免疫治疗在儿童哮喘的系统性综述证据：GRADE系统性综述
2018/01/15
摘要
目的：大多数哮喘儿童都会应用ICS， 是否需要叠加免疫治疗需要临床评估。本研究再次评估皮下（SCIT）和舌下(SCIT)免疫治疗的有效性，主要纳入针对患者相关的临床转归研究以及应用ICS患儿。
方法：应用GRADE方法系统性搜索和评价预先设定主要研究终点（哮喘症状，哮喘控制和急性发作）。本研究通过纳入针对儿童哮喘患者的系统性综述和随机对照研究（1960-2017）。应用GRADE标准评价证据质量水平。
结果：由于较大的证据偏移和间接性（纳入未应用ICS儿童研究），SCIT研究依据级别较低。SCIT对于控制哮喘症状无作用；无针对哮喘控制研究；对于哮喘急性发作，研究倾向SCIT。但对这一研究判断，由于证据级别太低，难以取信。对于SLIT，由于较大的证据偏移、间接性和欠准确性，证据级别非常低。哮喘症状的终点因缺乏标准化和较大临床异质性无法计算。没有其他预先设定的终点需要报道。
结论：在更早时期关于儿童哮喘免疫治疗的有益作用不再适用，因其缺乏直接证据（研究并非参照现行哮喘指南进行ICS治疗）。缺乏足够的证据可以证明其有效性，故目前缺乏支持使用ICS的哮喘患儿接受免疫治疗的依据。
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.
BMJ Open. 2017 Dec 28;7(12):e016326. doi: 10.1136/bmjopen-2017-016326.
van de Griendt EJ, Tuut MK, de Groot H, Brand PLP.
Abstract
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：大多数哮喘儿童都会应用ICS， 是否需要叠加免疫治疗需要临床评估。本研究再次评估皮下（SCIT）和舌下(SCIT)免疫治疗的有效性，主要纳入针对患者相关的临床转归研究以及应用ICS患儿。
方法：应用GRADE方法系统性搜索和评价预先设定主要研究终点（哮喘症状，哮喘控制和急性发作）。本研究通过纳入针对儿童哮喘患者的系统性综述和随机对照研究（1960-2017）。应用GRADE标准评价证据质量水平。
结果：由于较大的证据偏移和间接性（纳入未应用ICS儿童研究），SCIT研究依据级别较低。SCIT对于控制哮喘症状无作用；无针对哮喘控制研究；对于哮喘急性发作，研究倾向SCIT。但对这一研究判断，由于证据级别太低，难以取信。对于SLIT，由于较大的证据偏移、间接性和欠准确性，证据级别非常低。哮喘症状的终点因缺乏标准化和较大临床异质性无法计算。没有其他预先设定的终点需要报道。
结论：在更早时期关于儿童哮喘免疫治疗的有益作用不再适用，因其缺乏直接证据（研究并非参照现行哮喘指南进行ICS治疗）。缺乏足够的证据可以证明其有效性，故目前缺乏支持使用ICS的哮喘患儿接受免疫治疗的依据。
（上海交通大学医学院附属瑞金医院呼吸与危重症医学科 周剑平 万欢英 摘译）
（BMJ Open. 2017 Dec 28;7(12):e016326. doi: 10.1136/bmjopen-2017-016326.）
（BMJ Open. 2017 Dec 28;7(12):e016326. doi: 10.1136/bmjopen-2017-016326.）
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.
BMJ Open. 2017 Dec 28;7(12):e016326. doi: 10.1136/bmjopen-2017-016326.
van de Griendt EJ, Tuut MK, de Groot H, Brand PLP.
Abstract
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.
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