Pub Date : 2024-12-12DOI: 10.1002/14651858.CD015397.pub2
Hannah Littlecott, Shari Krishnaratne, Julia Hummel, Ester Orban, Torben Heinsohn, Anna H Noel-Storr, Brigitte Strahwald, Caroline Jung-Sievers, Ulrike Ravens-Sieberer, Eva Rehfuess
<p><strong>Background: </strong>Throughout the COVID-19 pandemic, schools were a key setting for intervening with public health and social measures (PHSM) to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Consequently, there is a need to assess the varied unintended consequences associated with PHSM implemented in the school setting, for students, teachers, and school staff, as well as for families and the wider community. This is an update of a Cochrane scoping review first published in 2022.</p><p><strong>Objectives: </strong>To comprehensively identify and summarise the published literature on the unintended consequences of public health and social measures implemented in the school setting to reduce the spread of SARS-CoV-2. This will serve to identify critical knowledge gaps to inform future primary research and systematic reviews. It may also serve as a resource for future pandemic management.</p><p><strong>Search methods: </strong>We searched MEDLINE, Embase, CENTRAL, PsycINFO, ERIC, and Web of Science on 5 and 6 January 2023. We also searched two COVID-19-specific databases (Cochrane COVID-19 Study Register and WHO COVID-19 Global literature on coronavirus disease). Finally, we reviewed the included studies of all relevant systematic reviews and guidelines identified through the searches.</p><p><strong>Selection criteria: </strong>We included studies that empirically assessed the impact of PHSM implemented in the school setting to reduce the spread of SARS-CoV-2. We imposed no restrictions with regard to the types of populations and specific interventions. Outcomes of interest were consequences that were measured or experienced, but not anticipated consequences. This review focused on real-world evidence: empirical quantitative, qualitative, and mixed-method studies were eligible for inclusion, but modelling studies were ineligible.</p><p><strong>Data collection and analysis: </strong>The review was guided by a logic model. In line with the latest Cochrane effectiveness review of school measures to contain COVID-19 and a conceptual framework of PHSM, this logic model distinguishes between measures to make contacts safer (related to individual protection and the physical environment), measures to reduce contacts (related to social interactions, movement, and services) and surveillance and response measures. Unintended consequences comprise the following categories: health and well-being, health system and social welfare services, human and fundamental rights, acceptability and adherence, equality and equity, social and institutional, economic and resource, and ecological. The review team screened all titles and abstracts, then potentially eligible full-text articles, in duplicate. Across the included studies, we summarised and presented types of measures, consequences, and study designs using the predefined categories of the logic model, while allowing for emerging categories.</p><p><strong>Main result
背景:在2019冠状病毒病(COVID-19)大流行期间,学校是干预公共卫生和社会措施(PHSM)以减少严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)传播的关键场所。因此,有必要评估在学校环境中实施初级卫生保健对学生、教师和学校工作人员以及家庭和更广泛的社区产生的各种意想不到的后果。这是对2022年首次发表的Cochrane范围综述的更新。目的:全面识别和总结关于在学校环境中实施公共卫生和社会措施以减少SARS-CoV-2传播的意外后果的已发表文献。这将有助于确定关键的知识差距,为未来的初步研究和系统评价提供信息。它还可作为未来大流行管理的一种资源。检索方法:我们在2023年1月5日和6日检索了MEDLINE, Embase, CENTRAL, PsycINFO, ERIC和Web of Science。我们还检索了两个COVID-19特异性数据库(Cochrane COVID-19 Study Register和WHO COVID-19全球关于冠状病毒疾病的文献)。最后,我们回顾了通过检索确定的所有相关系统评价和指南的纳入研究。选择标准:我们纳入了经验评估在学校环境中实施PHSM对减少SARS-CoV-2传播的影响的研究。我们没有对人群类型和具体干预措施加以限制。感兴趣的结果是测量或体验的结果,而不是预期的结果。本综述侧重于真实世界的证据:经验定量、定性和混合方法研究符合纳入条件,但模型研究不符合纳入条件。数据收集和分析:审查由逻辑模型指导。根据最新的Cochrane对学校控制COVID-19措施的有效性评估和PHSM的概念框架,该逻辑模型区分了使接触更安全的措施(与个人保护和物理环境有关)、减少接触的措施(与社会互动、运动和服务有关)以及监测和应对措施。意外后果包括以下类别:健康和福祉、卫生系统和社会福利服务、人权和基本权利、可接受性和遵守性、平等和公平、社会和体制、经济和资源以及生态。审查小组筛选了所有标题和摘要,然后是可能符合条件的全文文章,一式两份。在纳入的研究中,我们使用逻辑模型的预定义类别总结并呈现了测量、结果和研究设计的类型,同时允许出现类别。主要结果:我们纳入了来自25个国家的60项研究(57项是本次更新的新研究)。31项定量研究,17项定性研究,12项混合方法研究。大多数针对学生(26项研究)、教师和学校工作人员(11项研究)或学生和学校工作人员(12项研究)。其他研究则评估了针对家长(2项研究)、员工和家长(1项研究)、学生和教师(3项研究)或全校(5项研究)的措施。这些措施与个人保护(26项研究)、物理环境(20项研究)、社会互动(25项研究)、服务(1项研究)、运动(3项研究)、监测(9项研究)和反应(7项研究)有关。9项研究评估了多种措施的综合效果。评估的主要后果来自健康和福祉(29项研究)、可接受性和依从性(31项研究)以及社会和机构(23项研究)。较少的研究涵盖了平等和公平(2项研究)、经济和资源(7项研究)和生态(1项研究)类别的结果。没有研究审查对卫生系统和社会福利服务或对人权和基本权利的影响。作者的结论:本范围审查概述了在学校环境中实施PHSM以减少SARS-CoV-2传播的意外后果的证据。纳入的60项研究描述了广泛的证据,涵盖了一系列措施和意想不到的后果,主要是对健康和福祉的后果、可接受性和依从性、社会和体制方面以及经济方面。确定的主要差距涉及学校措施对卫生系统和社会福利服务、人权和基本权利、平等和公平以及环境的影响。需要进一步的研究来填补这些空白,利用不同的方法方法。未来的研究应该更深入、更长期、在不同的人口群体和不同的背景下探索意想不到的后果——无论是有益的还是有害的。 一个更有力的证据基础可以为是否、如何以及何时在学校环境中实施或终止COVID-19风险缓解措施以及如何应对负面的意外后果提供信息和促进决策。资助:本出版物部分由德国联邦教育和研究部(BMBF)在大学医学网络(NUM) 1.0中资助,在项目CEOsys的背景下资助No. 01KX2021,以及NUM 2.0,在项目PREPARED和coverCHILD的背景下资助No. 01KX2121。注册:协议在开放科学框架(osf.io/bsxh8)上注册。之前的综述发表在Cochrane图书馆(10.1002/14651858.CD015397)。
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Pub Date : 2024-12-10DOI: 10.1002/14651858.CD014439
Sharika Raga, Nicol Voermans, Ivan Perez-Neri, Jim Dowling, Heinz Jungbluth, Giovanni Baranello, Laurent Servais, Alice Tillema, Jo Wilmshurst
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Primary objective To analyse the benefits and harms of pharmacological or other interventions (e.g. special diet, exercise programme) compared with placebo or standard care for RYR1-related disorders, including both permanent myopathies and intermittent (episodic) presentations (exertional myalgia and rhabdomyolysis), with the aim to improve motor and respiratory function and/or to reduce the frequency of episodes, respectively. Secondary objectives To assess whether the interventions, compared with placebo or standard of care, change the outcome of RYR1-related diseases. To assess whether the interventions, compared with placebo or usual care, change the expression of the disease state in patients with RYR1-related diseases. To identify a set of standardised outcome tools to be used in future studies.
