进行的一项单中心前瞻性研究,TP前患者404例,TP后患者406例。
    结果:头孢唑林成为SAP的主要药物,在86.8%(703/810)的病例中受益。适当的头孢唑啉剂量从TP前的41%(129例)显着增加到TP后的92.6%(276例)(p<0.001),同时,患者对推荐给药时间的依从性从42.2%(133例)上升至62.8%(187例)(p<0.001).住院期间接受抗生素治疗的患者比例在术后TP降低(21-14.3%;p=0.012),出院时的抗生素处方也是如此(16.8-10.3%;p=0.008)。SSI的发生率从TP前的9.9%略微增加到TP后的13.3%(p=0.131)。
    结论:外科医生的常规培训课程成为优化患者护理和提高SAP依从率的重要策略。特别是考虑到外科团队面临的临床责任负担。
    BACKGROUND: Surgical site infections (SSI) are characterized by infections occurring in the surgical incision site, organ or cavity in the postoperative period. Adherence to surgical antimicrobial prophylaxis (SAP) is paramount in mitigating the occurrence of SSIs. In this study, we aimed to evaluate the appropriateness of SAP use in patients undergoing surgical procedures in the field of general surgery according to the American Society of Health-System Pharmacists (ASHP) guideline and to determine the difference between the pre-training period (pre-TP) and the post-training period (post-TP) organized according to this guideline.
    METHODS: It is a single-center prospective study conducted in general surgery wards between January 2022 and May 2023, with 404 patients pre-TP and 406 patients post-TP.
    RESULTS: Cefazolin emerged as the predominant agent for SAP, favored in 86.8% (703/810) of cases. Appropriate cefazolin dosage increased significantly from 41% (129 patients) in pre-TP to 92.6% (276 patients) in post-TP (p < 0.001), along with a rise in adherence to recommended timing of administration from 42.2% (133 patients) to 62.8% (187 patients) (p < 0.001). The proportion of patients receiving antibiotics during hospitalization in the ward postoperatively decreased post-TP (21-14.3%; p = 0.012), as did antibiotic prescription at discharge (16.8-10.3%; p = 0.008). The incidence of SSI showed a slight increase from 9.9% in pre-TP to 13.3% in post-TP (p = 0.131).
    CONCLUSIONS: Routine training sessions for surgeons emerged as crucial strategies to optimize patient care and enhance SAP compliance rates, particularly given the burden of clinical responsibilities faced by surgical teams.
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  • 文章类型: Journal Article
    目的:在使用肠道准备来减少结肠手术后的手术部位感染(SSI)方面存在明显的实践差异。虽然静脉注射抗生素+机械肠道准备+口服抗生素(IVA+MBP+OA)已被证明优于IVA+MBP和IVA,来自随机对照试验(RCT)的高质量数据不足以直接比较这些选项.这是一个重要的问题,因为如果IVA+OA与IVA+MBP+OA有相似的效果,机械肠道准备可以安全地省略,并避免了相关的副作用。这项工作的目的是比较选择性结肠手术的IVAOAMBP(MBP)和IVAOA(OA)后的SSI率。
    方法:这是一个多中心,平行,双臂,非劣效性RCT比较IVA+OA+MBP与IVA+OA。主要结果是手术后30天的整体SSI发生率。次要结果是住院时间和30天急诊室就诊和再入院率。计划的样本量为1062名受试者,其中有四个参与的高容量中心。将使用一般线性模型比较治疗组之间的手术后30天的总体SSI率。次要结果将通过线性回归分析连续结果,二元结果的逻辑回归和计数数据的修正泊松回归。
    结论:预计IVA+OA的工作方式与IVA+MBP+OA相似,这项工作将提供明确的证据表明MBP对于降低SSI不是必需的。这与患者和医生高度相关,因为它将有可能显着改变加拿大及其他地区结肠手术后的实践和结果。
    OBJECTIVE: There is significant practice variation with respect to the use of bowel preparation to reduce surgical site infection (SSI) following colon surgery. Although intravenous antibiotics + mechanical bowel preparation + oral antibiotics (IVA + MBP + OA) has been shown to be superior to IVA + MBP and IVA, there are insufficient high-quality data from randomized controlled trails (RCTs) that directly compare these options. This is an important question, because if IVA + OA has similar effectiveness to IVA + MBP + OA, mechanical bowel preparation can be safely omitted, and the associated side effects avoided. The aim of this work is to compare rates of SSI following IVA + OA + MBP (MBP) versus IVA + OA (OA) for elective colon surgery.
