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Cochrane in context: Interventions for treating femoral shaft fractures in children and adolescents 儿童和青少年股骨干骨折的干预治疗
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1983
Vrisha Madhuri, Abhay Gahukamble
Cochrane Review: Interventions for treating femoral shaft fractures in children and adolescents Madhuri V, Dutt V, Gahukamble AD, Tharyan P. Interventions for treating femoral shaft fractures in children and adolescents. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD009076. DOI: 10.1002/14651858.CD009076.pub2. This companion piece to the review, “Interventions for treating femoral shaft fractures in children and adolescents,” contains the following pieces: The abstract of the review A commentary from one or more of the review authors, explaining why the review team felt the review was an important one to produce Some other recently published references on this topic
Madhuri V, Dutt V, Gahukamble AD, Tharyan P.治疗儿童和青少年股骨干骨折的干预措施。Cochrane Database of Systematic Reviews 2014,第7期。艺术。不。: CD009076。cd009076.pub2 DOI: 10.1002/14651858.。这篇综述的配套文章“儿童和青少年股骨干骨折的干预治疗”包含以下文章:
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引用次数: 3
Inhaled corticosteroids in children with persistent asthma: effects on growth 持续性哮喘儿童吸入皮质类固醇:对生长的影响
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1988
Linjie Zhang, Sílvio OM Prietsch, Francine M Ducharme

Background

Treatment guidelines for asthma recommend inhaled corticosteroids (ICS) as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, the potential systemic adverse effects related to regular use of these drugs have been and continue to be a matter of concern, especially the effects on linear growth.

Objectives

To assess the impact of ICS on the linear growth of children with persistent asthma and to explore potential effect modifiers such as characteristics of available treatments (molecule, dose, length of exposure, inhalation device) and of treated children (age, disease severity, compliance with treatment).

Search methods

We searched the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED and PsycINFO; we handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases to look for potential relevant unpublished studies. The literature search was conducted in January 2014.

Selection criteria

Parallel-group randomised controlled trials comparing daily use of ICS, delivered by any type of inhalation device for at least three months, versus placebo or non-steroidal drugs in children up to 18 years of age with persistent asthma.

Data collection and analysis

Two review authors independently performed study selection, data extraction and assessment of risk of bias in included studies. We conducted meta-analyses using the Cochrane statistical package RevMan 5.2 and Stata version 11.0. We used the random-effects model for meta-analyses. We used mean differences (MDs) and 95% CIs as the metrics for treatment effects. A negative value for MD indicates that ICS have suppressive effects on linear growth compared with controls. We performed a priori planned subgroup analyses to explore potential effect modifiers, such as ICS molecule, daily dose, inhalation device and age of the treated child.

Main results

We included 25 trials involving 8471 (5128 ICS-treated and 3343 control) children with mild to moderate persistent asthma. Six molecules (beclomethasone dipropionate, budesonide, cicl

