社区获得性肺炎的抗生素治疗时间：一项多中心随机临床试验。

Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial.

机构信息

Department of Pneumology, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain.

Research Unit, Basurto University Hospital, Bilbao, Bizkaia, Spain.

出版信息

JAMA Intern Med. 2016 Sep 1;176(9):1257-65. doi: 10.1001/jamainternmed.2016.3633.

DOI:10.1001/jamainternmed.2016.3633

PMID:27455166

Abstract

IMPORTANCE

The optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) has not been well established.

OBJECTIVE

To validate Infectious Diseases Society of America/American Thoracic Society guidelines for duration of antibiotic treatment in hospitalized patients with CAP.

DESIGN, SETTING, AND PARTICIPANTS: This study was a multicenter, noninferiority randomized clinical trial performed at 4 teaching hospitals in Spain from January 1, 2012, through August 31, 2013. A total of 312 hospitalized patients diagnosed as having CAP were studied. Data analysis was performed from January 1, 2014, through February 28, 2015.

INTERVENTIONS

Patients were randomized at day 5 to an intervention or control group. Those in the intervention group were treated with antibiotics for a minimum of 5 days, and the antibiotic treatment was stopped at this point if their body temperature was 37.8°C or less for 48 hours and they had no more than 1 CAP-associated sign of clinical instability. Duration of antibiotic treatment in the control group was determined by physicians.

MAIN OUTCOMES AND MEASURES

Clinical success rate at days 10 and 30 since admission and CAP-related symptoms at days 5 and 10 measured with the 18-item CAP symptom questionnaire score range, 0-90; higher scores indicate more severe symptoms.

RESULTS

Of the 312 patients included, 150 and 162 were randomized to the control and intervention groups, respectively. The mean (SD) age of the patients was 66.2 (17.9) years and 64.7 (18.7) years in the control and intervention groups, respectively. There were 95 men (63.3%) and 55 women (36.7%) in the control group and 101 men (62.3%) and 61 women (37.7%) in the intervention group. In the intent-to-treat analysis, clinical success was 48.6% (71 of 150) in the control group and 56.3% (90 of 162) in the intervention group at day 10 (P = .18) and 88.6% (132 of 150) in the control group and 91.9% (147 of 162) in the intervention group at day 30 (P = .33). The mean (SD) CAP symptom questionnaire scores were 24.7 (11.4) vs 27.2 (12.5) at day 5 (P = .10) and 18.6 (9.0) vs 17.9 (7.6) at day 10 (P = .69). In the per-protocol analysis, clinical success was 50.4% (67 of 137) in the control group and 59.7% (86 of 146) in the intervention group at day 10 (P = .12) and 92.7% (126 of 137) in the control group and 94.4% (136 of 146) in the intervention group at day 30 (P = .54). The mean (SD) CAP symptom questionnaire scores were 24.3 (11.4) vs 26.6 (12.1) at day 5 (P = .16) and 18.1 (8.5) vs 17.6 (7.4) at day 10 (P = .81).

CONCLUSIONS AND RELEVANCE

The Infectious Diseases Society of America/American Thoracic Society recommendations for duration of antibiotic treatment based on clinical stability criteria can be safely implemented in hospitalized patients with CAP.

TRIAL REGISTRATION

clinicaltrialsregister.eu Identifier: 2011-001067-51.

摘要

重要性

社区获得性肺炎（CAP）的最佳抗生素治疗持续时间尚未得到很好的确定。

目的

验证美国传染病学会/美国胸科学会关于 CAP 住院患者抗生素治疗持续时间的指南。

设计、地点和参与者：这项多中心、非劣效性随机临床试验于 2012 年 1 月 1 日至 2013 年 8 月 31 日在西班牙的 4 所教学医院进行。共研究了 312 例诊断为 CAP 的住院患者。数据分析于 2014 年 1 月 1 日至 2015 年 2 月 28 日进行。

干预措施

患者在第 5 天随机分为干预组或对照组。干预组患者接受至少 5 天的抗生素治疗，如果体温降至 37.8°C 以下且持续 48 小时，且 CAP 相关临床不稳定迹象不超过 1 项，则停止抗生素治疗。对照组中抗生素治疗的持续时间由医生决定。

主要结果和测量

入院后第 10 天和第 30 天的临床成功率以及第 5 天和第 10 天使用 18 项 CAP 症状问卷评分范围（0-90 分；得分越高，症状越严重）测量的 CAP 相关症状。

结果

在纳入的 312 例患者中，150 例和 162 例分别随机分为对照组和干预组。对照组和干预组患者的平均（SD）年龄分别为 66.2（17.9）岁和 64.7（18.7）岁。对照组中 95 例为男性（63.3%），55 例为女性（36.7%）；干预组中 101 例为男性（62.3%），61 例为女性（37.7%）。意向治疗分析中，对照组第 10 天临床成功率为 48.6%（71/150），干预组为 56.3%（90/162）（P=0.18），第 30 天为 88.6%（132/150），干预组为 91.9%（147/162）（P=0.33）。第 5 天 CAP 症状问卷平均（SD）评分分别为 24.7（11.4）与 27.2（12.5）（P=0.10），第 10 天为 18.6（9.0）与 17.9（7.6）（P=0.69）。在符合方案分析中，对照组第 10 天临床成功率为 50.4%（67/137），干预组为 59.7%（86/146）（P=0.12），第 30 天为 92.7%（126/137），干预组为 94.4%（136/146）（P=0.54）。第 5 天 CAP 症状问卷平均（SD）评分分别为 24.3（11.4）与 26.6（12.1）（P=0.16），第 10 天为 18.1（8.5）与 17.6（7.4）（P=0.81）。