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Digital technology for monitoring adherence to inhaled therapies in people with cystic fibrosis. 用于监测囊性纤维化患者吸入治疗依从性的数字技术。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-10 DOI: 10.1002/14651858.CD013733.pub3
Rebecca Calthorpe, Sherie Smith, Nikki Jahnke, Alan R Smyth
<p><strong>Rationale: </strong>Improved understanding and treatment of cystic fibrosis (CF) has led to longer life expectancy, which is accompanied by an increasingly complex regimen of treatments. Suboptimal adherence to the treatment plan, in the context of respiratory disease, is associated with poorer health outcomes. With digital technology being more accessible, it can be used to monitor adherence to inhaled therapies via chipped nebulisers, mobile phone applications and web-based platforms. This technology can allow monitoring of adherence, as well as clinical outcomes, and allow feedback to both the person with CF and their healthcare team.</p><p><strong>Objectives: </strong>To assess the effects of using digital technology to monitor adherence to inhaled therapies and health status in adults and children with CF.</p><p><strong>Search methods: </strong>We searched the Cochrane CF Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched Embase and three clinical trial registries, and checked the references of included studies. The date of last search was 27 February 2025.</p><p><strong>Eligibility criteria: </strong>We searched for randomised controlled trials (RCTs) looking at the effects of digital technology for monitoring adherence to inhaled therapies of children and adults with CF.</p><p><strong>Outcomes: </strong>We assessed available data (at up to three months in one study, and up to 12 months in the second) for adherence to the inhaled treatment, treatment burden, quality of life (QoL) and the change from baseline in forced expiratory volume in one second (FEV<sub>1</sub>). We assessed the number of pulmonary exacerbations by the end of each study.</p><p><strong>Risk of bias: </strong>Using Cochrane's Risk of Bias 2 tool, we assessed the risk of bias within each of the included trials and for each outcome from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome and selection of the reported result.</p><p><strong>Synthesis methods: </strong>Two review authors screened the search results for studies eligible for inclusion in the review and extracted their data. Due to the difference in the studies' interventions, we analysed the data separately. We assessed the overall certainty of the evidence using GRADE.</p><p><strong>Included studies: </strong>We included two studies with 628 participants aged five to 41 years. There was one study in each of two different comparisons.</p><p><strong>Synthesis of results: </strong>Nebuliser target inhalation mode versus standard inhalation mode One parallel study was carried out over 10 weeks after a run-in period of four to six weeks. The study compared the effects of a digitally enhanced inhalation mode (target inhalation mode) for nebulised antibiotics compared to standard mode in children attending a regional CF clinic in the UK. The primary outcome
理由:对囊性纤维化(CF)的理解和治疗的提高导致了预期寿命的延长,这伴随着越来越复杂的治疗方案。在呼吸系统疾病的情况下,对治疗计划的不理想依从性与较差的健康结果相关。随着数字技术更容易获得,它可以通过芯片雾化器、手机应用程序和网络平台来监测吸入疗法的依从性。这项技术可以监测依从性和临床结果,并允许向CF患者及其医疗团队提供反馈。目的:评估使用数字技术监测成人和儿童CF患者吸入治疗依从性和健康状况的效果。检索方法:我们检索了Cochrane CF试验注册表,该注册表由电子数据库检索和手工检索期刊和会议摘要书籍汇编而成。我们还检索了Embase和三个临床试验注册库,并检查了纳入研究的参考文献。最后一次搜索日期是2025年2月27日。入选标准:我们检索了随机对照试验(RCTs),研究数字技术对监测儿童和成人慢性阻塞性肺病患者吸入治疗依从性的影响。结果:我们评估了吸入治疗依从性、治疗负担、生活质量(QoL)和一秒钟用力呼气量(FEV1)从基线变化的可用数据(一项研究长达3个月,另一项研究长达12个月)。在每项研究结束时,我们评估了肺恶化的数量。偏倚风险:使用Cochrane's Risk of bias 2工具,我们评估了每个纳入的试验和随机化过程的每个结果的偏倚风险、预期干预的偏差、缺失的结果数据、结果的测量和报告结果的选择。综合方法:两位综述作者筛选符合纳入综述的研究的搜索结果并提取其数据。由于研究干预的差异,我们对数据进行了单独分析。我们使用GRADE评估证据的总体确定性。纳入的研究:我们纳入了两项研究,共有628名参与者,年龄在5至41岁之间。在两种不同的比较中,每一种都有一项研究。一项平行研究在4至6周的磨合期后进行,为期10周。该研究比较了数字增强吸入模式(目标吸入模式)对雾化抗生素的效果,与在英国参加区域性CF诊所的儿童的标准模式相比。主要结果是完成吸入治疗所需的时间,但研究作者也报告了治疗的依从性。结果显示,采用目标吸入模式可改善依从性(平均差值(MD) 24.0%, 95%可信区间(CI) 2.95 ~ 45.05;1项研究,20名参与者;确定性的证据)。目标吸入方式可能对预测的FEV1 %影响很小或没有影响(MD 1.00%, 95% CI -9.37至11.37;1项研究,20名受试者;低确定性证据)。该研究未报告治疗负担、生活质量或肺恶化。由于样本量小,我们降低了证据的确定性,因为不精确,而且由于研究是在儿童中进行的,结果可能不适用于成人,因此我们降低了证据的间接性。一项大型多中心随机对照试验通过数据跟踪雾化器监测了12个月的依从性。干预组还可以访问基于网络的在线平台CFHealthHub,该平台提供研究作者量身定制的灵活支持,以及他们的依从性数据、教育和解决问题的信息。与常规治疗相比,数字干预可能提高吸入治疗的依从性(MD 18%, 95% CI 12.90至23.10;1项研究,588名参与者;中等确定性证据);可能导致治疗负担轻微减轻(MD 5.10, 95% CI 1.79 - 8.41; 1项研究,539名受试者;中等确定性证据);并可能导致FEV1 %的预测略有改善(MD 3.70%, 95% CI -0.23至7.63;1项研究,556名参与者;低确定性证据)。两组间肺恶化的发生率或生活质量可能几乎没有差异。我们降低了间接证据的确定性,因为干预措施仅在成人人群中进行评估,因此可能不适用于儿童。作者的结论是:数字监测加上通过在线平台的量身定制支持可能在中期提高吸入治疗的依从性并减轻治疗负担(但没有相应的生活质量变化)(低和中等确定性证据)。 在较短的时间内,吸入抗生素的技术增强可能会提高对治疗的依从性(低确定性证据)。两种干预措施对肺功能的影响可能很小或没有影响,在线监测可能对肺恶化没有影响。未来的研究应评估数字技术对儿童和成人吸入治疗依从性的影响。考虑对整个治疗方案的依从性也很重要,因为对吸入疗法的改善依从性可能以对治疗方案其他部分的依从性为代价。资助:原综述由Cochrane基础设施基金支持,该基金来自美国国立卫生研究院(NIHR)。本综述由CF基金会和英国CF信托基金资助的Cochrane CF进行更新。注册:协议(2020)DOI: 10.1002/14651858。CD013733原综述(2023)DOI: 10.1002/14651858.CD013733.pub2。
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引用次数: 0
High-flow nasal cannula oxygen therapy for asthma exacerbation. 高流量鼻插管氧疗治疗哮喘加重。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-09 DOI: 10.1002/14651858.CD016205
Aiko Honda, Yoshitaka Watanabe, Yoshifusa Abe, Sojiro Kusumoto, Takeshi Hasegawa, Hisashi Noma, Erika Ota, Takanori Imai, Noyuri Yamaji, Edward Barroga

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the clinical effectiveness and safety of high-flow nasal cannula (HFNC) oxygen therapy compared with conventional oxygen therapy for the management of asthma exacerbations in children and adults. We will also explore potential equity implications, including differences in access to and outcomes of HFNC oxygen therapy across diverse healthcare settings and populations.