背景:哮喘治疗指南推荐将吸入皮质类固醇(ICS)作为儿童持续性哮喘的一线治疗。虽然ICS治疗在儿童中通常被认为是安全的,但与经常使用这些药物相关的潜在全身不良反应一直是并将继续是一个令人关注的问题,特别是对线性生长的影响。目的评估ICS对持续性哮喘儿童线性生长的影响,并探讨潜在的影响调节因素,如现有治疗方法(分子、剂量、暴露时间、吸入装置)和治疗儿童(年龄、疾病严重程度、治疗依从性)的特征。检索方法检索Cochrane Airways Group specialized Register of trials (CAGR),该数据库来源于CENTRAL、MEDLINE、EMBASE、CINAHL、AMED和PsycINFO等文献数据库的系统检索;我们手工检索呼吸期刊和会议摘要。我们还对ClinicalTrials.gov和制造商的临床试验数据库进行了搜索,以寻找潜在的相关未发表的研究。文献检索于2014年1月进行。选择标准:平行组随机对照试验比较18岁以下持续性哮喘儿童每日使用ICS(通过任何类型的吸入装置输送)与安慰剂或非甾体类药物至少三个月的疗效。两位综述作者独立进行了纳入研究的研究选择、数据提取和偏倚风险评估。我们使用Cochrane统计软件包RevMan 5.2和Stata version 11.0进行meta分析。我们使用随机效应模型进行meta分析。我们使用平均差异(md)和95% ci作为治疗效果的指标。MD为负值表明与对照相比,ICS对线性生长有抑制作用。我们进行了一个先验的计划亚组分析,以探索潜在的效果调节剂,如ICS分子、日剂量、吸入装置和治疗儿童的年龄。我们纳入了25项试验,涉及8471例(5128例ics治疗组和3343例对照组)轻度至中度持续性哮喘儿童。六种分子(二丙酸倍氯米松、布地奈德、环莱索内德、氟尼索内德、丙酸氟替卡松和糠酸莫米松)每日低剂量或中等剂量,使用时间为3个月至4至6年。大多数试验是盲法的,超过一半的试验退出率超过20%。与安慰剂或非甾体类药物相比,ICS在线性生长速度(14项试验,5717名受试者,MD -0.48 cm/y, 95% CI -0.65至-0.30,中等质量证据)和身高从基线变化(15项试验,3275名受试者;MD为-0.61 cm/y, 95% CI为-0.83至-0.38,证据质量中等)。亚组分析显示,6个分子治疗1年期间线性生长速度的平均降低量组间差异有统计学意义(Chi2 = 26.1,自由度(df) = 5, P值<0.0001)。即使分析仅限于使用相当于200 μg/d的氢氟烷烃(HFA)-倍氯米松剂量的试验,组间差异仍然存在。亚组分析显示,在一年的治疗期间,日剂量(低剂量vs中剂量)、吸入装置或参与者年龄对ics诱导的线性生长速度抑制的程度没有统计学意义。然而,需要进行头对头比较来评估不同药物分子、剂量、吸入装置或患者年龄的影响。在治疗的第二年,接受ICS治疗的参与者和对照组之间的线性生长速度没有统计学上的显著差异(5项试验,3174名参与者;MD -0.19 cm/y, 95% CI -0.48 ~ 0.11, P值0.22)。在两项报告治疗第三年线性生长速度的试验中,一项涉及667名参与者的试验显示布地奈德组和安慰剂组之间的生长速度相似(5.34 cm/y vs 5.34 cm/y),另一项涉及1974名参与者的试验显示布地奈德组的生长速度比安慰剂组低(MD -0.33 cm/y, 95% CI -0.52至-0.14,P值0.0005)。 在四个报告治疗停止后线性增长数据的试验中,三个没有描述ICS组在治疗停止后2至4个月的统计学显著追赶增长。一项试验显示,在停止治疗12个月后,氟替卡松组的线性生长速度加快,但在三年试验结束时,氟替卡松组和安慰剂组的身高仍有0.7厘米的统计学差异。一项随访至成年期的试验显示,与接受安慰剂治疗的参与者相比,接受布地奈德400 μg/d治疗平均持续4.3年的青春期前参与者的成人身高平均降低1.20厘米(95% CI -1.90至-0.50)。作者的结论是,在轻度至中度持续性哮喘儿童的一年治疗期间,定期使用低或中等日剂量的ICS与线性生长速度平均降低0.48 cm/y和身高较基线变化0.61 cm相关。ICS对线性生长速度的影响大小似乎与ICS分子的关系比与装置或剂量(低至中剂量范围)的关系更强。ics诱导的生长抑制似乎在治疗的第一年是最大的,在随后的几年治疗中不太明显。然而,需要进一步的研究来更好地描述生长抑制的分子依赖性,特别是新分子(莫米松、环莱奈德),以明确分子、日剂量、吸入装置和患者年龄对ICS效应大小的各自作用,并确定持续哮喘儿童数年的ICS治疗的生长抑制效果。吸入糖皮质激素是否会降低持续性哮喘患儿的生长发育?回顾问题:我们回顾了吸入皮质类固醇(ICS)是否会影响患有持续性哮喘的儿童生长的证据,持续性哮喘是指需要定期使用药物控制症状的更严重的哮喘。背景:哮喘治疗指南推荐ICS作为儿童持续性哮喘的一线治疗。虽然ICS治疗通常被认为对儿童是安全的,但家长和医生总是担心ICS对生长的潜在负面影响。检索日期:我们检索了2014年1月之前发表的试验。研究特点:我们纳入了本综述试验,比较了18岁以下持续性哮喘儿童每日使用皮质类固醇(通过任何类型的吸入装置给予至少三个月)与安慰剂或非类固醇药物的疗效。主要结果:本综述纳入了25项试验,涉及8471例轻中度持续性哮喘儿童(5128例接受ICS治疗,3343例接受安慰剂或非甾体类药物治疗)。80%的试验在两个以上不同的中心进行,被称为多中心研究;五项是在非洲、亚太、欧洲和美洲的高收入和低收入国家进行的国际多中心研究。68%的人得到了制药公司的财政支持。荟萃分析(一种结合多项研究结果并提供高水平证据的统计技术)表明,在治疗的第一年,每天接受ICS治疗的儿童每年的生长可能比未接受这些药物治疗的儿童少大约半厘米。ics相关生长减少的幅度可能取决于药物的类型。生长减少似乎在治疗的第一年是最大的,在随后的几年治疗中不太明显。本综述提供的证据使我们得出这样的结论:对于18岁以下患有持续性哮喘的儿童,每天使用ICS可导致身高的小幅下降;与这些药物对哮喘控制的已知益处相比,这种效果似乎微不足道。证据质量:25项试验中有11项没有报告他们如何保证参与者有相同的机会接受ICS或安慰剂或非甾体类药物。除了6项试验外,其他试验都没有报告研究人员如何不知道治疗分配清单。然而,这种方法学上的限制可能不会显著影响证据的质量,因为当我们从分析中排除这些试验时,结果几乎没有变化。
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引用次数: 97
A meta-epidemiological study to examine the association between bias and treatment effects in neonatal trials 一项荟萃流行病学研究,旨在检查新生儿试验中偏倚与治疗效果之间的关系
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1985
Liza Bialy, Ben Vandermeer, Thierry Lacaze-Masmonteil, Donna M. Dryden, Lisa Hartling

Background:

Randomized controlled trials are considered the gold standard for evidence on therapeutic interventions; however, they are susceptible to bias. The objectives of this observational study were to describe the methodological quality of neonatal randomized controlled trials and quantify the bias related to specific methodological and study-level characteristics.

