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Rehabilitation interventions for oropharyngeal dysphagia in people with Parkinson's disease. 帕金森病患者口咽吞咽困难的康复干预。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-21 DOI: 10.1002/14651858.CD015816.pub2
Irene Battel, Chiara Arienti, Matteo Johann Del Furia, Stefano Giuseppe Lazzarini, Tobias Warnecke, Margaret Walshe
<p><strong>Rationale: </strong>Oropharyngeal dysphagia is a common and disabling symptom in people with Parkinson's disease, affecting the safety and efficiency of swallowing and increasing the risk of malnutrition and aspiration pneumonia. Despite its clinical relevance, the effectiveness of rehabilitation interventions for managing dysphagia in this population remains uncertain.</p><p><strong>Objectives: </strong>To assess the effectiveness of rehabilitation interventions for oropharyngeal dysphagia in improving swallowing safety and efficiency in people with Parkinson's disease.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Speech Pathology Database for Best Interventions and Treatment Efficacy up to 26 September 2025. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to retrieve ongoing and recently completed trials, and OpenGrey for grey literature.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) of rehabilitation interventions aimed at improving oropharyngeal dysphagia in people with Parkinson's disease. We included any rehabilitation intervention for oropharyngeal dysphagia, alone or in combination with another rehabilitation intervention, with or without concurrent pharmacological treatments. Comparators included no intervention, usual care, a placebo/sham stimulation or attention control intervention, or any other rehabilitation intervention.</p><p><strong>Outcomes: </strong>Critical outcomes: swallowing safety and swallowing efficiency Important outcomes: dysphagia severity, saliva management, quality of life, respiratory outcomes, nutritional and dietary outcomes, and adverse events RISK OF BIAS: We assessed the risk of bias in the included studies using Cochrane's revised risk of bias (RoB 2) tool.</p><p><strong>Synthesis methods: </strong>When two or more studies were pooled, we conducted a random-effects meta-analysis to calculate standardised mean differences (SMDs) and 95% confidence intervals (CIs). When only one study was available, we used a fixed-effect model to estimate the effect, calculating mean differences (MDs) or odds ratios (ORs) with 95% CIs for all outcomes. We used the GRADE approach to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>We included 18 studies (1216 participants). Five studies were conducted in Europe, four in the USA, and nine in the rest of the world. Generally, studies were heterogeneous and often poorly reported. We included only two studies in the meta-analysis. Ten studies tested behavioural interventions, while eight studies tested one or more stimulation interventions: neuromuscular treatments (three studies), repetitive transcranial magnetic stimulation (two studies), deep brain stimulation (tw
