The aim of this multicenter, open, randomized study was to compare the efficacy and tolerability of a 5-day treatment course with oral moxifloxacin (MXF) vs a 7-day course with i.m. ceftriaxone (CRO) in 476 patients with acute exacerbations of chronic bronchitis (AECB), and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service (INHS) and society. The study was conducted in Italy. Clinical success rates at test-of-cure in the 423 patients of the PP (Per Protocol) population (primary efficacy parameter) were 90.6% and 89.0% for MXF and CRO, respectively. Statistical non-inferiority of MXF vs CRO was confirmed. Similar results were found between study drugs on the secondary efficacy parameters, including success at end-of-treatment (95.3% for MXF vs 92.9% for CRO), success at test-of-cure in bacteriologically-positive patients (94.1% vs 90.7%) and eradication/presumed eradication rates (91.7% vs 93.3%). ITT (Intention-to-Treat) analysis confirmed these data. There was a low incidence of adverse events (10.8% vs 9.1%). During a 6-month follow-up period, relapse rates were lower for MXF vs CRO (23.3% vs 28.3%; p > .05). Compared with CRO, MXF was associated with cost savings per patient ranging from Euro226.57 (INHS perspective) to Euro448.23 (societal perspective), with lower hospitalization rate the major variable contributing to reduced costs. MXF appears to be an ideal candidate for AECB treatment.
Both antibiotic regimens were safe and effective in achieving clinical resolution of symptoms at the test-of-cure visit, but patients taking moxifloxacin reported a more rapid response to treatment and return to daily activities
在成年人中是常见的慢性支气管炎,感染加重大大有助于发病率和死亡率。我们的目的是比较莫西沙星的安全性和有效性的怀疑细菌来源的慢性支气管炎(慢性支气管炎急性发作)的急性发作患者的治疗阿奇霉素。一九九八年十月至一九九九年四月,与慢性支气管炎急性发作567例患者参加在美国和加拿大的37个中心,280(49%),其中有急性细菌感染发作的慢性支气管炎(即治疗前的病原体)。患者被随机口服莫西沙星400毫克每天服用一次,连续5天5天或阿奇霉素(500毫克QD×1,然后250毫克QD x 4)。所有患者致盲研究的目的,收到包裹的片剂。主要成果的措施是在测试固化访问(治疗后14-21天)的临床疗效。二级措施包括细菌学响应和消灭细菌(中心)的时间,当然。三个病人群体的疗效分析:临床有效微生物有效(即与治疗前的病原体),意向性治疗(即至少接受了一次研究药物的剂量)。在测试固化访问的临床反应的疗效,有效的组,在各治疗组的患者为88%。237微生物无效的患者,相应的临床解决率分别为88%,为5天莫西沙星与86%为期5天的阿奇霉素。细菌根除率在治疗结束时分别为95%,为5天莫西沙星和阿奇霉素组的94%。在测试固化访问相应的根除率分别为89%和86%,分别。值得注意的是,在血红素测试固化根除率。 philos流感和副流感H.莫西沙星分别为97%和88%相比,83%和62%分别为阿奇霉素。其中567意向性治疗的患者(283莫西沙星和阿奇霉素284),与毒品有关的事件的报道,分别为22%和17%。腹泻和恶心是最常见的药物相关的活动,在各治疗组报道。莫西沙星400毫克,连续5天每天一次被发现是临床和细菌学相当于证明细菌病因治疗慢性支气管炎急性发作的为期5天的阿奇霉素。鉴于其优良的体外活性,特别是对抗生素耐药性的呼吸道病原体,其可接受的安全性,莫西沙星应被视为一种有效的替代疗法与慢性支气管炎急性发作的患者,怀疑细菌来源。