目的:这是Cochrane综述(干预)的一个方案。目的:评价高流量鼻插管(HFNC)氧疗与常规氧疗治疗儿童和成人哮喘加重的临床疗效和安全性。我们还将探讨潜在的公平影响,包括在不同医疗机构和人群中HFNC氧疗的可及性和结果的差异。
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引用次数: 0
Conservative kidney management versus dialysis for stage 5 chronic kidney disease in older people. 保守肾管理与透析治疗老年人5期慢性肾病
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-09 DOI: 10.1002/14651858.CD015151.pub2
Jae Won Yang, Patrizia Natale, Sukyeong Kim, Minjy Kim, Min Soo Jeon, Daeho Yi, Yu Ah Hong, Sungjin Chung, Woo Yeong Park, Young Youl Hyun, Soon Hyo Kwon, Sung Joon Shin, Dong Ah Park, Jimin Kim, Jae Hung Jung, Giovanni Fm Strippoli, Jun Young Lee
<p><strong>Rationale: </strong>The prevalence of kidney failure in people aged 65 years and above is gradually increasing. However, there is insufficient evidence to determine which treatment is better for people with kidney failure, conservative kidney management (CKM) or dialysis.</p><p><strong>Objectives: </strong>We aimed to assess the effects of CKM and dialysis in older people with kidney failure.</p><p><strong>Search methods: </strong>We searched the Cochrane Kidney and Transplant Register of Studies, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and regional databases (LILACS, KoreaMed, CADTH), as well as grey literature repositories up to 22 September 2025.</p><p><strong>Eligibility criteria: </strong>Randomised and non-randomised studies evaluated CKM compared to dialysis in people aged 65 years and above with kidney failure.</p><p><strong>Outcomes: </strong>The critical outcomes included death (any cause), cardiovascular death, cardiovascular events, and health-related quality of life (HRQoL). The important outcomes included overall adverse events, hospitalisation, malnutrition, sarcopenia, and residual kidney function.</p><p><strong>Risk of bias: </strong>Two authors independently performed the risk of bias analysis. We used the 'Risk Of Bias In Non-randomised Studies of Interventions' (ROBINS-I) tool to assess the risk of bias in the included studies.</p><p><strong>Synthesis methods: </strong>Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR), mean difference (MD), or standard mean difference (SMD) with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.</p><p><strong>Included studies: </strong>We included 24 non-randomised studies that involved 26,127 people with kidney failure. These studies compared CKM to dialysis.</p><p><strong>Synthesis of results: </strong>Compared to dialysis, CKM had uncertain effects on death (any cause) (23 studies, 24,628 participants: 813 per 1000 with CKM versus 630 per 1000 with dialysis) (RR 1.28, 95% CI 1.17 to 1.41; I² = 89%; very low-certainty evidence) and cardiovascular death (3 studies, 262 participants: 114 per 1000 with CKM versus 66 per 1000 with dialysis) (RR 1.72, 95% CI 0.68 to 4.34; I² = 0%; very low-certainty evidence). For HRQoL, the Physical Component Summary (PCS) score (2 studies, 186 participants) was on average about 1.46 points lower with CKM compared with dialysis (MD -1.46, 95% CI -12.08 to 9.16; I² = 77%; very low-certainty evidence). The Mental Component Summary (MCS) score (2 studies, 186 participants) was about 2.5 points lower with CKM (MD -2.50, 95% CI -7.82 to 2.82; I² = 19%; very low-certainty evidence). We found no randomised controlled trials. The certainty of evidence from non-randomised studies was very low due to a high risk of bias, because of significant imbalances in prognostic factors that could not be
理由:65岁及以上人群肾衰竭的患病率逐渐增加。然而,没有足够的证据来确定哪种治疗对肾衰竭患者更好,保守肾管理(CKM)或透析。目的:我们旨在评估CKM和透析对老年肾衰竭患者的影响。检索方法:我们检索了Cochrane肾脏和移植研究注册、MEDLINE、Embase、WHO国际临床试验注册平台(ICTRP)、ClinicalTrials.gov和区域数据库(LILACS、KoreaMed、CADTH),以及截至2025年9月22日的灰色文献库。资格标准:随机和非随机研究评估了65岁及以上肾衰竭患者CKM与透析的比较。结局:关键结局包括死亡(任何原因)、心血管死亡、心血管事件和健康相关生活质量(HRQoL)。重要结局包括总体不良事件、住院、营养不良、肌肉减少症和残余肾功能。偏倚风险:两位作者独立进行了偏倚风险分析。我们使用“非随机干预研究的偏倚风险”(ROBINS-I)工具来评估纳入研究的偏倚风险。综合方法:使用随机效应两两荟萃分析总结治疗估计,并以相对危险度(RR)、平均差异(MD)或标准平均差异(SMD)表示,并给出相应的95%置信区间(CI)。证据确定性采用GRADE评估。纳入的研究:我们纳入了24项非随机研究,涉及26127名肾衰竭患者。这些研究比较了CKM和透析。综合结果:与透析相比,CKM对死亡(任何原因)有不确定的影响(23项研究,24,628名参与者:CKM组813 / 1000,透析组630 / 1000)(RR 1.28, 95% CI 1.17 - 1.41; I²= 89%;极低确定性证据)和心血管死亡(3项研究,262名参与者:CKM组114 / 1000,透析组66 / 1000)(RR 1.72, 95% CI 0.68 - 4.34; I²= 0%;极低确定性证据)。对于HRQoL,与透析相比,CKM的物理成分总结(PCS)评分(2项研究,186名参与者)平均低约1.46分(MD -1.46, 95% CI -12.08至9.16;I²= 77%;非常低确定性证据)。CKM患者的心理成分总结(MCS)评分(2项研究,186名受试者)约低2.5分(MD -2.50, 95% CI -7.82至2.82;I²= 19%;非常低确定性证据)。我们没有发现随机对照试验。来自非随机研究的证据的确定性非常低,因为有很高的偏倚风险,因为预后因素的显著不平衡无法完全解决。纳入的研究均未报告心血管事件、营养不良、肌肉减少症、残留肾功能或不良事件。作者的结论是:与透析相比,CKM对死亡(任何原因)、心血管死亡、住院和HRQoL有不确定的影响。资助:由国家循证医疗合作机构(NA21 - 001)支持。注册:协议可通过https://doi.org/10.1002/14651858.CD015151获得。
{"title":"Conservative kidney management versus dialysis for stage 5 chronic kidney disease in older people.","authors":"Jae Won Yang, Patrizia Natale, Sukyeong Kim, Minjy Kim, Min Soo Jeon, Daeho Yi, Yu Ah Hong, Sungjin Chung, Woo Yeong Park, Young Youl Hyun, Soon Hyo Kwon, Sung Joon Shin, Dong Ah Park, Jimin Kim, Jae Hung Jung, Giovanni Fm Strippoli, Jun Young Lee","doi":"10.1002/14651858.CD015151.pub2","DOIUrl":"10.1002/14651858.CD015151.