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Umbilical cord antiseptics for preventing sepsis and death among newborns. 用于预防新生儿败血症和死亡的脐带防腐剂。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-26 DOI: 10.1002/14651858.CD008635.pub3
Aamer Imdad, Melissa Medina, Chris Cooper, Zulfiqar A Bhutta
<p><strong>Rationale: </strong>The umbilical cord, composed of blood vessels and connective tissue, connects the fetus to the placenta during pregnancy. After birth, the remaining cord stump may serve as an entry point for harmful bacteria, potentially leading to serious infection (neonatal sepsis) and death, particularly in low- and middle-income countries (LMICs). Applying antiseptics - substances that prevent the growth of microorganisms on living tissues - may help reduce the risk of infection through the umbilical stump.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of the application of antiseptics on a newborn's umbilical cord versus no antiseptics for the prevention of morbidity and mortality in infants in low- or middle-income countries (LMICs), and high-income countries (HIC).</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, LILACS and trial registries in December 2025. We checked reference lists of included studies and/or studies/systematic reviews where subject matter related to the intervention or population examined in this review.</p><p><strong>Eligibility criteria: </strong>We included individual and cluster-randomized controlled trials comparing any antiseptic with no antiseptic applied to the umbilical cord of newborns (0 to 28 days of life), regardless of gestational age, birthweight, delivery setting, or maternal infection risk. We excluded studies involving newborns with congenital malformations, quasi-randomized or observational designs, trials comparing different formulations or concentrations of the same antiseptic, and studies involving only topical antibiotics or antiseptic-antibiotic combinations.</p><p><strong>Outcomes: </strong>Our outcomes were all-cause neonatal mortality, omphalitis, and cord separation time. All the outcomes were measured during the neonatal period (i.e. from birth to 28 days of life).</p><p><strong>Risk of bias: </strong>The risk of bias was assessed by using the Cochrane risk of bias tool (RoB 1).</p><p><strong>Synthesis methods: </strong>Two review authors independently assessed studies for inclusion and evaluated the risk of bias. One review author extracted the data, and a second author verified the extraction for accuracy. We analyzed studies conducted in low- and middle-income countries (LMICs) separately from those in high-income countries (HICs), given the differing baseline risks. Where appropriate, we synthesized results using random-effects meta-analysis. We assessed the certainty of the evidence for each outcome using the GRADE approach.</p><p><strong>Included studies: </strong>We included 18 trials in the review (143,150 participants), two studies are awaiting classification and four studies are ongoing trials. The included studies evaluated antiseptics such as 70% alcohol, 4.0% chlorhexidine (CHX), silver sulfadiazine, and povidone iodine in LMICs. In HIC, the studies evaluated CHX and alcohol.</p><p><strong>Synthesis of results: <