Methods:

Twenty-five systematic reviews yielding 208 neonatal trials were included. Two independent reviewers assessed risk of bias (RoB) on seven domains consisting of nine items. For each domain, meta-analyses with at least one high/unclear and one low risk study were included in the analysis. For the primary outcome within each meta-analysis a ratio of odds ratios with a 95% confidence interval was generated. The ratio of odds ratios for each meta-analysis were combined using meta-analytic techniques with inverse-variance weighting and a random effects model to obtain a summary ratio of odds ratio.

Results:

None of the studies had an overall low RoB. Most studies had a low RoB for the domain of incomplete outcome data (89%), while 63%, 55% and 46% of trials had low RoB for sequence generation, other sources of bias, and blinding of outcome assessors, respectively. For all other domains (allocation concealment, blinding of parents and investigators and selective outcome reporting), the majority of trials were assessed as unclear. Selective outcome reporting was rated as unclear RoB for 55% and high for 42% of studies. The only domain that showed a statistically significant association with the treatment effect was selective outcome reporting: trials at unclear/high risk of bias for this domain significantly overestimated the treatment effects compared with those assessed at low risk of bias (ROR = 1.87, 95% confidence interval: 1.26–2.78).

Conclusions:

This observational study of a sample of neonatal trials showed that most were at high risk of bias, indicating that there is room for improvement in the design, conduct and reporting of neonatal trials to ensure valid results for the most clinically important outcomes. We did not find an association between most risk of bias domains and effect estimates; however, we found that randomized controlled trials at high risk for selective outcome reporting were associated with overestimates of treatment benefits. These results need to be confirmed in larger samples.

背景:随机对照试验被认为是治疗干预证据的金标准;然而,他们很容易受到偏见的影响。本观察性研究的目的是描述新生儿随机对照试验的方法学质量,并量化与特定方法学和研究水平特征相关的偏倚。方法:纳入25项系统综述,共208项新生儿试验。两名独立审稿人评估了七个领域包括九个项目的偏倚风险(RoB)。对于每个领域,至少包含一项高/不清楚风险研究和一项低风险研究的荟萃分析被纳入分析。对于每个荟萃分析中的主要结果,产生具有95%置信区间的比值比。各荟萃分析的优势比采用反方差加权的荟萃分析技术和随机效应模型进行组合,得到优势比的汇总比。结果:没有一项研究的总体RoB较低。大多数研究在不完整结果数据领域的RoB较低(89%),而分别有63%、55%和46%的试验在序列生成、其他偏倚来源和结果评估者的盲化方面的RoB较低。对于所有其他领域(分配隐藏,家长和研究者的盲法和选择性结果报告),大多数试验被评估为不明确。55%的选择性结局报告被评为不明确的罗伯,42%的研究被评为高罗伯。唯一显示与治疗效果有统计学显著关联的领域是选择性结局报告:与低偏倚风险评估相比,该领域偏倚不明确/高风险的试验显著高估了治疗效果(ROR = 1.87, 95%置信区间:1.26-2.78)。结论:这项对新生儿试验样本的观察性研究显示,大多数试验存在高偏倚风险,这表明新生儿试验的设计、实施和报告都有改进的空间,以确保最重要的临床结果的有效。我们没有发现大多数偏倚风险域和效应估计之间存在关联;然而,我们发现选择性结果报告高风险的随机对照试验与治疗益处的高估有关。这些结果需要在更大的样本中得到证实。
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引用次数: 25
Cochrane in context: Inhaled corticosteroids in children with persistent asthma: effects on growth and dose–response effects on growth 持续性哮喘儿童吸入皮质类固醇:对生长的影响和对生长的剂量反应效应
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1984
Linjie Zhang, Aniela I. Pruteanu, Sílvio O. M. Prietsch, Bhupendrasinh F. Chauhan, Francine M. Ducharme

Cochrane Review: Inhaled corticosteroids in children with persistent asthma: effects on growth Zhang L, Prietsch SOM, Ducharme FM. Inhaled corticosteroids in children with persistent asthma: effects on growth. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD009471. DOI: 10.1002/14651858.CD009471.pub2

Cochrane Review: Inhaled corticosteroids in children with persistent asthma: dose-response effects on growth Pruteanu AI, Chauhan BF, Zhang L, Prietsch SOM, Ducharme FM. Inhaled corticosteroids in children with persistent asthma: dose–response effects on growth. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD009878. DOI: 10.1002/14651858.CD009878.pub2

This companion piece to the reviews, “Inhaled corticosteroids in children with persistent asthma: effects on growth” and “Inhaled corticosteroids in children with persistent asthma: dose–response effects on growth,” contains the following pieces:

Cochrane综述:吸入性皮质类固醇对儿童持续性哮喘生长的影响。持续性哮喘儿童吸入皮质类固醇:对生长的影响。Cochrane Database of Systematic Reviews 2014,第7期。艺术。不。: CD009471。cd009471 DOI: 10.1002/14651858.。pub2Cochrane综述:吸入性糖皮质激素对儿童持续性哮喘的剂量-反应效应。持续性哮喘儿童吸入皮质类固醇:对生长的剂量反应效应。Cochrane Database of Systematic Reviews 2014,第7期。艺术。不。: CD009878。cd009878 DOI: 10.1002/14651858.。这篇综述的配套文章,“持续性哮喘儿童吸入糖皮质激素:对生长的影响”和“持续性哮喘儿童吸入糖皮质激素:对生长的剂量反应效应”,包含以下文章:
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引用次数: 11
Formoterol or salmeterol for asthma—should they be used as monotherapy? 治疗哮喘的福莫特罗或沙美特罗是否应该单独使用?
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1982
Mike Steiner

Eco-paediatrics is an occasional feature in Evidence-Based Child Health: A Cochrane Review Journal. Our goal is to contribute to the worldwide discussion on reducing waste in health care. In each instalment, we will select a recent Cochrane review highlighting a practice, still in use, which the available evidence tells us should be discontinued.

生态儿科是《基于证据的儿童健康:Cochrane评论杂志》中偶尔出现的特色。我们的目标是促进世界范围内关于减少卫生保健浪费的讨论。在每一期中,我们将选择一篇最近的Cochrane综述,重点介绍一种仍在使用的做法,现有证据告诉我们应该停止这种做法。
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引用次数: 1
Interventions for treating femoral shaft fractures in children and adolescents 儿童和青少年股骨干骨折的干预治疗
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1987
Vrisha Madhuri, Vivek Dutt, Abhay D Gahukamble, Prathap Tharyan

Background

Fractures of the femoral shaft in children are relatively uncommon but serious injuries that disrupt the lives of children and their carers and can result in significant long-term disability. Treatment involves either surgical fixation, such as intramedullary nailing or external fixation, or conservative treatment involving prolonged immobilisation, often in hospital.

Objectives

To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), EMBASE (1980 to 2012 week 9), CINAHL (16 August 2013), clinical trials registries, conference proceedings and reference lists; and contacted trial authors and experts in the field.

Selection criteria

Randomised and quasi-randomised controlled trials comparing conservative and surgical interventions for diaphyseal fractures of the femur in children under 18 years of age. Our primary outcomes were functional outcome measures, unacceptable malunion, and serious adverse events.

Data collection and analysis

Two authors independently screened and selected trials, assessed risk of bias and extracted data. We assessed the overall quality of the evidence for each outcome for each comparison using the GRADE approach. We pooled data using a fixed-effect model.

Main results

We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories.