    METHODS: This is a multicentre, parallel, two-arm, noninferiority RCT comparing IVA + OA + MBP versus IVA + OA. The primary outcome is the overall rate of SSI 30 days following surgery. Secondary outcomes are length of stay and 30-day emergency room visit and readmission rates. The planned sample size is 1062 subjects with four participating high-volume centres. Overall SSI rates 30 days following surgery between the treatment groups will be compared using a general linear model. Secondary outcomes will be analysed with linear regression for continuous outcomes, logistic regression for binary outcomes and modified Poisson regression for count data.
    CONCLUSIONS: It is expected that IVA + OA will work similarly to IVA + MBP + OA and that this work will provide definitive evidence showing that MBP is not necessary to reduce SSI. This is highly relevant to both patients and physicians as it will have the potential to significantly change practice and outcomes following colon surgery in Canada and beyond.
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  • 文章类型: Journal Article
    本研究旨在评估磷霉素氨丁胺醇的新预防方案在接受选择性HoLEP(前列腺钬激光摘除术)或TURP(经尿道前列腺电切术)治疗良性前列腺增生的患者中的疗效。在2022年2月至2023年6月期间,受良性前列腺增生影响并接受选择性HoLEP或TURP手术的患者被前瞻性纳入。在第-1天晚上8.00分12小时给药两次3g口服磷霉素氨丁三醇剂量(即,HoLEP或TURP手术前一天)和第0天上午8点(即,手术当天)。评估了以下结果:在外科手术后的前48小时内发生的发烧患病率;外科手术后发生的泌尿系统并发症的患病率;术后14天的经证实的尿路感染(UTI)和/或血流感染(BSIs)的患病率;以及术后14天的UTI相关败血症急诊入院的患病率。单变量分析比较有和没有经过证实的UTI的患者,BSI,或在手术后14天进行急诊科入院。总的来说,前瞻性纳入96例接受HoLEP(82.3%)或TURP(17.7%)的患者(中位年龄70岁)。早晨服用磷霉素后的手术中值(IQR)时间为226.5分钟(范围为88.5-393.75分钟)。术后48h发热发生率为3/96(3.1%)。经证实的UTI在14天时的患病率低至1.0%(1/96),而在第14天没有患者被证实为BSI或UTI相关脓毒症,需要急诊入院.我们的发现支持以下观点:在手术干预前12小时间隔使用两种剂量的磷霉素氨丁三醇的预防方案可能是预防接受HoLEP或TURP的泌尿外科患者感染并发症的有价值的策略。有必要进行更大规模的确定性验证性研究。
    This study aimed to assess the efficacy of a novel prophylactic scheme of fosfomycin trometamol in patients undergoing elective HoLEP (holmium laser enucleation of the prostate) or TURP (transurethral resection of the prostate) procedures for treating benign prostatic hyperplasia. Patients affected by benign prostatic hyperplasia and undergoing elective HoLEP or TURP procedures during the period February 2022-June 2023 were prospectively enrolled. Two 3 g oral fosfomycin trometamol doses 12 h apart were administered at 8.00 p.m. on day -1 (i.e., the day before HoLEP or TURP procedure) and at 8.00 a.m. on day 0 (i.e., the day of the surgical procedure). The following outcomes were assessed: prevalence of fever occurring in the first 48 h after surgical procedure; prevalence of urological complications occurring after the surgical procedure; prevalence of proven urinary tract infections (UTIs) and/or bloodstream infections (BSIs) at 14 days post-procedure; and prevalence of emergency department admission for UTI-related sepsis at 14 days post-procedure. Univariate analysis comparing patients with and without proven UTI, BSI, or emergency department admission at 14 days post-procedure was carried out. Overall, 96 patients (median age 70 years) undergoing HoLEP (82.3%) or TURP (17.7%) were prospectively included. Median (IQR) time of surgical procedure after the morning fosfomycin dose was 226.5 min (range 88.5-393.75 min). Fever in the post-surgical 48 h occurred in 3/96 patients (3.1%). Prevalence of proven UTI at 14 days was as low as 1.0% (1/96), whereas no patient had proven BSI or UTI-related sepsis requiring emergency department admission at 14 days. Our findings support the contention that a prophylactic scheme based on two doses of fosfomycin trometamol 12 h apart before surgical intervention may represent a valuable strategy for preventing infectious complications in urologic patients undergoing HoLEP or TURP. Larger definitive confirmatory studies are warranted.