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Pub Date : 2024-12-09DOI: 10.1002/14651858.CD016136
Lily Nicholson, Emma Axon, Jahnavi Daru, Ewelina Rogozińska
<p><strong>Rationale: </strong>Intravenous iron is increasingly used to treat iron-deficient anaemia (IDA) in pregnancy. A previous network meta-analysis suggested that intravenous irons have a greater effect on haematological parameters than oral irons; however, the impact on serious pregnancy complications such as postpartum haemorrhage (PPH) or the need for blood transfusion was unclear. Since then, several new randomised controlled trials (RCTs) have been conducted.</p><p><strong>Objectives: </strong>To evaluate the effect and safety of intravenous versus oral iron preparations for treating IDA in pregnancy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, and two trial registries (ClinicalTrials.gov and the WHO ICTRP) for eligible studies. The latest search was performed on 19 March 2024.</p><p><strong>Eligibility criteria: </strong>We included RCTs in pregnant women with confirmed IDA (haemoglobin (Hb) level < 11 g/dL as per World Health Organization (WHO) criteria) comparing intravenous (iron sucrose, ferric carboxymaltose, ferric derisomaltose, ferumoxytol) and oral (ferrous sulfate, ferrous fumarate, ferrous gluconate) iron preparations.</p><p><strong>Outcomes: </strong>Our outcomes were antenatal and postnatal Hb levels, antenatal and postnatal anaemia status, PPH, blood transfusion, maternal satisfaction, maternal well-being, breastfeeding, maternal mortality, maternal morbidity, and adverse events (AEs).</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 1 tool to assess risk of bias in the included RCTs.</p><p><strong>Synthesis methods: </strong>We followed standard Cochrane methods. Two review authors independently assessed studies for eligibility and scientific rigour, evaluated the risk of bias of included studies, and extracted data. Where appropriate, we pooled data using a fixed-effect model in the first instance. We reported dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous data as mean differences (MDs) with 95% CIs. We assessed the certainty of the evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included 13 RCTs (3939 participants) mainly conducted in India and Africa (8/13). Gestational age at baseline ranged from 13 to 37 weeks, and Hb levels ranged from 5.0 to just below 11.0 g/dL. The most frequently compared preparations were intravenous iron sucrose versus oral ferrous sulfate (5/13). Most RCTs were at low risk of bias, and the certainty of evidence ranged from moderate to very low, mainly due to concerns over attrition bias, imprecision, and inconsistency.</p><p><strong>Synthesis of results: </strong>Antenatal outcomes Compared with oral iron, intravenous iron likely slightly increases Hb level three to six weeks after treatment start (MD 0.49, 95% CI 0.28 to 0.69; 11 RCTs; 2935 participants; moderate-certainty evidence) and likely reduces anaemia status three to six weeks after treatment start (RR 0.81, 95% CI
理由:静脉注射铁越来越多地用于治疗妊娠缺铁性贫血(IDA)。先前的网络荟萃分析表明,静脉铁比口服铁对血液学参数的影响更大;然而,对严重的妊娠并发症,如产后出血(PPH)或需要输血的影响尚不清楚。从那时起,进行了几项新的随机对照试验(rct)。目的:评价静脉注射与口服铁制剂治疗妊娠期IDA的疗效和安全性。检索方法:我们检索了CENTRAL、MEDLINE、Embase和两个试验注册中心(ClinicalTrials.gov和WHO ICTRP)以寻找符合条件的研究。最近一次搜索是在2024年3月19日进行的。资格标准:我们纳入了确诊IDA(血红蛋白(Hb)水平< 11 g/dL,根据世界卫生组织(WHO)标准)的孕妇的随机对照试验,比较静脉注射(蔗糖铁、三羧基麦糖铁、三异麦糖铁、阿魏木糖醇)和口服(硫酸亚铁、富马酸亚铁、葡萄糖酸亚铁)铁制剂。结果:我们的结果是产前和产后Hb水平、产前和产后贫血状态、PPH、输血、孕产妇满意度、孕产妇健康、母乳喂养、孕产妇死亡率、孕产妇发病率和不良事件(ae)。偏倚风险:我们使用Cochrane RoB 1工具评估纳入的随机对照试验的偏倚风险。合成方法:采用标准Cochrane方法。两位综述作者独立评估了研究的合格性和科学严谨性,评估了纳入研究的偏倚风险,并提取了数据。在适当的情况下,我们在第一个实例中使用固定效应模型汇集数据。我们将二分类数据报告为具有95%置信区间(ci)的风险比(RRs),将连续数据报告为具有95% ci的平均差异(md)。我们使用GRADE方法评估证据的确定性。纳入的研究:我们纳入了13项rct(3939名受试者),主要在印度和非洲进行(8/13)。胎龄基线范围为13至37周,Hb水平范围为5.0至11.0 g/dL以下。最常见的比较制剂是静脉注射蔗糖铁和口服硫酸亚铁(5/13)。大多数随机对照试验偏倚风险较低,证据的确定性从中等到非常低,主要是由于对损耗偏倚、不精确和不一致的担忧。与口服铁相比,静脉注射铁可能在治疗开始后3至6周略有增加Hb水平(MD 0.49, 95% CI 0.28至0.69;11个相关;2935名参与者;中等确定性证据)并可能在治疗开始后3至6周降低贫血状态(RR 0.81, 95% CI 0.77至0.86;5相关;2189名参与者;moderate-certainty证据)。与口服铁相比,静脉注射铁可能会轻微增加出生前后的Hb水平(MD 0.55, 95% CI 0.33至0.77;6相关;1574名参与者;中等确定性证据)并可能降低出生前后的贫血状况(RR 0.85, 95% CI 0.77至0.93;4相关的;1240名参与者;moderate-certainty证据)。与口服铁相比,静脉注射铁可轻微提高产后Hb水平(MD 0.54, 95% CI 0.41 ~ 0.68;3相关;1950名参与者;确定性的证据)。它还可能降低贫血状态(RR 0.66, 95% CI 0.59 ~ 0.73;3相关;1950名参与者;低确定性证据)和产后严重贫血(RR 0.16, 95% CI 0.03 ~ 0.84;2相关的;1581名参与者;非常低确定性的证据),尽管后一种结果的证据非常不确定。与口服铁相比,静脉注射铁可能导致PPH几乎没有差异(RR 1.44, 95% CI 0.50至4.20;3相关;2251名参与者;低确定性证据),可能导致输血需求几乎没有差异(RR 0.97, 95% CI 0.58至1.60;6相关;2592名参与者;中等确定性证据)或母乳喂养率(RR 1.04, 95% CI 0.97至1.12;1个随机对照试验;404名参与者;moderate-certainty证据)。没有关于产妇满意度或产妇幸福感的试验报告。与口服铁相比,静脉注射铁可能对孕产妇死亡率几乎没有影响,但证据非常不确定(RR 0.91, 95% CI 0.13 ~ 6.39;4相关的;2152名参与者;非常低确定性证据)。与口服铁相比,静脉注射铁可能不会增加产妇发病率:严重感染(RR 1.01, 95% CI 0.47至2.18;1个随机对照试验;1881名参与者;中等确定性证据)和延长住院时间(RR 0.86, 95% CI 0.62 ~ 1.21;1个随机对照试验;1764名参与者;中等确定性证据),可能不会增加重症监护病房(ICU)的入院率(RR 1.99, 95% CI 0.18 ~ 21.87;2相关的;2069名参与者;确定性的证据)。与口服铁相比,静脉注射铁可能不会增加ae (RR 1.05, 95% CI 0.82 - 1)。 35;1个随机对照试验;349名参与者;中等确定性证据),可能不会增加严重ae (RR 1.25, 95% CI 0.61 - 2.59;1个随机对照试验;1934名参与者;确定性的证据)。然而,在不同的试验中,个别不良事件的报告不一致。作者的结论是:与口服铁相比,静脉注射铁可能会轻微增加血红蛋白水平,并可能减少妊娠期贫血。产后血红蛋白水平可能轻微增加静脉铁,但对产后严重贫血状态的影响非常不确定。静脉注射铁可能导致PPH几乎没有差异,输血率可能不受给药途径的影响。由于不良结果的罕见性和次优报告,综合不良结果证明具有挑战性。静脉注射铁对孕产妇死亡率和ICU入院率的影响非常不确定,在严重感染和延长住院时间方面,两组之间可能几乎没有差异。静脉注射铁可能不会增加ae,也可能不会增加严重ae;然而,这两种情况下95%的ci都有潜在的危害。此外,这一发现应谨慎对待,因为两种类型的铁制剂的不同的不良事件概况。来自正在进行的多中心试验的数据可能会弥补一些已确定的证据空白。然而,显然有必要围绕临床重要的结果测量时间点、其定义的同质性和安全性报告加强研究工作的协调。资助:本Cochrane综述部分由世界卫生组织资助,并由英国医学研究委员会资助。报名:报名(2024):普洛斯彼罗,CRD42024523791,邮箱:www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024523791。
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Pub Date : 2024-12-09DOI: 10.1002/14651858.CD015005.pub2
Ben Ridley, Francesco Nonino, Elisa Baldin, Ilaria Casetta, Gerardo Iuliano, Graziella Filippini
<p><strong>Background: </strong>Multiple sclerosis (MS) is an immune-mediated, chronic, inflammatory demyelinating disease of the central nervous system, impacting around 2.8 million people worldwide. Characterised by recurrent relapses or progression, or both, it represents a substantial global health burden, affecting people, predominantly women, at a young age (the mean age of diagnosis is 32 years). Azathioprine is used to treat chronic inflammatory and autoimmune diseases, and it is used in clinical practice as an off-label intervention for MS, especially where access to on-label disease-modifying treatments (DMTs) for MS is limited. Given this, a review of azathioprine's benefits and harms would be timely and valuable to inform shared healthcare decisions.