原理:脐带由血管和结缔组织组成,在怀孕期间将胎儿与胎盘连接起来。出生后,剩余的脐带残端可能成为有害细菌的入口,可能导致严重感染(新生儿败血症)和死亡,特别是在低收入和中等收入国家。使用防腐剂——一种防止微生物在活组织上生长的物质——可能有助于减少通过脐带残端感染的风险。目的:评价在低收入或中等收入国家(LMICs)和高收入国家(HIC)新生儿脐带上使用防腐剂与不使用防腐剂在预防婴儿发病率和死亡率方面的利与弊。检索方法:检索了2025年12月的CENTRAL、MEDLINE、Embase、LILACS和试验注册库。我们检查了纳入研究和/或研究/系统评价的参考文献列表,这些研究和/或研究/系统评价的主题与本综述中所检查的干预措施或人群相关。入选标准:我们纳入了个体和群体随机对照试验,比较使用任何消毒剂和未使用消毒剂的新生儿脐带(0 - 28天),而不考虑胎龄、出生体重、分娩环境或产妇感染风险。我们排除了涉及先天性畸形新生儿的研究,准随机或观察性设计,比较不同配方或浓度的相同防腐剂的试验,以及仅涉及局部抗生素或防腐剂-抗生素联合的研究。结果:我们的结果是全因新生儿死亡率、脐炎和脐带分离时间。在新生儿期(即从出生到28天)测量所有结果。偏倚风险:使用Cochrane偏倚风险工具(RoB 1)评估偏倚风险。综合方法:两位综述作者独立评估了纳入研究并评估了偏倚风险。一位综述作者提取数据,另一位作者验证提取的准确性。考虑到不同的基线风险,我们将在低收入和中等收入国家(LMICs)和高收入国家(HICs)进行的研究分开分析。在适当的情况下,我们使用随机效应荟萃分析综合结果。我们使用GRADE方法评估每个结果证据的确定性。纳入的研究:我们在综述中纳入了18项试验(143,150名受试者),2项研究正在等待分类,4项研究正在进行试验。纳入的研究评估了中低收入国家使用的防腐剂,如70%酒精、4.0%氯己定(CHX)、磺胺嘧啶银和聚维酮碘。在HIC中,研究评估了CHX和酒精。结果综合:五项基于人群的试验研究了低收入国家CHX的全因死亡率数据,包括129,381名参与者的2280例死亡。综合结果显示,局部应用CHX可使全因新生儿死亡率从18/1000小幅降低至15/1000(平均风险比(RR) 0.86;95%置信区间(CI) 0.73 ~ 1.01;129381名参与者,5项研究;确定性的证据)。在LMIC中进行的CHX研究中,局部应用CHX可能将鼻咽炎的风险从对照组的87/1000降低到CHX组的62/1000 (RR 0.71; 95% CI 0.60至0.85;128,486名受试者,5项研究;中等确定性证据)。与对照组相比,局部应用CHX可能使CHX组脐带分离时间延长1.85天(平均差(MD) 1.85天;95% CI 0.81 ~ 2.90;47,533名参与者,6项研究;中等确定性证据)在中低收入国家进行的研究。一项研究评估了HIC的CHX,但没有报告全因新生儿死亡率数据。关于局部应用CHX预防咽喉炎的证据非常不确定(RR 0.28; 95% CI 0.06至1.35;669名受试者,1项研究;极低确定性证据),表明研究结果应谨慎解释。同样,对脐带分离时间的影响(MD: -0.80; 95% CI -1.21至-0.39;669名参与者,1项研究;极低确定性证据)也非常不确定。中低收入国家的四项研究评估了酒精的局部应用,但没有一项研究报告了全因死亡率的数据。根据两项研究(RR 1.22; 95% CI 0.34 - 4.44; 270名受试者,2项研究;极低确定性证据),局部应用酒精预防咽喉炎的证据非常不确定。酒精对脐带分离时间的影响基于四个试验的数据非常不确定(MD -0.00天;95% CI -1.75至1.75;598名参与者,4项研究;非常低确定性证据)。在HIC中进行的四项研究评估了酒精的局部应用。汇总结果表明,脐带分离时间可能增加1。 酒精组比对照组多63天(MD 1.63天;95% CI 1.11 - 2.15; 2117名受试者,4项研究;中等确定性证据)。在HIC中评估酒精局部应用的四项研究中,没有一项报告了预防全因死亡率或脐炎的数据。总体而言,纳入的研究存在中等风险的选择和流失偏倚,高风险的检测和表现偏倚,以及不明确的报告偏倚风险。作者的结论:在脐带上局部应用4.0%的氯己定可能降低脐带感染的风险,并可能降低中低收入国家的新生儿死亡率,尽管它可能将脐带分离推迟约两天。在高收入国家,氯己定的证据非常不确定。对于70%酒精,来自低收入和中等收入国家的证据在预防感染方面非常不确定,使用70%酒精可能导致脐带分离时间很少或没有差异。在高收入国家,中等确定性的证据表明,酒精可能略微推迟脐带分离。资金来源:Cochrane综述没有专门的资金来源。注册:2010年方案可用doi.org/10.1002/14651858.CD008635 2013年发表审查可用doi.org/10.1002/14651858.CD008635.pub2。
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引用次数: 0
Interactive movement- and mindfulness-based interventions for promoting parent-infant bonding in the postpartum period. 互动运动和正念为基础的干预措施,促进亲子关系在产后时期。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-25 DOI: 10.1002/14651858.CD016340
Tessy Boedt, Katleen Van Der Gucht, Noor de Waal, Anne-Catherine Vanhove, Myrthe Boekhorst

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of interactive movement- and mindfulness-based interventions compared with standard of care, waitlist control, no intervention, or attention control for promoting parent-infant bonding during the postpartum period (birth to 12 months).

目的:这是Cochrane综述(干预)的一个方案。目的如下:在产后(出生至12个月)期间,与标准护理、候补控制、不干预或注意控制相比,评估以互动运动和正念为基础的干预对促进亲子关系的利弊。
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引用次数: 0
Non-clotting factor therapies for preventing bleeds in people with congenital hemophilia A or B. 预防先天性血友病A或B患者出血的非凝血因子疗法。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-24 DOI: 10.1002/14651858.CD014544.pub3
Omotola O Olasupo, Noella Noronha, Megan S Lowe, Derek Ansel, Mihir Bhatt, Davide Matino
<p><strong>Background: </strong>Management of congenital hemophilia A and B is by prophylactic or on-demand replacement therapy with clotting factor concentrates. The effects of newer non-clotting factor therapies such as emicizumab, concizumab, marstacimab, and fitusiran compared with existing standards of care are yet to be systematically reviewed.</p><p><strong>Objectives: </strong>To assess the effects (clinical, economic, patient-reported, and adverse outcomes) of non-clotting factor therapies for preventing bleeding and bleeding-related complications in people with congenital hemophilia A or B compared with prophylaxis with clotting factor therapies, bypassing agents, placebo, or no prophylaxis.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, electronic databases, conference proceedings, and reference lists of relevant articles and reviews. The date of the last search was 16 August 2023.</p><p><strong>Selection criteria: </strong>Randomized controlled trials (RCTs) evaluating people with congenital hemophilia A or B with and without inhibitors, who were treated with non-clotting factor therapies to prevent bleeds.