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  • 文章类型: Journal Article
    假体周围感染(PJIs)的最常见原因是术中污染;因此,抗生素预防在预防中起着至关重要的作用。如果对当前方案具有高抗性的微生物发生率,则可以考虑对标准预防进行修改。迄今为止,很少有关于微生物病因学的研究在意大利发表。在这个单一中心,在米兰的IRCCSOspedaleGaleazzi-Sant\'Ambrogio进行的回顾性研究,我们分析了臀部,膝盖,2021年1月1日17日至12月31日期间接受首次植入的患者的肩部PJIs。主要目的是得出当地的微生物病例史。次要目的是评估术前抗生素预防与已鉴定细菌有关的充分性。共鉴定出57种PJIs和65种病原体:16种金黄色葡萄球菌,15表皮葡萄球菌,和10个其他凝固酶阴性葡萄球菌(CoNS),占隔离的63%。共有86.7%的表皮葡萄球菌耐甲氧西林(MRSE)。根据其他病例报告,我们发现葡萄球菌感染占主导地位,MRSA的比例低于意大利平均水平,而我们发现了很高比例的MRSE.我们估计分离出的细菌中有44.6%对头孢唑啉具有抗性,我们的标准预防措施.这些PJI可以通过单独使用糖肽或与头孢唑林联合使用来预防,但是文献报道了关于这种预防的充分性的相互矛盾的结果.总之,我们的研究表明,在我们当地的医院,我们的标准抗生素预防对几乎一半的病例无效,强调根据每个机构的当地细菌流行情况定义特定抗生素指南的重要性。
    The most frequent cause of periprosthetic infections (PJIs) is intraoperative contamination; hence, antibiotic prophylaxis plays a crucial role in prevention. Modifications to standard prophylaxis can be considered if there is a high incidence of microorganisms resistant to current protocols. To date, very few studies regarding microbial etiology have been published in Italy. In this single-center, retrospective study conducted at IRCCS Ospedale Galeazzi-Sant\'Ambrogio in Milan, we analyzed hip, knee, and shoulder PJIs in patients undergoing first implantation between 1 January 17 and 31 December 2021. The primary aim was to derive a local microbiological case history. The secondary aim was to evaluate the adequacy of preoperative antibiotic prophylaxis in relation to the identified bacteria. A total of 57 PJIs and 65 pathogens were identified: 16 S. aureus, 15 S. epidermidis, and 10 other coagulase-negative staphylococci (CoNS), which accounted for 63% of the isolations. A total of 86.7% of S. epidermidis were methicillin-resistant (MRSE). In line with other case reports, we found a predominance of staphylococcal infections, with a lower percentage of MRSA than the Italian average, while we found a high percentage of MRSE. We estimated that 44.6% of the bacteria isolated were resistant to cefazolin, our standard prophylaxis. These PJIs could be prevented by using glycopeptide alone or in combination with cefazolin, but the literature reports conflicting results regarding the adequacy of such prophylaxis. In conclusion, our study showed that in our local hospital, our standard antibiotic prophylaxis is ineffective for almost half of the cases, highlighting the importance of defining specific antibiotic guidelines based on the local bacterial prevalence of each institution.