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of azathioprine (AZA) for relapsing and progressive multiple sclerosis (MS), compared to other disease-modifying treatments (DMTs), placebo or no treatment. Specifically, we will assess the following comparisons. AZA compared with other DMTs or placebo as first-choice treatment for relapsing forms of multiple sclerosis AZA compared with other DMTs or placebo for relapsing forms of MS when switching from another DMT AZA compared with other DMTs or placebo as first-choice treatment for progressive forms of MS AZA compared with other DMTs or placebo for progressive forms of MS when switching from another DMT SEARCH METHODS: We conducted an extensive search for relevant literature using standard Cochrane search methods. The most recent search date was 9 August 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) lasting 12 months or more that compared azathioprine versus DMTs, placebo or no intervention in adults with MS. We considered evidence from non-randomised studies of interventions (NRSIs) as these studies may provide additional evidence not available from RCTS. We excluded cluster-randomised trials, cross-over trials, interrupted time series, case reports and studies of within-group design with no control group.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodology. There were three outcomes we considered to be critical: disability, relapse and serious adverse events (SAEs, as defined in the studies). We were also interested in other important outcomes: quality-of-life (QoL) impairment (mental score), short-term adverse events (gastrointestinal disorders), long-term adverse events (neoplasms) and mortality.</p><p><strong>Main results: </strong>We included 14 studies: eight RCTs (1076 participants included in meta-analyses) and six NRSIs (1029 participants). These studies involved people with relapsing and progressive MS. Most studies included more women (57 to 83%) than men, with participants' average age at the onset of MS being between 29.4 and 33.4 years. Five RCTs and all six NRSIs were conducted in Europe (1793 participants); t
背景:多发性硬化症(MS)是一种免疫介导的中枢神经系统慢性炎症性脱髓鞘疾病,影响全球约280万人。该病的特点是反复发作或进展,或两者兼而有之,是一项重大的全球健康负担,影响人群,主要是妇女,年龄很小(平均诊断年龄为32岁)。硫唑嘌呤用于治疗慢性炎症和自身免疫性疾病,在临床实践中,它被用作MS的标签外干预,特别是在标签上的疾病改善治疗(DMTs)的可及性有限的情况下。鉴于此,对硫唑嘌呤的利弊进行回顾将是及时和有价值的,可以为共同的医疗保健决策提供信息。目的:与其他疾病改善治疗(dmt)、安慰剂或不治疗相比,评估硫唑嘌呤(AZA)治疗复发性和进行性多发性硬化症(MS)的益处和危害。具体来说,我们将评估以下比较。AZA与其他DMT或安慰剂作为多发性硬化症复发型首选治疗的比较:AZA与其他DMT或安慰剂作为多发性硬化症复发型首选治疗的比较:AZA与其他DMT或安慰剂作为进展型多发性硬化症首选治疗的比较:AZA与其他DMT或安慰剂作为进展型多发性硬化症首选治疗的比较:AZA与其他DMT或安慰剂作为进展型多发性硬化症的比较我们使用标准Cochrane检索方法对相关文献进行了广泛的检索。最近一次搜索日期是2023年8月9日。选择标准:我们纳入了持续12个月或更长时间的随机对照试验(RCTs),这些试验比较了硫唑嘌呤与dmt、安慰剂或无干预治疗的成人ms患者。我们考虑了来自非随机干预研究(NRSIs)的证据,因为这些研究可能提供了RCTs无法提供的额外证据。我们排除了集群随机试验、交叉试验、中断时间序列、病例报告和没有对照组的组内设计研究。资料收集与分析:采用标准科克伦方法学。我们认为有三个结局是关键的:残疾、复发和严重不良事件(研究中定义的sae)。我们还对其他重要结果感兴趣:生活质量(QoL)损害(精神评分)、短期不良事件(胃肠道疾病)、长期不良事件(肿瘤)和死亡率。主要结果:我们纳入了14项研究:8项rct(纳入meta分析的1076名受试者)和6项NRSIs(1029名受试者)。这些研究涉及复发性和进展性MS患者,大多数研究的女性(57%至83%)多于男性,参与者发病时的平均年龄在29.4至33.4岁之间。在欧洲进行了5项随机对照试验和全部6项NRSIs(1793名参与者);在美国进行了两项随机对照试验(126名受试者),在伊朗进行了一项随机对照试验(94名受试者)。随机对照试验持续了2到3年,而nri研究则持续了10年。四项研究得到了商业利益的资助或支持,五项研究由政府或慈善机构资助;另外5家没有提供有关资金的信息。目前有三项正在进行的研究。对照组包括其他DMTs(干扰素β和环孢素A),安慰剂或未治疗。下面,我们报道了与干扰素β相比,硫唑嘌呤作为复发性多发性硬化症患者的“首选”治疗方法,没有一项研究报告了进展性多发性硬化症的任何关键或重要的比较结果,没有研究将硫唑嘌呤与安慰剂或其他dmt进行比较,无论是复发性多发性硬化症还是进展性多发性硬化症,NRSIs没有提供rct中没有涵盖的信息。与其他dmt(特别是干扰素β)相比,硫唑嘌呤作为复发性MS的首选治疗方法-与干扰素β相比,硫唑嘌呤对两年内残疾进展人数的影响证据非常不确定(风险比(RR) 0.19, 95%置信区间(CI) 0.02至1.58;1项随机对照试验,148名受试者;非常低确定性证据)。-与干扰素β相比,硫唑嘌呤可减少1 - 2年随访期间复发的人数(RR 0.61, 95% CI 0.43 - 0.86;2项随机对照试验,242名受试者;确定性的证据)。-与干扰素β相比,硫唑嘌呤可能导致两年内发生SAEs的人数增加(RR 6.64, 95% CI 0.35至126.27;1项随机对照试验,148名受试者;确定性的证据)。-与干扰素β相比,硫唑嘌呤对两年内发生胃肠道疾病短期不良事件的人数的影响证据非常不确定(RR 5.30, 95% CI 0.15至185.57;2项随机对照试验,242名受试者;非常低确定性证据)。 我们没有发现将硫唑嘌呤与其他dmt在生活质量损害(精神评分)、长期不良事件(肿瘤)或死亡率方面进行比较的证据。作者的结论:当获得批准的标签上的dmt有限时,特别是在资源有限的情况下,硫唑嘌呤已被提议作为MS的替代治疗方法。现有的有限证据表明,与干扰素β -1b相比,对于复发缓解型多发性硬化症患者,硫唑嘌呤可能在复发频率方面有适度的益处,可能会增加SAEs。对残疾进展和短期不良事件的影响的证据是非常不确定的。在解释本综述的结论时需要谨慎,因为我们对硫唑嘌呤治疗多发性硬化症的益处和危害的现有证据的确定性很低到非常低,这意味着进一步的证据可能会改变我们的结论。我们注意到现有证据的一个重要限制是缺乏与其他治疗方法的长期比较,并且大多数研究未能衡量对多发性硬化症患者重要的结果,如生活质量和认知能力下降。在与进行性多发性硬化症相关的证据中尤其如此。
{"title":"Azathioprine for people with multiple sclerosis.","authors":"Ben Ridley, Francesco Nonino, Elisa Baldin, Ilaria Casetta, Gerardo Iuliano, Graziella Filippini","doi":"10.1002/14651858.CD015005.pub2","DOIUrl":"10.1002/14651858.CD015005.pub2","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is an immune-mediated, chronic, inflammatory demyelinating disease of the central nervous system, impacting around 2.8 million people worldwide. Characterised by recurrent relapses or progression, or both, it represents a substantial global health burden, affecting people, predominantly women, at a young age (the mean age of diagnosis is 32 years). Azathioprine is used to treat chronic inflammatory and autoimmune diseases, and it is used in clinical practice as an off-label intervention for MS, especially where access to on-label disease-modifying treatments (DMTs) for MS is limited. Given this, a review of azathioprine's benefits and harms would be timely and valuable to inform shared healthcare decisions.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of azathioprine (AZA) for relapsing and progressive multiple sclerosis (MS), compared to other disease-modifying treatments (DMTs), placebo or no treatment. Specifically, we will assess the following comparisons. AZA compared with other DMTs or placebo as first-choice treatment for relapsing forms of multiple sclerosis AZA compared with other DMTs or placebo for relapsing forms of MS when switching from another DMT AZA compared with other DMTs or placebo as first-choice treatment for progressive forms of MS AZA compared with other DMTs or placebo for progressive forms of MS when switching from another DMT SEARCH METHODS: We conducted an extensive search for relevant literature using standard Cochrane search methods. The most recent search date was 9 August 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) lasting 12 months or more that compared azathioprine versus DMTs, placebo or no intervention in adults with MS. We considered evidence from non-randomised studies of interventions (NRSIs) as these studies may provide additional evidence not available from RCTS. We excluded cluster-randomised trials, cross-over trials, interrupted time series, case reports and studies of within-group design with no control group.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodology. There were three outcomes we considered to be critical: disability, relapse and serious adverse events (SAEs, as defined in the studies). We were also interested in other important outcomes: quality-of-life (QoL) impairment (mental score), short-term adverse events (gastrointestinal disorders), long-term adverse events (neoplasms) and mortality.</p><p><strong>Main results: </strong>We included 14 studies: eight RCTs (1076 participants included in meta-analyses) and six NRSIs (1029 participants). These studies involved people with relapsing and progressive MS. Most studies included more women (57 to 83%) than men, with participants' average age at the onset of MS being between 29.4 and 33.4 years. Five RCTs and all six NRSIs were conducted in Europe (1793 participants); t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015005"},"PeriodicalIF":8.8,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1002/14651858.CD011044.pub3