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Rationale: &lt;/strong&gt;The prevalence of kidney failure in people aged 65 years and above is gradually increasing. However, there is insufficient evidence to determine which treatment is better for people with kidney failure, conservative kidney management (CKM) or dialysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;We aimed to assess the effects of CKM and dialysis in older people with kidney failure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We searched the Cochrane Kidney and Transplant Register of Studies, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and regional databases (LILACS, KoreaMed, CADTH), as well as grey literature repositories up to 22 September 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Eligibility criteria: &lt;/strong&gt;Randomised and non-randomised studies evaluated CKM compared to dialysis in people aged 65 years and above with kidney failure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcomes: &lt;/strong&gt;The critical outcomes included death (any cause), cardiovascular death, cardiovascular events, and health-related quality of life (HRQoL). The important outcomes included overall adverse events, hospitalisation, malnutrition, sarcopenia, and residual kidney function.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Risk of bias: &lt;/strong&gt;Two authors independently performed the risk of bias analysis. We used the 'Risk Of Bias In Non-randomised Studies of Interventions' (ROBINS-I) tool to assess the risk of bias in the included studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Synthesis methods: &lt;/strong&gt;Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR), mean difference (MD), or standard mean difference (SMD) with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Included studies: &lt;/strong&gt;We included 24 non-randomised studies that involved 26,127 people with kidney failure. These studies compared CKM to dialysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Synthesis of results: &lt;/strong&gt;Compared to dialysis, CKM had uncertain effects on death (any cause) (23 studies, 24,628 participants: 813 per 1000 with CKM versus 630 per 1000 with dialysis) (RR 1.28, 95% CI 1.17 to 1.41; I² = 89%; very low-certainty evidence) and cardiovascular death (3 studies, 262 participants: 114 per 1000 with CKM versus 66 per 1000 with dialysis) (RR 1.72, 95% CI 0.68 to 4.34; I² = 0%; very low-certainty evidence). For HRQoL, the Physical Component Summary (PCS) score (2 studies, 186 participants) was on average about 1.46 points lower with CKM compared with dialysis (MD -1.46, 95% CI -12.08 to 9.16; I² = 77%; very low-certainty evidence). The Mental Component Summary (MCS) score (2 studies, 186 participants) was about 2.5 points lower with CKM (MD -2.50, 95% CI -7.82 to 2.82; I² = 19%; very low-certainty evidence). We found no randomised controlled trials. The certainty of evidence from non-randomised studies was very low due to a high risk of bias, because of significant imbalances in prognostic factors that could not be ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015151"},"PeriodicalIF":8.8,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12687411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707721","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}
引用次数: 0
Manual therapy with exercise for neck pain. 颈部疼痛的运动疗法。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-09 DOI: 10.1002/14651858.CD011225.pub2
Nejin Chacko, Anita R Gross, Jordan Miller, Pasqualina L Santaguida, Stephen J Burnie, Geoffrey M Gelley, Jean-Philippe Paquin, Mujeeb-Rehman Duranai, Pierre Langevin, Neha Chopra-Tandon, Nga Ting Chak, Jan L Hoving, Pavlos Bobos
<p><strong>Rationale: </strong>Manual therapy and exercise are supported by evidence of effectiveness as single modal interventions for neck pain; however, their combined effect remains unclear.</p><p><strong>Objectives: </strong>To assess the benefits and harms of manual therapy with exercise versus placebo or no treatment for acute to chronic neck pain with or without radicular symptoms or cervicogenic headache in adults.</p><p><strong>Search methods: </strong>We searched multiple databases (CENTRAL, MEDLINE, Embase, CINAHL, Index to Chiropractic Literature, trial registries) together with reference checking and handsearching up to 5 March 2025.</p><p><strong>Eligibility criteria: </strong>We included parallel, cross-over, or cluster-randomised controlled trials (RCTs) in adults with neck pain, which compared manual therapy and exercise with placebo or no treatment. We excluded studies in people with myelopathy or headaches not of cervical origin.</p><p><strong>Outcomes: </strong>Our outcomes were pain intensity, function or disability, health-related quality of life, participant-reported treatment success, and serious or non-serious adverse events, measured at short-term and long-term follow-up.</p><p><strong>Risk of bias: </strong>We used RoB 1 plus an additional six items to assess bias in the included studies.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using meta-analysis or, when not possible, SWiM methods. We used random-effects models to calculate mean differences (MD) or standardised mean differences (SMD) and 95% confidence intervals (CI) for continuous outcomes, and risk ratios (RR) with 95% CI for adverse events. We used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>We included nine RCTs (seven parallel, two cross-over) with a total of 694 participants. Studies were conducted in outpatient settings across North America, Europe, Central Asia, East Asia, and the Pacific. Manual therapy with exercise was compared with placebo (two studies) or no treatment (seven studies). Participants were 76% female, with a mean age of 46 years and mean pain severity of 4.75 on a 0 to 10 scale. Six studies (67%) reported receiving institutional or government funding. The disorder classification included chronic (n = 8) and subacute (n = 1) neck pain.</p><p><strong>Synthesis of results: </strong>The main biases affecting our findings were selection (44%), performance (100%), detection (100%), and reporting bias (78%). Performance bias is an inherent limitation in manual therapy and exercise RCTs, while detection bias was unavoidable due to reliance on self-reported outcomes. All data reflect short-term follow-up (closest to four weeks). Manual therapy with exercise versus placebo (short-term) Manual therapy with exercise may result in: 1) little or no difference in pain, which was a mean of 3.35 with placebo and showed little to no improvement of 0.91 points (95% CI 1.85 better