理由:口咽吞咽困难是帕金森病患者常见的致残症状,影响吞咽的安全性和效率,增加营养不良和吸入性肺炎的风险。尽管其临床相关性,康复干预治疗吞咽困难在这一人群中的有效性仍然不确定。目的:评价帕金森病患者口咽吞咽困难的康复干预措施在提高吞咽安全性和效率方面的有效性。检索方法:我们检索了Cochrane中央对照试验注册库(Central)、MEDLINE、Embase、护理和联合健康文献累积索引、Web of Science和语言病理学数据库,以获取截至2025年9月26日的最佳干预措施和治疗效果。我们还检索了ClinicalTrials.gov和世界卫生组织国际临床试验注册平台,检索正在进行和最近完成的试验,并检索了OpenGrey的灰色文献。入选标准:我们纳入了旨在改善帕金森病患者口咽吞咽困难的康复干预的随机对照试验(rct)。我们纳入了对口咽吞咽困难的任何康复干预,单独或联合另一种康复干预,有或没有同时进行药物治疗。比较者包括无干预、常规护理、安慰剂/假刺激或注意控制干预,或任何其他康复干预。主要结局:吞咽安全性和吞咽效率。重要结局:吞咽困难严重程度、唾液管理、生活质量、呼吸结局、营养和饮食结局、不良事件。偏倚风险:我们使用Cochrane修订的偏倚风险(RoB 2)工具评估纳入研究的偏倚风险。综合方法:当两项或两项以上的研究合并时,我们进行随机效应荟萃分析来计算标准化平均差异(SMDs)和95%置信区间(ci)。当只有一项研究可用时,我们使用固定效应模型来估计效果,计算所有结果的95% ci的平均差异(md)或优势比(ORs)。我们使用GRADE方法来评估证据的确定性。纳入研究:纳入18项研究(1216名受试者)。五项研究在欧洲进行,四项在美国进行,九项在世界其他地区进行。一般来说,这些研究是异质的,而且往往报道不充分。我们在荟萃分析中只纳入了两项研究。10项研究测试了行为干预,8项研究测试了一种或多种刺激干预:神经肌肉治疗(3项研究)、重复经颅磁刺激(2项研究)、深部脑刺激(2项研究)和经颅直流电刺激(1项研究)。结果综合:与假呼气肌力训练(EMST)相比,EMST可能在治疗四周结束时改善吞咽安全性(SMD -0.66, 95% CI -1.04至-0.28;I²= 0%;2项研究;113名受试者;极低确定性证据),但证据非常不确定。同样,与假EMST相比,EMST对以下所有结果的影响证据也非常不确定:三个月后的吞咽安全性(MD -0.18, 95% CI -0.69至0.33;1项研究,45名参与者);治疗结束时的吞咽效率(MD -4.4, 95% CI -7.5至-1.3;1项研究,45名参与者)和3个月后(MD -1.7, 95% CI -4.58至1.18;1项研究,45名参与者);治疗结束时(MD -2.78, 95% CI -18.04 - 12.48, 1项研究,45名受试者)和3个月后(MD -2.9, 95% CI -16.94 - 11.14, 1项研究,45名受试者)吞咽困难严重程度;治疗结束时的生活质量(MD 14.69, 95% CI -63.52至92.90;1项研究,45名参与者)和三个月后(MD 11.4, 95% CI -67.95至90.75;1项研究,45名参与者)。最后,治疗五周后,EMST可能导致呼气流量峰值几乎没有差异(MD -0.5 L/秒,95% CI -1.05至0.05;1项研究,58名参与者;低确定性证据)。关于视频辅助吞咽治疗(VAST)加言语语言治疗(SLT)与单独使用SLT相比在以下所有结果上的效果,证据非常不确定:治疗结束时的生活质量(MD 1.62, 95% CI 0.33至2.91,1项研究,42名参与者)和6个月后的生活质量(MD 1.86, 95% CI 0.82至2.9,1项研究,42名参与者);和治疗结束时的吞咽困难严重程度(MD -0.7, 95% CI -5.13至3.73;1项研究,42名参与者)和长期(MD -4.03, 95% CI -7.85至-0.21;1项研究,42名参与者)。关于神经肌肉电刺激(NMES)加SLT与假NMES加SLT对吞咽安全性的影响,证据非常不确定(MD -1.34, 95% CI -2.32至-0)。 36个;1项研究,18名参与者;极低确定性证据)和治疗四周结束时的吞咽效率(MD -2.34, 95% CI -7.16至2.48;1项研究,18名受试者;极低确定性证据)。证据也非常不确定舌力训练加SLT与单独SLT治疗8周后对吞咽困难严重程度的影响(MD = 0.13, 95% CI = -0.17 - 0.43; 1项研究,60名参与者;非常低确定性证据)。由于不精确(样本量小)、与预期干预措施偏差、结果测量和随机化过程相关的高偏倚风险以及报告不足,我们对这些发现的确定性非常低。作者的结论:尽管自2001年Cochrane发表关于该主题的综述以来,随机对照试验的数量有所增加,但吞咽康复对帕金森病患者的有效性仍然存在不确定性。行为干预,特别是EMST,可能通过减少渗透和误吸来提高吞咽安全性,但证据非常不确定。大多数纳入的研究规模小,方法有限,限制了结论的稳健性。需要大规模、设计良好的安慰剂对照试验来评估帕金森病患者口咽吞咽困难康复干预的有效性。经费:没有收到这项工作的经费。注册:协议(2024)DOI: 10.1002/14651858.CD015816。
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引用次数: 0
Occupational therapy for multiple sclerosis. 多发性硬化的职业疗法。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-20 DOI: 10.1002/14651858.CD015371.pub2
Daphne Kos, Ashley Boers, Ciara O'Meara, Geertruida E Bekkering, Leen De Coninck, Marja Koen, Jennifer Freeman, Sinéad M Hynes, Isaline Cjm Eijssen
<p><strong>Rationale: </strong>Occupational therapy (OT) enables individuals to engage in meaningful daily activities and is considered a valuable component of care for people with multiple sclerosis (MS). However, the specific impact of OT on MS remains unclear.</p><p><strong>Objectives: </strong>To assess the benefits and harms of occupational therapy interventions for improving daily functioning, participation and quality of life in people with multiple sclerosis.</p><p><strong>Search methods: </strong>We searched seven electronic bibliographic databases until November 2024. We also searched grey literature and trial registers.</p><p><strong>Eligibility criteria: </strong>We included randomised and non-randomised controlled trials that compared OT for adults with MS versus no intervention, usual care or active control.</p><p><strong>Outcomes: </strong>Critical outcomes were daily functioning, quality of life and adverse effects. Important outcomes were participation, self-efficacy, self-management, mood, resilience and impact on caregivers. Our time points of interest were post-intervention, medium term (up to six months after the end of the intervention) and long term (longest follow-up after six months).