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  • 文章类型: Journal Article
    背景:全膝关节置换术(TKA)后假体周围感染(PJI)是一种毁灭性的并发症。在脊柱手术中,已证明吸入万古霉素粉末可降低感染率,但其在关节置换术中的作用仍存在争议。这项前瞻性随机对照试验旨在评估感内万古霉素预防原发性TKA后PJI的疗效。
    方法:共有1,022名患者被随机分为研究组(n=507,在关节切开术闭合前接受2克伤口内万古霉素粉末)或对照组(n=515,无局部万古霉素),最少随访12个月。主要结果是PJI或手术部位感染(SSI)的发生率。次要结果包括相关的轻微并发症,如缝合脓肿,持续性伤口引流,和延迟拆线。评估的其他参数包括再手术率和肾毒性发生率。
    结果:1,022例患者的总感染率为0.66%。研究组(N=1;0.2%)与对照组(N=3;0.58%)的PJI率无显著差异,P=.264。研究组(N=4;0.78%)和对照组(N=5;0.97%)的再手术率,研究组(N=1;0.2%)和对照组(N=2;0.38%)的SSI发生率相当.万古霉素队列,然而,与对照组(n=39;7.56%,P<0.05)。亚组分析显示,研究组中糖尿病患者的轻微伤口并发症发生率也较高(24[14.1%]对10[6.2%];P<05]。多变量分析发现,使用万古霉素(比值比=1.64)和吸烟(比值比=1.85)与发生轻微伤口并发症的风险增加相关。未报告肾毒性病例。
    结论:吸入万古霉素粉剂似乎不会降低原发性全膝关节置换术中的PJI/SSI率,包括高危人群。虽然从肾脏的角度来看是安全的,万古霉素与术后无菌伤口并发症的增加有关。吸入万古霉素可能不能有效降低原发性TKA中PJI的发生率。
    BACKGROUND: Periprosthetic joint infection (PJI) after total knee arthroplasty (TKA) is a devastating complication. Intrawound vancomycin powder has been shown to reduce infection rates in spine surgery, but its role in arthroplasty remains controversial. This prospective randomized control trial aimed to evaluate the efficacy of intrawound vancomycin in preventing PJI after primary TKA.
    METHODS: A total of 1,022 patients were randomized to the study group (n = 507, who received 2 grams intrawound vancomycin powder before arthrotomy closure) or to the control group (n = 515, no local vancomycin) with a minimum follow-up of 12-months. The primary outcome was the incidence of PJI or surgical site infection (SSI). Secondary outcomes included associated minor complications such as stitch abscess, persistent wound drainage, and delayed stitch removal. Other parameters evaluated include reoperation rates and incidences of nephrotoxicity.
    RESULTS: The overall infection rate in 1,022 patients was 0.66%. There was no significant difference in PJI rate in the study group (N = 1; 0.2%) versus the control group (N = 3; 0.58%), P = .264. Reoperation rates in the study group (N = 4; 0.78%) and control (N = 5; 0.97%), and SSI rates in the study (N = 1; 0.2%) and control groups (N = 2; 0.38%) were comparable. The Vancomycin cohort, however, demonstrated a significantly higher number of minor wound complications (n = 67; 13.2%) compared to the control group (n = 39; 7.56%, P < .05). Subgroup analysis showed diabetics in the study group to also have a higher incidence of minor wound complications (24 [14.1%] versus 10 [6.2%]; P < 05]. Multivariate analyses found that vancomycin use (odds ratio = 1.64) and smoking (odds ratio = 1.85) were associated with an increased risk of developing minor wound complications. No cases of nephrotoxicity were reported.
    CONCLUSIONS: Intrawound vancomycin powder does not appear to reduce PJI/SSI rate in primary total knee arthroplasties, including high-risk groups. Although safe from a renal perspective, intrawound vancomycin was associated with an increase in postoperative aseptic wound complications. Intrawound vancomycin may not be effective in reducing the rate of PJI in primary TKA.