</p><p><strong>Data collection and analysis: </strong>Two review authors independently reviewed studies for eligibility, assessed risk of bias, and extracted data for the primary outcomes (bleeding rates, health-related quality of life (HRQoL), adverse events) and secondary outcomes (joint health, pain scores, and economic outcomes). We assessed the mean difference (MD), risk ratio (RR), 95% confidence interval (CI) of effect estimates, and evaluated the certainty of the evidence using GRADE.</p><p><strong>Main results: </strong>Six RCTs (including 397 males aged 12 to 75 years) were eligible for inclusion. Prophylaxis versus on-demand therapy in people with inhibitors Four trials (189 participants) compared emicizumab, fitusiran, and concizumab with on-demand therapy in people with inhibitors. Prophylaxis using emicizumab likely reduced annualized bleeding rates (ABR) for all bleeds (MD -22.80, 95% CI -37.39 to -8.21), treated bleeds (MD -20.40, 95% CI -35.19 to -5.61), and annualized spontaneous bleeds (MD -15.50, 95% CI -24.06 to -6.94), but did not significantly reduce annualized joint and target joint bleeding rates (AjBR and AtjBR) (1 trial; 53 participants; moderate-certainty evidence). Fitusiran also likely reduced ABR for all bleeds (MD -28.80, 95% CI -40.07 to -17.53), treated bleeds (MD -16.80, 95% CI -25.80 to -7.80), joint bleeds (MD -12.50, 95% CI -19.91 to -5.09), and spontaneous bleeds (MD -14.80, 95% CI -24.90 to -4.71; 1 trial; 57 participants; moderate-certainty evidence). No evidence was available on the effect of bleed prophylaxis using fitusiran versus on-demand therapy on AtjBR. Concizumab may reduce ABR for all bleeds (MD -12.31, 95% CI -19.17 to -5.45), treated bleeds (MD -10.10, 95% CI -17.74 to -2.46), joint blee
背景:先天性血友病A和B的管理是预防性或按需替代治疗与凝血因子浓缩物。较新的非凝血因子疗法,如emicizumab、concizumab、marstacimab和fitusiran,与现有的护理标准相比,其效果尚待系统评价。目的:评估非凝血因子治疗在预防先天性血友病A或B患者出血和出血相关并发症方面的效果(临床、经济、患者报告和不良结局),与预防凝血因子治疗、旁路药物、安慰剂或无预防相比较。检索方法:我们检索了Cochrane囊性纤维化和遗传疾病组的凝血病试验注册、电子数据库、会议记录以及相关文章和综述的参考文献列表。最后一次搜索的日期是2023年8月16日。选择标准:随机对照试验(rct)评估有或没有抑制剂的先天性血友病A或B患者,这些患者接受非凝血因子治疗以预防出血。数据收集和分析:两位综述作者独立地回顾了研究的合格性,评估了偏倚风险,并提取了主要结局(出血率、健康相关生活质量(HRQoL)、不良事件)和次要结局(关节健康、疼痛评分和经济结局)的数据。我们评估了效应估计的平均差值(MD)、风险比(RR)、95%置信区间(CI),并使用GRADE评估了证据的确定性。主要结果:6项rct(包括397名年龄在12 ~ 75岁的男性)符合纳入条件。4项试验(189名受试者)比较了emicizumab、fitusiran和concizumab与抑制剂患者的按需治疗。使用emicizumab预防可能降低所有出血的年化出血率(ABR) (MD -22.80, 95% CI -37.39至-8.21),治疗出血(MD -20.40, 95% CI -35.19至-5.61)和年化自发性出血(MD -15.50, 95% CI -24.06至-6.94),但没有显著降低年化关节和目标关节出血率(AjBR和AtjBR)(1项试验,53名参与者,中等确定性证据)。Fitusiran也可能降低所有出血的ABR (MD -28.80, 95% CI -40.07至-17.53)、治疗出血(MD -16.80, 95% CI -25.80至-7.80)、关节出血(MD -12.50, 95% CI -19.91至-5.09)和自发性出血(MD -14.80, 95% CI -24.90至-4.71;1项试验,57名参与者;中等确定性证据)。没有证据表明使用菲图西兰预防出血与按需治疗对AtjBR的影响。Concizumab可降低所有出血(MD -12.31, 95% CI -19.17至-5.45)、治疗出血(MD -10.10, 95% CI -17.74至-2.46)、关节出血(MD -9.55, 95% CI -13.55至-5.55)和自发性出血(MD -11.96, 95% CI -19.89至-4.03;2项试验;78名受试者;极低确定性证据)的ABR,但不能降低目标关节出血(MD -1.00, 95% CI -3.26至1.26)。Emicizumab预防导致无出血参与者比例增加11.31倍,fitusiran增加12.5倍,concizumab增加6.05倍。使用血友病成人生活质量问卷(haemiophilia Quality Life Questionnaire for Adults, haema - qol)测量的HRQoL,使用emicizumab、fitusiran和concizumab预防后,身体和总健康评分得到改善(低确定性证据)。与按需治疗相比,非凝血因子治疗的非严重不良事件更高,注射部位反应是最常见的不良事件。报告了菲图西兰和古珠单抗的短暂抗药抗体。两项试验(208名受试者)比较了emicizumab和fitusiran与无抑制剂人群的按需治疗。一项试验评估了两种剂量的emicizumab(每周1.5 mg/kg和每两周3.0 mg/kg)。菲图西兰80 mg/月,半蜜珠单抗1.5 mg/kg/周,半蜜珠单抗3.0 mg/kg双周,所有出血、所有治疗出血和关节出血的ABR都可能大幅降低。两种给药方案均未降低AtjBR。未评估菲图西兰预防目标关节出血的效果。非图西兰组(MD -20.21, 95% CI -32.12至-8.30)和双周埃米珠单抗组(MD -15.30, 95% CI -30.46至-0.14)可能减少自发性出血,但埃米珠单抗组(MD -14.60, 95% CI -29.78至0.58)不可能减少自发性出血。与按需治疗相比,emicizumab 1.5 mg/kg/周(50%对0%),emicizumab 3.0 mg/kg双周(40%对0%)和非图西兰预防(40%对5%)后零出血的参与者百分比更高。Emicizumab 1。 