理论基础:有证据支持手工疗法和运动作为颈部疼痛的单模态干预措施的有效性;然而,它们的综合影响尚不清楚。目的:评估在成人急性到慢性颈部疼痛伴有或不伴有神经根症状或颈源性头痛的情况下,手工运动疗法与安慰剂或不治疗相比的利与弊。检索方法:我们检索了多个数据库(CENTRAL, MEDLINE, Embase, CINAHL, Index to Chiropractic Literature, trial registry),并进行了参考文献检查和手工检索,检索时间截止到2025年3月5日。入选标准:我们纳入了平行、交叉或集群随机对照试验(rct),研究对象为患有颈部疼痛的成人,这些试验将手工治疗和运动与安慰剂或不治疗进行了比较。我们排除了脊髓病或非颈椎源性头痛患者的研究。结果:我们的结果是疼痛强度、功能或残疾、与健康相关的生活质量、参与者报告的治疗成功、严重或非严重不良事件,通过短期和长期随访进行测量。偏倚风险:我们使用RoB 1和另外6个项目来评估纳入研究的偏倚。综合方法:我们使用荟萃分析或在不可能的情况下使用SWiM方法综合每个结局的结果。我们使用随机效应模型来计算连续结局的平均差异(MD)或标准化平均差异(SMD)和95%置信区间(CI),以及不良事件的95% CI的风险比(RR)。我们使用GRADE来评估证据的确定性。纳入的研究:我们纳入了9项随机对照试验(7项平行试验,2项交叉试验),共694名受试者。研究在北美、欧洲、中亚、东亚和太平洋地区的门诊环境中进行。手工运动疗法与安慰剂(2项研究)或不治疗(7项研究)进行比较。参与者中76%为女性,平均年龄为46岁,平均疼痛严重程度为4.75分(0到10分)。六项研究(67%)报告得到了机构或政府的资助。疾病分类包括慢性(n = 8)和亚急性(n = 1)颈部疼痛。结果综合:影响我们研究结果的主要偏倚是选择偏倚(44%)、表现偏倚(100%)、检测偏倚(100%)和报告偏倚(78%)。表现偏倚是手工治疗和运动随机对照试验的固有局限性,而检测偏倚是不可避免的,因为依赖于自我报告的结果。所有数据均反映短期随访(最接近四周)。手工运动疗法与安慰剂(短期)手工运动疗法可能导致:1)疼痛的差异很小或没有差异,安慰剂组的平均值为3.35,在0到10的量表上几乎没有改善0.91点(95% CI 1.85好到0.04差),其中得分越低表明疼痛越少(I²= 0%;2项研究,114名参与者;由于不精确,性能和检测偏差导致的低确定性证据);2)功能适度增加,安慰剂组平均为21.50分,在0到100的量表上改善10.20分(95% CI 16.84更好至3.56更好),其中0表示最佳功能(I²= 0%;2项研究,115名参与者);这代表转换后的数据(SMD 0.77更好,95% CI 1.15更好至0.39更好;由于不精确、性能和检测偏差导致的低确定性证据);3)与健康相关的生活质量改善很少或没有改善,安慰剂组的平均值为52.10,在Short -12 0 - 100量表上略有改善2.00点(95% CI为5.78较好至1.78较差),其中0表示生活质量较好(1项研究,64名参与者;由于不精确、性能和检测偏差导致的低确定性证据)。没有参与者报告的治疗成功和不良反应的数据。手工治疗加运动与不治疗(短期)手工治疗加运动可能导致:1)疼痛大幅度减轻,在0到10的量表上,没有治疗的疼痛平均减轻4.01分,疼痛大幅度减轻2.44分(95% CI 3.23更好至1.65更好),分数越低表明疼痛越少(I²= 66%;7项研究,360名参与者;由于不精确、性能和检测偏差导致的低确定性证据);2)功能的中度改善,在0到100的量表上,未经治疗的平均值为22.38,改善了13.84点(95% CI 25.24 better至2.44 better),其中0表示最佳功能(I²= 92%;5项研究,303名参与者;由于不精确,性能和检测偏差导致的低确定性证据);3)健康相关生活质量的中度改善,在Short -36 0 - 100量表上,未治疗的健康相关生活质量平均为53.60,改善了24.80点(95% CI 31.38 better至18.22 better),其中0表示生活质量改善(1项研究,65名参与者;由于不精确、性能和检测偏差,证据的确定性较低);4)参与者报告的治疗成功(SMD)证据非常不确定。
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引用次数: 0
Medical and surgical interventions for neurotrophic keratopathy. 神经营养性角膜病变的内科和外科治疗。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-05 DOI: 10.1002/14651858.CD015723.pub2
Zanna Kruoch, Adeline Ym Choo, Andrew Kemp, Marcus Gonzales, Tsz Wing Yim, Paul McCann, Su-Hsun Liu, Darren Shu Jeng Ting, Irene C Kuo
<p><strong>Rationale: </strong>Alterations to the corneal nerves can lead to neurotrophic keratopathy (NK), which is marked by breakdown of the corneal epithelium and impaired healing. If untreated, NK can cause severe corneal damage and significant visual impairment. Etiologies include infection, inflammation, chemical or mechanical trauma, systemic disease (e.g. diabetes mellitus), drug toxicity, contact lens overuse, and ophthalmic, neurosurgical, or otolaryngologic surgery. Treatments are often clinician-dependent and include an array of topical medications and surgical techniques to promote re-epithelialization and preserve vision. There is no consensus on the "gold standard" treatment.</p><p><strong>Objectives: </strong>To examine the efficacy and safety of medical and surgical interventions when compared with no treatment, placebo, standard care, or an alternative treatment, for people with neurotrophic keratopathy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PubMed, LILACS, and trial registries on 10 January 2025.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs) in which medical or surgical interventions were compared with no treatment, placebo (e.g. ophthalmic vehicle, normal saline), standard care (e.g. artificial tears, bandage contact lens (BCL)), or an alternative treatment.</p><p><strong>Outcomes: </strong>Our outcomes of interest were corneal re-epithelialization, visual acuity, corneal sensitivity, worsening or relapse of the disease, and adverse events as assessed by investigators. We analyzed most outcome data at one to three months post-intervention; we assessed disease progression at six months or longer, and non-serious and serious adverse events at the longest follow-up time point.</p><p><strong>Risk of bias: </strong>Using Cochrane's risk of bias tool RoB 2, we assessed the risk of bias for outcomes reported in our summary of findings table.</p><p><strong>Synthesis methods: </strong>We performed separate comparisons for medical and surgical interventions. In addition to the qualitative synthesis of included studies, where possible, we conducted fixed-effect meta-analyses, calculating risk ratios (RRs) with 95% confidence intervals (CI) for dichotomous outcomes and mean differences (MDs) and 95% CIs for continuous outcomes. We checked continuous data for skewness. We assessed the certainty of evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included seven parallel-group RCTs with a total of 494 participants (study sample size: 18 to 156 participants; mean age: 25 to 68 years; proportion of female participants: 60% to 77%). Follow-up duration in the studies ranged from 28 days to 18 months. Four studies (57.1%) were multicenter RCTs in the USA and Europe; three studies were conducted in Europe or Asia. Five studies (71.4%) that reported funding sources were industry-sponsored. Six studies compared medical interventions v