</p><p><strong>Risk of bias: </strong>We assessed risk of bias (RoB) for the outcomes reported in our summary of findings tables. We used the Cochrane tools RoB-2 (for randomised controlled trials) and ROBINS-I (for non-randomised controlled trials).</p><p><strong>Synthesis methods: </strong>We synthesised results using meta-analysis (random-effects model, inverse variance). The effect measure was mean difference (MD) or standardised mean difference (SMD). Where meta-analysis was not possible, we synthesised results narratively using Synthesis Without Meta-analysis guidelines. We used GRADE to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>We included 20 studies (1628 participants), three of which were non-randomised. Nineteen of the studies were conducted in high-income countries. The studies included adults with MS (aged 18 to 70 years) with low to moderate levels of disability. Ten studies evaluated fatigue management programmes, nine examined OT interventions for daily functioning (e.g. skills training) and one targeted social participation.</p><p><strong>Synthesis of results: </strong>Daily functioning Post-intervention: OT interventions may provide a small benefit for daily functioning compared to active control (SMD 0.22, 95% CI -0.02 to 0.46; I² = 17%; 7 studies, 364 participants; low certainty), and a moderate benefit compared to no intervention (SMD 0.56, 95% CI -0.26 to 1.37; I² = 68%; 2 studies, 164 participants; low certainty). There may be a large effect compared to usual care, but the evidence is very uncertain (SMD 1.19, 95% CI 0.29 to 2.09; I² = 62%; 2 studies, 120 participants; very low certainty). Medium term: OT may make little to no difference to daily functioning compared to active control
原理:职业治疗(OT)使个体能够从事有意义的日常活动,被认为是多发性硬化症(MS)患者护理的一个有价值的组成部分。然而,OT对MS的具体影响尚不清楚。目的:评估职业治疗干预对改善多发性硬化症患者日常功能、参与和生活质量的利弊。检索方法:截止到2024年11月检索了7个电子书目数据库。我们还检索了灰色文献和试验登记。入选标准:我们纳入了随机和非随机对照试验,比较了治疗成人多发性硬化症与不干预、常规治疗或积极对照。结果:主要结果为日常功能、生活质量和不良反应。重要的结果是参与、自我效能、自我管理、情绪、恢复力和对照顾者的影响。我们感兴趣的时间点是干预后、中期(干预结束后6个月)和长期(6个月后最长的随访)。偏倚风险:我们评估了结果摘要表中报告的结果的偏倚风险(RoB)。我们使用Cochrane工具robins -2(用于随机对照试验)和robins - 1(用于非随机对照试验)。综合方法:我们使用荟萃分析(随机效应模型,逆方差)综合结果。效应测量为平均差(MD)或标准化平均差(SMD)。在无法进行meta分析的情况下,我们使用不进行meta分析的综合指南对结果进行叙述性综合。我们使用GRADE来评估证据的确定性。纳入的研究:我们纳入了20项研究(1628名受试者),其中3项是非随机的。其中19项研究是在高收入国家进行的。这些研究包括患有多发性硬化症的成年人(年龄在18岁到70岁之间),他们有低到中度的残疾。10项研究评估了疲劳管理方案,9项研究检查了日常功能(如技能培训)的OT干预措施,1项研究针对社会参与。干预后:与主动对照组相比,OT干预可能在日常功能方面提供较小的益处(SMD 0.22, 95% CI -0.02至0.46;I²= 17%;7项研究,364名受试者;低确定性),与不干预相比,有中等的益处(SMD 0.56, 95% CI -0.26至1.37;I²= 68%;2项研究,164名受试者;低确定性)。与常规护理相比,可能有很大的影响,但证据非常不确定(SMD 1.19, 95% CI 0.29至2.09;I²= 62%;2项研究,120名参与者;非常低的确定性)。中期:与主动对照组相比,OT可能对日常功能几乎没有影响(SMD 0.11, 95% CI -0.13至0.35;I²= 0%;4项研究,264名受试者;低确定性),但与常规护理相比可能有很大影响(SMD 0.99, 95% CI 0.57至1.41;I²不适用;1项研究,98名受试者;低确定性)。与主动控制或常规护理相比,OT对日常功能的长期影响非常不确定。没有关于OT与无干预的中期或长期数据的报道。干预后:与积极对照相比,OT可能对精神健康相关生活质量(HR-QoL)有较小的改善(SMD 0.33, 95% CI -0.01至0.66;I²= 42%;5项研究,296名受试者;低确定性),但对身体HR-QoL几乎没有改善(SMD 0.17, 95% CI -0.09至0.42;I²= 12%;5项研究,295名受试者;低确定性)。与常规护理相比,对身体HR-QoL (SMD 0.69, 95% CI -1.18至2.56;I²= 91%;2项研究,166名受试者;极低确定性)和精神HR-QoL (SMD 0.44, 95% CI -1.27至2.16;I²= 91%;2项研究;极低确定性)的中度影响非常不确定。与无干预相比,OT可适度改善精神HR-QoL (SMD 0.68, 95% CI -0.09 ~ 1.45; I²= 0%;3项研究,192名受试者;极低确定性),尽管证据非常不确定;可能对身体的HR-QoL影响很小或没有影响(SMD 0.12, 95% CI -0.62至0.86;I²= 0%;3项研究,192名参与者;非常低的确定性),但证据非常不确定。中期:与主动对照相比,OT对精神HR-QoL可能有小的益处,但证据非常不确定(SMD 0.21, 95% CI -0.08至0.49;I²= 20%;4项研究,270名参与者;非常低的确定性)。