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口服及早期转换治疗社区获得性肺炎的疗效与安全性:一项随机对照试验

Efficacy and safety of oral and early-switch therapy for community-acquired pneumonia: a randomized controlled trial.

作者信息

Castro-Guardiola A, Viejo-Rodríguez A L, Soler-Simon S, Armengou-Arxé A, Bisbe-Company V, Peñarroja-Matutano G, Bisbe-Company J, García-Bragado F

机构信息

Internal Medicine Departments of the Hospital de Girona Doctor Josep Trueta, Girona, Spain.

出版信息

Am J Med. 2001 Oct 1;111(5):367-74. doi: 10.1016/s0002-9343(01)00868-3.

Abstract

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 < or =5 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% CI for between-group [early switch vs. full course] difference: -2% to 6%, P = 0.5). The time to resolution of morbidity was < or =5 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.

摘要

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、有效性及成本。对于非重症肺炎患者,将传统(胃肠外)治疗与口服治疗进行比较;对于重症肺炎患者,将传统治疗与早期从胃肠外治疗转换为口服治疗进行比较。

研究对象与方法

我们将85例住院的非重症肺炎患者随机分为两组:41例从入院起接受口服抗菌药物治疗,44例接受胃肠外抗菌药物治疗,直至体温正常72小时后改为口服治疗。我们将103例最初接受胃肠外抗菌药物治疗的重症肺炎患者随机分为两组:48例在治疗48小时后改为口服治疗(早期转换),55例接受为期10天的全程胃肠外抗生素治疗。

结果

在非重症肺炎患者中,口服治疗组无死亡病例,胃肠外治疗组有1例死亡(2%)(两组间[口服减去胃肠外]差异的95%置信区间[CI]:-7%至2%,P = 0.3)。口服治疗组34例(83%)患者和胃肠外治疗组39例(88%)患者病情缓解时间≤5天(P = 0.5);口服治疗组4例(10%)患者和胃肠外治疗组14例(32%)患者治疗失败(P = 0.02)。在重症肺炎患者中,早期转换组有1例(2%)死亡,全程胃肠外抗生素治疗组无死亡病例(两组间[早期转换与全程治疗]差异的95%CI:-2%至6%,P = 0.5)。早期转换组38例(79%)患者和全程治疗组41例(75%)患者病情缓解时间≤5天(P = 0.3)。早期转换组有12例(25%)治疗失败,全程治疗组有13例(24%)治疗失败(P = 0.9)。口服治疗组和早期转换组的不良事件较少,主要是因为与输液相关的静脉炎发生率较低。早期转换组的重症肺炎患者因住院时间较短而节省了大量费用。

结论

非重症社区获得性肺炎住院患者从入院时起即可用口服抗菌药物进行有效且安全的治疗,而重症肺炎患者可用早期转换疗法进行治疗。

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