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头孢他啶与安慰剂治疗囊性纤维化患者急性加重期呼吸疾病的随机试验

Randomized trial of ceftazidime versus placebo in the management of acute respiratory exacerbations in patients with cystic fibrosis.

作者信息

Gold R, Carpenter S, Heurter H, Corey M, Levison H

机构信息

Department of Pediatrics, University of Toronto, Ontario, Canada.

出版信息

J Pediatr. 1987 Dec;111(6 Pt 1):907-13. doi: 10.1016/s0022-3476(87)80217-2.

DOI:10.1016/s0022-3476(87)80217-2
PMID:3316565
Abstract

A randomized trial of ceftazidime versus placebo was conducted in patients with cystic fibrosis hospitalized for acute respiratory exacerbations. Patients 12 years of age or older were included if they had mild to moderately severe illness according to the following criteria: erythrocyte sedimentation rate less than or equal to 50 mm/hr and less than three other abnormalities (leukocyte count greater than or equal to 15,000/microliter, pulse greater than or equal to 100 beats/min, respirations greater than or equal to 30/min, or temperature greater than or equal to 38.5 degrees C). In all 16 episodes treated with ceftazidime, the patients were rated improved in comparison with 10 of 12 patients treated with placebo. Three placebo-treated patients dropped out of the study within 3 to 5 days because they wanted antibiotic therapy. None of the 15 placebo-treated patients showed clinical deterioration. There were no significant differences in rate of improvement of symptom score, weight gain, or pulmonary function between the two treatment groups. There was no difference in the course during the 6 to 24 months after the study period. Intravenous antibiotics are not essential in the management of all acute respiratory exacerbations of mild to moderate severity in patients with cystic fibrosis.

摘要

在因急性呼吸道加重而住院的囊性纤维化患者中进行了一项头孢他啶与安慰剂对比的随机试验。年龄在12岁及以上、根据以下标准患有轻度至中度严重疾病的患者被纳入研究:红细胞沉降率小于或等于50毫米/小时,且其他异常情况少于三项(白细胞计数大于或等于15,000/微升、脉搏大于或等于100次/分钟、呼吸频率大于或等于30次/分钟,或体温大于或等于38.5摄氏度)。在所有接受头孢他啶治疗的16个病例中,与接受安慰剂治疗的12例患者中的10例相比,患者被评定为病情有所改善。3名接受安慰剂治疗的患者在3至5天内退出了研究,因为他们希望接受抗生素治疗。15名接受安慰剂治疗的患者中没有一人出现临床病情恶化。两个治疗组在症状评分改善率、体重增加或肺功能方面没有显著差异。在研究期后的6至24个月期间病程也没有差异。对于囊性纤维化患者轻度至中度严重程度的所有急性呼吸道加重的治疗,静脉使用抗生素并非必不可少。

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