Lucy Haggstrom, Wei Yen Chan, Adnan Nagrial, Lorraine A Chantrill, Hao-Wen Sim, Desmond Yip, Venessa Chin
<p><strong>Background: </strong>Pancreatic cancer (PC) is a lethal disease with few effective treatment options. Many anti-cancer therapies have been tested in the locally advanced and metastatic setting, with mixed results. This review synthesises all the randomised data available to help better inform patient and clinician decision-making. It updates the previous version of the review, published in 2018.</p><p><strong>Objectives: </strong>To assess the effects of chemotherapy, radiotherapy, or both on overall survival, severe or life-threatening adverse events, and quality of life in people undergoing first-line treatment of advanced pancreatic cancer.</p><p><strong>Search methods: </strong>We searched for published and unpublished studies in CENTRAL, MEDLINE, Embase, and CANCERLIT, and handsearched various sources for additional studies. The latest search dates were in March and July 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing chemotherapy, radiotherapy, or both with another intervention or best supportive care. Participants were required to have locally advanced, unresectable pancreatic cancer or metastatic pancreatic cancer not amenable to curative intent treatment. Histological confirmation was required. Trials were required to report overall survival.</p><p><strong>Data collection and analysis: </strong>We used standard methodological procedures expected by Cochrane.</p><p><strong>Main results: </strong>We included 75 studies in the review and 51 in the meta-analysis (11,333 participants). We divided the studies into seven categories: any anti-cancer treatment versus best supportive care; various chemotherapy types versus gemcitabine; gemcitabine-based combinations versus gemcitabine alone; various chemotherapy combinations versus gemcitabine plus nab-paclitaxel; fluoropyrimidine-based studies; miscellaneous studies; and radiotherapy studies. In general, the included studies were at low risk for random sequence generation, detection bias, attrition bias, and reporting bias, at unclear risk for allocation concealment, and high risk for performance bias. Compared to best supportive care, chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 1.08, 95% confidence interval (CI) 0.88 to 1.33; absolute risk of death at 12 months of 971 per 1000 versus 962 per 1000; 4 studies, 298 participants; moderate-certainty evidence). The adverse effects of chemotherapy and impacts on quality of life (QoL) were uncertain. Many of the chemotherapy regimens were outdated. Eight studies compared non-gemcitabine-based chemotherapy regimens to gemcitabine. These showed that 5-fluorouracil (5FU) likely reduces OS (HR 1.69, 95% CI 1.26 to 2.27; risk of death at 12 months of 914 per 1000 versus 767 per 1000; 1 study, 126 participants; moderate certainty), and grade 3/4 adverse events (QoL not reported). Fixed dose rate gemcitabine likely improves OS (HR 0.79, 95% CI
{"title":"Chemotherapy and radiotherapy for advanced pancreatic cancer.","authors":"Lucy Haggstrom, Wei Yen Chan, Adnan Nagrial, Lorraine A Chantrill, Hao-Wen Sim, Desmond Yip, Venessa Chin","doi":"10.1002/14651858.CD011044.pub3","DOIUrl":"10.1002/14651858.CD011044.pub3","url":null,"abstract":"<p><strong>Background: </strong>Pancreatic cancer (PC) is a lethal disease with few effective treatment options. Many anti-cancer therapies have been tested in the locally advanced and metastatic setting, with mixed results. This review synthesises all the randomised data available to help better inform patient and clinician decision-making. It updates the previous version of the review, published in 2018.</p><p><strong>Objectives: </strong>To assess the effects of chemotherapy, radiotherapy, or both on overall survival, severe or life-threatening adverse events, and quality of life in people undergoing first-line treatment of advanced pancreatic cancer.</p><p><strong>Search methods: </strong>We searched for published and unpublished studies in CENTRAL, MEDLINE, Embase, and CANCERLIT, and handsearched various sources for additional studies. The latest search dates were in March and July 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing chemotherapy, radiotherapy, or both with another intervention or best supportive care. Participants were required to have locally advanced, unresectable pancreatic cancer or metastatic pancreatic cancer not amenable to curative intent treatment. Histological confirmation was required. Trials were required to report overall survival.</p><p><strong>Data collection and analysis: </strong>We used standard methodological procedures expected by Cochrane.</p><p><strong>Main results: </strong>We included 75 studies in the review and 51 in the meta-analysis (11,333 participants). We divided the studies into seven categories: any anti-cancer treatment versus best supportive care; various chemotherapy types versus gemcitabine; gemcitabine-based combinations versus gemcitabine alone; various chemotherapy combinations versus gemcitabine plus nab-paclitaxel; fluoropyrimidine-based studies; miscellaneous studies; and radiotherapy studies. In general, the included studies were at low risk for random sequence generation, detection bias, attrition bias, and reporting bias, at unclear risk for allocation concealment, and high risk for performance bias. Compared to best supportive care, chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 1.08, 95% confidence interval (CI) 0.88 to 1.33; absolute risk of death at 12 months of 971 per 1000 versus 962 per 1000; 4 studies, 298 participants; moderate-certainty evidence). The adverse effects of chemotherapy and impacts on quality of life (QoL) were uncertain. Many of the chemotherapy regimens were outdated. Eight studies compared non-gemcitabine-based chemotherapy regimens to gemcitabine. These showed that 5-fluorouracil (5FU) likely reduces OS (HR 1.69, 95% CI 1.26 to 2.27; risk of death at 12 months of 914 per 1000 versus 767 per 1000; 1 study, 126 participants; moderate certainty), and grade 3/4 adverse events (QoL not reported). Fixed dose rate gemcitabine likely improves OS (HR 0.79, 95% CI ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD011044"},"PeriodicalIF":8.8,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11619003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1002/14651858.CD016029
Marcus Glenton Prescott, Milena Geist, Emma Olsson, Michelle Fiander, Roger F Soll, Matteo Bruschettini
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of infant positioning, nesting, and swaddling for promoting development and preventing morbidity in preterm infants.