理由:角膜神经的改变可导致神经营养性角膜病变(NK),其特征是角膜上皮的破坏和愈合受损。如果不治疗,NK会造成严重的角膜损伤和严重的视力障碍。病因包括感染、炎症、化学或机械创伤、全身性疾病(如糖尿病)、药物毒性、隐形眼镜过度使用以及眼科、神经外科或耳鼻喉外科手术。治疗通常依赖于临床医生,包括一系列局部药物和手术技术,以促进再上皮化和保护视力。对于“金本位”的治疗方法,目前还没有达成共识。目的:研究与不治疗、安慰剂、标准治疗或替代治疗相比,药物和手术干预对神经营养性角膜病变患者的疗效和安全性。检索方法:我们检索了CENTRAL、MEDLINE、Embase、PubMed、LILACS和2025年1月10日的试验注册库。入选标准:我们纳入了随机对照试验(RCTs),其中将药物或手术干预与无治疗、安慰剂(如眼科载体、生理盐水)、标准护理(如人工泪液、绷带接触镜(BCL))或替代治疗进行比较。结果:我们感兴趣的结果是角膜再上皮化、视力、角膜敏感性、疾病恶化或复发以及研究者评估的不良事件。我们分析了干预后一到三个月的大多数结果数据;我们评估了6个月或更长时间的疾病进展,以及最长随访时间点的非严重和严重不良事件。偏倚风险:使用Cochrane的偏倚风险工具RoB 2,我们评估了结果摘要表中报告的结果的偏倚风险。综合方法:我们分别对内科和外科干预进行了比较。除了对纳入的研究进行定性综合外,在可能的情况下,我们进行了固定效应荟萃分析,以95%置信区间(CI)计算二分类结局的风险比(rr),以95%置信区间(CI)计算连续结局的平均差异(md)和95% CI。我们检查了连续数据的偏度。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7个平行组随机对照试验,共494名参与者(研究样本量:18至156名参与者;平均年龄:25至68岁;女性参与者比例:60%至77%)。研究的随访时间从28天到18个月不等。4项研究(57.1%)为美国和欧洲的多中心随机对照试验;三项研究分别在欧洲和亚洲进行。5项研究(71.4%)报告的资金来源是行业赞助的。六项研究比较了医疗干预与眼载体或人工泪液;医学干预包括两种外用生物干预(20 μg/ml重组人神经生长因子(rhNGF; 2项研究)和重组牛碱性成纤维细胞生长因子(rb-bFGF)),以及三种非生物干预(0.1% RGN-259、外用胞胆碱和维生素B12 (Cit-B12)和CACICOL20 (T4020))。一项试验比较了羊膜移植与泪膜修补术或BCL治疗NK。综合结果:六项研究评估了药物干预与载体或人工泪液的对比。两项研究的荟萃分析显示,rhNGF可能略微改善角膜再上皮化(定义为角膜染色< 0.5 mm) (RR 1.88, 95% CI 1.37至2.58;I2 = 0%; 148名参与者;低确定性证据)。同样的两项研究评估了完全的角膜再上皮化(定义为角膜染色< 0.1 mm),发现了相似的结果,但在荟萃分析中存在很大的异质性(RR 2.75, 95% CI 1.82至4.16;I2 = 72%; 148名参与者;低确定性证据)。一项CACICOL20的试验发现,它可能不会增加角膜再上皮化的参与者比例(RR 0.89, 95% CI 0.66至1.19;148名参与者;低确定性证据),而一项0.1% RGN-259的试验发现了相同的结果(RR 9.00, 95% CI 0.57至141.88;18名参与者;低确定性证据)。两项研究的荟萃分析显示rhNGF可能不能改善视力(RR 0.07, 95% CI -0.58 ~ 0.71; I2 = 0%; 151名受试者;低确定性证据)。两项研究的荟萃分析表明,医疗干预,特别是rb-bFGF,可能改善角膜敏感性(MD 8.43, 95% CI 1.90至14.97;I2 = 0%; 60名受试者;极低确定性证据),但证据非常不确定。一项试验显示rhNGF可能不能改善角膜敏感性(MD 1.08, 95% CI -0.32 - 2.48; 33名受试者;极低确定性证据),但这一结果的证据也非常不确定。两项研究叙述性地报道了rhNGF与眼部载体相比较低的疾病复发率。 CACICOL20的一项试验发现,与对照组相比,它可能导致不良事件的风险几乎没有差异(RR 0.98, 95% CI 0.63至1.52;152名参与者;低确定性证据);在两项rhNGF研究的荟萃分析中也发现了类似的结果(RR 1.08, 95% CI 0.62 ~ 1.86; I2 = 0%; 151名受试者;低确定性证据)。只有一项试验评估了手术干预,比较了羊膜移植与泪膜修补术或BCL。羊膜可能对角膜再上皮化的受试者比例(RR 1.10, 95% CI 0.69至1.76;30名受试者;极低确定性证据)或视力改善的影响很小或没有影响(RR 1.40, 95% CI 0.57至3.43;30名受试者;极低确定性证据),但证据非常不确定。在该比较中未报告其他预先指定的结果。作者的结论:神经营养性角膜病变是一种罕见的疾病,其病因多种多样,这对研究设计、参与者招募和客观结果测量的共识提出了挑战。我们的综述发现,关于药物或手术干预对角膜再上皮化、视力和角膜敏感性的影响,证据的确定性很低或非常低。我们降低了证据的确定性,主要是因为不精确,其次是间接、偏倚风险和不一致。鉴于目前的证据和缺乏通用指南,临床医生应该根据临床判断和现有资源进行个体化治疗。我们预计,未来的研究将检验更广泛的干预措施,能够提供更高质量的证据,并产生更结论性的评估。经费:本综述没有内部支持来源。外部来源:美国国立卫生研究院国立眼科研究所;联合王国公共卫生署;英国贝尔法斯特女王大学;伯明翰健康伙伴,英国。注册:协议可通过doi.org/10.1002/14651858.CD015723获得。
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引用次数: 0
Music therapy for end-of-life care. 临终关怀的音乐疗法。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-05 DOI: 10.1002/14651858.CD016311
Jose A Calvache, Daniela Collazos Girón, Isabela Bolaños, Joke Bradt, Cheryl Dileo, Markus Klimek

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of standard care combined with music therapy for the management of physical symptoms and psychosocial outcomes in individuals receiving end-of-life care, compared with (a) standard care alone or (b) standard care plus other non-music interventions To evaluate the relative benefits and harms of different types of music therapy interventions (e.g. music listening, songwriting, or improvisation as part of a structured therapeutic process) for the management of physical symptoms and psychosocial outcomes in individuals receiving end-of-life care.

目的:这是Cochrane综述(干预)的一个方案。目标如下:与(a)单独的标准治疗或(b)标准治疗加其他非音乐干预相比,评估标准治疗结合音乐治疗对接受临终关怀的个体的身体症状和心理社会结果的管理的利弊。评估不同类型的音乐治疗干预(如听音乐、写歌、(或作为结构化治疗过程的一部分的即兴表演)用于管理接受临终关怀的个人的身体症状和心理社会结果。
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引用次数: 0
Acupuncture for insomnia in people with cancer. 针灸治疗癌症患者失眠。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-05 DOI: 10.1002/14651858.CD015177.pub2
Qin Ma, Chunyu Liu, Guozhen Zhao, Shiqi Guo, Hancong Li, Bo Zhang, Bo Li, Zhaolun Cai
<p><strong>Rationale: </strong>Insomnia is a common issue affecting people with cancer. Although acupuncture is widely used as a treatment option for insomnia, its effects on cancer patients require a rigorous and up-to-date evaluation.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of acupuncture for insomnia in people with cancer.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, and five other databases or trial registries in January 2024.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) with a minimum duration of four weeks that evaluated acupuncture (defined as needle insertion at specific acupoints) for treating insomnia in patients with cancer.</p><p><strong>Outcomes: </strong>Our outcomes were insomnia severity measured by the Insomnia Severity Index (ISI), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), adverse events, and sleep diary outcomes including sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE).</p><p><strong>Risk of bias: </strong>We assessed the risk of bias using the RoB 2 tool.</p><p><strong>Synthesis methods: </strong>We performed random-effects meta-analysis to calculate risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CIs). We assessed the certainty of evidence with GRADE and interpreted findings for continuous outcomes against minimally important differences (MIDs).</p><p><strong>Included studies: </strong>We included five studies with 402 participants. The participants were predominantly females with breast cancer, and most were people following primary cancer treatment.</p><p><strong>Synthesis of results: </strong>We identified three comparisons with outcomes assessed at the end of the interventions. We rated the certainty of the evidence as very low-to-moderate, mainly due to risk of bias and the imprecision of effect estimates from the small studies. Acupuncture versus sham acupuncture We are very uncertain about all results due to very low-certainty evidence. Compared to sham acupuncture, acupuncture may have little to no effect on post-intervention ISI scores (MD -3.17, 95% CI -10.39 to 4.05; MID -4.7 points; 2 studies, 152 participants; very low-certainty evidence) and PSQI scores (MD -1.16, 95% CI -3.53 to 1.22; MID -3 points; 2 studies, 152 participants; very low-certainty evidence). Acupuncture may increase the risk of adverse events (RR 2.60, 95% CI 0.98 to 6.90; 1 study, 138 participants; very low-certainty evidence), but this result is very uncertain. Regarding sleep diary outcomes, acupuncture compared with sham acupuncture may improve post-intervention SOL (MD -10.02 min, 95% CI -19.09 to -0.94; MID 20 minutes; 2 studies, 152 participants; very low-certainty evidence) and SE (MD 4.90%, 95% CI 1.98 to 7.82; MID 10%; 2 studies, 152 participants; very low-c
