Frati F, Incorvaia C, Cadario G, Fiocchi A, Senna G E, Rossi O, Romano A, Scala E, Romano C, Ingrassia A, Zambito M, Dell'albani I, Scurati S, Passalacqua G, Canonica G W
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Eur Ann Allergy Clin Immunol. 2013 Oct 1;45 Suppl 2:11-6.
The evidence of efficacy of allergen immunotherapy (AIT) for respiratory allergy has been demonstrated by a number of meta-analyses. However, the daily practice of AIT is quite different from controlled trials, facing challenges in terms of selection of patients, practical performance, and, of particular importance, use of allergen extracts of inadequate quality. We here performed a survey, named the Allergen Immunotherapy Decision Analysis (AIDA), to evaluate which criteria are used by specialists to choose a product for sublingual immunotherapy (SLIT) in patients with respiratory allergy. A questionnaire composed of 14 items to be ranked by each participant according to the importance attributed when choosing SLIT products was submitted to 444 Italian specialists. The responses of the 169 (38.1%) physicians, who answered all questions, were analysed. Most of the respondents were allergists (79%), followed by pulmonologists (10.8%), both allergists and pulmonologists (4.8%), and otorhinolaryngologists (3%); 59.8% of the respondents were males and 40.2% were females. The age distribution showed that 89.9% of the respondents were aged between 35 and 64 years. All respondents usually prescribed AIT products in their clinical practice: 31.4% used only SLIT, whereas 69.2% used both subcutaneous and sublingual administration. The rankings, expressed as means, attributed by physicians for each of the 14 items were as follows: level of evidence-based medicine (EBM ) validation of efficacy (3.44), level of EBM validation of safety (4.30), standardization of the product (5.37), efficacy based on personal experience (5.82), defined content(s) of the major allergen(s) in micrograms (5.96), scientific evidence for each single allergen (6.17), safety based on personal experience (6.32), ease of administration protocol (8.08), cost and terms of payment (e.g. instalments) (9.17), dose personalization (9.24), patient preference (9.25), ease of product storage (9.93), reimbursement (10.12), and availability of a helpline or on-line assistance from the manufacturer (11.89). These attitudes need to be taken into consideration by regulatory agencies as well as by producers.
多项荟萃分析已证实变应原免疫疗法(AIT)对呼吸道过敏的疗效。然而,AIT的日常实践与对照试验有很大不同,在患者选择、实际操作方面面临挑战,尤其重要的是,使用质量不佳的变应原提取物。我们在此开展了一项名为变应原免疫疗法决策分析(AIDA)的调查,以评估专家在为呼吸道过敏患者选择舌下免疫疗法(SLIT)产品时使用哪些标准。一份由14个项目组成的问卷提交给了444名意大利专家,每位参与者需根据选择SLIT产品时所认为的重要性对这些项目进行排序。对回答了所有问题的169名(38.1%)医生的回复进行了分析。大多数受访者是过敏症专科医生(79%),其次是肺病学家(10.8%)、既是过敏症专科医生又是肺病学家的(4.8%)以及耳鼻喉科医生(3%);59.8%的受访者为男性,40.2%为女性。年龄分布显示,89.9%的受访者年龄在35至64岁之间。所有受访者在临床实践中通常都会开具AIT产品:31.4%仅使用SLIT,而69.2%同时使用皮下和舌下给药。医生对14个项目中每个项目的排序(以均值表示)如下:循证医学疗效验证水平(3.44)、循证医学安全性验证水平(4.30)、产品标准化(5.37)、基于个人经验的疗效(5.82)、主要变应原以微克计的规定含量(5.96)、每种单一变应原的科学证据(6.17)、基于个人经验的安全性(6.32)、给药方案的简便性(8.08)、成本及支付条款(如分期付款)(9.17)、剂量个性化(9.24)、患者偏好(9.25)、产品储存的简便性(9.93)、报销(10.12)以及制造商提供热线或在线协助的可获得性(11.89)。监管机构以及生产商需要考虑这些态度。