既往关于免疫疗法的系统评价证据在儿童哮喘治疗当前实践中的适用性：一项GRADE（推荐分级的评估、制定与评价）系统评价
Applicability of evidence from previous systematic reviews on immunotherapy in current practice of childhood asthma treatment: a GRADE (Grading of Recommendations Assessment, Development and Evaluation) systematic review.
作者信息
van de Griendt Erik-Jonas, Tuut Mariska K, de Groot Hans, Brand Paul L P
机构信息
Department of Paediatrics, De Kinderkliniek, Almere, The Netherlands.
Department of Paediatric Pulmonology, Academic Medical Centre, Amsterdam, The Netherlands.
出版信息
BMJ Open. 2017 Dec 28;7(12):e016326. doi: 10.1136/bmjopen-2017-016326.
OBJECTIVE
Because most children with asthma now use inhaled corticosteroids (ICS), the added benefit of immunotherapy in asthmatic children needs to be examined. We re-assessed the effectiveness of subcutaneous (SCIT) and sublingual immunotherapy (SLIT) in childhood asthma treatment focusing on studies with patient-relevant outcome measures and children using ICS.
METHODS
We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to systematically search and appraise the evidence using predefined critical patient-relevant outcomes (asthma symptoms, asthma control and exacerbations). We searched to retrieve systematic reviews and randomised controlled trials on immunotherapy for asthma in children (1960-2017). We assessed the quality of the body of evidence with GRADE criteria.
RESULTS
The quality of the evidence for SCIT was very low due to a large risk of bias and indirectness (dated studies in children not using ICS). No effect of SCIT was found for asthma symptoms; no studies reported on asthma control. For asthma exacerbations, studies favoured SCIT. We have little confidence in this effect estimate, due to the very low quality of evidence. For SLIT, quality of the evidence was very low due to a large risk of bias, indirectness and imprecision. The outcome 'asthma symptoms' could not be calculated due to lack of standardisation and large clinical heterogeneity. Other predefined outcomes were not reported.
CONCLUSION
The beneficial effects of immunotherapy in childhood asthma found in earlier reviews are no longer considered applicable, because of indirectness (studies performed in children not being treated according to current asthma guidelines with ICS). There was absence of evidence to properly determine the effectiveness or lack thereof of immunotherapy in asthma treatment in children with ICS.
目的
由于目前大多数哮喘儿童使用吸入性糖皮质激素（ICS），因此需要研究免疫疗法对哮喘儿童的附加益处。我们重新评估了皮下免疫疗法（SCIT）和舌下免疫疗法（SLIT）在儿童哮喘治疗中的有效性，重点关注与患者相关结局指标的研究以及使用ICS的儿童。
方法
我们采用推荐分级评估、制定和评价（GRADE）方法，使用预定义的与患者相关的关键结局（哮喘症状、哮喘控制和病情加重）来系统检索和评估证据。我们检索了1960年至2017年间关于儿童哮喘免疫疗法的系统评价和随机对照试验。我们根据GRADE标准评估证据的质量。
结果
由于存在较大的偏倚风险和间接性（针对未使用ICS的儿童的过时研究），SCIT的证据质量非常低。未发现SCIT对哮喘症状有影响；没有关于哮喘控制的研究报告。对于哮喘病情加重，研究倾向于SCIT。由于证据质量非常低，我们对这一效应估计几乎没有信心。对于SLIT，由于存在较大的偏倚风险、间接性和不精确性，证据质量非常低。由于缺乏标准化和较大的临床异质性，无法计算“哮喘症状”这一结局。未报告其他预定义结局。
结论
早期综述中发现的免疫疗法对儿童哮喘的有益效果不再被认为适用，因为存在间接性（研究对象为未按照当前哮喘指南使用ICS治疗 的儿童）。缺乏证据来正确确定免疫疗法在使用ICS的儿童哮喘治疗中的有效性或无效性。
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