Surgical versus conservative treat

背景:儿童股骨干骨折相对不常见,但严重的损伤会扰乱儿童及其护理人员的生活,并可能导致严重的长期残疾。治疗包括手术固定,如髓内钉或外固定,或保守治疗,包括长期固定,通常在医院。目的评价儿童和青少年股骨干骨折干预治疗的效果(利与弊)。我们检索了Cochrane骨、关节和肌肉创伤组专门注册(2013年8月16日访问)、Cochrane中央对照试验注册(Cochrane图书馆2013年第7期)、MEDLINE(1946年至2013年8月第1周)、EMBASE(1980年至2012年第9周)、CINAHL(2013年8月16日)、临床试验注册、会议记录和参考文献列表;并联系了试验作者和该领域的专家。选择标准:比较保守和手术治疗18岁以下儿童股骨骨干骨折的随机和准随机对照试验。我们的主要结局是功能性结局测量、不可接受的骨不愈合和严重不良事件。数据收集和分析两位作者独立筛选和选择试验,评估偏倚风险并提取数据。我们使用GRADE方法评估每个比较的每个结果的证据的总体质量。我们使用固定效应模型汇总数据。我们纳入了10项试验(6项随机试验和4项准随机试验),共涉及527名儿童(531例骨折)。所有的试验都存在一定的偏倚风险,包括表现偏倚,因为护理人员盲法并不实际,但程度不同。只有一项试验存在低选择偏倚风险。考虑到偏倚的风险和研究结果的不准确性,我们认为大多数结果的证据质量为“低”,这意味着我们对效果的估计不确定。大多数试验都没有报告自我评估的功能或儿童恢复正常活动的时间。这些试验评估了10种不同的比较,分为三个主要类别。手术与保守治疗4项试验对264名4 - 12岁儿童进行了比较。低质量证据(一项试验,101名儿童)显示,与保守治疗(spica石膏)相比,在手术(外固定)后两年使用RAND健康状态评分评估儿童的功能非常相似:平均69比68。其他三个试验没有关于功能的报道。有中等质量的证据(4项试验,264名儿童,年龄4至12岁,随访3至24个月)表明手术降低了畸形愈合的风险(风险比(RR) 0.29, 95%可信区间(CI) 0.15至0.59,4项试验)。假设保守治疗儿童的基线风险为每1000例115例畸形愈合,这些数据相当于每1000例手术治疗儿童的畸形愈合减少81例(95% CI为47 - 97)。相反,低质量的证据表明手术后感染等更严重的不良事件(RR 2.39, 95% CI 1.10 ~ 5.17, 4项试验)。假设保守治疗的基线风险为每1000例40例严重不良事件,这些数据相当于每1000例接受手术治疗的儿童多发生56例(95% CI为4 ~ 167例)严重不良事件。有低质量的证据(一项试验,101名儿童)表明,仅采用外固定和石膏石膏的手术对儿童和家长的满意度相似。然而,有低质量的证据(一项试验,46名儿童)表明,与牵引后石膏相比,更多的家长对髓内钉治疗感到满意,而且手术减少了缺课时间。不同保守治疗方法的比较这一类的三个试验进行了三个不同的比较。我们非常不确定在3 - 10岁的儿童进行6 - 8周的随访后,立即髋关节骨裂与骨骼牵引后骨裂的不可接受的不愈合率是否存在差异(RR 4.0, 95% CI 0.5 - 32.9;一项试验,42名儿童;非常低质量的证据)。在5 - 13岁的儿童中,5 - 10年的畸形愈合率在牵引后使用功能性矫形器与牵引后使用spica石膏之间可能没有差异(RR 0.98, 95% CI 0.46 - 2)。 12;一项试验,43名儿童;证据质量低)。我们非常不确定(非常低质量的证据)单腿和双腿spica石膏是否有功能或严重不良事件(零事件报告)差异(一项试验,52名2至7岁的幼儿)。关于同一比较的低质量证据表明,单腿石膏对父母来说不那么尴尬,对孩子来说更舒适,并且可能需要更少的护理时间。不同手术治疗方法的比较这一类的三个试验进行了三个不同的比较。非常低质量的证据意味着我们非常不确定使用弹性稳定髓内钉或外固定固定的儿童骨折的不愈合率、严重不良事件、返回学校的时间或家长满意度是否存在差异(一项试验,19名儿童)。在接受动态和静态外固定治疗的儿童中,严重不良事件的发生率和恢复完全负重的时间也是如此(一项试验,52名儿童)。非常低质量的证据(一项试验,47名儿童)意味着我们不知道髓内钉与肌下钢板之间愈合不良、严重不良事件和恢复体重的时间是否有实际差异。然而,随后的钢板移除可能会有更多的困难。作者的结论:没有足够的证据来确定手术和保守治疗之间的长期功能是否不同。在4至12岁的儿童中,手术导致的畸形愈合率较低,但可能增加严重不良事件的风险。弹性稳定髓内钉可缩短恢复时间。不同保守治疗方法或不同手术治疗方法的比较证据不足,无法对纳入试验中比较的治疗方法的相对效果得出结论。儿童和青少年股骨骨干骨折的不同治疗方法虽然不常见,但儿童股骨骨干(大腿骨)骨折可能需要长期住院治疗,有时需要手术治疗。这可能会引起严重的不适,并可能扰乱儿童及其家庭的生活。这篇综述比较了治疗这些骨折的不同方法。外科治疗包括固定骨折的不同方法,例如内置钉子或与外部框架结合的销钉(外固定)。非手术或保守治疗通常包括不同类型的石膏模型,有或没有牵引(在腿部施加拉力)。我们检索了2013年8月之前的医学文献。该综述包括10项随机或准随机对照试验,共招募了527名儿童。四项试验比较了不同的手术与非手术治疗;3例比较非手术治疗的不同方法,3例比较手术治疗的不同方法。一般来说,我们对这些试验的结果不确定,因为有些试验有偏倚的风险,有些结果是矛盾的,而且通常证据太少,不能排除偶然发现的可能性。大多数试验都没有报告自我评估的功能或儿童恢复正常活动的时间。低质量证据(一项试验,101名儿童)显示,与石膏石膏治疗的儿童相比,手术后两年包括外固定的儿童功能相似。其他三个试验没有报告这一结果。有中等质量的证据(4项试验,264名儿童,年龄4至12岁,随访3至24个月)表明,与非手术治疗相比,手术降低了畸形愈合(腿部变形)的风险。然而,低质量的证据(四项试验)表明,术后有更严重的不良事件,如感染。有低质量的证据(一项试验,101名儿童)表明,仅采用外固定和石膏石膏的手术对儿童和家长的满意度相似。然而,有低质量的证据(一项试验,46名儿童)表明,与牵引后石膏手术相比,更多的家长对采用内钉手术感到满意,而且手术减少了缺课时间。 非常低质量的证据意味着我们非常不确定在立即石膏石膏治疗与牵引后石膏石膏治疗(一项试验,42名儿童)之间的儿童畸形愈合率是否不同,或者在牵引后使用功能性矫形器(允许一定活动的支架或石膏)或石膏治疗(一项试验,43名儿童)之间的儿童畸形愈合率是否不同。我们非常不确定使用单腿和双腿石膏固定的幼儿(2 - 7岁)的功能或严重不良事件是否有差异(一项试验,52名儿童)。然而,单腿石膏似乎更容易由父母管理,对孩子来说更舒适。非常低质量的证据意味着我们非常不确定使用内钉或外固定物固定骨折的儿童的不愈合率、严重不良事件、返回学校的时间或家长满意度是否存在差异(一项试验,19名儿童)。与静态外固定相比,采用动态(刚性较低)外固定治疗的儿童的严重不良事件发生率和恢复完全负重的时间也存在同样的差异(一项试验,52名儿童)。非常低质量的证据(一项试验
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引用次数: 43
Pros and cons … 赞成和反对……
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1986
Michael B.H. Smith
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引用次数: 0
Inhaled corticosteroids in children with persistent asthma: dose-response effects on growth 持续性哮喘儿童吸入皮质类固醇:对生长的剂量反应效应
Pub Date : 2014-12-15 DOI: 10.1002/ebch.1989
Aniela I Pruteanu, Bhupendrasinh F Chauhan, Linjie Zhang, Sílvio OM Prietsch, Francine M Ducharme