{"title":"Infant positioning for promoting development and preventing morbidity in preterm infants.","authors":"Marcus Glenton Prescott, Milena Geist, Emma Olsson, Michelle Fiander, Roger F Soll, Matteo Bruschettini","doi":"10.1002/14651858.CD016029","DOIUrl":"10.1002/14651858.CD016029","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of infant positioning, nesting, and swaddling for promoting development and preventing morbidity in preterm infants.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD016029"},"PeriodicalIF":8.8,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-04DOI: 10.1002/14651858.CD014541.pub2
Ahmed A Kolkailah, Bahaa Abdelghaffar, Farida Elshafeey, Rana Magdy, Menna Kamel, Yasmeen Abuelnaga, Ashraf F Nabhan, Gregory Piazza
<p><strong>Background: </strong>Venous thromboembolism (VTE) includes two interrelated conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). Risk factors include dehydration, prolonged immobilization, acute medical illness, trauma, clotting disorders, previous thrombosis, varicose veins with superficial vein thrombosis, exogenous hormones, malignancy, chemotherapy, infection, inflammation, pregnancy, obesity, smoking, and advancing age. It is estimated that hospitalized patients are 100 times more likely to develop VTE and, compared with surgical patients, medical patients often have more severe forms of VTE. VTE carries a significant risk of morbidity and mortality. Prophylactic strategies, including mechanical and pharmacological methods, are recommended for patients at risk of VTE. Pharmacological prophylaxis is considered the standard practice for acutely ill medical patients at risk of developing VTE in the absence of contraindications. For hospitalized patients, the risk of VTE extends beyond hospital stay and up to 90 days, with most events occurring within 45 days of discharge. Despite that, it remains unclear whether extended-duration anticoagulation for primary VTE prophylaxis would provide benefits without added risks or harm.</p><p><strong>Objectives: </strong>To assess the benefits and risks of standard- versus extended-duration anticoagulation for primary VTE prophylaxis in acutely ill medical patients.</p><p><strong>Search methods: </strong>The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialized Register, CENTRAL, MEDLINE, Embase, CINAHL and Web of Science databases, as well as the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers up to 27 March 2023. We also searched reference lists of all included studies for additional references and searched the last five years of the American Society of Hematology conference proceedings.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) comparing standard-duration versus extended-duration anticoagulation for primary VTE prophylaxis in acutely ill medical patients (adults being treated in a medical inpatient setting).</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures set by Cochrane. At least two authors independently screened titles and abstracts for inclusion and performed data extraction. Two authors independently assessed the risk of bias (RoB) using the Cochrane RoB 2 tool. We analyzed outcomes data using the risk ratio (RR) with 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence for each outcome. Our outcomes of interest were assessed in the short term (during the treatment period and within 45 days of hospitalization) and long term (assessed beyond 45 days of hospitalization). Primary outcomes were symptomatic VTE, major bleeding, and all-cause mo
背景:静脉血栓栓塞(VTE)包括两个相互关联的条件,深静脉血栓形成(DVT)和肺栓塞(PE)。危险因素包括脱水、长期固定、急性内科疾病、创伤、凝血障碍、既往血栓形成、静脉曲张伴浅表静脉血栓形成、外源性激素、恶性肿瘤、化疗、感染、炎症、妊娠、肥胖、吸烟和高龄。据估计,住院患者发生静脉血栓栓塞的可能性是手术患者的100倍,与手术患者相比,内科患者往往有更严重的静脉血栓栓塞形式。静脉血栓栓塞有很大的发病和死亡风险。预防策略,包括机械和药理学方法,推荐给有静脉血栓栓塞风险的患者。在没有禁忌症的情况下,药理学预防被认为是有发生静脉血栓栓塞风险的急性病患者的标准做法。对于住院患者,静脉血栓栓塞的风险延长至住院后90天,大多数事件发生在出院后45天内。尽管如此,对于初级静脉血栓栓塞预防的延长抗凝时间是否能在不增加风险或伤害的情况下提供益处仍不清楚。目的:评估标准抗凝治疗与延长抗凝治疗对急性内科病人静脉血栓栓塞初级预防的益处和风险。检索方法:Cochrane血管信息专家检索了截至2023年3月27日的Cochrane血管专科注册、CENTRAL、MEDLINE、Embase、CINAHL和Web of Science数据库,以及世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册。我们还检索了所有纳入研究的参考文献列表以获取额外的参考文献,并检索了近五年的美国血液学会会议记录。选择标准:我们纳入了随机对照试验(rct),比较标准持续时间抗凝治疗与延长持续时间抗凝治疗对急性内科患者(在医疗住院环境中接受治疗的成人)初级静脉血栓栓塞预防的效果。资料收集和分析:我们采用Cochrane制定的标准方法程序。至少有两位作者独立筛选标题和摘要,并进行数据提取。两位作者使用Cochrane RoB 2工具独立评估了偏倚风险(RoB)。我们使用95%置信区间(ci)的风险比(RR)分析结局数据。我们使用GRADE方法来评估每个结果证据的确定性。我们感兴趣的结果分为短期(治疗期间和住院45天内)和长期(住院45天以上)评估。主要结局是有症状的静脉血栓栓塞、大出血和全因死亡率。次要结局是静脉血栓栓塞总发生率、致死性和不可逆血管事件(包括心肌梗死、非致死性PE、心肺死亡、中风)、致死性出血和静脉血栓栓塞相关死亡率。主要结果:共有7项rct符合我们的纳入标准,包括40,846名受试者。所有为我们的结果提供数据的研究在所有领域的偏倚风险都很低。大多数研究报告的结果是短期的。与标准时间抗凝治疗相比,急性内科患者的静脉血栓栓塞初级预防延长时间抗凝治疗降低了短期症状性静脉血栓栓塞的风险(RR 0.60, 95% CI 0.46 ~ 0.78;标准持续时间12 / 1000,延长持续时间7 / 1000,95% CI 6 ~ 10;获得额外有益结果所需治疗的人数[NNTB] 204人,95% CI 136 - 409;4项研究,24773名受试者;高确定性的证据)。然而,这种益处被短期大出血风险的增加所抵消(RR 2.05, 95% CI 1.51 - 2.79;标准持续时间3 / 1000,延长持续时间6 / 1000,95% CI为5 ~ 8;额外有害结果需要治疗的人数[NNTH] 314, 95% CI 538 ~ 222;7项研究,40374名受试者;高确定性的证据)。延长抗凝时间与标准抗凝时间相比,短期全因死亡率几乎没有差异(RR 0.97, 95% CI 0.87 ~ 1.08;标准工期34 / 1000,延长工期33 / 1000,95% CI 30 ~ 37;5项研究,38,080名受试者;高确定性证据),短期总VTE降低(RR 0.75, 95% CI 0.67 ~ 0.85;标准工期37 / 1000,延长工期28 / 1000,95% CI 25 ~ 32;NNTB 107, 95% CI 76 ~ 178;5项研究,33,819名受试者;高确定性证据),以及致命和不可逆血管事件的短期复合(RR 0.71, 95% CI 0.56 ~ 0.91;标准工期41 / 1000,延长工期29 / 1000,95% CI为23 ~ 37;NNTB 85, 95% CI 50 ~ 288;1项研究,7513名参与者;高确定性的证据)。 延长抗凝时间可能导致短期致死性出血几乎没有差异(RR 2.28, 95% CI 0.84 ~ 6.22;标准持续时间0 / 1000,延长持续时间0 / 1000,95% CI 0 ~ 1;7项研究,40374名受试者;低确定性证据),并且可能导致vte相关的短期死亡率几乎没有差异(RR 0.78, 95% CI 0.58至1.05;标准持续时间5 / 1000,延长持续时间4 / 1000 95% CI 3 ~ 6;6项研究,36170名参与者;moderate-certainty证据)。作者的结论是:在短期内,延长抗凝时间与标准抗凝时间相比,对急性内科患者进行静脉血栓栓塞的初级预防,以增加大出血的风险为代价,降低了症状性静脉血栓栓塞的风险。延长抗凝时间导致的全因死亡率几乎没有差异。延长抗凝时间降低了静脉血栓栓塞总发生率以及致死性和不可逆血管事件的综合发生率,但在致死性出血和静脉血栓栓塞相关死亡率方面可能几乎没有差异。需要进一步的数据和更长的随访时间来确定急性内科病人初级静脉血栓栓塞预防的最佳药物和持续时间。
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Pub Date : 2024-12-03DOI: 10.1002/14651858.CD009362.pub4
Declan Patton, Zena Eh Moore, Fiona Boland, Wendy P Chaboyer, Sharon L Latimer, Rachel M Walker, Pinar Avsar
