Gómez René Maximiliano, Moreno Pablo, Compalati Enrico, Canonica Giorgio Walter, Ansotegui Zubeldia Ignacio Javier
Argentinean Association of Allergy & Clinical Immunology (AAAeIC), Argentina.
Ayre Foundation, Salta, Argentina.
World Allergy Organ J. 2023 Jul 11;16(7):100795. doi: 10.1016/j.waojou.2023.100795. eCollection 2023 Jul.
Fexofenadine emerged as one of the most representative second generation histamine H1 antagonist drugs since the 1990s, with an outstanding efficacy and appreciable safety for the treatment of allergic patients. While allergic rhino-conjunctivitis represents the most frequent atopic disease globally, an update of fexofenadine efficacy and safety on this entity was proposed as a surrogate of allergic condition.
Double blind, placebo controlled, randomized clinical trials investigating the efficacy and safety of fexofenadine for the treatment of Allergic Rhinitis were searched in 5 major global databases. Eligibility criteria and characteristics, risk of bias, and validity assessment, data extraction and heterogeneity evaluation are described. Primary outcome selected corresponded to 12-reflective and instantaneous total symptom scores (TSS), besides morning instantaneous TSS and the frequency of reported adverse events (AEs); analysis was planned on the intention-to-treat population.Standardized mean differences of scoring systems were analyzed, and Cochran's Q statistic test and the I test were assessed for heterogeneity.
From the initial 83 identified records, 12 eligible studies were selected. In the evaluated patients, individuals receiving fexofenadine (1910) showed a significant reduction of TSS compared with those who received placebo (1777), change from baseline: standardized mean difference (SMD) -0.33; 95% CI-0.47 to -0.18, p < 0.0001. Morning instantaneous TSS also demonstrated lower symptoms (change from baseline: SMS -1.42; 95% CI -2.22 to -0.62, p = 0.0005). Heterogeneity was found across selected studies.Frequency of AEs was similar compared to placebo (OR = 1.04; 0.88-1.21), with no detection of heterogeneity across these 12 studies.
According to this new evidence, fexofenadine maintains its beneficial profile on signs and symptoms of patients with allergic conditions, as well as its attributes as one of the major candidates for an ideal antihistamine medication (including special conditions such as pregnancy and pre-school age), providing support to its over-the-counter condition in several countries.
自20世纪90年代以来，非索非那定成为最具代表性的第二代组胺H1拮抗剂药物之一，在治疗过敏患者方面疗效显著且安全性良好。虽然变应性鼻结膜炎是全球最常见的特应性疾病，但有人提议更新非索非那定对该疾病实体的疗效和安全性，以此作为过敏状况的替代指标。
在全球5个主要数据库中检索调查非索非那定治疗变应性鼻炎疗效和安全性的双盲、安慰剂对照、随机临床试验。描述了纳入标准和特征、偏倚风险、有效性评估、数据提取和异质性评估。除了早晨瞬间总症状评分和报告的不良事件（AE）频率外，选定的主要结局对应于12项反映性和瞬间总症状评分（TSS）；计划对意向性治疗人群进行分析。分析了评分系统的标准化均值差异，并评估了Cochran's Q统计检验和I检验的异质性。
从最初识别的83条记录中，选择了12项符合条件的研究。在评估的患者中，接受非索非那定治疗的个体（1910例）与接受安慰剂治疗的个体（1777例）相比，TSS显著降低，与基线相比的变化：标准化均值差异（SMD）为-0.33；95%置信区间为-0.47至-0.18，p<0.0001。早晨瞬间TSS也显示症状较轻（与基线相比的变化：SMS为-1.42；95%置信区间为-2.22至-0.62，p = 0.0005）。在选定的研究中发现了异质性。与安慰剂相比，AE的频率相似（OR = 1.04；0.88 - 1.21），在这12项研究中未检测到异质性。
根据这一新证据，非索非那定在过敏患者的体征和症状方面保持其有益特性，以及作为理想抗组胺药物主要候选药物之一的属性（包括妊娠和学龄前等特殊情况）, 为其在多个国家的非处方状态提供了支持。