可能对身体的HR-QoL影响很小或没有影响(SMD 0.19, 95% CI -0.05 ~ 0.43; I²= 0%;4项研究,268名参与者;低确定性)。与常规护理相比,对身体(SMD 0.26, 95% CI -0.33 ~ 0.86; I²= 81%;2项研究,242名受试者;极低确定性)和精神HR-QoL (SMD 0.18, 95% CI -0.63 ~ 0.98; I²= 90%;2项研究,242名受试者;极低确定性)的影响非常不确定。与不干预相比,OT的中期效果尚无结果。OT对生活质量的长期影响非常不确定。 没有研究系统地报告了不良反应的频率或类型。与主动控制相比,职业治疗可能对干预后的参与几乎没有影响。其他比较和时间点的结果不可用或只能提供非常低确定性的证据。作者的结论是:无论采用何种比较干预,职业治疗均可改善干预后患者的日常功能和心理健康相关生活质量。在日常功能(与常规护理相比)和与精神健康相关的生活质量(与主动控制相比)方面,这些潜在益处可能会在中期持续存在。长期影响尚不确定。很少有证据表明,与主动比较者相比,职业治疗可能对身体健康相关的生活质量影响很小或没有影响。我们没有发现关于职业治疗不良反应的证据。我们的综合效应需要谨慎解释,因为干预的异质性和我们排除了多学科研究,没有单独的数据用于职业治疗,限制了我们对证据的确定性。未来的研究需要有可靠的设计和系统的结果评估,以得出关于多发性硬化症患者职业治疗效果的确切结论。资助:Elizabeth Casson Trust Research Grant_2022(英国);卫生研究委员会(爱尔兰)和HSC公共卫生机构(授予ESI-2021-001)通过证据合成/科克伦爱尔兰注册:协议DOI 10.1002/14651858.CD015371。
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引用次数: 0
Cannabis-based medicines for chronic neuropathic pain in adults. 大麻类药物治疗成人慢性神经性疼痛。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-19 DOI: 10.1002/14651858.CD012182.pub3
Gülay Ateş, Patrick Welsch, Petra Klose, Tudor Phillips, Britta Lambers, Winfried Häuser, Lukas Radbruch
<p><strong>Rationale: </strong>Estimates of the population prevalence of chronic pain with neuropathic components range from 6% to 10%. Current pharmacological treatments for neuropathic pain help only a minority. New treatments are needed. Cannabis is increasingly promoted in the media as a treatment for chronic pain. This is an update of a review first published in 2018.</p><p><strong>Objectives: </strong>To assess the benefits and harms of cannabis-based medicines (herbal, plant-based, synthetic) compared to placebo or conventional drugs for chronic neuropathic pain conditions in adults.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, and three trial registries, together with reference checking. The latest search date was 29 January 2025.</p><p><strong>Eligibility criteria: </strong>We selected randomised, double-blind controlled trials of medical cannabis, plant-derived and synthetic cannabinoids, against placebo or any other active treatment for chronic neuropathic pain conditions in adults, with a treatment duration of at least two weeks. We excluded studies whose double-blind duration was less than two weeks and studies which did not explicitly state that the pain was of a neuropathic nature.</p><p><strong>Outcomes: </strong>Critical outcomes were the number of participants reporting pain relief of at least 50%, a Patient Global Impression of Change (PGIC) rating of 'much' or 'very much' improved, serious adverse events, and withdrawals due to adverse events.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias (RoB) for seven outcomes reported in three summary of findings tables using the Cochrane RoB 1 tool.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using meta-analysis with a random-effects model by calculating absolute risk differences (RD) and standardised mean differences (SMD) with 95% confidence intervals (CI) for dichotomous outcomes and continuous outcomes, respectively. We used GRADE to assess the certainty of evidence for prespecified outcomes.