与25周时按需治疗相比,5mg /kg/周没有改善haema - qol身体和总健康评分、EQ-5D-5L VAS或效用指数评分(低确定性证据)。Emicizumab 3.0 mg/kg双周治疗可改善HRQoL(由haema - qol身体健康评分测量)(MD为-15.97,95% CI为-29.14至-2.80)和EQ-5D-5L VAS (MD为9.15,95% CI为2.05至16.25;1项试验;43名受试者;低确定性证据)。Fitusiran可能导致HRQoL的改善,表现为hm - a - qol总分(MD -7.06, 95% CI -11.50至-2.62)和身体健康评分(MD -19.75, 95% CI -25.76至-11.94;1项试验,103名参与者;低确定性证据)。在没有抑制剂的受试者中,emicizumab或fitusiran预防与按需治疗相比,严重不良事件的风险也可能没有差异(中等确定性证据)。在4%(3/80)的受试者中报告了短暂的抗药物抗体,对降凝血酶没有观察到的效果。emicizumab不同给药方案的比较发现在出血、安全性或患者报告的结果方面没有差异。在任何研究组中均未报告与治疗相关的癌症或死亡病例。纳入的研究均未评估关节健康、临床关节功能和经济结果的次要结局。纳入的研究均未对marstacimab进行评估。作者的结论:来自随机对照试验的证据表明,与按需治疗相比,使用非凝血因子治疗的预防可以减少出血事件,增加零出血个体的百分比,增加非严重不良事件的发生率,并改善HRQoL。与其他预防方案的比较评估、长期联合结果评估和经济结果评估将改善在出血预防中使用这些疗法的循证决策。
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引用次数: 0
Early intervention for high-risk smoldering multiple myeloma (SMM). 高危阴燃性多发性骨髓瘤(SMM)的早期干预。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-18 DOI: 10.1002/14651858.CD015494.pub2
Po-Huang Chen, Hong-Jie Jhou, Ching-Liang Ho, Hai-Lun Huang, Cho-Hao Lee
<p><strong>Rationale: </strong>Smoldering multiple myeloma (SMM) represents an intermediate stage between monoclonal gammopathy of undetermined significance (MGUS) and active multiple myeloma. Early identification and intervention for people with high-risk SMM may prevent or delay progression to symptomatic disease. Current evidence on the optimal timing and choice of intervention remains controversial, necessitating a systematic evaluation.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of different early interventions compared to observation alone or placebo in people with high-risk smoldering multiple myeloma.</p><p><strong>Search methods: </strong>We searched MEDLINE, Embase, CENTRAL, two clinical trial registries, and conference proceedings up to 1 October 2025.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs) comparing early intervention with observation or placebo in adults with high-risk SMM, defined by validated risk stratification models or International Myeloma Working Group criteria. Eligible interventions included monoclonal antibodies, immunomodulatory agents, alkylating agents, and cytokine inhibitors.</p><p><strong>Outcomes: </strong>Our critical outcome was progression-free survival. Our important outcomes were overall survival, overall adverse events, serious adverse events, and health-related quality of life. We evaluated outcomes at all reported time points, prioritizing the longest available follow-up data.</p><p><strong>Risk of bias: </strong>We used the original Cochrane risk of bias tool (RoB 1) to assess risk of bias in the included RCTs.</p><p><strong>Synthesis methods: </strong>We conducted meta-analyses using a random-effects model, applying the Hartung-Knapp-Sidik-Jonkman (HKSJ) method for pooled analyses where appropriate. We used hazard ratios (HRs) for time-to-event outcomes, odds ratios (ORs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes. For each effect estimate, we calculated the corresponding 95% confidence interval (CI). We assessed heterogeneity using I² statistics, and we assessed the evidence certainty using GRADE methodology.</p><p><strong>Included studies: </strong>We included seven RCTs (1096 participants) evaluating four intervention types: a monoclonal antibody (1 trial, 390 participants), immunomodulatory agents (3 trials, 427 participants), alkylating agents (2 trials, 195 participants), and a cytokine inhibitor (1 trial, 85 participants). Follow-up ranged from 29.2 months to 150 months.</p><p><strong>Synthesis of results: </strong>Monoclonal antibodies versus active monitoring Evidence from one large trial suggests that early intervention with daratumumab compared with active monitoring may reduce the risk of disease progression or death slightly (HR 0.49, 95% CI 0.36 to 0.67; 389 participants; low-certainty evidence) and may also reduce the risk of death slightly (HR 0.52, 95% CI 0.27 to 0.99; 389 part
