University Hospital Cologne, Cologne, Germany.
PLoS One. 2013 Apr 23;8(4):e61927. doi: 10.1371/journal.pone.0061927. Print 2013.
We conducted a prospective, non-controlled, multi-centre Phase IV observational cohort study of patients with acute bacterial rhinosinusitis who were treated with moxifloxacin in clinical practice in 19 countries in Asia Pacific, Europe and the Middle East. With the data collected we evaluated the presentation and course of the current disease episode, particularly in terms of the principal clinical signs and symptoms of acute rhinosinusitis and diagnostic procedures. A final assessment of moxifloxacin therapy was made to evaluate the impact of the sinusitis episode on activities of daily life and on sleep disturbance, and to evaluate the clinical outcome of treatment. A total of 7,090 patients were enrolled, of whom 3909 (57.6%) were included in the valid for clinical outcome and safety population. Regional differences were observed in the main symptoms of acute rhinosinusitis and, according to several characteristics, disease episodes appeared to be more severe in patients in Europe than in the Asia Pacific or Middle East regions. The sinusitis episode impacted on daily living for mean (SD) periods of 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) days and disturbed sleep for 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) nights in the Asia Pacific, Europe and Middle East regions, respectively. With moxifloxacin treatment, the mean (SD) time to improvement of symptoms was 3.0 (1.5), 3.4 (1.6) and 3.2 (1.5) days, and the time to resolution of symptoms was 4.8 (2.6) days, 5.7 (2.4) days and 5.5 (2.5) days, in the Asia Pacific, Europe and Middle East regions, respectively. In conclusion, acute rhinosinusitis remains a substantial health burden with significant impact on patients' quality of life, and there are differences between global regions in the clinical presentation, diagnosis and clinical course of disease episodes. Moxifloxacin was an effective and well-tolerated treatment option in the overall population.
ClinicalTrials.gov Identifier: NCT00930488.
我们在亚太、欧洲和中东的 19 个国家进行了一项前瞻性、非对照、多中心 IV 期观察性队列研究，评估了莫西沙星治疗急性细菌性鼻-鼻窦炎的疗效。
入选患者在临床实践中接受莫西沙星治疗，评估当前疾病发作的表现和过程，特别是急性鼻-鼻窦炎的主要临床体征和症状以及诊断程序。最后评估莫西沙星治疗的疗效，评价鼻窦炎发作对日常生活和睡眠干扰的影响，并评估治疗的临床转归。
共入选 7090 例患者，其中 3909 例（57.6%）纳入临床疗效和安全性人群。急性鼻-鼻窦炎的主要症状存在地区差异，根据多项特征，欧洲患者的疾病发作似乎比亚太或中东地区患者更严重。鼻窦炎发作分别导致亚太、欧洲和中东地区患者平均（标准差）3.6（3.2）、4.6（3.9）和 3.1（3.0）天的日常生活受影响和 3.6（3.2）、4.6（3.9）和 3.1（3.0）夜的睡眠受干扰。接受莫西沙星治疗后，症状改善的平均（标准差）时间分别为 3.0（1.5）、3.4（1.6）和 3.2（1.5）天，症状缓解的平均（标准差）时间分别为 4.8（2.6）、5.7（2.4）和 5.5（2.5）天。
急性鼻-鼻窦炎仍是重大的健康负担，对患者生活质量有重大影响，不同地区在疾病发作的临床表现、诊断和临床病程方面存在差异。莫西沙星是一种有效且耐受良好的治疗选择。
临床试验.gov 标识符：NCT00930488。
