Efficacy and safety of oral and early-switch therapy for community-acquired pneumonia:: A randomized controlled trial
Efficacy and safety of oral and early-switch therapy for community-acquired pneumonia:: A randomized controlled trial
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DOI：
10.1016/s0002-9343(01)00868-3
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发表时间：
2001-10-01
影响因子：
5.9
通讯作者：
García-Bragado, F
中科院分区：
文献类型：
--
作者：
Castro-Guardiola, A;Viejo-Rodríguez, AL;García-Bragado, F
目的：我们试图确定社区获得性肺炎患者口服治疗的安全性、有效性和费用。在非重症肺炎患者中，将常规（胃肠外）治疗与口服途径进行比较；在重症肺炎患者中，将常规治疗与早期从胃肠外治疗转为口服治疗进行比较。 对象和方法：我们将 85 名住院的非重症肺炎患者随机分配到两组中的一组：41 例从入院起接受口服抗菌药物，44 例接受肠外抗菌药物，直到他们在转为口服治疗前 72 小时无发热。我们将 103 名最初接受肠外抗菌药物治疗的重症肺炎患者随机分配到两组中的一组：48 名患者在治疗 48 小时后转为口服治疗（早期转换），55 名患者接受为期 10 天的肠外抗生素治疗。 结果：在非重症肺炎患者中，口服治疗组没有死亡，肠外治疗组有 1 例死亡（2%）（95% 置信区间 [CI] 为组间[口服减去肠胃外]差异：-7% 至 2%，P = 0.3）。口服治疗组有 34 名患者 (83%) 和肠胃外治疗组有 39 名患者 (88%) 患者发病时间小于或等于 5 天 (P = 0.5)；口服治疗组有 4 名患者（10%）出现治疗失败，胃肠外治疗组有 14 名患者（32%）出现治疗失败（P = 0.02）。在重症肺炎患者中，早期换药组有 1 例 (2%) 死亡，全疗程肠外抗生素组无死亡（组间 95% CI [早期换药与全疗程]差异：-2% 至 6%，P = 0.5）。早期转换组中有 38 名患者 (79%) 和全程组有 41 名患者 (75%) 的发病时间小于或等于 5 天 (P = 0.3)。早期转换组有 12 例（25%）治疗失败，全程组有 13 例（24%）治疗失败（P = 0.9）。口服组和早期转换组的不良事件较少，主要是由于输注相关静脉炎的发生率较低。早期转换组的重症肺炎患者可以显着节省费用，主要是由于住院时间缩短。结论：住院的非重症社区获得性肺炎患者从入院时起就可以有效、安全地接受口服抗菌药物治疗，而重症肺炎患者可以采用早期转换治疗。 (C) 2001 年，Excerpta Medica, Inc.
PURPOSE: We sought to determine the safety, efficacy, and cost of oral therapy for patients with community-acquired pneumonia. In patients with nonsevere pneumonia, conventional (parenteral) treatment was compared with the oral route; in patients with severe pneumonia, conventional treatment was compared with early switch from parenteral to oral therapy.SUBJECTS AND METHODS: We randomly assigned 85 hospitalized patients with nonsevere pneumonia to one of two groups: 41 received oral antimicrobials from admission, and 44 received parenteral antimicrobials until they had been afebrile for 72 hours before switching to oral treatment. We randomly assigned 103 patients with severe pneumonia who had initially been treated with parenteral antimicrobials to one of two groups: 48 were switched to oral therapy after 48 hours of treatment (early switch), and 55 received a full 10-day course of parenteral antibiotics.RESULTS: Among patients with nonsevere pneumonia, there were no deaths in the oral treatment group, and one death (2%) in the parenteral treatment group (95% confidence interval [CI] for between-group [oral minus parenteral] difference: -7% to 2%, P = 0.3). The time to resolution of morbidity was less than or equal to5 days in 34 (83%) patients in the oral treatment group and 39 (88%) patients in the parenteral treatment group (P = 0.5); there were treatment failures in 4 (10%) patients in the oral treatment group and 14 (32%) patients in the parenteral treatment group (P = 0.02). Among patients with severe pneumonia, there was one (2%) death in the early-switch group and no deaths in the full course of parenteral antibiotics groups (95% Cl for between-group [early switch vs. full course] difference: -2% to 6%, P = 0.5). The time to resolution of morbidity was less than or equal to5 days in 38 (79%) patients in the early-switch group and 41 (75%) in the full-course group (P = 0.3). There were 12 (25%) treatment failures in the early-switch group and 13 (24%) in the full-course group (P = 0.9). There were fewer adverse events in the oral and early-switch groups, primarily due to lower rates of infusion-related phlebitis. Significant cost savings, mainly due to a shorter hospitalization, occurred among patients with severe pneumonia in the early-switch group.CONCLUSION: Inpatients with nonsevere community-acquired pneumonia can be effectively and safely treated with oral antimicrobials from the time of admission, whereas those with severe pneumonia:can be treated with early-switch therapy. (C) 2001 by Excerpta Medica, Inc.