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  • 文章类型: Journal Article
    背景:由于人工关节感染(PJI)导致的两阶段交换后,新的假体有很高的再感染风险(RePJI).关于第二阶段手术中的抗生素预防没有确凿的证据。这项研究的目的是描述该手术中使用的抗生素预防方法,并评估其对发展RePJI风险的影响。
    方法:西班牙医院的回顾性多中心病例对照研究。该研究包括接受两阶段交换治疗的PJI病例,随后出现了新的感染。对于每种情况,包括两个对照,与假体位置相匹配,中心,和手术年份。预防方案根据其抗菌谱进行分组,我们使用条件逻辑回归计算了方案类型与RePJI发展之间的关联,针对可能的混杂因素进行了调整。
    结果:我们包括来自12个中心的90例病例,与172个对照进行比较。最常见的致病微生物是表皮葡萄球菌,占34例(37.8%)。葡萄球菌50例(55.6%),其中32(64%)耐甲氧西林。革兰阴性杆菌30例(33.3%),最常见的铜绿假单胞菌。总的来说,83种不同的抗生素预防方案用于第二阶段手术,最常见的单剂量的头孢唑林(48次;18.3%);然而,最常见的是糖肽和β-内酰胺的组合,具有抗假单胞菌的活性(99例,25.2%)。在调整后的分析中,包括具有耐甲氧西林葡萄球菌和假单胞菌活性的抗生素的治疗方案与RePJI的风险显著降低相关(校正OR=0.24;95%IC:0.09-0.65).
    结论:第2次手术预防缺乏标准化解释了该手术中使用的方案的多样性。结果表明,该手术中的抗生素预防应包括具有耐甲氧西林葡萄球菌和假单胞菌活性的抗生素。
    BACKGROUND: After two-stage exchange due to prosthetic joint infection (PJI), the new prosthesis carries a high risk of reinfection (RePJI). There isn`t solid evidence regarding the antibiotic prophylaxis in 2nd-stage surgery. The objective of this study is to describe what antibiotic prophylaxis is used in this surgery and evaluate its impact on the risk of developing RePJI.
    METHODS: Retrospective multicenter case-control study in Spanish hospitals. The study included cases of PJI treated with two-stage exchange and subsequently developed a new infection. For each case, two controls were included, matched by prosthesis location, center, and year of surgery. The prophylaxis regimens were grouped based on their antibacterial spectrum, and we calculated the association between the type of regimen and the development of RePJI using conditional logistic regression, adjusted for possible confounding factors.
    RESULTS: We included 90 cases from 12 centers, which were compared with 172 controls. The most frequent causative microorganism was Staphylococcus epidermidis with 34 cases (37.8%). Staphylococci were responsible for 50 cases (55.6%), 32 of them (64%) methicillin-resistant. Gram-negative bacilli were involved in 30 cases (33.3%), the most common Pseudomonas aeruginosa. In total, 83 different antibiotic prophylaxis regimens were used in 2nd-stage surgery, the most frequent a single preoperative dose of cefazolin (48 occasions; 18.3%); however, it was most common a combination of a glycopeptide and a beta-lactam with activity against Pseudomonas spp (99 cases, 25.2%). In the adjusted analysis, regimens that included antibiotics with activity against methicillin-resistant staphylococci AND Pseudomonas spp were associated with a significantly lower risk of RePJI (adjusted OR = 0.24; 95% IC: 0.09-0.65).
    CONCLUSIONS: The lack of standardization in 2nd-satge surgery prophylaxis explains the wide diversity of regimens used in this procedure. The results suggest that antibiotic prophylaxis in this surgery should include an antibiotic with activity against methicillin-resistant staphylococci and Pseudomonas.
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  • 文章类型: Journal Article
    背景:作为下腰痛(LBP)原因的细菌感染和Modic变化(MC)存在争议。两项随机对照试验的结果不同,该试验研究了含和不含克拉维酸的阿莫西林与安慰剂对慢性LBP(cLBP)和MC患者的影响。以前的活检研究在方法上受到批评,很少有病人和对照组,和措施不足以减少围手术期污染。在这项研究中,我们将污染风险降至最低,包括一个控制组,并优化统计能力。主要目的是比较有和没有MC的患者之间的细菌生长。
    方法:这个多中心,病例对照研究检查cLBP患者的椎间盘和椎体活检。病例有组织取样水平的MC,控件没有。以前手术的患者作为一个亚组。在抗生素预防之前用单独的仪器对组织取样。我们将在活检中应用微生物学方法和组织学,并为显著的细菌生长预定标准,可能的污染和没有增长。微生物学家,外科医生和病理学家对病例或对照的分配视而不见。初级分析分别评估MC1相对于对照和MC2相对于对照的显著生长。先前手术患者的细菌椎间盘生长,融合组中患有大MC和椎体生长的患者都被认为是探索性分析.
