Shorr Andrew F, Khashab Mohammed M, Xiang Jim X, Tennenberg Alan M, Kahn James B
Department of Medicine, Pulmonary and Critical Care Medicine, Room 2A-38D, Washington Hospital Center, 110 Irving St. NW, Washington, DC 20010, USA.
Respir Med. 2006 Dec;100(12):2129-36. doi: 10.1016/j.rmed.2006.03.019. Epub 2006 May 26.
The efficacy and safety of 750-mg, 5-day levofloxacin was recently shown to be comparable to 500-mg, 10-day levofloxacin in a randomized, double-blind, multicentre clinical trial for mild-to-severe community-acquired pneumonia (CAP). This subgroup analysis attempted to compare the safety and efficacy of a short-course levofloxacin regimen with traditional levofloxacin dosing for PSI Class III/IV patients.
This retrospective, subgroup analysis focused on Pneumonia Severity Index Class III and IV patients enrolled in the study. Measurements included clinical and microbiological success rates, adverse events, and symptom resolution by day 3 of therapy.
Of the 528 patients in the ITT population, 219 (41.5%) were categorized as PSI Class III/IV and included in this analysis. Among the clinically evaluable patients, 90.8% (69/76) of patients treated with the 750-mg regimen achieved clinical success, compared with 85.5% (71/83) treated with 500-mg levofloxacin (95% CI,-15.9 to 5.4). Eradication rates in the microbiologically evaluable population were comparable for the 750- and 500-mg regimens (88.9% vs 87.5%, respectively; 95% CI,-18.3 to 15.6). Both regimens were well tolerated and had comparable safety profiles. A greater proportion of patients in the 750-mg treatment group experienced resolution of fever (48.4% vs 34.0%; P=.046) and purulent sputum (48.4% vs 27.5%; P=.007) by day 3 of therapy.
The 750-mg, 5-day levofloxacin course achieved comparable clinical and microbiologic efficacy to the 500-mg, 10-day regimen. By day 3 of therapy, a greater proportion of patients in the 750-mg group had objective and subjective resolution of fever. Further research is needed to determine the economic significance of short-course levofloxacin therapy.
在一项针对轻至重度社区获得性肺炎（CAP）的随机、双盲、多中心临床试验中，最近显示750毫克、疗程5天的左氧氟沙星的疗效和安全性与500毫克、疗程10天的左氧氟沙星相当。这项亚组分析试图比较短疗程左氧氟沙星方案与传统左氧氟沙星给药方案对肺炎严重指数（PSI）III/IV级患者的安全性和疗效。
这项回顾性亚组分析聚焦于研究中纳入的肺炎严重指数III级和IV级患者。测量指标包括临床和微生物学成功率、不良事件以及治疗第3天时症状的缓解情况。
在意向性分析（ITT）人群的528例患者中，219例（41.5%）被归类为PSI III/IV级并纳入本分析。在可进行临床评估的患者中，接受750毫克方案治疗的患者有90.8%（69/76）取得临床成功，而接受500毫克左氧氟沙星治疗的患者为85.5%（71/83）（95%置信区间，-15.9至5.4）。在微生物学可评估人群中，750毫克和500毫克方案的根除率相当（分别为88.9%和87.5%；95%置信区间，-18.3至15.6）。两种方案耐受性均良好，且安全性特征相当。在治疗第3天时，750毫克治疗组中有更高比例的患者发热（48.4%对34.0%；P = 0.046）和脓性痰症状（48.4%对27.5%；P = 0.007）得到缓解。
750毫克、疗程5天的左氧氟沙星疗程与500毫克、疗程10天的方案取得了相当的临床和微生物学疗效。在治疗第3天时，750毫克组中有更高比例的患者发热在客观和主观上均得到缓解。需要进一步研究以确定短疗程左氧氟沙星治疗的经济学意义。
