Alvarez M P, Simón M, Sánchez S, Apaloaza I, Prieto J
Departamento Médico, Laboratorios Pfizer S.A., Madrid.
Rev Esp Quimioter. 2000 Sep;13(3):297-305.
Our aim was to study a new form of azithromycin (500 mg tablets) in order to evaluate the tolerability and the influence of the ingestion of food on tolerability, the efficacy and treatment compliance in a large number of patients with respiratory tract infections. We carried out an open, non-comparative, multicenter, observational and prospective pharmacovigilance study of 3223 outpatients with respiratory tract infections randomly assigned to receive a daily dose of azithromycin for three months taken either during or outside meals. Patients were evaluated during an initial visit and two later ones in order to record the adverse events and establish the clinical efficacy. The diagnostics were as follows: pharyngotonsillitis (1200), acute otitis media (394), acute bronchitis (1134), exacerbation of chronic bronchitis (436), and community-acquired pneumonia (53). The overall therapeutic efficacy was satisfactory (cure or improvement) in 96% to 97% at the second visit and in 93% to 94% in the third (pharyngotonsillitis, 93%; acute otitis media, 91%; acute bronchitis, 94%; exacerbation of chronic bronchitis, 94%; and community-acquired pneumonia, 96%). A total of 170 adverse events were reported in 141 patients (4.4%); 12 were severe yet not related to the study medication. Eighty-eight patients showed adverse events presumed to be related to azithromycin; most were in the digestive tract. No differences in tolerability were observed in relation to food intake. Treatment compliance was high (97%). The elevated clinical efficacy, adequate compliance and the excellent tolerability profile of azithromycin tablets make them a safe and effective alternative in the treatment of respiratory tract infections.
我们的目的是研究一种新型阿奇霉素（500毫克片剂），以评估其耐受性以及食物摄入对耐受性、疗效和大量呼吸道感染患者治疗依从性的影响。我们对3223例呼吸道感染门诊患者进行了一项开放、非对照、多中心、观察性和前瞻性药物警戒研究，这些患者被随机分配接受每日一剂阿奇霉素，为期三个月，服药时间为餐中或餐外。在首次就诊及随后的两次就诊期间对患者进行评估，以记录不良事件并确定临床疗效。诊断结果如下：咽扁桃体炎（1200例）、急性中耳炎（394例）、急性支气管炎（1134例）、慢性支气管炎急性加重（436例）和社区获得性肺炎（53例）。第二次就诊时总体治疗效果令人满意（治愈或改善）的比例为96%至97%，第三次就诊时为93%至94%（咽扁桃体炎为93%；急性中耳炎为91%；急性支气管炎为94%；慢性支气管炎急性加重为94%；社区获得性肺炎为96%）。共有141例患者（4.4%）报告了170起不良事件；12起严重不良事件与研究药物无关。88例患者出现了推测与阿奇霉素有关的不良事件；大多数发生在消化道。未观察到食物摄入对耐受性有差异。治疗依从性较高（97%）。阿奇霉素片剂的临床疗效高、依从性好且耐受性优良，使其成为治疗呼吸道感染的一种安全有效的选择。