</p><p><strong>Included studies: </strong>We included six new studies involving 450 participants, along with 15 studies involving 1737 participants from the 2018 review, for a total of 21 studies with 2187 participants. The studies ranged from two to 26 weeks in duration. Sample sizes ranged from 18 to 339 participants. Participants' mean age ranged from 34 to 61 years, and the proportion of women ranged from 0% to 90%. Five studies included participants with central neuropathic pain, 14 studies included participants with peripheral neuropathic pain, and two studies included both types. Seven studies administered tetrahydrocannabinol (THC)-dominant medicines; nine studies, balanced THC and cannabidiol (CBD) medicines; and five studies, CBD-dominant medicines. Twenty studies compared cannabis-based medicine to placebo, and one study's comparator was dihydrocodeine. We judged the overall risk of bias to be low
理由:估计人群中伴有神经性成分的慢性疼痛患病率在6%到10%之间。目前对神经性疼痛的药物治疗只对少数人有帮助。需要新的治疗方法。媒体越来越多地宣传大麻是一种治疗慢性疼痛的药物。这是对2018年首次发表的一篇综述的更新。目的:评估以大麻为基础的药物(草药、植物、合成)与安慰剂或常规药物相比治疗成人慢性神经性疼痛的益处和危害。检索方法:检索了CENTRAL、MEDLINE、Embase和三个试验注册中心,并进行了参考文献检查。最近的搜索日期是2025年1月29日。入选标准:我们选择了随机、双盲对照试验,将医用大麻、植物衍生和合成大麻素与安慰剂或任何其他治疗成人慢性神经性疼痛的积极疗法进行对照,治疗持续时间至少为两周。我们排除了双盲持续时间少于两周的研究和没有明确说明疼痛是神经性的研究。结果:关键结果是报告疼痛缓解至少50%的参与者人数,患者总体印象变化(PGIC)评分“非常”或“非常”改善,严重不良事件和因不良事件而退出。偏倚风险:我们使用Cochrane RoB 1工具评估了三个结果摘要表中报告的七个结果的偏倚风险(RoB)。综合方法:我们使用随机效应模型进行meta分析,分别计算绝对风险差异(RD)和标准化平均差异(SMD),对二分类结局和连续结局分别采用95%置信区间(CI)。我们使用GRADE来评估预先指定结果证据的确定性。纳入的研究:我们纳入了6项涉及450名受试者的新研究,以及2018年综述中涉及1737名受试者的15项研究,共计21项研究,涉及2187名受试者。研究持续时间从2周到26周不等。样本量从18人到339人不等。参与者的平均年龄从34岁到61岁不等,女性所占比例从0%到90%不等。5项研究包括中枢神经性疼痛,14项研究包括周围神经性疼痛,2项研究包括两种类型。七项研究使用四氢大麻酚(THC)为主的药物;9项研究,平衡THC和大麻二酚(CBD)药物;还有五项研究是cbd主导药物。20项研究比较了以大麻为基础的药物和安慰剂,其中一项研究的比较物是二氢可待因。我们判断6项研究的总体偏倚风险为低,10项研究的偏倚风险为不明确,5项研究的偏倚风险为高。综合结果:四氢大麻酚为主的药物与安慰剂。没有明确的证据表明影响疼痛的至少50% (RD 0.14, 95%可信区间-0.07到0.37;7研究中,534名参与者),PGIC评级“多”或“非常”的改进(RD 0.17, 95%可信区间-0.24到0.58;2研究中,72名参与者),取款由于不良事件(RD 0.03, 95%可信区间-0.02到0.08,6个研究中,511名参与者)、严重不良事件(RD 0.02, 95%可信区间-0.01到0.06;7研究中,537名参与者),至少30%的缓解疼痛(RD 0.16, 95%可信区间-0.08到0.40;7项研究,566名受试者),以及精神障碍相关不良事件(RD为0.01,95% CI为-0.01至0.03;4项研究,368名受试者),均为极低确定性证据。它们可能增加神经系统不良事件(RD = 0.25, 95% CI = 0.14 - 0.37; 5项研究,439名受试者;低确定性证据)。四氢大麻酚/大麻二酚平衡药物与安慰剂。没有明确的证据表明疼痛缓解效果至少达到50% (RD为0.04,95% CI为0.00至0.08;8项研究,746名参与者)和严重不良事件(RD为0.01,95% CI为-0.02至0.03;11项研究,1449名参与者),两者的证据都是非常低确定性的。证据非常不确定对神经系统相关(RD 0.39, 95% CI 0.23至0.55;11项研究,1445名受试者)和精神障碍相关不良事件(RD 0.08, 95% CI 0.03至0.13;9项研究,1375名受试者)的影响,两者都是非常低确定性的证据。它们可能会增加PGIC“非常”或“非常”改善的评分(RD为0.07,95% CI为0.02至0.11;7项研究,1145名参与者),疼痛缓解至少30% (RD为0.07,95% CI为0.02至0.12;10项研究,1285名参与者),以及因不良事件而停药(RD为0.05,95% CI为0.02至0.09;11项研究,1449名参与者),所有这些都是低确定性证据,尽管这些效果与临床无关。以cbd为主的药物与安慰剂。没有明确的证据表明疼痛缓解效果至少达到50% (RD -0.08, 95% CI -0.20 - 0.05; 5项研究,208名受试者;非常低确定性的证据)。 他们可能会增加或减少PGIC评级“多”或“非常”的改进(RD -0.03, 95%可信区间-0.22到0.16;2研究中,79名参与者),取款由于不良事件(RD 0.02, 95%可信区间-0.03到0.06;5研究中,213名参与者)、严重不良事件(RD 0.02, 95%可信区间-0.03到0.06;5研究中,213名参与者),缓解疼痛的至少30% (RD -0.04, 95%可信区间-0.17到0.09;5研究中,218名参与者),神经系统相关的不良事件(RD -0.03, 95%可信区间-0.10到0.03;5项研究,208名受试者)和精神障碍相关不良事件(RD -0.01, 95% CI -0.06 ~ 0.04; 5项研究,208名受试者),均为低确定性证据。作者的结论是:没有明确的证据表明四氢大麻酚为主的药物对疼痛缓解的效果达到50%或更高,PGIC评级为“非常”或“非常”改善,由于不良事件和严重不良事件而停药(非常低确定性的证据)。没有明确的证据表明四氢大麻酚/ cbd平衡药物对疼痛缓解50%或以上和严重不良事件的影响(非常低确定性的证据)。他们可能会增加PGIC“非常”或“非常”改善的评级,并因不良事件而退出(低确定性证据)。没有明确的证据表明以cbd为主的药物对疼痛缓解的效果达到50%或更高(非常低确定性的证据)。它们可能会增加或降低PGIC“非常”或“非常”改善的评级、严重不良事件和不良事件导致的停药(低确定性证据)。资金:没有资金。注册号:DOI 2018 review: 10.1002/14651858.CD012182.pub2。
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引用次数: 0
Percutaneous coronary intervention plus guideline-directed medical therapy (GDMT) versus GDMT alone in adults with stable coronary artery disease. 经皮冠状动脉介入治疗加指南指导药物治疗(GDMT)对稳定冠状动脉疾病的成人GDMT