理由:阴燃型多发性骨髓瘤(SMM)是介于单克隆性γ病(MGUS)和活动性多发性骨髓瘤之间的一个中间阶段。对高危SMM患者的早期识别和干预可以预防或延缓其发展为有症状的疾病。目前关于干预的最佳时机和选择的证据仍然存在争议,需要进行系统的评估。目的:评价与单独观察或安慰剂相比,不同早期干预对高危阴燃性多发性骨髓瘤患者的利与弊。检索方法:检索到2025年10月1日的MEDLINE、Embase、CENTRAL、两个临床试验注册中心和会议记录。入选标准:我们纳入了随机对照试验(rct),比较早期干预与观察或安慰剂对成人高风险SMM的影响,这些高风险SMM由经过验证的风险分层模型或国际骨髓瘤工作组标准定义。合格的干预措施包括单克隆抗体、免疫调节剂、烷基化剂和细胞因子抑制剂。结局:我们的关键结局是无进展生存期。我们的重要结局是总生存、总不良事件、严重不良事件和与健康相关的生活质量。我们评估了所有报告时间点的结果,优先考虑可获得的最长随访数据。偏倚风险:我们使用原始Cochrane偏倚风险工具(RoB 1)来评估纳入的随机对照试验的偏倚风险。综合方法:我们使用随机效应模型进行meta分析,适当时采用hartung - knap - sidik - jonkman (HKSJ)方法进行合并分析。我们使用风险比(hr)来衡量时间到事件的结局,使用优势比(ORs)来衡量二分类结局,使用平均差异(MDs)来衡量连续结局。对于每个效应估计,我们计算了相应的95%置信区间(CI)。我们使用I²统计量评估异质性,并使用GRADE方法评估证据确定性。纳入的研究:我们纳入了7项随机对照试验(1096名受试者),评估了四种干预类型:单克隆抗体(1项试验,390名受试者)、免疫调节剂(3项试验,427名受试者)、烷基化剂(2项试验,195名受试者)和细胞因子抑制剂(1项试验,85名受试者)。随访时间为29.2至150个月。一项大型试验的证据表明,与主动监测相比,早期干预达拉单抗可能会稍微降低疾病进展或死亡的风险(HR 0.49, 95% CI 0.36至0.67;389名参与者;低确定性证据),也可能会稍微降低死亡的风险(HR 0.52, 95% CI 0.27至0.99;389名参与者;低确定性证据)。该药与总体和严重不良事件的风险增加有关,但这些结果的证据非常不确定。非常低确定性的证据表明,达拉单抗与健康相关生活质量的主动监测之间几乎没有差异。免疫调节剂与观察/主动对照这类药物的证据非常不确定,部分原因是来那度胺和沙利度胺之间存在很大的异质性和相互矛盾的结果。汇总分析表明,免疫调节剂和观察/主动对照在无进展生存期、总生存期和健康相关生活质量方面几乎没有差异。由于结果相互矛盾,我们决定不汇总总体和严重不良事件的数据。关于西妥昔单抗与安慰剂在无进展生存期、总体不良反应和严重不良反应方面的影响,一项小型试验的证据非常不确定。该试验没有提供总体生存率或健康相关生活质量的数据。一项较早的试验中,关于melphalan-prednisone对总生存率的影响,与观察结果相比,证据非常不确定。该试验没有提供无进展生存期、总体和严重不良事件或健康相关生活质量的数据。作者的结论是:早期干预达拉单抗可以降低高风险SMM患者疾病进展和死亡率的风险。关于达拉单抗不良事件风险的证据非常不确定。对于免疫调节剂,现有证据的确定性非常低,部分原因是结果相互矛盾,因此我们无法就其作用得出结论。没有足够的证据支持使用较老的药物,如烷基化剂或细胞因子抑制剂。在高风险的SMM患者中,早期治疗的决定需要仔细的、个性化的风险-收益评估和共同决策。资助:本Cochrane综述由三服务总医院(TSGH-D-114168)支持。 注册:协议(2023)DOI: 10.1002/14651858.CD015494。
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引用次数: 0
School food environment interventions for health and sustainability. 促进健康和可持续性的学校食品环境干预措施。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-17 DOI: 10.1002/14651858.CD015882
Anna Leibinger, Nicole Holliday, Carmen Klinger, Xiao Tan, Laura Busert-Sebela, Lukas Schwingshackl, Eva Rehfuess, Solange Durao, Peter von Philipsborn

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Primary objective To assess the effects of interventions that change the school food environment on health, nutritional, and educational outcomes in children aged 2 to 19 years, as well as on sustainability outcomes (food waste and greenhouse gas emissions). Secondary objective To examine how the effectiveness of school food environment interventions varies by schooling level, income level of the country, presence of co-interventions, socioeconomic status, sex/gender, and rurality.

目的:这是Cochrane综述(干预)的一个方案。主要目标评估改变学校食物环境的干预措施对2至19岁儿童的健康、营养和教育成果以及可持续性成果(食物浪费和温室气体排放)的影响。次要目的研究学校食品环境干预措施的有效性如何因学校教育水平、国家收入水平、共同干预措施的存在、社会经济地位、性别/性别和农村而变化。
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引用次数: 0
Digital interventions for improving quality of life and physical function in adults aged 50 and over living with rheumatic and musculoskeletal diseases. 改善50岁及以上患有风湿性和肌肉骨骼疾病的成年人的生活质量和身体功能的数字干预措施。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-16 DOI: 10.1002/14651858.CD016341
Ana Rita Henriques, Carolina Andrade, Sofia Silvério Serra, Teresa Costa, Elsa Mateus, Monserrat Conde, Nuno Mendonça, Diederik De Cock, Ana Maria Rodrigues

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the effectiveness of digital health interventions, compared with usual care, non-digital structured intervention, or no intervention, in improving quality of life and physical function among community-dwelling adults (i.e. people living in the community) aged 50 years or over, diagnosed with osteoarthritis, osteoporosis, low-back pain, rheumatoid arthritis, or polymyalgia rheumatica.