理由:失眠是影响癌症患者的常见问题。虽然针灸作为一种治疗失眠的方法被广泛使用,但它对癌症患者的影响需要一个严格的和最新的评估。目的:评价针刺治疗癌症患者失眠的利与弊。检索方法:检索了2024年1月的CENTRAL、MEDLINE、Embase、PsycINFO等5个数据库或试验注册库。入选标准:我们纳入了至少持续四周的随机对照试验(RCTs),评估针灸(定义为针刺特定穴位)治疗癌症患者失眠的效果。结果:我们的结果是通过失眠严重程度指数(ISI)测量的失眠严重程度,通过匹兹堡睡眠质量指数(PSQI)测量的睡眠质量,不良事件和睡眠日记结果,包括睡眠发作潜伏期(SOL),睡眠发作后醒来(WASO),总睡眠时间(TST)和睡眠效率(SE)。偏倚风险:我们使用RoB 2工具评估偏倚风险。综合方法:我们进行随机效应荟萃分析,以95%可信区间(ci)计算二分类结局的风险比(RR)和连续结局的平均差异(MD)。我们用GRADE评估了证据的确定性,并针对最小重要差异(MIDs)解释了连续结果的结果。纳入的研究:我们纳入了5项研究,共402名受试者。参与者主要是患有乳腺癌的女性,而且大多数是接受了原发性癌症治疗的人。结果综合:我们确定了干预结束时评估结果的三个比较。我们将证据的确定性评级为非常低至中等,主要是由于小研究的偏倚风险和效果估计的不精确。由于证据的确定性非常低,我们对所有结果都非常不确定。与假针灸相比,针灸对干预后ISI评分(MD -3.17, 95% CI -10.39至4.05;MID -4.7分;2项研究,152名受试者;极低确定性证据)和PSQI评分(MD -1.16, 95% CI -3.53至1.22;MID -3分;2项研究,152名受试者;极低确定性证据)的影响可能很小或没有影响。针灸可能增加不良事件的风险(RR 2.60, 95% CI 0.98 - 6.90; 1项研究,138名受试者;极低确定性证据),但这一结果非常不确定。关于睡眠日记结果,与假针相比,针灸可以非常轻微地改善干预后的睡眠质量(MD -10.02 min, 95% CI -19.09 ~ -0.94; MID 20分钟;2项研究,152名受试者;极低确定性证据)和睡眠质量(MD 4.90%, 95% CI 1.98 ~ 7.82; MID 10%; 2项研究,152名受试者;极低确定性证据)。它可能对TST有很大的影响(MD 45.94 min, 95% CI -0.93 ~ 92.80; MID 15 min; 2项研究;152名参与者;极低确定性证据),但这一结果非常不确定。WASO的数据无法获得。结果均未超过MID,且具有统计学意义。由于证据的确定性非常低,我们对所有结果都非常不确定。与非活动对照组相比,针灸可使干预后ISI评分(MD -3.88, 95% CI -7.25至-0.52;MID -4.7分;2项研究,46名受试者;极低确定性证据)和PSQI评分(-2.20,95% CI -3.35至-1.04;MID -3分;3项研究,98名受试者;极低确定性证据)略有降低,但可能增加不良事件的风险(RR 15.49, 95% CI 2.12至113.10;2项研究,76名受试者;极低确定性证据)。关于睡眠日记结果,针灸可略微改善干预后睡眠质量(MD -15.61分钟,95% CI -29.23至-1.99;MID 20分钟;2项研究,46名受试者;极低确定性证据),TST (MD 34.61分钟,95% CI 12.54至56.69;MID 15分钟;2项研究,46名受试者;极低确定性证据)和睡眠质量(MD 5.65, 95% CI 0.99至10.32;MID 10%; 2项研究,46名受试者;极低确定性证据)。然而,它可能导致干预后WASO的差异很小或没有差异(MD 5.70 min, 95% CI -17.25至28.65;1项研究,30名受试者;极低确定性证据)。针灸与认知行为疗法治疗失眠(CBT-I)相比,针灸可能导致干预后ISI评分(MD 2.60, 95% CI 1.13至4.07;1项研究,160名参与者;中等确定性证据)和PSQI评分(MD 1.51, 95% CI 0.51至2.51;1项研究,160名参与者;中等确定性证据)略高(更差)。然而,它可能对不良事件几乎没有影响(RR 1.68, 95% CI 0.59 - 4.79; 1项研究;160名参与者;低确定性证据)。关于睡眠日记结果,与CBT-I相比,针灸可能会使干预后的睡眠质量稍微恶化(MD 16.33 min, 95% CI 8.22 ~ 24)。
{"title":"Acupuncture for insomnia in people with cancer.","authors":"Qin Ma, Chunyu Liu, Guozhen Zhao, Shiqi Guo, Hancong Li, Bo Zhang, Bo Li, Zhaolun Cai","doi":"10.1002/14651858.CD015177.pub2","DOIUrl":"10.1002/14651858.CD015177.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Rationale: &lt;/strong&gt;Insomnia is a common issue affecting people with cancer. Although acupuncture is widely used as a treatment option for insomnia, its effects on cancer patients require a rigorous and up-to-date evaluation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To evaluate the benefits and harms of acupuncture for insomnia in people with cancer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We searched CENTRAL, MEDLINE, Embase, PsycINFO, and five other databases or trial registries in January 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Eligibility criteria: &lt;/strong&gt;We included randomised controlled trials (RCTs) with a minimum duration of four weeks that evaluated acupuncture (defined as needle insertion at specific acupoints) for treating insomnia in patients with cancer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcomes: &lt;/strong&gt;Our outcomes were insomnia severity measured by the Insomnia Severity Index (ISI), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), adverse events, and sleep diary outcomes including sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Risk of bias: &lt;/strong&gt;We assessed the risk of bias using the RoB 2 tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Synthesis methods: &lt;/strong&gt;We performed random-effects meta-analysis to calculate risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CIs). We assessed the certainty of evidence with GRADE and interpreted findings for continuous outcomes against minimally important differences (MIDs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Included studies: &lt;/strong&gt;We included five studies with 402 participants. The participants were predominantly females with breast cancer, and most were people following primary cancer treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Synthesis of results: &lt;/strong&gt;We identified three comparisons with outcomes assessed at the end of the interventions. We rated the certainty of the evidence as very low-to-moderate, mainly due to risk of bias and the imprecision of effect estimates from the small studies. Acupuncture versus sham acupuncture We are very uncertain about all results due to very low-certainty evidence. Compared to sham acupuncture, acupuncture may have little to no effect on post-intervention ISI scores (MD -3.17, 95% CI -10.39 to 4.05; MID -4.7 points; 2 studies, 152 participants; very low-certainty evidence) and PSQI scores (MD -1.16, 95% CI -3.53 to 1.22; MID -3 points; 2 studies, 152 participants; very low-certainty evidence). Acupuncture may increase the risk of adverse events (RR 2.60, 95% CI 0.98 to 6.90; 1 study, 138 participants; very low-certainty evidence), but this result is very uncertain. Regarding sleep diary outcomes, acupuncture compared with sham acupuncture may improve post-intervention SOL (MD -10.02 min, 95% CI -19.09 to -0.94; MID 20 minutes; 2 studies, 152 participants; very low-certainty evidence) and SE (MD 4.90%, 95% CI 1.98 to 7.82; MID 10%; 2 studies, 152 participants; very low-c","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015177"},"PeriodicalIF":8.8,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12679689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676648","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}
