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新型抗生素在临床实践中的适应证:替加环素初始使用登记研究结果

Indications of a new antibiotic in clinical practice: results of the tigecycline initial use registry.

作者信息

Curcio Daniel, Fernández Francisco, Cané Alejandro, Barcelona Laura, Stamboulian Daniel

机构信息

Infectious Diseases Department, San José Hospital, Buenos Aires, Argentina.

出版信息

Braz J Infect Dis. 2008 Jun;12(3):198-201. doi: 10.1590/s1413-86702008000300007.

DOI:10.1590/s1413-86702008000300007
PMID:18833403
Abstract

Tigecycline is the first of a new class of antibiotics named glycylcyclines and it was approved for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Notwithstanding this, tigecycline's pharmacological and microbiological profile which includes multidrug-resistant pathogens encourages physicians' use of the drug in other infections. We analyzed, during the first months after its launch, the tigecycline prescriptions for 113 patients in 12 institutions. Twenty-five patients (22%) received tigecycline for approved indications, and 88 (78%) for "off label" indications (56% with scientific support and 22% with limited or without any scientific support). The most frequent "off label" use was ventilator associated pneumonia (VAP) (63 patients). The etiology of infections was established in 105 patients (93%). MDR-Acinetobacter spp. was the microorganism most frequently isolated (50% of the cases). Overall, attending physicians reported clinical success in 86 of the 113 patients (76%). Our study shows that the "off label" use of tigecycline is frequent, especially in VAP. due to MDR-Acinetobacter spp., where the therapeutic options are limited (eg: colistin). Physicians must evaluate the benefits/risks of using this antibiotic for indications that lack rigorous scientific support.

摘要

替加环素是新型抗生素——甘氨酰环素类中的首个药物,已被批准用于治疗复杂性腹腔内感染以及复杂性皮肤和皮肤结构感染。尽管如此,替加环素的药理学和微生物学特性(包括对多重耐药病原体有效)促使医生将该药用于其他感染。我们在替加环素上市后的头几个月,分析了12家机构中113例患者的替加环素处方情况。25例患者(22%)因获批适应症接受替加环素治疗,88例(78%)用于“非标签”适应症(56%有科学依据支持,22%依据有限或无任何科学依据)。最常见的“非标签”用途是呼吸机相关性肺炎(VAP)(63例患者)。105例患者(93%)明确了感染病因。多重耐药鲍曼不动杆菌是最常分离出的微生物(50%的病例)。总体而言,主治医生报告113例患者中有86例(76%)临床治疗成功。我们的研究表明,替加环素的“非标签”使用很常见,尤其是在由多重耐药鲍曼不动杆菌引起的VAP中,因为针对此类感染的治疗选择有限(如:黏菌素)。医生必须评估将这种抗生素用于缺乏严格科学依据支持的适应症时的利弊。

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Indications of a new antibiotic in clinical practice: results of the tigecycline initial use registry.新型抗生素在临床实践中的适应证:替加环素初始使用登记研究结果
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