    背景:挪威医疗和健康研究伦理区域委员会(REC东南部,参考编号2015/697)已批准该研究。参与研究需要书面知情同意书。该研究在ClinicalTrials.gov(NCT03406624)注册。结果将在同行评审的期刊上传播,科学会议和耐心论坛。
    背景:NCT03406624。
    BACKGROUND: Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.
    METHODS: This multicentre, case-control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.
    BACKGROUND: The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.
    BACKGROUND: NCT03406624.
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  • 文章类型: Journal Article
    目的:评估与抗生素预防治疗复发性尿路感染的成本效益。
    方法:多中心,开放标签,随机化,非自卑审判。
    方法:英国的八个中心,2016年6月至2018年6月招募。
    方法:年龄≥18岁的女性反复尿路感染,需要预防性治疗。
    方法:女性被随机分配接受每日一次抗生素预防或每日两次马尿酸甲胺预防,为期12个月。治疗分配没有被掩盖,并且允许手臂之间的交叉。
    方法:主要经济结果是18个月时每质量调整生命年(QALY)的增量成本。所有费用都是从英国国家卫生服务的角度收集的。QALY是根据对基线时施用的EQ-5D-5L的反应进行估计的,3、6、9、12和18个月。增量成本和QALY是使用调整后的分析估算的,该分析控制了观察到的和未观察到的特征。随机敏感性分析用于说明成本效益平面和成本效益可接受性曲线上的不确定性。敏感性分析,协议中未指定,考虑到与抗生素耐药性相关的成本。
    结果:经济分析中包括了205名参与者的数据。平均而言,与抗生素预防相比,马尿酸亚甲基胺的成本更低(-40英镑;95%CI:-684至603),更有效(0.014QALYs;95%CI:-0.05至0.07)。在为附加QALY考虑的值范围内,马尿酸亚甲基胺被认为具有成本效益的概率为51%~67%.
    结论:平均而言,与抗生素预防相比,马尿酸甲胺成本更低,更有效,但这些结果存在不确定性。当分析中包括减少抗生素使用的益处时,马尿酸甲胺更有可能被认为具有成本效益。
    背景:ISRCTN70219762。
    OBJECTIVE: To estimate the cost-effectiveness of methenamine hippurate compared with antibiotic prophylaxis in the management of recurrent urinary tract infections.
    METHODS: Multicentre, open-label, randomised, non-inferiority trial.
    METHODS: Eight centres in the UK, recruiting from June 2016 to June 2018.
    METHODS: Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment.
    METHODS: Women were randomised to receive once-daily antibiotic prophylaxis or twice-daily methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed.
    METHODS: The primary economic outcome was the incremental cost per quality-adjusted life year (QALY) gained at 18 months. All costs were collected from a UK National Health Service perspective. QALYs were estimated based on responses to the EQ-5D-5L administered at baseline, 3, 6, 9, 12 and 18 months. Incremental costs and QALYs were estimated using an adjusted analysis which controlled for observed and unobserved characteristics. Stochastic sensitivity analysis was used to illustrate uncertainty on a cost-effectiveness plane and a cost-effectiveness acceptability curve. A sensitivity analysis, not specified in the protocol, considered the costs associated with antibiotic resistance.
    RESULTS: Data on 205 participants were included in the economic analysis. On average, methenamine hippurate was less costly (-£40; 95% CI: -684 to 603) and more effective (0.014 QALYs; 95% CI: -0.05 to 0.07) than antibiotic prophylaxis. Over the range of values considered for an additional QALY, the probability of methenamine hippurate being considered cost-effective ranged from 51% to 67%.
    CONCLUSIONS: On average, methenamine hippurate was less costly and more effective than antibiotic prophylaxis but these results are subject to uncertainty. Methenamine hippurate is more likely to be considered cost-effective when the benefits of reduced antibiotic use were included in the analysis.
    BACKGROUND: ISRCTN70219762.
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