Antihistamines for atopic dermatitis (eczema): systematic review and network meta-analysis of randomised trials.

Methods

Systematic reviewand network meta-analysisof randomised trials.

随机试验的系统评价和网络荟萃分析。

data_sources

Medline, Embase, CENTRAL, the United States Food and Drug Administration, and the European Medicines Agency databases from database inception to 5 May 2025.

Medline、Embase、CENTRAL、美国食品药品监督管理局和欧洲药品管理局数据库，从数据库建立之初至2025年5月5日。

study_selection

Randomised trials assessing add-on oral H1 antihistamines, H2 blockers, mast cell stabilisers (nedocromil sodium and sodium cromoglycate), or their combinations.

评估附加口服H1抗组胺药、H2阻断剂、肥大细胞稳定剂（如奈多罗米钠和色甘酸钠）或它们组合的随机试验。

Paired reviewers independently screened records, extracted data, and assessed risk of bias using a modified Cochrane Risk of Bias tool version 2.

配对评审员独立筛选记录、提取数据，并使用修改版的Cochrane风险偏倚工具第2版评估偏倚风险。

Methods

Random effects bayesian meta-analyses synthesised atopic dermatitis severity (oSCORAD-objective scoring atopic dermatitis, 0-83; minimal important difference 8.2; lower better), itch severity (numerical rating scale, 0-10; minimal important difference 3; lower better), sleep disturbance, atopic dermatitis related quality of life, and harms.

随机效应贝叶斯元分析综合了异位性皮炎的严重程度（oSCORAD-异位性皮炎客观评分，0-83分；最小重要差异为8.2分；数值越低越好），瘙痒程度（数字评分量表，0-10分；最小重要差异为3分；数值越低越好），睡眠干扰，异位性皮炎相关的生活质量以及不良事件。

The network meta-analysisGRADE (Grading of Recommendations Assessment, Development and Evaluation) and Core GRADE approaches informed certainty of evidence ratings.

网络荟萃分析GRADE（推荐等级的评估、发展和评价）和核心GRADE方法提供了证据确定性的评价。

Results

47 trials enrolled 6230 children and adults with primarily moderate to severe atopic dermatitis.

47项试验招募了6230名患有中度至重度特应性皮炎的儿童和成人。

With moderate certainty, compared with placebo, adding a first generation or second generation H1 antihistamine likely resulted in a small reduction in atopic dermatitis severity (mean difference -1.87, 95% credible interval -3.47 to -0.27) and itch severity (-0.89, -1.41 to -0.37).

中等程度的确定性表明，与安慰剂相比，添加第一代或第二代H1抗组胺药可能会导致特应性皮炎严重程度（平均差异-1.87，95%可信区间-3.47至-0.27）和瘙痒严重程度（-0.89，-1.41至-0.37）的轻微降低。

Although statistically detectable, these effects are well below established minimal important differences (smallest change in an outcome that a patient would identify as important).

尽管这些效果在统计上是可检测的，但它们远低于已建立的最小重要差异（患者能够识别为重要的最小结果变化）。

With low certainty, all studied interventions may not improve sleep disturbance or reduce atopic dermatitis exacerbations.

根据低确定性的证据，所有研究的干预措施可能无法改善睡眠障碍或减少异位性皮炎的加重。

First generation agents probably increase cognitive impairment and may increase treatment discontinuation because of adverse events (risk difference 66 more per 1000, 95% credible interval 0 to 231 more; moderate certainty).

第一代药物可能会增加认知障碍，并且可能会因为不良事件导致治疗中断（风险差异为每1000人中增加66例，95%可信区间为0到231例；中等确定性）。

Second generation agents differ in their risk of cognitive impairment (range of mean effects 0 more per 1000 for loratadine, 16 more per 1000 for levocetirizine, and 17 more per 1000 for cetirizine).

第二代药物在认知损害风险上有所不同（平均效应范围：对于洛拉他定为每1000人中增加0例，对于左西替利嗪为每1000人中增加16例，对于西替利嗪为每1000人中增加17例）。

Conclusions

Among patients with atopic dermatitis, adding H1 antihistamines probably results in a clinically unimportant reduction in atopic dermatitis severity and itch severity, and may not reduce sleep disturbance or atopic dermatitis exacerbations.

对于异位性皮炎患者，添加H1抗组胺药可能会导致异位性皮炎严重程度和瘙痒程度的临床上不重要的减轻，并可能不会减少睡眠干扰或异位性皮炎的加重。

First generation agents increase cognitive impairment and may increase treatment discontinuation because of adverse events.

第一代药物会增加认知功能损害的风险，并可能因不良事件导致治疗中断。

Cognitive impairment risk differs among second generation agents.

第二代药物之间认知功能损害的风险存在差异。

These findings provide evidence against routine antihistamine use in atopic dermatitis management and will inform updated clinical guidelines.

这些发现提供了反对在异位性皮炎管理中常规使用抗组胺药的证据，并将为更新的临床指南提供信息。

systematic_review_registration

PROSPERO CRD42022345643.

PROSPERO CRD42022345643。