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-19 DOI: 10.1002/14651858.CD016213
Arturo J Martí-Carvajal, Mark J Dayer, Diana Monge Martín, Mario A Gemmato-Valecillos, Gabriella Comunián-Carrasco, Ricardo Riera Lizardo, Eduardo Alegría-Barrero, Ivan Perez-Neri, Irshad Bajeer, Bhone Myint Kyaw, Mona Abdalla, Raquel Esther Gonzalez Hormostay, Cristina Elena Martí-Amarista, Gursimer Jeet, José M Palacios-González, Fernando-María Caballero-Martínez

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the clinical benefits and harms of percutaneous coronary intervention plus guideline-directed medical therapy compared with guideline-directed medical therapy alone for stable coronary artery disease in adults.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评价经皮冠状动脉介入治疗加指南药物治疗与单独指南药物治疗对成人稳定型冠状动脉疾病的临床利弊。
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引用次数: 0
Exercise training for adults with chronic kidney disease not requiring dialysis. 不需要透析的成人慢性肾病患者的运动训练。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-16 DOI: 10.1002/14651858.CD014654
Florence Lamarche, Flavie Brousseau-La Rosa, Pierre-Henri Heitz, Nadim A Beruni, Nicola P Bondonno, Germaine Wong, Amelie Bernier-Jean

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of regular, structured exercise training in adults with chronic kidney disease not requiring dialysis, focusing on patient-important outcomes such as death, cardiovascular events, fatigue, functional capacity, and depression.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评估不需要透析的慢性肾脏疾病成人患者定期、有组织的运动训练的利与弊,重点关注患者重要的结果,如死亡、心血管事件、疲劳、功能能力和抑郁。
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引用次数: 0
Branched-chain amino acids for people with cirrhosis and hepatic encephalopathy. 肝硬化和肝性脑病患者的支链氨基酸。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-16 DOI: 10.1002/14651858.CD001939.pub5
Luise Aamann, Neha Deshpande, Gitte Dam, Iñigo Les, Giulio Marchesini, Mette Borre, Niels Kristian Aagaard, Hendrik Vilstrup, Lise Lotte Gluud
<p><strong>Rationale: </strong>Hepatic encephalopathy is a brain dysfunction characterised by neurological and psychiatric changes due to liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. The previous version of this updated review meta-analysed data from 16 randomised clinical trials on branched-chain amino acids (BCAAs) versus control interventions, and found that BCAAs did not affect mortality but had a beneficial effect on hepatic encephalopathy. As data on critical outcomes were insufficient and new trials were published, we updated the review again.</p><p><strong>Objectives: </strong>To assess the beneficial and harmful effects of BCAAs versus any control intervention for people with cirrhosis and hepatic encephalopathy.</p><p><strong>Search methods: </strong>We identified trials through manual and electronic searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Latin American and Caribbean Health Science Information database (LILACS), Science Citation Index Expanded, and Conference Proceedings Citation Index - Science. We also searched other resources and contacted experts for additional published and unpublished trials. The latest search date was 12 December 2024.