Background

Inhaled corticosteroids (ICS) are the first-line treatment for children with persistent asthma. Their potential for growth suppression remains a matter of concern for parents and physicians.

Objectives

To assess whether increasing the dose of ICS is associated with slower linear growth, weight gain and skeletal maturation in children with asthma.

Search methods

We searched the Cochrane Airways Group Specialised Register of trials (CAGR) and the ClinicalTrials.gov website up to March 2014.

Selection criteria

Studies were eligible if they were parallel-group randomised trials evaluating the impact of different doses of the same ICS using the same device in both groups for a minimum of three months in children one to 17 years of age with persistent asthma.

Data collection and analysis

Two review authors ascertained methodological quality independently using the Cochrane Risk of bias tool. The primary outcome was linear growth velocity. Secondary outcomes included change over time in growth velocity, height, weight, body mass index and skeletal maturation.

Main results

Among 22 eligible trials, 17 group comparisons were derived from 10 trials (3394 children with mild to moderate asthma), measured growth and contributed data to the meta-analysis. Trials used ICS (beclomethasone, budesonide, ciclesonide, fluticasone or mometasone) as monotherapy or as combination therapy with a long-acting beta2-agonist and generally compared low (50 to 100 μg) versus low to medium (200 μg) doses of hydrofluoroalkane (HFA)-beclomethasone equivalent over 12 to 52 weeks. In the four comparisons reporting linear growth over 12 months, a significant group difference was observed, clearly indicating lower growth velocity in the higher ICS dose group of 5.74 cm/y compared with 5.94 cm/y on lower-dose ICS (N = 728 school-aged children; mean difference (MD)0.20 cm/y, 95% confidence interval (CI) 0.02 to 0.39; high-quality evidence): No statistically significant heterogeneity was noted between trials contributing data. The ICS molecules (ciclesonide, fluticasone, mometasone) used in these four comparisons did not significantly influence the magnitude of effect (X2 = 2.19 (2 df), P value 0.33). Subgroup analyses on age, baseline severity of airway obstructi

