A multicenter study of grepafloxacin and clarithromycin in the treatment of patients with community-acquired pneumonia
A multicenter study of grepafloxacin and clarithromycin in the treatment of patients with community-acquired pneumonia
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DOI：
10.1378/chest.116.4.974
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发表时间：
1999-10-01
期刊：
影响因子：
9.6
通讯作者：
Staley, H
中科院分区：
文献类型：
--
作者：
Moola, S;Hagberg, L;Staley, H
研究目的：根据临床反应，包括影像学证据和细菌学疗效，比较10天格雷帕沙星（GPX） （Raxar或Vaxar； Glare Wellcome; Greenford， UK） 600 qd和克拉霉素（CLA） （Klacid、Biaxin或Klaracid； Abbott Laboratories; Chicago， IL） 500 mg bid治疗社区获得性肺炎（CAP）患者的疗效。设计：IIIb期，双盲，双假人，随机，前瞻性，平行组，比较研究，在11个国家的58个中心进行。患者和环境：有影像学证据证实的CAP体征和症状且不需要肠外治疗的成年患者被纳入研究。评估：患者在治疗前，治疗中，治疗后和随访（治疗完成后28至35天）进行评估。评估临床反应。血液和痰标本培养细菌病原体，血清学检测非典型肺炎。结果：共有504例患者入组，其中251例随机接受GFX治疗，253例接受CLA治疗。在能够进行临床评估的患者中，随访的临床成功率为GFX组163例患者中的147例（90%）和CLA组167例患者中的148例（89%）（95%置信区间，-6%至9%）。504例患者中有131例（26%）通过培养或血清学检测确认了预处理病原体，主要病原体为肺炎链球菌（22%）、流感嗜血杆菌（17%）、肺炎支原体（25%）和肺炎衣原体（11%）。对于能够评估具有典型病原体的患者，每个治疗组中92%的患者取得了细菌学上的成功。对于能够评估患有非典型病原体的患者，GPX组18例患者（100%）和CLA组26例患者中23例（88%）的临床结果成功。两组不良事件发生率相似，导致停药率小于或等于7%；胃肠道疾病是最常见的。结论：GFX （600 mg cid）与CLA （500 mg bid）在治疗成人CAP患者中的作用相当。两种治疗均具有良好的耐受性。
Study objectives: To compare the efficacies of 10-day regimens of grepafloxacin (GPX) (Raxar or Vaxar; Glare Wellcome; Greenford, UK), 600 qd, and clarithromycin (CLA) (Klacid, Biaxin, or Klaracid; Abbott Laboratories; Chicago, IL), 500 mg bid, in patients with community-acquired pneumonia (CAP), on the basis of clinical response, including radiographic evidence, and bacteriologic efficacy.Design: Phase IIIb, double-blind, double-dummy, randomized, prospective, parallel-group, comparative study conducted at 58 centers in 11 countries.Patients and setting: Adult patients with signs and symptoms of CAP that was confirmed by radiographic evidence and who did not require parenteral therapy were included in the study.Assessments: Patients were assessed before treatment, during treatment, after treatment, and at follow-up (28 to 35 days after treatment completion). Clinical response was evaluated. Blood and sputum samples were cultured for bacterial pathogens, and serology testing was performed to detect atypical pneumonia.Results: A total of 504 patients were enrolled into the trial: 251 were randomly assigned to receive GFX and 253 to receive CLA. In patients able to be clinically evaluated, clinical success rates at follow-up were 147 of 163 patients (90%) in the GFX group and 148 of 167 patients (89%) in the CLA group (95% confidence interval, -6% to 9%). Pretreatment pathogens were confirmed in 131 of 504 patients (26%), either by culture or serology testing, the primary pathogens being Streptococcus pneumoniae (22%), Haemophilus influenzae (17%), Mycoplasma pneumoniae (25%), and Chlamydia pneumoniae (11%). For patients able to be evaluated who had typical pathogens, bacteriologic success was achieved in 92% of the patients in each treatment group. For patients able to be evaluated who had atypical pathogens, 18 of 18 patients (100%) in the GPX and 23 of 26 patients (88%) in the CLA group had a successful clinical outcome. There were similar rates of adverse events in each group, resulting in less than or equal to 7% withdrawal from treatment; gastrointestinal events were the most common.Conclusions: GFX, 600 mg cid, was equivalent to CLA, 500 mg bid, in treating adult patients with CAP. Both treatments were well tolerated.