Sridhar A V, McKean M
Leicester Royal Infirmary, Department of Child Health, Clinical Sciences Building, Leicester, Leicestershire, UK LE1 5WW.
Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004108. doi: 10.1002/14651858.CD004108.pub2.
Currently inhaled corticosteroids are the main stay in the maintenance treatment of chronic asthma in children. Although inhaled corticosteroids play a crucial role in the management of childhood asthma, the long-term side effects of inhaled corticosteroids used in the management of chronic asthma in children are not clearly known.
The objective of this review is to compare the safety and efficacy of inhaled nedocromil sodium with placebo in the treatment of chronic asthma in children.
We searched the Cochrane airway group trials register, Cochrane controlled trials register, Current contents, review articles, reference lists of articles. We also contacted the drug manufacturer and primary authors for additional citations. We also searched abstracts of major respiratory society meetings. The last search was carried out in October 2004
Randomised placebo controlled trials comparing nedocromil sodium to placebo in the treatment of chronic asthma in children (0 to 18 years).
Both authors independently assessed trial quality and extracted data. Study authors were contacted for additional information.
Fifteen trials (twelve parallel group studies; three crossover trials recruiting 1422 children (837 males and 585 females)) were included. The studies were generally of good methodological quality. Two large long term studies used nedocromil for six months and four to six years and showed conflicting results in symptom free days. Short term studies (duration between 4 weeks to 12 weeks) showed that nedocromil sodium produced some improvement in a number of efficacy measures compared to placebo including FEV(1), FVC, FEV(1) % predicted, PC20 FEV(1), evening PEF and symptom scores. The parent's assessment of efficacy was in favour of nedocromil (odds ratio (OR) 0.5 (95% CI 0.3 to 0.8). Nedocromil sodium has a good safety profile. The only significant side effect observed was unpleasant taste. There was little evidence for a clinically dose response effect and only a few studies recruited participants with severe asthma.
AUTHORS' CONCLUSIONS: A limited number of small studies have shown that nedocromil is of benefit in improving lung function and some measures of symptoms, but the evidence with regard to the primary outcome of the review was conflicting. Two long-term trials did not show consistent effects on lung function outcomes, whereas several small short-term trials have shown benefit in these outcomes. Differing severities at baseline may explain this difference with milder participants experiencing less benefit, although the discrepancy between study findings may also reflect publication bias. Nedocromil sodium is associated with a very good safety profile with no significant short term or long- term adverse side effects. Although nedocromil may have advantages over inhaled corticosteroids in terms of side effects, there is a need for head to head trials of nedocromil and inhaled corticosteroids to establish whether asthma control is similar, especially in mild asthma. It is not yet clear where nedocromil should sit in relation to other therapies in the treatment of asthma in children.
目前，吸入性糖皮质激素是儿童慢性哮喘维持治疗的主要药物。尽管吸入性糖皮质激素在儿童哮喘管理中起着关键作用，但用于儿童慢性哮喘管理的吸入性糖皮质激素的长期副作用尚不清楚。
本综述的目的是比较吸入奈多罗米钠与安慰剂治疗儿童慢性哮喘的安全性和有效性。
我们检索了Cochrane气道组试验注册库、Cochrane对照试验注册库、《现刊目次》、综述文章、文章的参考文献列表。我们还联系了药品制造商和主要作者以获取更多引用文献。我们还检索了主要呼吸学会会议的摘要。最后一次检索于2004年10月进行。
比较奈多罗米钠与安慰剂治疗儿童（0至18岁）慢性哮喘的随机安慰剂对照试验。
两位作者独立评估试验质量并提取数据。联系研究作者以获取更多信息。
纳入了15项试验（12项平行组研究；3项交叉试验，共招募1422名儿童（837名男性和585名女性））。这些研究的方法学质量总体良好。两项大型长期研究使用奈多罗米6个月以及4至6年，在无症状天数方面显示出相互矛盾的结果。短期研究（持续时间为4周至12周）表明，与安慰剂相比，奈多罗米钠在一些疗效指标上有一定改善，包括第一秒用力呼气量（FEV₁）、用力肺活量（FVC）、预测FEV₁百分比、FEV₁的激发浓度为20%时的累积激发剂量（PC20 FEV₁）、夜间呼气峰值流速（PEF）和症状评分。家长对疗效的评估倾向于奈多罗米（优势比（OR）为0.5（95%置信区间为0.3至0.8））。奈多罗米钠具有良好的安全性。观察到的唯一显著副作用是口味不佳。几乎没有证据表明存在临床剂量反应效应，且仅有少数研究招募了重度哮喘患者。
少数小型研究表明，奈多罗米在改善肺功能和一些症状指标方面有益，但关于本综述主要结局的证据相互矛盾。两项长期试验未显示对肺功能结局有一致影响，而几项小型短期试验显示在这些结局上有获益。基线时不同的严重程度可能解释了这种差异，病情较轻的参与者获益较少，尽管研究结果之间的差异也可能反映了发表偏倚。奈多罗米钠具有非常好的安全性，没有显著的短期或长期不良副作用。尽管在副作用方面奈多罗米可能优于吸入性糖皮质激素，但需要进行奈多罗米与吸入性糖皮质激素的直接对比试验，以确定哮喘控制情况是否相似，尤其是在轻度哮喘中。目前尚不清楚在儿童哮喘治疗中奈多罗米相对于其他疗法的地位。