背景:吸入皮质类固醇(ICS)是儿童持续性哮喘的一线治疗方法。它们抑制生长的潜力仍然是家长和医生关注的问题。目的评估ICS剂量增加是否与哮喘儿童线性生长、体重增加和骨骼成熟减慢有关。检索方法我们检索了截至2014年3月的Cochrane Airways Group specialized Register of trials (CAGR)和ClinicalTrials.gov网站。如果研究是平行组随机试验,评估两组使用相同装置使用不同剂量的相同ICS对1至17岁持续性哮喘儿童至少三个月的影响,则研究符合条件。资料收集和分析两位综述作者使用Cochrane偏倚风险工具独立确定方法学质量。主要观察指标为线性生长速度。次要结果包括生长速度、身高、体重、身体质量指数和骨骼成熟度随时间的变化。在22项符合条件的试验中,17组比较来自10项试验(3394名轻度至中度哮喘儿童),测量了生长并为荟萃分析提供了数据。试验使用ICS(倍氯米松、布地奈德、环来奈德、氟替卡松或莫米松)作为单一疗法或与长效β - 2激动剂联合疗法,通常比较低剂量(50至100 μg)与低至中剂量(200 μg)的氢氟烷烃-倍氯米松当量,持续12至52周。在报告12个月内线性生长的4个比较中,观察到显著的组差异,清楚地表明高剂量ICS组的生长速度为5.74 cm/y,低于低剂量ICS组的5.94 cm/y (N = 728学龄儿童;平均差(MD)0.20 cm/y, 95%置信区间(CI) 0.02 ~ 0.39;高质量证据):在提供数据的试验之间没有发现统计学上显著的异质性。在这四种比较中使用的ICS分子(环来奈德、氟替卡松、莫米松)对效果的大小没有显著影响(X2 = 2.19 (2 df), P值0.33)。由于各试验相似或报告不充分,未进行年龄、气道阻塞基线严重程度、ICS剂量和同时使用非甾体类平喘药的亚组分析。从零到三个月,未调整的身高变化有统计学意义的组间差异(9个比较;N = 944例;MD 0.15, 95% CI -0.28 ~ -0.02;中等质量证据)支持较高的ICS剂量。在其他时间点未观察到身高变化的组间差异有统计学意义,体重、骨量指数和骨骼成熟度的差异也没有报道,由于不精确,证据质量较低。作者的结论:在患有轻度至中度持续性哮喘的青春期前学龄儿童中,观察到低剂量ICS和中低剂量hfa -倍氯米松当量在生长速度上存在小但有统计学意义的组差异,这有利于使用低剂量ICS。莫米松、环替奈德和氟替卡松这三种分子报告一年生长速度的影响程度没有明显差异。鉴于普遍存在的家长和医生对ICS生长抑制作用的担忧,超过86%(19/22)的符合条件的儿科试验(包括使用倍氯米松和布地奈德的试验)缺乏或不完整的生长速度报告令人担忧。未来所有比较不同剂量ICS与安慰剂或无安慰剂的儿科试验都应系统地记录生长。研究结果支持在哮喘儿童中使用最小有效ICS剂量。改变吸入皮质类固醇的剂量对哮喘儿童的生长有影响吗?背景:哮喘指南推荐,当仅使用缓解吸入器治疗症状时,吸入皮质类固醇(ICS)作为无法很好控制的持续性哮喘儿童的首选治疗方法。类固醇通过减少肺部炎症起作用,并且已知可以控制哮喘的潜在症状。
{"title":"Inhaled corticosteroids in children with persistent asthma: dose-response effects on growth","authors":"Aniela I Pruteanu,&nbsp;Bhupendrasinh F Chauhan,&nbsp;Linjie Zhang,&nbsp;Sílvio OM Prietsch,&nbsp;Francine M Ducharme","doi":"10.1002/ebch.1989","DOIUrl":"10.1002/ebch.1989","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Inhaled corticosteroids (ICS) are the first-line treatment for children with persistent asthma. Their potential for growth suppression remains a matter of concern for parents and physicians.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To assess whether increasing the dose of ICS is associated with slower linear growth, weight gain and skeletal maturation in children with asthma.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Search methods</h3>\u0000 \u0000 <p>We searched the Cochrane Airways Group Specialised Register of trials (CAGR) and the ClinicalTrials.gov website up to March 2014.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Selection criteria</h3>\u0000 \u0000 <p>Studies were eligible if they were parallel-group randomised trials evaluating the impact of different doses of the same ICS using the same device in both groups for a minimum of three months in children one to 17 years of age with persistent asthma.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data collection and analysis</h3>\u0000 \u0000 <p>Two review authors ascertained methodological quality independently using the Cochrane Risk of bias tool. The primary outcome was linear growth velocity. Secondary outcomes included change over time in growth velocity, height, weight, body mass index and skeletal maturation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main results</h3>\u0000 \u0000 <p>Among 22 eligible trials, 17 group comparisons were derived from 10 trials (3394 children with mild to moderate asthma), measured growth and contributed data to the meta-analysis. Trials used ICS (beclomethasone, budesonide, ciclesonide, fluticasone or mometasone) as monotherapy or as combination therapy with a long-acting beta<sub>2</sub>-agonist and generally compared low (50 to 100 μg) versus low to medium (200 μg) doses of hydrofluoroalkane (HFA)-beclomethasone equivalent over 12 to 52 weeks. In the four comparisons reporting linear growth over 12 months, a significant group difference was observed, clearly indicating lower growth velocity in the higher ICS dose group of 5.74 cm/y compared with 5.94 cm/y on lower-dose ICS (N = 728 school-aged children; mean difference (MD)0.20 cm/y, 95% confidence interval (CI) 0.02 to 0.39; high-quality evidence): No statistically significant heterogeneity was noted between trials contributing data. The ICS molecules (ciclesonide, fluticasone, mometasone) used in these four comparisons did not significantly influence the magnitude of effect (X<sup>2</sup> = 2.19 (2 df), P value 0.33). Subgroup analyses on age, baseline severity of airway obstructi","PeriodicalId":12162,"journal":{"name":"Evidence-based child health : a Cochrane review journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/ebch.1989","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32905820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 70
An issue full of issues 一个充满问题的问题
Pub Date : 2014-09-19 DOI: 10.1002/ebch.1981
Joan Robinson
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引用次数: 0
Combined and alternating paracetamol and ibuprofen therapy for febrile children 对乙酰氨基酚和布洛芬联合及交替治疗发热儿童
Pub Date : 2014-09-19 DOI: 10.1002/ebch.1978
Tiffany Wong, Antonia S Stang, Heather Ganshorn, Lisa Hartling, Ian K Maconochie, Anna M Thomsen, David W Johnson

Background

Health professionals frequently recommend fever treatment regimens for children that either combine paracetamol and ibuprofen or alternate them. However, there is uncertainty about whether these regimens are better than the use of single agents, and about the adverse effect profile of combination regimens.

