Lode H, Garau J, Grassi C, Hosie J, Huchon G, Legakis N, Segev S, Wijnands G
Pneumology Dept I, Hospital Zehlendorf, Berlin, Germany.
Eur Respir J. 1995 Dec;8(12):1999-2007. doi: 10.1183/09031936.95.08121999.
The treatment of community-acquired pneumonia is empirical in most cases and must cover a wide range of potential pathogens, such as Streptococcus pneumoniae, including penicillin-resistant strains, Haemophilus influenzae and intracellular microorganisms. The objective of this double-blind, randomized, parallel group study was to compare the efficacy and safety of sparfloxacin (400 mg loading dose, followed by 200 mg o.d.) with that of oral amoxycillin-clavulanic acid (500/125 mg t.i.d.) or oral erythromycin (1 g b.i.d.), during 7-14 days in 808 patients with confirmed community-acquired pneumonia. The overall success rates for sparfloxacin (87%), amoxycillin-clavulanic acid (80%) and erythromycin (85%) were similar in evaluable patients, and the equivalence hypothesis used for the statistical analysis showed at least an equivalent efficacy for the three antibiotics tested. The analysis of microbiologically documented infections (40% of the patients) showed that overall success rates were similar for S. pneumoniae and H. influenzae infections. Treatment withdrawal was necessary in 3.5, 2.5 and 7.7% of the patients treated with sparfloxacin, amoxycillin-clavulanic acid and erythromycin, respectively. This study indicates that sparfloxacin was at least as effective as amoxycillin-clavulanic acid or erythromycin in the treatment of mild-to-moderate community-acquired pneumonia and that the adverse effects were similar in the three groups.
在大多数情况下，社区获得性肺炎的治疗是经验性的，必须覆盖多种潜在病原体，如肺炎链球菌（包括耐青霉素菌株）、流感嗜血杆菌和细胞内微生物。这项双盲、随机、平行组研究的目的是比较司帕沙星（400mg负荷剂量，随后每日200mg）与口服阿莫西林-克拉维酸（500/125mg每日三次）或口服红霉素（1g每日两次）在808例确诊的社区获得性肺炎患者中治疗7 - 14天的疗效和安全性。在可评估的患者中，司帕沙星（87%）、阿莫西林-克拉维酸（80%）和红霉素（85%）的总体成功率相似，用于统计分析的等效性假设表明，所测试的三种抗生素至少具有等效疗效。对微生物学确诊感染（占患者的40%）的分析表明，肺炎链球菌和流感嗜血杆菌感染的总体成功率相似。接受司帕沙星、阿莫西林-克拉维酸和红霉素治疗的患者中，分别有3.5%、2.5%和7.7%的患者需要停药。这项研究表明，司帕沙星在治疗轻至中度社区获得性肺炎方面至少与阿莫西林-克拉维酸或红霉素一样有效，且三组的不良反应相似。
