Corrêa João Carlos, Badaró Roberto, Bumroongkit Chaiwat, Mera Jorge Raúl, Dolmann Alberto Lorenzo, Juárez Martínez Luis Guillermo, Mayrinck Lusane Romero, Tamez Ricardo, Yang Joanna Y
Hospital da Venerável Ordem Terceira de São Francisco da Penitência, Rio de Janeiro, Brazil.
Clin Ther. 2003 May;25(5):1453-68. doi: 10.1016/s0149-2918(03)80132-7.
Empiric therapy for community-acquired pneumonia (CAP) requires the use of antibiotics with activity against a broad spectrum of respiratory pathogens and suitable pharmacokinetic properties to simplify IV-to-oral step-down therapy switches.
The aim of this study was to compare the efficacy and tolerability of IV gatifloxacin with the option for oral stepdown gatifloxacin with a standard regimen of IV ceftriaxone (with or without erythromycin or clarithromycin) with the option for oral stepdown clarithromycin in patients with mild to moderate CAP requiring hospitalization.
In a randomized, open-label, parallel-group, multicenter study, adults with CAP received 7 to 14 days of treatment with either IV gatifloxacin 400 mg QD with the stepdown option or IV ceftriaxone 1 or 2 g QD (with or without erythromycin 0.5 or 1 g QID or clarithromycin 500 mg BID) with the stepdown option.
One hundred seventy adults with CAP were included in the study. IV gatifloxacin was stepped down to oral gatifloxacin in 90.6% (7785) of patients; IV ceftriaxone was stepped down to oral clarithromycin in 87.1% (7485) of patients. Among clinically evaluable patients (n = 153), cure rates at 1 to 3 days after treatment were 97.4% in the gatifloxacin group (7476) and 90.9% in the ceftriaxone group (7077), with a 95% CI for the difference (-3.7% to 19.1%) indicating statistical equivalence. In patients in whom pathogens were isolated from pretreatment sputum cultures, bacteriologic eradication rates were 100.0% (2929) and 90.9% (3033), respectively. Both regimens were well tolerated; treatment-related adverse events occurred in 27.1% (2385) and 21.2% (1885) of patients, respectively.
In the population studied, treatment with IV gatifloxacin with an option for oral stepdown gatifloxacin was as effective for achieving clinical cure as IV ceftriaxone (with or without concomitant IV erythromycin or clarithromycin) with an option for oral stepdown clarithromycin. Both regimens were well tolerated.
社区获得性肺炎（CAP）的经验性治疗需要使用对多种呼吸道病原体有活性且具有合适药代动力学特性的抗生素，以简化从静脉给药到口服降阶梯治疗的转换。
本研究旨在比较静脉注射加替沙星并可转换为口服加替沙星与标准静脉注射头孢曲松（联合或不联合红霉素或克拉霉素）并可转换为口服克拉霉素方案，用于治疗需要住院的轻至中度CAP患者的疗效和耐受性。
在一项随机、开放标签、平行组、多中心研究中，患有CAP的成年人接受7至14天的治疗，治疗方案为：静脉注射加替沙星400mg每日一次并可进行降阶梯治疗，或静脉注射头孢曲松1或2g每日一次（联合或不联合红霉素0.5或1g每日四次或克拉霉素500mg每日两次）并可进行降阶梯治疗。
170名患有CAP的成年人纳入本研究。90.6%（77/85）的患者从静脉注射加替沙星转换为口服加替沙星；87.1%（74/85）的患者从静脉注射头孢曲松转换为口服克拉霉素。在可进行临床评估的患者（n = 153）中，加替沙星组治疗后1至3天的治愈率为97.4%（74/76），头孢曲松组为90.9%（70/77），差异的95%置信区间为（-3.7%至19.1%），表明具有统计学等效性。在预处理痰培养中分离出病原体的患者中，细菌清除率分别为100.0%（29/29）和90.9%（30/33）。两种治疗方案耐受性均良好；治疗相关不良事件分别发生在27.1%（23/85）和21.2%（18/85）的患者中。
在所研究的人群中，静脉注射加替沙星并可转换为口服加替沙星的治疗方案与静脉注射头孢曲松（联合或不联合静脉注射红霉素或克拉霉素）并可转换为口服克拉霉素的方案在实现临床治愈方面同样有效。两种治疗方案耐受性均良好。
