Berufsgenossenschaftliche Kliniken Bergmannstrost, Halle/Saale, Germany.
Clin Drug Investig. 2003;23(1):1-10. doi: 10.2165/00044011-200323010-00001.
A post-marketing surveillance (PMS) study was conducted to evaluate the efficacy and tolerability of moxifloxacin 400mg once daily in patients with acute exacerbation of chronic bronchitis (AECB) treated by pulmonologists and pulmonary specialists in community-based practice settings.
2338 patients with AECB (54% male; 46% female) were included in the analysis. PMS studies are prospective, open, uncontrolled and observational in design. All therapeutic decisions were made by the attending physician, based on their clinical practice and experience. This approach was adopted in order to provide valuable information on the safety and efficacy of moxifloxacin therapy in routine clinical practice.
The main symptoms of AECB (cough, expectoration, dyspnoea, chest pain and fever) were either resolved or improved in 80-97% of patients. Most patients (65%) improved within 3 days of starting moxifloxacin therapy and 91.6% by day 5. Mean time to improvement was 3.2±1.6 days. Overall, 96.1% of patients were judged by their physician to be either cured or improved following moxifloxacin therapy. Approximately 57% of patients had previously been treated with an antibiotic for their last episode of AECB. The antibiotics used were mostly macrolides (18.2% of patients), beta-lactams (16.9%), tetracycline/ doxycycline (9.9%) and quinolones (9.5%). The tolerability of moxifloxacin therapy was rated as 'very good' or 'good' in 95.4% of patients. Adverse events were reported in only 1.5% of patients.
In conclusion, moxifloxacin 400mg once daily was effective and well tolerated in this group of patients with AECB, combined with a rapid onset of action and a similarly high clinical success rate to that observed in controlled comparative clinical trials.
在社区实践环境中，进行了一项上市后监测（PMS）研究，以评估莫西沙星 400mg 每日一次治疗慢性支气管炎急性加重（AECB）患者的疗效和耐受性，这些患者由肺病专家和肺部专家治疗。
纳入分析的 2338 例 AECB 患者（54%为男性；46%为女性）。PMS 研究是前瞻性、开放性、非对照和观察性设计。所有治疗决策均由主治医生根据他们的临床实践和经验做出。采用这种方法是为了提供莫西沙星治疗在常规临床实践中的安全性和疗效的有价值信息。
AECB 的主要症状（咳嗽、咳痰、呼吸困难、胸痛和发热）在 80-97%的患者中得到缓解或改善。大多数患者（65%）在开始莫西沙星治疗后 3 天内改善，91.6%在第 5 天改善。平均改善时间为 3.2±1.6 天。总体而言，96.1%的患者经医生判断，在接受莫西沙星治疗后，病情要么治愈，要么改善。大约 57%的患者在上一次 AECB 发作时曾接受过抗生素治疗。使用的抗生素主要是大环内酯类（18.2%的患者）、β-内酰胺类（16.9%）、四环素/多西环素（9.9%）和喹诺酮类（9.5%）。莫西沙星治疗的耐受性在 95.4%的患者中被评为“非常好”或“好”。只有 1.5%的患者报告了不良反应。
总之，莫西沙星 400mg 每日一次治疗 AECB 患者有效且耐受性良好，起效迅速，临床成功率与对照临床试验中观察到的相似。
