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降钙素原指导的抗生素治疗在“现实生活”中用于下呼吸道感染的有效性和安全性:一项国际多中心研究后调查(ProREAL)

Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in "real life": an international, multicenter poststudy survey (ProREAL).

作者信息

Albrich Werner C, Dusemund Frank, Bucher Birgit, Meyer Stefan, Thomann Robert, Kühn Felix, Bassetti Stefano, Sprenger Martin, Bachli Esther, Sigrist Thomas, Schwietert Martin, Amin Devendra, Hausfater Pierre, Carre Eric, Gaillat Jacques, Schuetz Philipp, Regez Katharina, Bossart Rita, Schild Ursula, Mueller Beat

机构信息

Medical University Department, Kantonsspital Aarau, Aarau, Switzerland.

出版信息

Arch Intern Med. 2012 May 14;172(9):715-22. doi: 10.1001/archinternmed.2012.770.

DOI:10.1001/archinternmed.2012.770
PMID:22782201
Abstract

BACKGROUND

In controlled studies, procalcitonin (PCT) has safely and effectively reduced antibiotic drug use for lower respiratory tract infections (LRTIs). However, controlled trial data may not reflect real life.

METHODS

We performed an observational quality surveillance in 14 centers in Switzerland, France, and the United States. Consecutive adults with LRTI presenting to emergency departments or outpatient offices were enrolled and registered on a website, which provided a previously published PCT algorithm for antibiotic guidance. The primary end point was duration of antibiotic therapy within 30 days.

RESULTS

Of 1759 patients, 86.4% had a final diagnosis of LRTI (community-acquired pneumonia, 53.7%; acute exacerbation of chronic obstructive pulmonary disease, 17.1%; and bronchitis, 14.4%). Algorithm compliance overall was 68.2%, with differences between diagnoses (bronchitis, 81.0%; AECOPD, 70.1%; and community-acquired pneumonia, 63.7%; P < .001), outpatients (86.1%) and inpatients (65.9%) (P < .001), algorithm-experienced (82.5%) and algorithm-naive (60.1%) centers (P < .001), and countries (Switzerland, 75.8%; France, 73.5%; and the United States, 33.5%; P < .001). After multivariate adjustment, antibiotic therapy duration was significantly shorter if the PCT algorithm was followed compared with when it was overruled (5.9 vs 7.4 days; difference, -1.51 days; 95% CI, -2.04 to -0.98; P < .001). No increase was noted in the risk of the combined adverse outcome end point within 30 days of follow-up when the PCT algorithm was followed regarding withholding antibiotics on hospital admission (adjusted odds ratio, 0.83; 95% CI, 0.44 to 1.55; P = .56) and regarding early cessation of antibiotics (adjusted odds ratio, 0.61; 95% CI, 0.36 to 1.04; P = .07).

CONCLUSIONS

This study validates previous results from controlled trials in real-life conditions and demonstrates that following a PCT algorithm effectively reduces antibiotic use without increasing the risk of complications. Preexisting differences in antibiotic prescribing affect compliance with antibiotic stewardship efforts.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN40854211.

摘要

背景

在对照研究中,降钙素原(PCT)已安全有效地减少了下呼吸道感染(LRTI)的抗生素使用。然而,对照试验数据可能无法反映现实生活情况。

方法

我们在瑞士、法国和美国的14个中心进行了一项观察性质量监测。连续的成年LRTI患者到急诊科或门诊就诊,被纳入并在一个网站上注册,该网站提供了先前发表的用于抗生素指导的PCT算法。主要终点是30天内的抗生素治疗持续时间。

结果

在1759例患者中,86.4%最终诊断为LRTI(社区获得性肺炎,53.7%;慢性阻塞性肺疾病急性加重,17.1%;支气管炎,14.4%)。总体算法依从性为68.2%,不同诊断之间存在差异(支气管炎,81.0%;AECOPD,70.1%;社区获得性肺炎,63.7%;P <.001),门诊患者(86.1%)和住院患者(65.9%)之间存在差异(P <.001),有算法经验的中心(82.5%)和无算法经验的中心(60.1%)之间存在差异(P <.001),以及不同国家之间存在差异(瑞士,75.8%;法国,73.5%;美国,33.5%;P <.001)。多变量调整后,遵循PCT算法时的抗生素治疗持续时间显著短于未遵循该算法时(5.9天对7.4天;差异为-1.51天;95%CI,-2.04至-0.98;P <.001)。在遵循PCT算法关于入院时停用抗生素(调整后的优势比,0.83;95%CI,0.44至1.55;P =.56)和早期停用抗生素(调整后的优势比,0.61;95%CI,0.36至1.04;P =.07)的情况下,随访30天内联合不良结局终点的风险未增加。

结论

本研究在现实生活条件下验证了先前对照试验的结果,并表明遵循PCT算法可有效减少抗生素使用,且不增加并发症风险。抗生素处方方面预先存在的差异会影响抗生素管理措施的依从性。

试验注册

isrctn.org标识符:ISRCTN40854211。

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