目的:这是Cochrane综述(干预)的一个方案。目标如下:评估数字健康干预措施与常规护理、非数字结构化干预或不干预相比,在改善50岁或以上、诊断为骨关节炎、骨质疏松症、腰痛、类风湿性关节炎或风湿性多肌痛的社区居住成年人(即居住在社区的人)的生活质量和身体功能方面的有效性。
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引用次数: 0
Vagus nerve stimulation to improve post-stroke motor function and activity. 迷走神经刺激改善脑卒中后运动功能和活动。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-13 DOI: 10.1002/14651858.CD015859.pub2
Gauthier Everard, Ita Daryanti Saragih, Jesse Dawson, Dame Elysabeth Tarihoran, Shailesh M Advani, Huey-Ming Tzeng, Bih-O Lee, Geertruida E Bekkering
<p><strong>Rationale: </strong>After a stroke, many people experience persistent upper extremity (UE) motor impairments (that is, deficits in strength, coordination, and muscle tone), which can limit activities such as reaching, grasping, and manipulation. Despite conventional rehabilitation, recovery of UE function often remains limited. Vagus nerve stimulation (VNS), applied invasively or non-invasively (transcutaneously), has been proposed as an adjunct to rehabilitation to enhance neuroplasticity and improve motor outcomes after stroke. While early trials have reported mixed findings, the overall effectiveness and safety of VNS interventions in this context are uncertain.</p><p><strong>Objectives: </strong>To assess the potential benefits and harms of vagus nerve stimulation (VNS) as an add-on treatment to rehabilitate people who have post-stroke UE motor function impairments and activity limitations.</p><p><strong>Search methods: </strong>We searched for published trials in the Cochrane Library, MEDLINE, Embase, Scopus, PsycINFO, CINAHL and PEDro. We also handsearched for reference lists and looked for other relevant studies on Google Scholar. We performed the searches up to May 2025.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that assessed the effect of VNS paired with conventional rehabilitation, compared to conventional rehabilitation alone (or paired with sham VNS) in adults (≥ 18 years) with a first-ever ischaemic or haemorrhagic stroke, at any post-stroke phase.</p><p><strong>Outcomes: </strong>Our critical outcomes were UE motor function and the number of participants with at least one serious adverse event (SAE). Our main important outcomes were UE activity and quality of life.</p><p><strong>Risk of bias: </strong>Two review authors independently screened references, selected studies based on eligibility criteria, extracted data, and assessed the risk of bias in each included study using the Cochrane RoB 2 tool.</p><p><strong>Synthesis methods: </strong>When the studies were sufficiently similar, we synthesised VNS benefits and harms using a fixed-effects model meta-analysis for dichotomous outcomes and a random-effects model for continuous outcomes.</p><p><strong>Included studies: </strong>We included 10 studies with a total of 547 participants that met our inclusion criteria. The included studies took place in China, the UK, the USA, and Italy. All studies were published in peer-reviewed journals. Nine were written in English, and one in Chinese. Three studies applied VNS invasively and seven non-invasively (transcutaneously). All interventions were paired with rehabilitation (motor training) and compared with rehabilitation alone. All studies included both men and women. Most treatments were given in outpatient hospital services or health centres. All studies measured outcomes at short-term (six to 12 weeks after treatment), three studies at medium-term (six months after treatment)
原理:中风后,许多人会经历持续的上肢运动障碍(即力量、协调和肌肉张力的缺陷),这可能会限制诸如伸手、抓握和操作等活动。尽管有常规的康复,但UE功能的恢复往往仍然有限。迷走神经刺激(VNS),有创或无创(经皮)应用,已被提出作为一种辅助康复,以增强中风后神经可塑性和改善运动预后。虽然早期试验报告了不同的结果,但在这种情况下,VNS干预的总体有效性和安全性尚不确定。目的:评估迷走神经刺激(VNS)作为卒中后UE运动功能障碍和活动受限患者康复的附加治疗的潜在益处和危害。检索方法:我们在Cochrane Library、MEDLINE、Embase、Scopus、PsycINFO、CINAHL和PEDro中检索已发表的试验。我们还手工检索了参考文献列表,并在谷歌Scholar上查找了其他相关研究。我们一直搜索到2025年5月。入选标准:我们纳入了随机对照试验(RCTs),这些试验评估了首次缺血性或出血性卒中后任何阶段的成人(≥18岁)中,VNS与常规康复相结合的效果,与常规康复相比较(或与假VNS相结合)。结果:我们的关键结果是UE运动功能和至少发生一次严重不良事件(SAE)的参与者人数。我们的主要结果是UE活动和生活质量。偏倚风险:两位综述作者独立筛选参考文献,根据入选标准选择研究,提取数据,并使用Cochrane RoB 2工具评估每个纳入研究的偏倚风险。综合方法:当研究足够相似时,我们使用固定效应模型对二分类结果进行荟萃分析,使用随机效应模型对连续结果进行综合。纳入的研究:我们纳入了10项研究,共547名受试者,符合我们的纳入标准。纳入的研究在中国、英国、美国和意大利进行。所有的研究都发表在同行评议的期刊上。九封是用英文写的,一封是用中文写的。3项研究采用有创性VNS, 7项研究采用无创(经皮)VNS。所有干预措施都与康复(运动训练)相结合,并与单独的康复进行比较。所有的研究都包括男性和女性。大多数治疗是在门诊医院或保健中心进行的。所有研究都测量了短期(治疗后6至12周)、中期(治疗后6个月)和长期(治疗后12个月)的结果。我们还确定了23项正在进行的研究和14项等待分类的研究。综合结果:与单纯的常规康复相比,VNS联合康复在短期内对UE运动功能的影响的证据非常不确定(SMD 1.22, 95% CI 0.68 ~ 1.77; 10项研究,499名受试者;极低确定性证据)。与单独康复相比,VNS与康复相结合可能导致SAEs的风险增加很少或没有增加(RR 2.38, 95% CI 0.77至7.30;8项研究,416名参与者;低确定性证据)。短期内,与单独康复相比,VNS加康复对UE活动(SMD 0.88, 95% CI -0.09至1.86;6项研究,186名受试者;证据确定性极低)和生活质量(SMD 0.04, 95% CI -0.30至0.37;3项研究,180名受试者;证据确定性极低)的影响的证据非常不确定。对于关键和主要的重要结果,大多数研究总体偏倚风险较高。很少有纳入的研究进行了长期随访测量。作者的结论是:将VNS与康复相结合与单独的康复相比较,我们发现短期内对UE运动功能、UE活动和生活质量的影响证据非常不确定。VNS可能导致很少或没有增加SAEs的风险。由于纳入的研究存在偏倚风险、纳入的研究数量较少以及样本量相对较小,关于VNS的利弊的证据体受到限制。资助:本Cochrane综述未获得任何特定资助。注册:协议(2024)DOI: 10.1002/14651858.CD015859。
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引用次数: 0
Factors predicting adverse perinatal outcomes in women presenting with decreased fetal movements. 预测以胎动减少为表现的妇女不良围产期结局的因素。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-12 DOI: 10.1002/14651858.CD016339
Kristen L Haakons, Samantha Low-Choy, Billie Bradford, Alexander Heazell, Adrienne Gordon, Christine Andrews, Vicki Flenady

Objectives: This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: Primary objective To identify prognostic factors that predict adverse perinatal outcomes in pregnant women at or beyond 24 weeks' gestation presenting with decreased fetal movements (DFM). Secondary objective To determine the predictive value of DFM prognostic factors in different patients (primiparous versus multiparous; ethnic groups; gestational age and maternal age groups), settings (low- and middle-income versus high-income countries; rural versus urban), and presentations (first versus repeat presentations with DFM; DFM duration).

