Portier H, Brambilla C, Garre M, Paganin F, Poubeau P, Zuck P
CHU de Dijon, Hôpital du Bocage, BP 1542, 21034 Dijon Cedex, France.
Eur J Clin Microbiol Infect Dis. 2005 Jun;24(6):367-76. doi: 10.1007/s10096-005-1347-1.
The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5-7 days and 21-28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of -8.0-7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of -2.2-6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.
本研究的目的是评估莫西沙星与阿莫西林-克拉维酸加罗红霉素（对照药）在有危险因素的成年社区获得性肺炎（CAP）患者中的疗效和安全性。在这项比较性、随机、多中心、开放标签研究中，因CAP住院的患者接受为期10天的口服治疗，治疗药物为莫西沙星（400mg，每日一次）或阿莫西林-克拉维酸（1000/125mg，每日三次）加罗红霉素（150mg，每日两次）。在治愈测试和随访期间（分别在治疗结束后5 - 7天和21 - 28天）评估临床和细菌学结果。349例随机分组的患者中，346例纳入意向性分析，289例纳入符合方案分析。他们的基线特征具有可比性。最常见的死亡危险因素为年龄>65岁（50.0%）、酗酒（23.1%）和合并症（50.6%）；慢性阻塞性肺疾病（COPD）（25.4%）和糖尿病（13.6%）是最常见的相关合并症。346例患者中有66例（19.1%）记录到致病病原体（包括21例血培养阳性患者）。莫西沙星和对照药在治愈测试（主要疗效终点）时各自的符合方案临床成功率分别为151例中的131例（86.8%）和138例中的120例（87.0%），差异的95%置信区间（CI）为 - 8.0 - 7.6。细菌学成功率（根除）分别为30例中的23例（76.7%）和31例中的23例（74.2%）；血培养阳性患者的成功率分别为14例中的10例和6例中的4例。随访时持续临床成功率分别为120例中的118例（98.3%）和106例中的102例（96.2%），差异的95%CI为 - 2.2 - 6.4。意向性分析证实了这些结果。分别有171例患者中的42例（24.6%）和175例患者中的50例（28.）报告了与莫西沙星和对照药相关的不良事件，主要包括消化系统疾病，发生率分别为9.4%和21.1%。基于这些结果，对于有危险因素的CAP患者，单用每日一次口服莫西沙星与阿莫西林-克拉维酸加罗红霉素的疗效相当。