引用次数: 0
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). 哌醋甲酯治疗儿童和青少年注意缺陷多动障碍(ADHD)。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-04 DOI: 10.1002/14651858.CD009885.pub4
Ole Jakob Storebø, Maja Rosenberg Overby Storm, Johanne Pereira Ribeiro, Maria Skoog, Camilla Groth, Henriette E Callesen, Julie Perrine Schaug, Pernille Darling, Christel-Mie L Huus, Morris Zwi, Richard Kirubakaran, Erik Simonsen, Christian Gluud
<p><strong>Background: </strong>Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed and treated psychiatric disorders in childhood. Typically, children and adolescents with ADHD find it difficult to pay attention and they are hyperactive and impulsive. Methylphenidate is the psychostimulant most often prescribed, but the evidence on benefits and harms is uncertain. This is an update of our comprehensive systematic review on benefits and harms published in 2015.</p><p><strong>Objectives: </strong>To assess the beneficial and harmful effects of methylphenidate for children and adolescents with ADHD.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, three other databases and two trials registers up to March 2022. In addition, we checked reference lists and requested published and unpublished data from manufacturers of methylphenidate.</p><p><strong>Selection criteria: </strong>We included all randomised clinical trials (RCTs) comparing methylphenidate versus placebo or no intervention in children and adolescents aged 18 years and younger with a diagnosis of ADHD. The search was not limited by publication year or language, but trial inclusion required that 75% or more of participants had a normal intellectual quotient (IQ > 70). We assessed two primary outcomes, ADHD symptoms and serious adverse events, and three secondary outcomes, adverse events considered non-serious, general behaviour, and quality of life.</p><p><strong>Data collection and analysis: </strong>Two review authors independently conducted data extraction and risk of bias assessment for each trial. Six review authors including two review authors from the original publication participated in the update in 2022. We used standard Cochrane methodological procedures. Data from parallel-group trials and first-period data from cross-over trials formed the basis of our primary analyses. We undertook separate analyses using end-of-last period data from cross-over trials. We used Trial Sequential Analyses (TSA) to control for type I (5%) and type II (20%) errors, and we assessed and downgraded evidence according to the GRADE approach.</p><p><strong>Main results: </strong>We included 212 trials (16,302 participants randomised); 55 parallel-group trials (8104 participants randomised), and 156 cross-over trials (8033 participants randomised) as well as one trial with a parallel phase (114 participants randomised) and a cross-over phase (165 participants randomised). The mean age of participants was 9.8 years ranging from 3 to 18 years (two trials from 3 to 21 years). The male-female ratio was 3:1. Most trials were carried out in high-income countries, and 86/212 included trials (41%) were funded or partly funded by the pharmaceutical industry. Methylphenidate treatment duration ranged from 1 to 425 days, with a mean duration of 28.8 days. Trials compared methylphenidate with placebo (200 trials) and with no intervention (12 trials). Only
哌醋甲酯可能与非严重不良事件的风险增加有关,如睡眠问题和食欲下降。然而,所有结果的证据的确定性非常低,因此影响的真实程度仍然不清楚。由于与哌甲酯相关的非严重不良事件的频率,参与者和结果评估者的盲法特别具有挑战性。为了适应这一挑战,应该寻找并使用一种有效的安慰剂。找到这样一种药物可能很困难,但是找到一种可以模仿哌醋甲酯容易识别的副作用的物质,将避免对当前随机试验产生不利影响的解盲。未来的系统评价应该调查从哌甲酯中获益最多和最少的ADHD患者亚组。这可以通过个体参与者的数据来研究预测因素和修饰因素,如年龄、合并症和ADHD亚型。
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引用次数: 0
Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. 孕期补钙预防高血压疾病及相关问题。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-03 DOI: 10.1002/14651858.CD001059.pub6
Catherine A Cluver, Christa Rohwer, Anke C Rohwer
<p><strong>Rationale: </strong>Calcium supplementation may reduce the risk of developing pre-eclampsia, a common cause of serious maternal and neonatal morbidity and death. However, its effectiveness in preventing hypertensive disorders of pregnancy is uncertain. This updates a review last published in 2018.</p><p><strong>Objectives: </strong>To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries to 7 January 2025, and screened reference lists of retrieved studies and relevant systematic reviews.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that compared calcium supplementation during pregnancy with placebo or standard care only. We compared low and high doses. Trials conducted after 2010 had to be prospectively registered. We assessed trustworthiness.</p><p><strong>Outcomes: </strong>Critical outcomes were pre-eclampsia for women and perinatal loss for children. Important outcomes for women included maternal death, maternal death or severe morbidity, adverse effects and preterm delivery before 37 weeks. Important outcomes for children were neonatal death or severe morbidity, stillbirth, and neonatal death.