目的:这是Cochrane综述(预后)的一个方案。目的如下:主要目的确定预测以胎动减少(DFM)为表现的妊娠24周或以上孕妇不良围产期结局的预后因素。次要目的:确定DFM预后因素在不同患者(初产与多产、种族、胎龄和产妇年龄)、环境(低收入和中等收入国家与高收入国家、农村与城市)和症状(首次与重复出现DFM、DFM持续时间)中的预测价值。
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引用次数: 0
Retention versus replacement or removal of catheters for people with confirmed or suspected intravascular catheter-related infections. 确认或怀疑血管内导管相关感染的患者留置导管与置换或拔除导管。
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-11 DOI: 10.1002/14651858.CD016329
Junichi Izawa, Nick Daneman, Neill Kj Adhikari, Robert Fowler

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects (benefits and harms) of catheter retention (or delayed removal after an initial catheter retention strategy) compared to prompt catheter replacement or removal in people of all ages with a short- or long-term central venous catheter or any arterial catheter, and either (i) catheter-related or -associated infection, (ii) bloodstream infection from an uncertain source or (iii) sepsis from an uncertain source.

目的:这是Cochrane综述(干预)的一个方案。目的如下:评估导管保留(或在初始导管保留策略后延迟拔除)的效果(益处和危害),与使用短期或长期中心静脉导管或任何动脉导管的所有年龄段的人及时更换或拔除导管,以及(i)导管相关或相关感染,(ii)来源不确定的血液感染或(iii)来源不确定的败血症。
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引用次数: 0
High-intensity interval training for reducing cardiometabolic syndrome in healthy but sedentary populations. 高强度间歇训练减少健康但久坐人群的心脏代谢综合征
IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-03-11 DOI: 10.1002/14651858.CD013617.pub2
Juliette A Strauss, Richard Kirwan, Chathuranga Ranasinghe, Lukas Schwingshackl, Sam O Shepherd, Marty Chaplin, Yanina Sguassero, Jennifer Petkovic, Gemma Villanueva, Kerry Dwan
<p><strong>Rationale: </strong>The estimated global cost of inactivity is USD (US dollar) 53.8 billion. Exercise is a low-cost, effective, and accessible intervention that can reduce cardiovascular disease risk in sedentary populations. However, nearly one-third of adults do not meet the levels of physical activity recommended by the World Health Organization (WHO). WHO guidelines do not include advice for people who wish to undertake high-intensity interval training (HIIT), because it is unclear whether HIIT is an efficacious and acceptable method for sedentary populations to reduce their risk of cardiometabolic syndrome. As lack of time is the most frequently cited barrier to exercise, and HIIT requires a lower time commitment than moderate-intensity continuous training (MICT), this topic warrants a high-quality, non-biased exploration of the literature.</p><p><strong>Objectives: </strong>To assess the benefits and harms of high-intensity interval training (HIIT) on cardiometabolic health in healthy, sedentary adults.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Web of Science Core Collection (SCI-Expanded, SSCi, CPCI-S), and two trial registries up to 13 October 2025.</p><p><strong>Eligibility criteria: </strong>We included randomised control trials (RCTs) that compared HIIT with a non-exercise control (comparison 1) or with MICT (comparison 2) over four weeks or longer in healthy adults (aged 18-64 years) who were sedentary at baseline. We excluded studies of athletes, as we were interested in the benefits of HIIT for public health, not for performance. We also excluded studies of people with overweight (body mass index (BMI) 25-29.9 kg/m²) or obesity (BMI ≥ 30 kg/m²) who were recruited as a result of a medical event or diagnosis.