Objectives

To assess the effects and side effects of combining paracetamol and ibuprofen, or alternating them on consecutive treatments, compared with monotherapy for treating fever in children.

Search methods

In September 2013, we searched Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; LILACS; and International Pharmaceutical Abstracts (2009–2011).

Selection criteria

We included randomized controlled trials comparing alternating or combined paracetamol and ibuprofen regimens with monotherapy in children with fever.

Data collection and analysis

One review author and two assistants independently screened the searches and applied inclusion criteria. Two authors assessed risk of bias and graded the evidence independently. We conducted separate analyses for different comparison groups (combined therapy versus monotherapy, alternating therapy versus monotherapy, combined therapy versus alternating therapy).

Main results

Six studies, enrolling 915 participants, are included. Compared to giving a single antipyretic alone, giving combined paracetamol and ibuprofen to febrile children can result in a lower mean temperature at one hour after treatment (MD −0.27 °Celsius, 95% CI −0.45 to −0.08, two trials, 163 participants, moderate quality evidence). If no further antipyretics are given, combined treatment probably also results in a lower mean temperature at four hours (MD −0.70 °Celsius, 95% CI −1.05 to −0.35, two trials, 196 participants, moderate quality evidence), and in fewer children remaining or becoming febrile for at least four hours after treatment (RR 0.08, 95% CI 0.02 to 0.42, two trials, 196 participants, moderate quality evidence). Only one trial assessed a measure of child discomfort (fever associated symptoms at 24 hours and 48 hours), but did not find a significant difference in this measure between the treatment regimens (one

背景:卫生专业人员经常建议儿童发烧治疗方案,要么联合使用扑热息痛和布洛芬,要么交替使用。然而,这些方案是否比使用单一药物更好,以及联合方案的不良反应概况尚不确定。目的评价对乙酰氨基酚与布洛芬联用或联用连续治疗与单药治疗小儿发热的疗效和副作用。检索方法2013年9月,我们检索Cochrane传染病组专业注册;Cochrane中央对照试验登记册;MEDLINE;EMBASE;紫丁香;《国际药学文摘》(2009-2011)。我们纳入了比较对乙酰氨基酚和布洛芬交替或联合治疗方案与单药治疗发热儿童的随机对照试验。一名综述作者和两名助理独立筛选检索并应用纳入标准。两位作者独立评估了偏倚风险并对证据进行了分级。我们对不同的对照组进行了单独的分析(联合治疗与单一治疗,交替治疗与单一治疗,联合治疗与交替治疗)。主要结果纳入6项研究,共纳入915名受试者。与单独给予退烧药相比,给予发热儿童扑热息痛和布洛芬联合治疗可导致治疗后1小时的平均体温降低(MD为- 0.27℃,95% CI为- 0.45至- 0.08,两项试验,163名受试者,中等质量证据)。如果不给予进一步的退热药物,联合治疗也可能导致4小时平均体温降低(MD - 0.70摄氏度,95% CI - 1.05至- 0.35,2项试验,196名受试者,中等质量证据),并且在治疗后至少4小时仍保持或发热的儿童较少(RR 0.08, 95% CI 0.02至0.42,2项试验,196名受试者,中等质量证据)。只有一项试验评估了儿童不适的测量(24小时和48小时的发烧相关症状),但在治疗方案之间没有发现该测量的显著差异(一项试验,156名参与者,证据质量未分级)。在实践中,护理人员通常被建议最初只给一种药物(扑热息痛或布洛芬),如果孩子的发烧不能消退或复发,再给另一种剂量的药物。以这种方式进行交替治疗可能导致第二次剂量后1小时的平均体温降低(MD - 0.60摄氏度,95% CI - 0.94至- 0.26,两项试验,78名受试者,低质量证据),并且还可能导致在给药后3小时内保持或发热的儿童减少(RR 0.25, 95% CI 0.11至0.55,两项试验,109名受试者,低质量证据)。一项试验评估了儿童不适(24、48和72小时的平均疼痛评分),发现交替治疗的平均评分较低,尽管总体上给予的退烧药剂量较少(一项试验,480名参与者,低质量证据)。只有一项小型试验比较了交替治疗和联合治疗。在1小时、4小时或6小时的平均体温或发热儿童的数量上没有统计学上的显著差异(一项试验,40名参与者,证据质量非常低)。试验中没有直接归因于所使用药物的严重不良事件。有一些证据表明交替和联合退热治疗在降低体温方面可能比单独治疗更有效。然而,改善儿童不适措施的证据仍然没有定论。没有足够的证据表明哪种联合治疗或交替治疗可能更有益。未来的研究需要使用标准化的工具来测量儿童不适,并评估联合和交替退热治疗的安全性。交替或联合退烧药治疗儿童发热当儿童感染疾病时,通常会出现发烧。
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引用次数: 70
期刊
Evidence-based child health : a Cochrane review journal
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