奥玛珠单抗治疗中度至重度过敏性哮喘患者的报告结果：随机对照试验的系统回顾
2017/11/20
摘要
目的：随机对照试验（RCTs）已经确立了奥玛珠单抗临床参数方面的安全性和有效性，并且评估了其对患者报告结果（PRO）的影响。 本篇系统综述的目的是审查基于PRO终点的已发表数据，以确定奥玛珠单抗作为中重度持续性变应性哮喘患者吸入糖皮质激素的附加疗法的益处。
方法：系统回顾包括参考数据库和最近的会议。 随机对照试验包括以奥玛珠单抗为附加治疗的中重度持续性哮喘成人，青少年及儿童。 两名研究人员独立筛选和审查有关研究的纳入和排除标准的文章。
结果：二十六项试验符合纳入标准。 其中，PRO试验纳入19项试验中，以评估奥玛珠单抗对症状的影响，11项评估患者的健康相关生活质量（HRQoL），4项评估哮喘控制。 以及其他与治疗有效性和工作效率的全球评估相关的PRO。 总体而言，结果表明大多数赞成奥玛珠单抗的附加疗法与安慰剂或对照者相比有显着差异。
结论：PRO是哮喘相关临床试验结果评估的重要组成部分。 回顾性随机对照试验表明，奥马珠单抗治疗改善中重度持续性变应性哮喘患者的PROs，尤其是症状控制和HRQoL的方面。
Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials
Jonathan Corren, Abhishek Kavati
Abstract
Objective: Randomized controlled trials (RCTs) have established the safety and efficacy of omalizumab on clinical parameters, and have also evaluated its impact on patient-reported outcomes (PROs). The purpose of this systematic literature review was to review published data based on PRO endpoints in order to determine the benefit of omalizumab as add-on therapy to inhaled corticosteroids in patients with moderate-to-severe persistent allergic asthma.
Methods: A systematic literature review was conducted of reference databases and recent conferences. RCTs of add-on omalizumab therapy in adults, adolescents, and children with moderate-to-severe persistent asthma were included. Two researchers independently screened and reviewed articles with regards to inclusion and exclusion criteria for relevant studies.
Results: Twenty-six trials met the criteria for inclusion. Of these, PRO measures were included in 19 trials to capture the impact of omalizumab on symptoms, 11 assessed patients for health-related quality of life (HRQoL), and 4 evaluated asthma control. Other PROs related to global evaluation of treatment effectiveness and work productivity. Overall, results demonstrated a significant difference across most PROs in favor of omalizumab add-on therapy versus placebo or comparators.
Conclusions: PROs are an integral part of outcome assessment in clinical trials related to asthma. The RCTs reviewed demonstrate that omalizumab treatment improves PROs in patients with moderate-to-severe persistent allergic asthma, particularly symptom control and HRQoL.
目的：随机对照试验（RCTs）已经确立了奥玛珠单抗临床参数方面的安全性和有效性，并且评估了其对患者报告结果（PRO）的影响。 本篇系统综述的目的是审查基于PRO终点的已发表数据，以确定奥玛珠单抗作为中重度持续性变应性哮喘患者吸入糖皮质激素的附加疗法的益处。
方法：系统回顾包括参考数据库和最近的会议。 随机对照试验包括以奥玛珠单抗为附加治疗的中重度持续性哮喘成人，青少年及儿童。 两名研究人员独立筛选和审查有关研究的纳入和排除标准的文章。
结果：二十六项试验符合纳入标准。 其中，PRO试验纳入19项试验中，以评估奥玛珠单抗对症状的影响，11项评估患者的健康相关生活质量（HRQoL），4项评估哮喘控制。 以及其他与治疗有效性和工作效率的全球评估相关的PRO。 总体而言，结果表明大多数赞成奥玛珠单抗的附加疗法与安慰剂或对照者相比有显着差异。
结论：PRO是哮喘相关临床试验结果评估的重要组成部分。 回顾性随机对照试验表明，奥马珠单抗治疗改善中重度持续性变应性哮喘患者的PROs，尤其是症状控制和HRQoL的方面。
（中日友好医院呼吸与危重症医学科 张鑫 摘译 林江涛 审校）
（Current Medical Research and Opinion .23 Oct 2017）
（Current Medical Research and Opinion .23 Oct 2017）
Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials
Jonathan Corren, Abhishek Kavati
Abstract
Objective: Randomized controlled trials (RCTs) have established the safety and efficacy of omalizumab on clinical parameters, and have also evaluated its impact on patient-reported outcomes (PROs). The purpose of this systematic literature review was to review published data based on PRO endpoints in order to determine the benefit of omalizumab as add-on therapy to inhaled corticosteroids in patients with moderate-to-severe persistent allergic asthma.
Methods: A systematic literature review was conducted of reference databases and recent conferences. RCTs of add-on omalizumab therapy in adults, adolescents, and children with moderate-to-severe persistent asthma were included. Two researchers independently screened and reviewed articles with regards to inclusion and exclusion criteria for relevant studies.
Results: Twenty-six trials met the criteria for inclusion. Of these, PRO measures were included in 19 trials to capture the impact of omalizumab on symptoms, 11 assessed patients for health-related quality of life (HRQoL), and 4 evaluated asthma control. Other PROs related to global evaluation of treatment effectiveness and work productivity. Overall, results demonstrated a significant difference across most PROs in favor of omalizumab add-on therapy versus placebo or comparators.
Conclusions: PROs are an integral part of outcome assessment in clinical trials related to asthma. The RCTs reviewed demonstrate that omalizumab treatment improves PROs in patients with moderate-to-severe persistent allergic asthma, particularly symptom control and HRQoL.
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支气管热成形术治疗严重持续性哮喘的疗效和安全性
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根据血清游离IgE水平可以指导减少奥马珠单抗的剂量：一个病例报告