</p><p><strong>Eligibility criteria: </strong>We included randomised clinical trials, irrespective of bias control, language, outcomes reported, or publication status, that compared any form of branched-chain amino acid with no intervention, placebo, diets, non-absorbable disaccharides, antibiotics, or any other intervention with a potential effect on hepatic encephalopathy, in children and adults with overt or minimal hepatic encephalopathy associated with acute or chronic liver disease.</p><p><strong>Outcomes: </strong>The critical outcomes were all-cause mortality, hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and serious adverse events (including nausea and diarrhoea). The important outcomes were quality of life and markers of nutritional status, including serum albumin and nitrogen balance. We evaluated outcomes at the longest available follow-up duration. The longest follow-up was also our primary time point for analysis.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias (RoB) of the critical and important outcomes using the Cochrane RoB 2 tool.</p><p><strong>Synthesis methods: </strong>We used standard Cochrane methodology. We performed meta-analyses, based on intention-to-treat, with risk ratios (RRs) for dichotomous outcomes, standardised mean differences (SMDs) for continuous outcomes in trials using different scales, and mean differences (MDs) for continuous outcomes when trials used the same scales, all with 95% confidence intervals (CI). We conducted the main analysis using a random-effects model. We assessed the overall certainty of the evidence per outcome with
理由:肝性脑病是一种以肝功能不全或门静脉-全身分流引起的神经和精神改变为特征的脑功能障碍。严重程度从轻微症状到昏迷不等。这篇更新的综述的上一版本荟萃分析了来自16项关于支链氨基酸(BCAAs)与对照干预的随机临床试验的数据,发现BCAAs不影响死亡率,但对肝性脑病有有益作用。由于关键结果的数据不足,又有新的试验发表,我们再次更新了综述。目的:评估BCAAs与任何对照干预对肝硬化肝性脑病患者的有益和有害影响。检索方法:我们通过人工和电子检索在Cochrane肝胆对照试验注册库、Cochrane中央对照试验注册库、MEDLINE、Embase、拉丁美洲和加勒比健康科学信息数据库(LILACS)、科学引文索引扩展和会议论文集引文索引-科学中确定试验。我们还检索了其他资源,并联系了其他已发表和未发表试验的专家。最近一次搜索日期是2024年12月12日。入选标准:我们纳入了随机临床试验,无论偏倚对照、语言、报道的结局或发表状态如何,这些试验比较了任何形式的支链氨基酸与无干预、安慰剂、饮食、不可吸收双糖、抗生素或任何其他对肝性脑病有潜在影响的干预,适用于伴有急性或慢性肝病的明显或轻微肝性脑病的儿童和成人。结局:关键结局是全因死亡率、肝性脑病(肝性脑病无改善表现的人数)和严重不良事件(包括恶心和腹泻)。重要的结果是生活质量和营养状况指标,包括血清白蛋白和氮平衡。我们评估了最长随访时间的结果。最长的随访时间也是我们分析的主要时间点。偏倚风险:我们使用Cochrane RoB 2工具评估了关键和重要结局的偏倚风险(RoB)。综合方法:采用标准Cochrane方法学。我们进行了meta分析,基于意向治疗,使用不同量表的二分类结果的风险比(rr),使用不同量表的连续结果的标准化平均差异(SMDs),以及使用相同量表的连续结果的平均差异(MDs),均有95%的置信区间(CI)。我们使用随机效应模型进行主要分析。我们用GRADE方法评估了每个结果证据的总体确定性,包括五个组成部分(偏倚风险、间隔性、异质性、使用最小背景化方法的不精确性和传播偏倚)。纳入研究:我们在本次综述更新中增加了两项新的随机临床试验。因此,在1984年至2023年间发表的18项试验包括934名成年人(平均年龄47至64岁)。我们没有发现儿童试验。参与者有显性肝性脑病(13项试验)和隐性肝性脑病(5项试验)。10项试验评估了口服BCAA补充剂,8项试验评估了静脉注射BCAA。对照组不接受干预或安慰剂(2项试验)、饮食(11项试验)、乳果糖(3项试验)或新霉素(2项试验)。大多数参与者有肝硬化(至少97%)。一项试验包括急性肝炎患者。随访时间从4天到2年(104周)。10项试验在欧洲进行,4项在亚洲进行,2项在美国进行,巴西和澳大利亚各进行一次。三个试验以干预的形式得到了营利性组织的支持。结果综合:与对照干预相比,BCAAs可能对全因死亡率影响很小或没有影响,但证据非常不确定(RR 0.89, 95% CI 0.71至1.12;17项研究,867名受试者;极低确定性证据)。我们没有发现小规模研究效应的证据。所有试验都报道了支链氨基酸对肝性脑病的影响。证据表明,支链氨基酸可减少肝性脑病(RR 0.79, 95% CI 0.64 - 0.96; 18项研究,934名受试者;低确定性证据)。这两种结果的随访时间从4天到2年不等。恶心和腹泻被认为是严重的不良事件,BCAAs组477名参与者中有58名(12%)发生,对照组干预组538名参与者中有16名(3%)发生。关于支链氨基酸对恶心和腹泻的影响,证据非常不确定(RR 2.05, 95% CI 0.40 - 10.58; 6项研究,1015名受试者;极低确定性证据)。 三个试验提供了关于生活质量的数据,但由于使用了记录分数的方法,我们无法对数据进行meta分析。三个试验的所有参与者都有肝硬化,但有些人在基线时没有肝性脑病。当分析仅限于肝性脑病患者时,没有一项试验发现BCAAs对全球36项简短健康调查(SF-36)评分或任何子量表有有益或有害的影响。BCAAs可能对白蛋白浓度影响很小或没有影响(范围12至56周)(MD 0.60, 95% CI -0.90至2.09;I²= 0%;3项研究,176名受试者;非常低确定性证据),但证据不确定。BCAAs对氮平衡的影响(4天至2年)的证据非常不确定(SMD 0.82, 95% CI -1.01至2.64;3项研究,108名参与者;非常低确定性的证据)。由于存在偏倚、间接和不精确的风险,我们降低了证据的确定性。目前正在进行三项试验。作者结论:我们在分析中增加了两个新的试验。有证据表明,支链氨基酸可减少肝性脑病,但证据的确定性较低。由于证据的确定性非常低,我们不知道与对照组相比,支链氨基酸是否对全因死亡率、恶心和腹泻、白蛋白和氮平衡有任何影响。我们无法对生活质量数据进行meta分析。目前还缺乏针对儿童的试验。我们缺乏比较支链氨基酸与不可吸收双糖、利福昔明或其他抗生素等干预措施的随机临床试验。资助:无资助注册:协议(1997):Gluud C, Koretz RL。支链氨基酸治疗肝性脑病(Cochrane综述方案)。Cochrane图书馆,1997,第1期。原评审(2003):doi.org/10.1002/14651858.CD001939评审更新(2015年2月):doi.org/10.1002/14651858.CD001939.pub2评审更新(2015年9月)doi.org/10.1002/14651858.CD001939.pub3评审更新(2017年):doi.org/10.1002/14651858.CD001939.pub4。
