Wilson R, Jones P, Schaberg T, Arvis P, Duprat-Lomon I, Sagnier P P
Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK.
Thorax. 2006 Apr;61(4):337-42. doi: 10.1136/thx.2005.045930. Epub 2006 Jan 31.
The MOSAIC study compared moxifloxacin with three standard antibiotic regimens in patients with Anthonisen type 1 acute exacerbations of chronic bronchitis (AECB). Further exploratory analyses were performed to identify prognostic factors of short and long term clinical outcomes and their value for clinical research.
Outpatients aged > or =45 years were screened between AECB episodes, randomised to treatment upon presenting with an AECB, assessed 7-10 days after study treatment, and followed monthly until a new AECB or for up to 9 months. Logistic regression assessed the predictive factors for clinical cure (return to pre-AECB status) and clinical success (cure or improvement), and a stepwise Cox regression model time to a composite event (failure of study treatment, new AECB, or further antibiotic treatment for AECB).
In multivariate analyses, clinical cure was positively influenced by treatment with moxifloxacin (odds ratio (OR) 1.49; 95% CI 1.08 to 2.04) while cardiopulmonary disease (OR 0.59; 95% CI 0.38 to 0.90), forced expiratory volume in 1 second (FEV1) <50% predicted (OR 0.48; 95% CI 0.35 to 0.67), and > or =4 AECBs in the previous year (OR 0.68; 95% CI 0.48 to 0.97) predicted a poorer outcome. For clinical success, treatment with moxifloxacin had a positive influence (OR 1.57; 95% CI 1.03 to 2.41) while cardiopulmonary disease (OR 0.41; 95% CI 0.25 to 0.68) and use of acute bronchodilators (OR 0.50; 95% CI 0.30 to 0.84) predicted a poorer outcome. The occurrence of the composite event was influenced by antibiotic treatment (hazard ratio (HR) 0.82; 95% CI 0.68 to 0.98), age > or =65 years (HR 1.22; 95% CI 1.01 to 1.47), FEV1<50% predicted (HR 1.27; 95% CI 1.05 to 1.53), > or =4 AECBs in previous year (HR 1.63; 95% CI 1.34 to 1.99), and acute bronchodilator use (HR 1.48; 95% CI 1.17 to 1.87). For the composite event the beneficial effect of moxifloxacin was primarily seen in patients aged > or =65 years.
Despite selection of a homogeneous population of patients with chronic bronchitis, between group differences relating to antibiotic treatment could still be confounded by factors related to medical history, severity of disease, and use of concomitant medications. The design of future clinical trials should take these factors into account.
MOSAIC研究比较了莫西沙星与三种标准抗生素治疗方案用于慢性支气管炎1型急性加重期（AECB）患者的疗效。进行了进一步的探索性分析，以确定短期和长期临床结局的预后因素及其在临床研究中的价值。
年龄≥45岁的门诊患者在AECB发作间期进行筛查，出现AECB时随机分组接受治疗，在研究治疗7 - 10天后进行评估，并每月随访直至出现新的AECB或长达9个月。Logistic回归分析评估临床治愈（恢复到AECB前状态）和临床成功（治愈或改善）的预测因素，逐步Cox回归模型分析复合事件（研究治疗失败、新的AECB或因AECB接受进一步抗生素治疗）的发生时间。
在多因素分析中，莫西沙星治疗对临床治愈有积极影响（比值比（OR）1.49；95%置信区间1.08至2.04），而心肺疾病（OR 0.59；95%置信区间0.38至0.90）、预计第1秒用力呼气容积（FEV1）<50%（OR 0.48；95%置信区间0.35至0.67）以及前一年发生≥4次AECB（OR 0.68；95%置信区间0.48至0.97）提示预后较差。对于临床成功，莫西沙星治疗有积极影响（OR 1.57；95%置信区间1.03至2.41），而心肺疾病（OR 0.41；95%置信区间0.25至0.68）和使用急性支气管扩张剂（OR 0.50；95%置信区间0.30至0.84）提示预后较差。复合事件的发生受抗生素治疗影响（风险比（HR）0.82；95%置信区间0.68至0.98）、年龄≥65岁（HR 1.22；95%置信区间1.01至1.47）、FEV1<50%预计值（HR 1.27；95%置信区间1.05至1.