</p><p><strong>Risk of bias: </strong>We assessed risk of bias in RCTs using version 2 of the Cochrane tool (RoB 2).</p><p><strong>Synthesis methods: </strong>Two review authors independently selected trials, extracted data, and assessed bias and trustworthiness. We pooled data using random-effects meta-analysis. We assessed certainty of evidence using GRADE.</p><p><strong>Included studies: </strong>We included 10 RCTs with 37,504 participants. All trials provided standard care. Eight compared calcium supplementation to placebo, and two compared low- to high-dose calcium supplementation. We excluded 20 previously included trials; 11 because eligibility criteria changed and nine because they are awaiting classification due to trustworthiness issues.</p><p><strong>Synthesis of results: </strong>Calcium supplementation versus placebo Calcium may result in little to no difference in pre-eclampsia (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.67 to 1.04; 6 RCTs, 15,364 women; risk difference (RD) 9/1000 fewer, 95% CI 17 fewer to 2 more; low-certainty evidence). Sensitivity analysis excluding small studies (fewer than 500 participants) indicates little to no difference in pre-eclampsia (RR 0.92, 95% CI 0.79 to 1.05; 4 RCTs, 14,730 women; high-certainty evidence). The evidence is very uncertain about the effect of calcium on maternal death (RR 0.33, 95% CI 0.06 to 1.83; 3 RCTs, 9430 women; very low-certainty evidence) and on adverse effects (RR 2.16, 95% CI 0.43 to 10.78; 2 RCTs, 714 women; very low-certainty evidence). Calcium probably results in little to no difference in the composi
理由:补充钙可以降低发生子痫前期的风险,子痫前期是孕产妇和新生儿严重发病和死亡的常见原因。然而,其预防妊娠期高血压疾病的有效性尚不确定。这是对2018年发表的一篇综述的更新。目的:评估妊娠期补钙对妊娠期高血压疾病及相关母婴结局的影响。检索方法:检索截至2025年1月7日的CENTRAL、MEDLINE、Embase等4个数据库和2个试验注册库,筛选已检索研究的参考文献列表和相关系统评价。入选标准:我们纳入了随机对照试验(RCTs),将孕期补钙与安慰剂或标准护理进行比较。我们比较了低剂量和高剂量。2010年以后进行的试验必须进行前瞻性登记。我们评估了可信度。结局:关键结局为妇女先兆子痫和儿童围产期损失。妇女的重要结局包括产妇死亡、产妇死亡或严重发病率、不良反应和37周前早产。儿童的重要结局是新生儿死亡或严重发病率、死产和新生儿死亡。偏倚风险:我们使用Cochrane工具第2版(RoB 2)评估了rct的偏倚风险。综合方法:两位综述作者独立选择试验,提取数据,评估偏倚和可信度。我们使用随机效应荟萃分析汇总数据。我们使用GRADE评估证据的确定性。纳入研究:纳入10项随机对照试验,共37,504名受试者。所有试验均提供标准护理。8组比较钙补充剂和安慰剂,2组比较低剂量和高剂量钙补充剂。我们排除了20个先前纳入的试验;11个是因为资格标准发生了变化,9个是因为可信度问题而等待分类。结果综合:钙补充剂与安慰剂钙可能导致子痫前期差异很小或没有差异(风险比(RR) 0.83, 95%可信区间(CI) 0.67至1.04;6项随机对照试验,15364名女性;风险差(RD)减少9/1000,95% CI减少17至增加2;确定性的证据)。排除小型研究(少于500名受试者)的敏感性分析表明,先兆子痫的差异很小或没有差异(RR 0.92, 95% CI 0.79至1.05;4项随机对照试验,14,730名女性;高确定性证据)。钙对孕产妇死亡的影响(RR 0.33, 95% CI 0.06 - 1.83; 3项随机对照试验,9430名妇女;极低确定性证据)和不良反应(RR 2.16, 95% CI 0.43 - 10.78; 2项随机对照试验,714名妇女;极低确定性证据)的证据非常不确定。钙可能导致产妇死亡或严重发病率的综合结果几乎没有差异(RR 0.80, 95% CI 54至1.19;1项RCT, 8312名妇女;中等确定性证据),并且可能导致围产期损失几乎没有差异(RR 0.93, 95% CI 0.64至1.35;4项RCT, 6832名妇女;RD减少1/1000,95% CI 6少至6多;低确定性证据)。关于钙对37周前早产的影响,证据非常不确定(RR 0.83, 95% CI 0.65 ~ 1.05; 6项随机对照试验,15,074名妇女;非常低确定性证据)。排除小型研究的敏感性分析显示37周前早产差异不大或无差异(RR 0.97, 95% CI 0.85至1.11;4项随机对照试验,14,429名妇女;高确定性证据)。钙可能导致死产的差异很小或没有差异(RR 0.91, 95% CI 0.72至1.15;4项随机对照试验,14,085名妇女;中等确定性证据),但其对新生儿死亡的影响证据非常不确定(RR 1.09, 95% CI 0.50至2.38;4项随机对照试验,13,300名妇女;非常低确定性证据)。没有试验测量新生儿死亡或严重发病率。低剂量钙与高剂量钙在子痫前期可能几乎没有差异(RR 0.96, 95% CI 0.73 - 1.25; 2项随机对照试验,22,000名女性;低确定性证据)。关于低剂量与高剂量钙对孕产妇死亡的影响的证据非常不确定(RR 1.20, 95% CI 0.36至3.94;2项随机对照试验,22,000名妇女;极低确定性证据)。低剂量钙和高剂量钙在围产期损失(RR 1.02, 95% CI 0.91至1.16;2项随机对照试验,21,412名妇女;高确定性证据)和死产(RR 0.99, 95% CI 0.84至1.16;2项随机对照试验,21,131名妇女;高确定性证据)方面几乎没有差异。低剂量钙和高剂量钙在37周前早产中可能几乎没有差异(RR 0.98, 95% CI 0.81至1.17;2项随机对照试验,20,578名妇女;中等确定性证据)。没有试验测量产妇死亡或严重发病率、不良反应、新生儿死亡或严重发病率或新生儿死亡。 作者的结论:补钙与安慰剂荟萃分析显示,与安慰剂相比,补钙对先兆子痫的影响可能很小或没有差异,但我们非常不确定其对37周前早产的影响。然而,只有大型试验的敏感性分析(主要分析中95%的参与者)的高确定性证据显示,在37周之前的子痫前期和早产方面几乎没有差异。产妇死亡非常罕见,因此有关的证据非常不确定。补充钙可能对产妇死亡或严重发病率的综合结果几乎没有影响,可能对围产期损失几乎没有影响,可能对死产几乎没有影响。关于不良反应和新生儿死亡的证据非常不确定。没有试验测量新生儿死亡或严重发病率。基线钙摄入水平和先兆子痫风险状态对我们的研究结果没有影响。低剂量与高剂量补钙低剂量与高剂量补钙对低钙摄入人群中子痫前期高风险妇女的预后没有差异。低剂量补钙对子痫前期的影响微乎其微。产妇死亡(每10 000名妇女中有5人死亡)很罕见;证据非常不确定。低剂量钙对围产期损失和死产的影响微乎其微,对37周前早产的影响微乎其微。没有试验测量严重的产妇发病率、新生儿死亡、严重的新生儿发病率或不良反应。经费:本综述由世界卫生组织部分资助。注册:更新协议(2024)PROSPERO: CRD42024623889 Review update (2018) DOI: 10.1002/14651858.CD001059。pub5原综述(2002)DOI: 10.002 /14651858. cd001059。
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引用次数: 0
Robotic-assisted thoracoscopic surgery lobectomy versus open or video-assisted thoracoscopic surgery lobectomy for early-stage non-small cell lung cancer. 机器人辅助胸腔镜肺叶切除术与开放或视频辅助胸腔镜肺叶切除术治疗早期非小细胞肺癌。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-12-02 DOI: 10.1002/14651858.CD016158
Eduardo I Leão, Aline Rocha, Ana Carolina Pereira Nunes Pinto, Diego Adão, Humberto Saconato

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Objective 1: to assess the effects of robotic-assisted thoracoscopic surgery lobectomy versus conventional open lobectomy or video-assisted thoracoscopic surgery lobectomy in people with early-stage non-small cell lung cancer (NSCLC). Objective 2: to appraise full economic evaluations comparing robotic-assisted thoracoscopic surgery with open lobectomy or video-assisted thoracoscopic surgery lobectomy for early-stage NSCLC by extracting data on resource use, costs, utilities, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) from societal and healthcare perspectives.

目的:这是Cochrane综述(干预)的一个方案。目的1:评估机器人辅助胸腔镜肺叶切除术与传统开放肺叶切除术或视频辅助胸腔镜肺叶切除术在早期非小细胞肺癌(NSCLC)患者中的效果。目的2:通过从社会和医疗保健角度提取资源利用、成本、效用、质量调整生命年(QALYs)和增量成本-效果比(ICERs)的数据,对机器人辅助胸腔镜手术与开放肺叶切除术或视频辅助胸腔镜肺叶切除术治疗早期非小细胞肺癌的全面经济评价进行比较。
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引用次数: 0
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Cochrane Database of Systematic Reviews
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