</p><p><strong>Outcomes: </strong>Our main outcomes were cardiorespiratory fitness (measured as maximum oxygen consumption (VO<sub>2max</sub>) or peak oxygen consumption), systolic blood pressure, waist circumference, waist-to-hip ratio, all-cause mortality, circulating triglycerides, and adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tool (Rob 2) to assess the risk of bias in the RCTs.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using a random-effects meta-analysis. We used GRADE to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>Our review included 58 RCTs (2075 participants). Thirty-five studies evaluated HIIT versus MICT, and 11 evaluated HIIT versus no exercise. Twelve studies evaluated HIIT versus MICT versus another control (e.g. no exercise, walking); we included these studies in both comparisons in our review where possible.</p><p><strong>Synthesis of results: </strong>No studies reported all-cause mortality or adverse events. The certainty of the evidence was downgraded for inconsistency, imprecision, and risk of bias (mainly due to lack of detail on randomisation and
理由:据估计,全球不行动的成本为538亿美元。运动是一种低成本、有效和容易获得的干预措施,可以降低久坐人群患心血管疾病的风险。然而,近三分之一的成年人没有达到世界卫生组织(世卫组织)建议的身体活动水平。世卫组织指南不包括对希望进行高强度间歇训练(HIIT)的人的建议,因为目前尚不清楚HIIT对于久坐人群来说是否是一种有效和可接受的降低心脏代谢综合征风险的方法。由于缺乏时间是最常见的运动障碍,而HIIT需要的时间比中等强度连续训练(MICT)更少,因此该主题需要对文献进行高质量,无偏见的探索。目的:评估高强度间歇训练(HIIT)对健康久坐成年人心脏代谢健康的益处和危害。检索方法:检索了截至2025年10月13日的CENTRAL、MEDLINE、Embase、Web of Science Core Collection (SCI-Expanded, SSCi, CPCI-S)和两个试验注册库。入选标准:我们纳入了在基线时久坐的健康成人(18-64岁)中,将HIIT与非运动对照(对照1)或MICT(对照2)进行为期四周或更长时间比较的随机对照试验(rct)。我们排除了运动员的研究,因为我们感兴趣的是HIIT对公众健康的益处,而不是对表现的益处。我们还排除了因医疗事件或诊断而招募的超重(体重指数(BMI) 25-29.9 kg/m²)或肥胖(BMI≥30 kg/m²)人群的研究。结果:我们的主要结果是心肺健康(以最大耗氧量(VO2max)或峰值耗氧量测量)、收缩压、腰围、腰臀比、全因死亡率、循环甘油三酯和不良事件。偏倚风险:我们使用Cochrane偏倚风险工具(Rob 2)来评估随机对照试验的偏倚风险。综合方法:我们使用随机效应荟萃分析综合了每个结果的结果。我们使用GRADE来评估证据的确定性。纳入研究:本综述纳入58项随机对照试验(2075名受试者)。35项研究评估了HIIT与MICT, 11项研究评估了HIIT与不运动。12项研究评估了HIIT、MICT和另一组对照(如不运动、步行);在我们的综述中,我们尽可能将这些研究纳入两种比较。综合结果:没有研究报告全因死亡率或不良事件。由于不一致、不精确和偏倚风险(主要是由于缺乏随机化的细节和没有可用的方案或试验注册),证据的确定性被降低。与非运动对照组相比,高强度间歇训练与非运动对照组相比,可能会增加VO2max测量的心肺健康(平均差(MD) 5.98 mL/min/kg, 95%置信区间(CI) 4.66至7.30;16项研究,517名参与者;中等确定性证据)并降低腰围(MD -3.56 cm, 95% CI -6.14至-0.98;8项研究,270名受试者;高确定性证据)。与非运动对照组相比,HIIT可能导致腰臀比几乎没有差异(MD -0.01, 95% CI -0.03至0.01;6项研究,224名参与者;中等确定性证据),并且可能导致循环甘油三酯几乎没有差异(标准化平均差(SMD) -0.22, 95% CI -0.62至0.17;9项研究,262名受试者;确定性的证据)。HIIT对收缩压影响的证据非常不确定(MD -5.22 mmHg, 95% CI -12.27 - 1.84; 7项研究,215名参与者;非常低确定性证据)。与MICT相比,高强度间歇训练与中强度连续训练HIIT可能导致心肺功能(VO2max)略有增加(MD 1.39 mL/min/kg, 95% CI 0.44至2.34;37项研究,1115名参与者;低确定性证据)。与MICT相比,HIIT可能导致腰围(MD为0.06 cm, 95% CI为-1.49至1.62;15项研究,407名受试者;中等确定性证据)和腰臀比(MD为0.00,95% CI为-0.01至0.02;5项研究,155名受试者;中等确定性证据)差异很小或没有差异。与MICT相比,HIIT可能导致收缩压(MD -0.56 mmHg, 95% CI -3.02至1.90;18项研究,515名参与者;低确定性证据)和循环甘油三酯(SMD 0.00, 95% CI -0.28至0.27;18项研究,526名参与者;低确定性证据)的差异很小或没有差异。作者的结论是:与非运动对照组相比,HIIT可能会增加心肺功能,并略微减少腰围,但我们发现收缩压、腰臀比或循环甘油三酯没有明显差异。 对于循环甘油三酯和收缩压,证据的确定性很低,因此无法得出确切的结论。与MICT相比,HIIT可能会略微增加心肺功能,但我们发现收缩压、腰围、腰臀比或循环甘油三酯没有明显差异。在心肺适能、收缩压和循环甘油三酯方面,证据的确定性较低,因此无法得出确切的结论。两组比较均未报告全因死亡率。没有不良事件的报告,我们不确定这些研究是否积极监测了这些不良事件。我们的分析包括许多研究,但所有研究的参与者都相对较少。有证据表明,对于有心脏代谢疾病风险的久坐人群,HIIT可能是MICT的有效替代方案。为了确定HIIT的长期疗效和有效性,需要更大、更高质量、更长随访时间的随机对照试验。未来的研究应该调查无监督HIIT的可行性和安全性,因为本综述中包括的所有研究都检查了有监督的HIIT干预。资助:本Cochrane综述由国家卫生研究院(NIHR)和外交、联邦和发展部(FCDO)资助(部分)。注册:本Cochrane综述的方案于2020年5月在Cochrane图书馆发表,可通过10.1002/14651858.CD013617获得。
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