<p><strong>Background: </strong>Pressure ulcers occur when people cannot reposition themselves to relieve pressure over bony prominences. They are difficult to heal, costly, and reduce quality of life. Dressings and topical agents (lotions, creams, and oils) for pressure ulcer prevention are widely used. However, their effectiveness is unclear. This is the third update of this review.</p><p><strong>Objectives: </strong>To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age without existing pressure ulcers, but at risk of developing one, in any healthcare setting.</p><p><strong>Search methods: </strong>We used the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, two other databases, and two trial registers, together with reference checking, citation searching, and contact with study authors to identify the studies that are included in the review. The latest search date was November 2022. We imposed no restrictions on language, publication date, or setting.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials that enroled people at risk of developing a pressure ulcer.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methodological procedures.</p><p><strong>Main results: </strong>In this update, we added 33 new studies, resulting in a total of 51 trials (13,303 participants). Of these, 31 studies involved dressings, 16 topical agents, and four included both dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence. Dressings Pressure ulcer incidence We made a total of 13 comparisons with 9027 participants. We present seven prioritised comparisons in the summary of findings (SoF) tables, as follows: silicone foam dressing versus no dressing (18 trials, 5903 participants; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.33 to 0.77); foam dressing versus film dressing (3 trials, 569 participants; RR 0.72, 95% CI 0.20 to 2.67); hydrocellular foam dressing versus hydrocolloid dressing (1 trial, 80 participants; RR not estimable); silicone foam dressing type 1 versus silicone foam dressing type 2 (2 trials, 376 participants; RR 0.80, 95% CI 0.56 to 1.15); foam dressing versus fatty acid (2 trials, 300 participants; RR 1.67, 95% CI 0.49 to 5.72); polyurethane film versus hydrocolloid dressing (1 trial, 160 participants; RR 0.58, 95% CI 0.24 to 1.41); and hydrocolloid dressing versus no dressing (2 trials, 230 participants; RR 0.60, 95% CI 0.46 to 0.78). All low or very low-certainty evidence. The evidence is very uncertain about the effect of dressings on pressure ulcer development. Pressure ulcer stage Three comparisons reported pressure ulcer (PU) stage. Silicone foam dressing versus no dressing: PU stage 1 (8 trials, 1823 participants; RR 0.32, 95% CI 0.13 to 0.79); PU stage 2 (10 trials, 2873 participants; RR 0.47, 95% CI 0.30 to 0.73); PU stage 3 (3 trials, 718 participants; RR 0.45, 95% CI
背景:当人们不能重新定位以减轻骨突出部位的压力时,就会发生压疮。它们难以治愈,费用昂贵,并降低生活质量。用于预防压疮的敷料和局部药物(乳液、面霜和油)被广泛使用。然而,它们的效果尚不清楚。这是本综述的第三次更新。目的:评价敷料和外用药物对预防压疮的作用,在任何医疗机构中,在任何年龄没有压疮但有发生压疮风险的人群中。检索方法:我们使用Cochrane Wounds specialized Register、CENTRAL、MEDLINE、其他两个数据库和两个试验注册数据库,结合参考文献检查、引文检索和与研究作者的联系来确定纳入综述的研究。最近一次搜索日期是2022年11月。我们对语言、出版日期或设置没有限制。选择标准:我们纳入了随机对照试验,纳入了有发生压疮风险的人群。资料收集和分析:我们使用标准的Cochrane方法程序。主要结果:在本次更新中,我们增加了33项新研究,共纳入51项试验(13303名受试者)。其中,31项研究涉及敷料,16项外用药物,4项研究包括敷料和外用药物。所有试验都报告了压疮发生率的主要结局。我们共对9027名参与者进行了13次比较。我们在结果摘要(SoF)表中提出了七个优先比较,如下:硅胶泡沫敷料与无敷料(18项试验,5903名参与者;风险比(RR) 0.50, 95%可信区间(CI) 0.33 ~ 0.77);泡沫敷料与薄膜敷料(3项试验,569名受试者;RR 0.72, 95% CI 0.20 ~ 2.67);水细胞泡沫敷料与水胶体敷料对比(1项试验,80名受试者;RR不可估计);1型硅胶泡沫敷料与2型硅胶泡沫敷料对比(2项试验,376名受试者;RR 0.80, 95% CI 0.56 ~ 1.15);泡沫敷料与脂肪酸(2项试验,300名受试者;RR 1.67, 95% CI 0.49 ~ 5.72);聚氨酯薄膜与水胶体敷料(1项试验,160名受试者;RR 0.58, 95% CI 0.24 ~ 1.41);水胶体敷料与不敷料(2项试验,230名受试者;RR 0.60, 95% CI 0.46 ~ 0.78)。所有低或非常低确定性的证据。关于敷料对压疮发展的影响,证据非常不确定。压疮分期三个比较报道了压疮(PU)分期。硅胶泡沫敷料与不敷料:PU阶段1(8项试验,1823名参与者;RR 0.32, 95% CI 0.13 ~ 0.79);PU阶段2(10项试验,2873名受试者;RR 0.47, 95% CI 0.30 ~ 0.73);PU阶段3(3项试验,718名受试者;RR 0.45, 95% CI 0.06 ~ 3.21);PU阶段4(2项试验,610名受试者;RR 0.21, 95% CI 0.02 ~ 1.77);不可分期PU(1项试验,366名受试者;RR 0.20, 95% CI 0.01 ~ 4.09);深层组织损伤(3项试验,840名受试者;RR 0.32, 95% CI 0.09 ~ 1.08)。泡沫敷料与薄膜敷料:PU阶段1(1项试验,270名受试者;RR 0.56, 95% CI 0.39 ~ 0.80);PU阶段2(1项试验,270名受试者;RR 1.00, 95% CI 0.06 ~ 15.82);深部组织损伤(1项试验,270名受试者;RR 0.67, 95% CI 0.11 ~ 3.93)。水胶体敷料与不敷料:PU期1(1项试验,108名受试者;RR 0.54, 95% CI 0.31 ~ 0.94);PU二期(1项试验,108名受试者;RR 0.86, 95% CI 0.28 ~ 2.66)。所有低或非常低确定性的证据。关于敷料对压疮发展的不同阶段的影响,证据是非常不确定的。1例不良事件的比较报告:硅胶泡沫敷料与不敷料(3项试验,2317名受试者;RR不可估计;非常低确定性证据)。硅胶泡沫敷料可能对不良事件的发生率几乎没有影响,但证据是非常不确定的。我们对4276名参与者进行了7项比较评估。我们在SoF表中提出了以下五个优先比较:脂肪酸与安慰剂(6项试验,2201名受试者;RR 0.86, 95% CI 0.54 ~ 1.36);脂肪酸与常规治疗(7项试验,1058名受试者;RR 0.64, 95% CI 0.46 ~ 0.84);乳霜与脂肪酸(1项试验,120名受试者;RR 3.00, 95% CI 0.32 ~ 28.03);乳霜与安慰剂(3项试验,513名受试者;RR 1.18, 95% CI 0.59 ~ 2.36);面霜与常规护理(1项试验,47名受试者;RR 1.60, 95% CI 0.84 ~ 3.04)。都是非常不确定的证据。它们是否对PU的发展有任何影响,这是非常不确定的。压疮分期:两组比较报道PU分期。脂肪酸与常规治疗:PU期(2项试验,180名受试者;RR 1.00, 95% CI 0.49 ~ 2.03);PU阶段2(2项试验,180名受试者;RR 0.19, 95% CI 0.07 ~ 0.53)。面霜vs安慰剂:PU期3(1项试验,258名受试者;Rr 1.25, 95% ci 0。 34 - 4.55);PU期4(1项试验,258名受试者;RR 0.33, 95% CI 0.01 ~ 8.11)。低或非常低的证据。目前还不确定它们是否会对PU的发展阶段产生影响。一项比较报告了不良事件:脂肪酸与安慰剂(3项试验,967名受试者;RR 4.38, 95% CI 0.50 ~ 38.30;非常低确定性证据)。与安慰剂相比,脂肪酸可能对不良事件的发生率几乎没有影响,但证据非常不确定。偏倚和不精确的风险是降低证据确定性的主要原因。作者的结论:纳入的研究测试了各种各样的敷料和局部药物。所有干预措施的证据都不确定或非常不确定;因此,尚不清楚所研究的敷料或外用药物是否对压疮的发展有任何影响。未来的研究应与利益相关者合作,以确定优先干预措施。
