Abstract：
BACKGROUND: The benefits and harms of adding antileukotrienes to H1 antihistamines (AHs) for the management of urticaria (hives, itch, and/or angioedema) remain unclear.
OBJECTIVE: We sought to systematically synthesize the treatment outcomes of antileukotrienes in combination with AHs versus AHs alone for acute and chronic urticaria.
METHODS: As part of updating American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters urticaria guidelines, we searched Medline, Embase, Central, LILACS, WPRIM, IBECS, ICTRP, CBM, CNKI, VIP, Wanfang, US Food and Drug Administration, and European Medicines Agency databases from inception to December 18, 2023, for randomized controlled trials (RCTs) evaluating antileukotrienes and AHs versus AHs alone in patients with urticaria. Paired reviewers independently screened citations, extracted data, and assessed risk of bias. Random effects models pooled effect estimates for urticaria activity, itch, wheal, sleep, quality of life, and harms. The GRADE approach informed certainty of evidence ratings. The study was registered at the Open Science Framework (osf.io/h2bfx/).
RESULTS: Thirty-four RCTs enrolled 3324 children and adults. Compared to AHs alone, the combination of a leukotriene receptor antagonist with AHs probably modestly reduces urticaria activity (mean difference, -5.04; 95% confidence interval, -6.36 to -3.71; 7-day urticaria activity score) with moderate certainty. We made similar findings for itch and wheal severity as well as quality of life. Adverse events were probably not different between groups (moderate certainty); however, no RCT reported on neuropsychiatric adverse events.
CONCLUSIONS: Among patients with urticaria, adding leukotriene receptor antagonists to AHs probably modestly improves urticaria activity with little to no increase in overall adverse events. The added risk of neuropsychiatric adverse events in this population with leukotriene receptor antagonists is small and uncertain.
OBJECTIVE: We sought to systematically synthesize the treatment outcomes of antileukotrienes in combination with AHs versus AHs alone for acute and chronic urticaria.
METHODS: As part of updating American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters urticaria guidelines, we searched Medline, Embase, Central, LILACS, WPRIM, IBECS, ICTRP, CBM, CNKI, VIP, Wanfang, US Food and Drug Administration, and European Medicines Agency databases from inception to December 18, 2023, for randomized controlled trials (RCTs) evaluating antileukotrienes and AHs versus AHs alone in patients with urticaria. Paired reviewers independently screened citations, extracted data, and assessed risk of bias. Random effects models pooled effect estimates for urticaria activity, itch, wheal, sleep, quality of life, and harms. The GRADE approach informed certainty of evidence ratings. The study was registered at the Open Science Framework (osf.io/h2bfx/).
RESULTS: Thirty-four RCTs enrolled 3324 children and adults. Compared to AHs alone, the combination of a leukotriene receptor antagonist with AHs probably modestly reduces urticaria activity (mean difference, -5.04; 95% confidence interval, -6.36 to -3.71; 7-day urticaria activity score) with moderate certainty. We made similar findings for itch and wheal severity as well as quality of life. Adverse events were probably not different between groups (moderate certainty); however, no RCT reported on neuropsychiatric adverse events.
CONCLUSIONS: Among patients with urticaria, adding leukotriene receptor antagonists to AHs probably modestly improves urticaria activity with little to no increase in overall adverse events. The added risk of neuropsychiatric adverse events in this population with leukotriene receptor antagonists is small and uncertain.
摘要：
背景：在H1-抗组胺药中添加抗白细胞三烯用于治疗荨麻疹的益处和危害（荨麻疹，痒,和/或血管性水肿）尚不清楚。
目的：我们试图系统地合成抗白三烯联合H1-抗组胺与单独H1-抗组胺治疗急性和慢性荨麻疹的治疗结果。
方法：作为更新美国过敏学会的一部分，哮喘与免疫学和美国过敏学院，哮喘,和免疫学联合工作队实践参数荨麻疹指南，我们搜索了MEDLINE,Embase,中部,LILACS,WPRIM,IBECS,ICTRP,CBM,CNKI,VIP,万方,FDA,和EMA数据库从开始到12月18日，2023年随机对照试验（RCT）评估抗白三烯和H1-抗组胺药与单独H1-抗组胺药在荨麻疹患者中的作用。配对的审稿人独立筛选引文，提取的数据，并评估偏见的风险。随机效应模型汇集了荨麻疹活动的效应估计，痒,海燕,睡眠,生活质量,和伤害。等级方法为证据等级提供了确定性。开放科学框架注册：https://osf.io/h2bfx/。
结果：34个RCT纳入了3,324名儿童和成人。与单独的H1-抗组胺药相比，白三烯受体拮抗剂(LTRA)与H1-抗组胺药的组合可能适度降低荨麻疹活性(平均差:-5.04,95CI-6.36至-3.71;7天荨麻疹活性评分),且具有中等确定性.我们对瘙痒和风团的严重程度也有类似的发现，和生活质量。不良事件可能在组间没有差异（中度确定性），然而,没有RCT报告神经精神不良事件。
结论：在荨麻疹患者中，在H1-抗组胺药中加入LTRAs可能会适度改善荨麻疹的活性,而总体不良事件几乎没有增加.在患有LTRA的人群中，神经精神不良事件的额外风险很小且不确定。
目的：我们试图系统地合成抗白三烯联合H1-抗组胺与单独H1-抗组胺治疗急性和慢性荨麻疹的治疗结果。
方法：作为更新美国过敏学会的一部分，哮喘与免疫学和美国过敏学院，哮喘,和免疫学联合工作队实践参数荨麻疹指南，我们搜索了MEDLINE,Embase,中部,LILACS,WPRIM,IBECS,ICTRP,CBM,CNKI,VIP,万方,FDA,和EMA数据库从开始到12月18日，2023年随机对照试验（RCT）评估抗白三烯和H1-抗组胺药与单独H1-抗组胺药在荨麻疹患者中的作用。配对的审稿人独立筛选引文，提取的数据，并评估偏见的风险。随机效应模型汇集了荨麻疹活动的效应估计，痒,海燕,睡眠,生活质量,和伤害。等级方法为证据等级提供了确定性。开放科学框架注册：https://osf.io/h2bfx/。
结果：34个RCT纳入了3,324名儿童和成人。与单独的H1-抗组胺药相比，白三烯受体拮抗剂(LTRA)与H1-抗组胺药的组合可能适度降低荨麻疹活性(平均差:-5.04,95CI-6.36至-3.71;7天荨麻疹活性评分),且具有中等确定性.我们对瘙痒和风团的严重程度也有类似的发现，和生活质量。不良事件可能在组间没有差异（中度确定性），然而,没有RCT报告神经精神不良事件。
结论：在荨麻疹患者中，在H1-抗组胺药中加入LTRAs可能会适度改善荨麻疹的活性,而总体不良事件几乎没有增加.在患有LTRA的人群中，神经精神不良事件的额外风险很小且不确定。
