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首页> 外文期刊>Clinical drug investigation >Evaluation of treatment satisfaction in children with allergic disease treated with an antihistamine: an international, non-interventional, retrospective study.
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Evaluation of treatment satisfaction in children with allergic disease treated with an antihistamine: an international, non-interventional, retrospective study.

机译:用抗组胺药治疗的过敏性疾病患儿的治疗满意度评估:一项国际,非干预性回顾性研究。

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BACKGROUND AND OBJECTIVES: Histamine H(1)-receptor antagonists (antihistamines) have been shown to be efficacious and safe in children and are recommended as first-line treatment for the symptoms of allergic rhinitis and urticaria. No published study to date has directly compared satisfaction with the different antihistamines in children in a real-life clinical setting. This study aimed to investigate parent and physician satisfaction with the efficacy and tolerability of oral antihistamine treatment in children and to compare satisfaction between levocetirizine and the other antihistamines used by children in this cohort. METHODS: This was an international Observational Survey in Children with Allergic Rhinitis (OSCAR). Children aged 2-12 years, with a history of an allergic condition leading to a consultation, were enrolled from 424 primary-care/specialist allergy clinics across Bulgaria, India, Portugal, Romania, Russia, South Korea and Spain. At the consultation, parents and physicians of eligible children completed questionnaires evaluating their satisfaction with specific antihistamines currently employed for management of the child's allergic condition, as well as their intention for future use of that treatment. Parents' satisfaction scores for efficacy, tolerability and global satisfaction with the antihistamine used were primary study outcomes, while physicians' satisfaction scores for the same measures were secondary outcomes. Other secondary outcomes were parents' rating of the impact of the antihistamine treatment on their child's sleep and school performance, and parents' and physicians' willingness to use/recommend the same antihistamine in the future. RESULTS: A total of 4581 patients were enrolled; 3048 (66.5%) had allergic rhinitis (55.9% persistent allergic rhinitis and 44.1% intermittent allergic rhinitis), and 663 (14.5%) had urticaria as primary conditions. Additionally, 2465 patients (53.8%) suffered from other allergic diseases, including allergic asthma (33.3%), atopic dermatitis (17.6%), food allergy (5.3%), other allergies (5.0%) and drug hypersensitivity (2.0%). Parents' and physicians' satisfaction scores were closely concordant and demonstrated significantly greater global satisfaction for the second-generation antihistamines than for the first-generation antihistamines. Levocetirizine (n = 2339) and fexofenadine (n = 42) generally scored highest for efficacy, tolerability and global satisfaction, as well as for impact on the child's ability to function at school, quality of school activities and quality of sleep. Furthermore, >97% of parents and physicians indicated their desire to continue or recommend the use of levocetirizine in the future. Somnolence, the most commonly reported adverse event in this survey, was observed predominantly in patients treated with first-generation antihistamines. Among second-generation antihistamines, reports of somnolence were most frequent in the cetirizine group. CONCLUSION: Second-generation antihistamines have a better risk:benefit ratio than first-generation antihistamines, indicating that the latter should be avoided or their use limited in children whenever possible. Levocetirizine and fexofenadine were perceived by parents and physicians to produce significantly higher treatment satisfaction than the majority of the other antihistamines with respect to overall efficacy and tolerability, and impact on the child's sleep and school activities. The newer antihistamine levocetirizine seems to be a preferred and appropriate future treatment choice for children with allergic diseases.
机译:背景和目的:组胺H(1)受体拮抗剂(抗组胺药)已被证明对儿童有效且安全,被推荐作为过敏性鼻炎和荨麻疹症状的一线治疗。迄今为止,尚无已发表的研究在现实生活中直接比较儿童对不同抗组胺药的满意度。这项研究旨在调查父母和医生对儿童口服抗组胺药的疗效和耐受性的满意度,并比较该组儿童中左西替利嗪和其他抗组胺药的满意度。方法:这是一项儿童过敏性鼻炎(OSCAR)的国际观察性调查。保加利亚,印度,葡萄牙,罗马尼亚,俄罗斯,韩国和西班牙的424家初级保健/专科过敏诊所招募了2-12岁的儿童,他们有过敏症的病史,因此需要进行咨询。在咨询中,符合条件的儿童的父母和医生填写了问卷,评估了他们对目前用于控制儿童过敏状况的特定抗组胺药的满意度,以及他们将来使用该治疗的意向。父母对使用的抗组胺药的疗效,耐受性和总体满意度的满意度得分是主要的研究结果,而医师对相同措施的满意度得分是次要的结果。其他次要结果是父母对抗组胺药治疗对其孩子的睡眠和学习成绩的影响进行评估,以及父母和医生将来愿意使用/推荐相同的抗组胺药。结果:共纳入4581例患者; 3048名(66.5%)患有过敏性鼻炎(55.9%的持续性过敏性鼻炎和44.1%的间歇性过敏性鼻炎),有663名(14.5%)患有荨麻疹为主要疾病。此外,有2465名患者(53.8%)患有其他过敏性疾病,包括过敏性哮喘(33.3%),特应性皮炎(17.6%),食物过敏(5.3%),其他过敏(5.0%)和药物超敏性(2.0%)。父母和医生的满意度得分非常一致,并且表明第二代抗组胺药的全球满意度明显高于第一代抗组胺药。左西替利嗪(n = 2339)和非索非那定(n = 42)通常在疗效,耐受性和总体满意度以及对孩子在学校的功能,学校活动质量和睡眠质量的影响方面得分最高。此外,> 97%的父母和医生表示他们希望将来继续或推荐使用左西替利嗪。嗜睡症是本次调查中最常报告的不良事件,主要发生在接受第一代抗组胺药治疗的患者中。在第二代抗组胺药中,西替利嗪组中嗜睡的报道最为频繁。结论:第二代抗组胺药比第一代抗组胺药具有更好的风险:获益比,表明应避免使用后者或在儿童中限制使用。父母和医生认为左西替利嗪和非索非那定在总体功效和耐受性以及对孩子的睡眠和学校活动的影响方面,比大多数其他抗组胺药产生的治疗满意度明显高于大多数其他抗组胺药。较新的抗组胺药左西替利嗪似乎是过敏性疾病儿童的首选和适当的未来治疗选择。

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