{"title":"Dressings and topical agents for preventing pressure ulcers.","authors":"Declan Patton, Zena Eh Moore, Fiona Boland, Wendy P Chaboyer, Sharon L Latimer, Rachel M Walker, Pinar Avsar","doi":"10.1002/14651858.CD009362.pub4","DOIUrl":"10.1002/14651858.CD009362.pub4","url":null,"abstract":"<p><strong>Background: </strong>Pressure ulcers occur when people cannot reposition themselves to relieve pressure over bony prominences. They are difficult to heal, costly, and reduce quality of life. Dressings and topical agents (lotions, creams, and oils) for pressure ulcer prevention are widely used. However, their effectiveness is unclear. This is the third update of this review.</p><p><strong>Objectives: </strong>To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age without existing pressure ulcers, but at risk of developing one, in any healthcare setting.</p><p><strong>Search methods: </strong>We used the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, two other databases, and two trial registers, together with reference checking, citation searching, and contact with study authors to identify the studies that are included in the review. The latest search date was November 2022. We imposed no restrictions on language, publication date, or setting.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials that enroled people at risk of developing a pressure ulcer.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methodological procedures.</p><p><strong>Main results: </strong>In this update, we added 33 new studies, resulting in a total of 51 trials (13,303 participants). Of these, 31 studies involved dressings, 16 topical agents, and four included both dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence. Dressings Pressure ulcer incidence We made a total of 13 comparisons with 9027 participants. We present seven prioritised comparisons in the summary of findings (SoF) tables, as follows: silicone foam dressing versus no dressing (18 trials, 5903 participants; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.33 to 0.77); foam dressing versus film dressing (3 trials, 569 participants; RR 0.72, 95% CI 0.20 to 2.67); hydrocellular foam dressing versus hydrocolloid dressing (1 trial, 80 participants; RR not estimable); silicone foam dressing type 1 versus silicone foam dressing type 2 (2 trials, 376 participants; RR 0.80, 95% CI 0.56 to 1.15); foam dressing versus fatty acid (2 trials, 300 participants; RR 1.67, 95% CI 0.49 to 5.72); polyurethane film versus hydrocolloid dressing (1 trial, 160 participants; RR 0.58, 95% CI 0.24 to 1.41); and hydrocolloid dressing versus no dressing (2 trials, 230 participants; RR 0.60, 95% CI 0.46 to 0.78). All low or very low-certainty evidence. The evidence is very uncertain about the effect of dressings on pressure ulcer development. Pressure ulcer stage Three comparisons reported pressure ulcer (PU) stage. Silicone foam dressing versus no dressing: PU stage 1 (8 trials, 1823 participants; RR 0.32, 95% CI 0.13 to 0.79); PU stage 2 (10 trials, 2873 participants; RR 0.47, 95% CI 0.30 to 0.73); PU stage 3 (3 trials, 718 participants; RR 0.45, 95% CI","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD009362"},"PeriodicalIF":8.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-03DOI: 10.1002/14651858.CD004376.pub4
Belinda J Lawford, Michelle Hall, Rana S Hinman, Martin Van der Esch, Alison R Harmer, Libby Spiers, Alex Kimp, Andrea Dell'Isola, Kim L Bennell
<p><strong>Background: </strong>Knee osteoarthritis (OA) is a major public health issue causing chronic pain, impaired physical function, and reduced quality of life. As there is no cure, self-management of symptoms via exercise is recommended by all current international clinical guidelines. This review updates one published in 2015.</p><p><strong>Objectives: </strong>We aimed to assess the effects of land-based exercise for people with knee osteoarthritis (OA) by comparing: 1) exercise versus attention control or placebo; 2) exercise versus no treatment, usual care, or limited education; 3) exercise added to another co-intervention versus the co-intervention alone.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trial registries (ClinicalTrials.gov and World Health Organisation International Clinical Trials Registry Platform), together with reference lists, from the date of the last search (1st May 2013) until 4 January 2024, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) that evaluated exercise for knee OA versus a comparator listed above. Our outcomes of interest were pain severity, physical function, quality of life, participant-reported treatment success, adverse events, and study withdrawals.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures expected by Cochrane for systematic reviews of interventions.</p><p><strong>Main results: </strong>We included 139 trials (12,468 participants): 30 (3065 participants) compared exercise to attention control or placebo; 60 (4834 participants) compared exercise with usual care, no intervention or limited education; and 49 (4569 participants) evaluated exercise added to another intervention (e.g. weight loss diet, physical therapy, detailed education) versus that intervention alone. Interventions varied substantially in duration, ranging from 2 to 104 weeks. Most of the trials were at unclear or high risk of bias, in particular, performance bias (94% of trials), detection bias (94%), selective reporting bias (68%), selection bias (57%), and attrition bias (48%). Exercise versus attention control/placebo Compared with attention control/placebo, low-certainty evidence indicates exercise may result in a slight improvement in pain immediately post-intervention (mean 8.70 points better (on a scale of 0 to 100), 95% confidence interval (CI) 5.70 to 11.70; 28 studies, 2873 participants). Moderate-certainty evidence indicates exercise likely results in an improvement in physical function (mean 11.27 points better (on a scale of 0 to 100), 95% CI 7.64 to 15.09; 24 studies, 2536 participants), but little to no improvement in quality of life (mean 6.06 points better (on a scale of 0 to 100), 95% CI -0.13 to 12.26; 6 studies, 454 participants). There was moderate-certainty evidence that exercise likely increase
