Rubinstein E
Infectious Diseases Unit, Sheba Medical Center, Tel Aviv University Sackler School of Medicine, Tel-Hashomer, Israel.
J Antimicrob Chemother. 1996 May;37 Suppl A:145-60. doi: 10.1093/jac/37.suppl_a.145.
A total of 2081 adult patients with community-acquired lower respiratory tract infections participated in Phase III clinical trials of sparfloxacin. A total of 1040 patients were randomised to sparfloxacin and 1041 patients received a comparator regimen. Sparfloxacin was administered as a 400 mg loading dose on day 1 followed by 200 mg once daily to patients with community-acquired pneumonia and as a 200 mg loading dose on day 1 followed by 100 mg daily to patients with acute exacerbations of chronic obstructive pulmonary disease. Comparator regimens were amoxycillin/clavulanic acid 500/125 mg tid, amoxycillin 1000 mg tid, a combination of amoxycillin 1000 mg tid plus ofloxacin 200 mg bid or erythromycin 1000 mg bid. The incidence of adverse events, the incidence and severity of antibacterial-related adverse events and the incidence of antibacterial discontinuation due to adverse events were no different among patients treated with sparfloxacin compared with those who received a comparator antibacterial agent. Sparfloxacin appears to be as well tolerated as other oral antibacterial regimens commonly used to treat lower respiratory tract infections.
共有2081例社区获得性下呼吸道感染成年患者参与了司帕沙星的III期临床试验。共有1040例患者被随机分配接受司帕沙星治疗，1041例患者接受对照治疗方案。对于社区获得性肺炎患者，司帕沙星在第1天给予400mg负荷剂量，随后每天一次给予200mg；对于慢性阻塞性肺疾病急性加重患者，在第1天给予200mg负荷剂量，随后每天给予100mg。对照治疗方案为阿莫西林/克拉维酸500/125mg每日三次、阿莫西林1000mg每日三次、阿莫西林1000mg每日三次加氧氟沙星200mg每日两次的联合用药或红霉素1000mg每日两次。与接受对照抗菌药物治疗的患者相比，接受司帕沙星治疗的患者不良事件发生率、抗菌药物相关不良事件的发生率和严重程度以及因不良事件而停用抗菌药物的发生率并无差异。司帕沙星的耐受性似乎与其他常用于治疗下呼吸道感染的口服抗菌治疗方案相当。