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引用次数: 0
Anti-vascular endothelial growth factor (anti-VEGF) agents for neovascular age-related macular degeneration (nAMD): a network meta-analysis. 抗血管内皮生长因子(anti-VEGF)药物治疗新生血管性年龄相关性黄斑变性(nAMD):网络荟萃分析
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-15 DOI: 10.1002/14651858.CD016298
Ersilia Lucenteforte, Sueko M Ng, Rosella Saulle, Geraldine Hoad, Robert Schillinger, Gianni Virgili

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the comparative efficacy and safety of anti-vascular endothelial growth factor (anti-VEGF) agents and their biosimilars for people with neovascular age-related macular degeneration (nAMD), and provide a relative ranking of interventions using network meta-analysis (NMA) methods, considering differences in treatment intensity.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评估抗血管内皮生长因子(anti-VEGF)药物及其生物仿制药对新生血管性年龄相关性黄斑变性(nAMD)患者的相对疗效和安全性,并在考虑治疗强度差异的情况下,使用网络荟萃分析(NMA)方法提供干预措施的相对排名。
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引用次数: 0
Midline catheters versus peripherally inserted central catheters for intravenous therapy in adults. 成人静脉治疗中线置管与外周中心置管的比较。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-15 DOI: 10.1002/14651858.CD016316
Hideto Yasuda, Yutaro Shinzato, Mari Abe, Shinya Miura, Manabu Tomida, Mari Saito, Yusuke Terasaka

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of midline catheters versus PICCs for intravenous therapy in adults.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评估成人静脉注射中线导管与PICCs的利弊。
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引用次数: 0
Surgical interventions for treating vesicovaginal fistula in women. 手术治疗女性膀胱阴道瘘。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-13 DOI: 10.1002/14651858.CD015413
Yoshiyuki Okada, Tomomi Matsushita, Takeshi Hasegawa, Hisashi Noma, Erika Ota, Bob Achila, Yasukuni Yoshimura

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of surgical interventions for treating vesicovaginal fistula in women.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评估手术干预治疗女性膀胱阴道瘘的利弊。
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引用次数: 0
Physiology- versus angiography-guided percutaneous coronary intervention for people with coronary artery disease. 冠状动脉疾病患者经皮冠状动脉介入治疗的生理vs血管造影引导。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-01-12 DOI: 10.1002/14651858.CD016318
Satoshi Higuchi, Noyuri Yamaji, Hisashi Noma, Marie Ito, Yuya Yokota, Erika Ota, Takeshi Hasegawa

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Primary objectives To evaluate the benefits and harms of physiology-guided PCI compared to angiography-guided PCI for cardiovascular events in individuals with CCS and ACS. Secondary objectives To assess potential differences in the effectiveness and safety of physiology-guided PCI according to patient characteristics, including sex and age, from the perspective of equity.

目的:这是Cochrane综述(干预)的一个方案。主要目的评价生理引导下PCI与血管造影引导下PCI治疗CCS和ACS患者心血管事件的利弊。次要目的从公平的角度评估生理引导下PCI治疗根据患者性别、年龄等特征在有效性和安全性方面的潜在差异。
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引用次数: 0
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