背景:膝骨关节炎(OA)是一个主要的公共卫生问题,引起慢性疼痛、身体功能受损和生活质量下降。由于无法治愈,目前所有国际临床指南都建议通过运动来自我管理症状。这篇综述更新了2015年发表的一篇综述。目的:我们的目的是通过比较:1)运动与注意力控制或安慰剂的对比,评估陆上运动对膝关节骨关节炎(OA)患者的影响;2)锻炼与不治疗、常规护理或有限教育;3)运动加入另一项联合干预与单独联合干预。检索方法:我们检索了Cochrane中央对照试验注册库(Central)、MEDLINE、Embase和两个试验注册库(ClinicalTrials.gov和世界卫生组织国际临床试验注册平台)以及参考文献列表,检索时间从最后一次检索日期(2013年5月1日)至2024年1月4日,不受语言限制。选择标准:我们纳入了随机对照试验(rct),这些试验评估了运动对膝关节OA的影响。我们感兴趣的结局是疼痛严重程度、身体功能、生活质量、参与者报告的治疗成功、不良事件和研究退出。数据收集和分析:我们使用Cochrane期望的标准方法程序对干预措施进行系统评价。主要结果:我们纳入139项试验(12,468名受试者):30项(3065名受试者)比较运动与注意控制或安慰剂;60名(4834名参与者)将运动与常规护理、不干预或有限教育进行比较;49名(4569名参与者)评估了运动与另一种干预(如减肥饮食、物理治疗、详细教育)相比单独的干预。干预措施的持续时间差别很大,从2周到104周不等。大多数试验存在不明确或高风险的偏倚,特别是表现偏倚(94%的试验)、检测偏倚(94%)、选择性报告偏倚(68%)、选择偏倚(57%)和消耗偏倚(48%)。与注意控制/安慰剂相比,低确定性证据表明,运动可能会导致干预后疼痛的轻微改善(平均改善8.70分(在0到100的范围内),95%置信区间(CI) 5.70到11.70;28项研究,2873名参与者)。中等确定性证据表明,运动可能导致身体功能的改善(平均11.27分更好(在0到100的范围内),95% CI 7.64到15.09;24项研究,2536名参与者),但生活质量几乎没有改善(平均提高6.06分(在0到100的范围内),95% CI -0.13至12.26;6项研究,454名参与者)。有中等确定性证据表明,锻炼可能会增加参与者报告的治疗成功率(风险比(RR) 1.46, 95% CI 1.11至1.92;2项研究364名参与者),并且可能不会增加研究退出(RR 1.08, 95% CI 0.92至1.26;29项研究,2907名参与者)。有低确定性证据表明,运动可能不会增加不良事件(RR 2.02, 95% CI 0.62 ~ 6.58;11项研究,1684名参与者)。与不治疗/常规护理/有限教育相比,低确定性证据表明,运动可能导致干预后疼痛立即改善(平均改善13.14分(0至100分),95% CI 10.36至15.91;56项研究,4184名参与者)。中等确定性证据表明,运动可能导致身体功能的改善(平均12.53分更好(在0到100的范围内),95% CI 9.74到15.31;54项研究,4352名参与者)和生活质量的轻微改善(平均改善5.37分(在100分范围内),95% CI 3.19至7.54;28项研究,2328名参与者)。有低确定性证据表明,运动可能导致参与者报告的治疗成功率没有差异(RR 1.33, 95% CI 0.71至2.49;3项研究,405名参与者)。有中等确定性的证据表明,运动可能不会导致退出研究的差异(RR 1.03, 95% CI 0.88至1.20;53项研究,4408名参与者)。有低确定性证据表明,运动可能会增加不良事件(RR 3.17, 95% CI 1.17 - 8.57;18项研究,1557名参与者)。中等确定性证据表明,与单独联合干预相比,在联合干预中加入运动可能会在干预后立即改善疼痛(平均改善10.43分(在0到100的范围内),95% CI 8.06到12.79;47项研究,4441名参与者)。它也可能导致身体功能的轻微改善(平均改善9.66点,95% CI 7.48至11.97(0至100分);44项研究,4381名参与者)和生活质量(平均4。 提高22分(0 - 100分制),95% CI 1.36 - 7.07;12项研究,1660名参与者)在干预后立即进行。有中等确定性的证据表明,锻炼可能会增加参与者报告的治疗成功率(RR 1.63, 95% CI 1.18至2.24;6项研究,1139名受试者),稍微减少了研究退出(RR 0.82, 95% CI 0.70 - 0.97;41项研究,3502名受试者),并略微增加不良事件(RR 1.72, 95% CI 1.07至2.76;19项研究,2187名参与者)。亚组分析和meta回归我们没有发现不同类型运动之间的效果有任何差异,我们也没有发现疼痛或身体功能的变化与规定的运动总次数或与医疗保健提供者实时咨询的比率(在运动组和比较组之间)之间的关系。为了确定所发现的结果是否会对膝关节OA患者产生有临床意义的差异,我们将我们的结果与疼痛(0到100分中的12分)、身体功能(13分)和生活质量(15分)的“最小重要差异”(MID)评分进行了比较。我们发现,平均差异的置信区间要么没有达到这些阈值,要么包括临床重要和临床不重要的改善。作者的结论:我们发现了低到中等确定性的证据,表明运动可能会在短期内改善疼痛、身体功能和生活质量。然而,基于我们使用的最小重要差异阈值,这些益处的临床重要性尚不确定。大多数试验的参与者不是盲法的,因此知道他们的治疗,这可能有助于报告的改善。
{"title":"Exercise for osteoarthritis of the knee.","authors":"Belinda J Lawford, Michelle Hall, Rana S Hinman, Martin Van der Esch, Alison R Harmer, Libby Spiers, Alex Kimp, Andrea Dell'Isola, Kim L Bennell","doi":"10.1002/14651858.CD004376.pub4","DOIUrl":"10.1002/14651858.CD004376.pub4","url":null,"abstract":"<p><strong>Background: </strong>Knee osteoarthritis (OA) is a major public health issue causing chronic pain, impaired physical function, and reduced quality of life. As there is no cure, self-management of symptoms via exercise is recommended by all current international clinical guidelines. This review updates one published in 2015.</p><p><strong>Objectives: </strong>We aimed to assess the effects of land-based exercise for people with knee osteoarthritis (OA) by comparing: 1) exercise versus attention control or placebo; 2) exercise versus no treatment, usual care, or limited education; 3) exercise added to another co-intervention versus the co-intervention alone.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trial registries (ClinicalTrials.gov and World Health Organisation International Clinical Trials Registry Platform), together with reference lists, from the date of the last search (1st May 2013) until 4 January 2024, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) that evaluated exercise for knee OA versus a comparator listed above. Our outcomes of interest were pain severity, physical function, quality of life, participant-reported treatment success, adverse events, and study withdrawals.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures expected by Cochrane for systematic reviews of interventions.</p><p><strong>Main results: </strong>We included 139 trials (12,468 participants): 30 (3065 participants) compared exercise to attention control or placebo; 60 (4834 participants) compared exercise with usual care, no intervention or limited education; and 49 (4569 participants) evaluated exercise added to another intervention (e.g. weight loss diet, physical therapy, detailed education) versus that intervention alone. Interventions varied substantially in duration, ranging from 2 to 104 weeks. Most of the trials were at unclear or high risk of bias, in particular, performance bias (94% of trials), detection bias (94%), selective reporting bias (68%), selection bias (57%), and attrition bias (48%). Exercise versus attention control/placebo Compared with attention control/placebo, low-certainty evidence indicates exercise may result in a slight improvement in pain immediately post-intervention (mean 8.70 points better (on a scale of 0 to 100), 95% confidence interval (CI) 5.70 to 11.70; 28 studies, 2873 participants). Moderate-certainty evidence indicates exercise likely results in an improvement in physical function (mean 11.27 points better (on a scale of 0 to 100), 95% CI 7.64 to 15.09; 24 studies, 2536 participants), but little to no improvement in quality of life (mean 6.06 points better (on a scale of 0 to 100), 95% CI -0.13 to 12.26; 6 studies, 454 participants). There was moderate-certainty evidence that exercise likely increase","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD004376"},"PeriodicalIF":8.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-03DOI: 10.1002/14651858.CD016068
Sharon R Lewis, Philip Riley, Eleni Deligianni, Anne-Marie Glenny, Michael Glick, Lucy O'Malley, Tanya Walsh, Helen V Worthington
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of photobiomodulation for the prevention of oral mucositis in people undergoing treatment for head and neck cancers, other solid cancers, and haematological cancers.
{"title":"Interventions for preventing oral mucositis in people receiving cancer treatment: photobiomodulation.","authors":"Sharon R Lewis, Philip Riley, Eleni Deligianni, Anne-Marie Glenny, Michael Glick, Lucy O'Malley, Tanya Walsh, Helen V Worthington","doi":"10.1002/14651858.CD016068","DOIUrl":"10.1002/14651858.CD016068","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of photobiomodulation for the prevention of oral mucositis in people undergoing treatment for head and neck cancers, other solid cancers, and haematological cancers.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD016068"},"PeriodicalIF":8.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}