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[莫西沙星与阿莫西林治疗拉丁美洲社区获得性肺炎的比较:一项多中心临床试验结果]

[A comparison of moxifloxacin and amoxicillin in the treatment of community-acquired pneumonia in Latin America: results of a multicenter clinical trial].

作者信息

Jardim J R, Rico G, de la Roza C, Obispo E, Urueta J, Wolff M, Miravitlles M

机构信息

Universidade Federal de Sao Paulo. Sao Paulo. Brazil.

出版信息

Arch Bronconeumol. 2003 Sep;39(9):387-93. doi: 10.1016/s0300-2896(03)75413-1.

Abstract

Since community-acquired pneumonia (CAP) is a common disease with a high morbidity rate, it is important to obtain information concerning its etiology and susceptibility to antibiotics across different geographic areas. This study presents data obtained in 5 Latin American counties in the course of an international clinical trial that evaluated the efficacy and safety of treatment with either moxifloxacin or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection. Details are given of the pathogens identified, the patterns of sensitivity to antibiotics observed, and the clinical and microbiological results obtained.A total of 84 patients were studied, of whom 70 (83.3%) were evaluated at the end of the trial to determine the efficacy and safety of the treatment received. Gram-positive bacteria were found in samples from 29 patients (80.5%). The pathogen was Streptococcus pneumoniae in 28 of those cases (77.7%). Gram-negative bacteria were found in 7 patients (19.4%), the most common being Haemophilus influenzae in 3 patients (8.3%). The presence of atypical microorganisms was detected in 18 of the 70 patients (25%), mainly Mycobacterium pneumoniae (n=11), and in 6 cases (8.5%) the infection was mixed. Ten strains of S. pneumoniae (35.7%) were shown to be susceptible to penicillin, 2 (7.1%) were highly resistant, and 16 (57.1%) showed moderate resistance. The clinical success rate at the final visit after treatment was 94.1% for moxifloxacin and 91.7% for amoxicillin. The results of this trial demonstrate a high prevalence of S. pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America. It also revealed a high incidence of atypical pathogens and mixed infection in 8.6% of patients. This information should be taken into account when establishing protocols for empirical treatment of CAP in Latin America.

摘要

由于社区获得性肺炎(CAP)是一种发病率很高的常见疾病,获取不同地理区域有关其病因及对抗生素敏感性的信息非常重要。本研究展示了在一项国际临床试验过程中于5个拉丁美洲国家获得的数据,该试验评估了莫西沙星或阿莫西林对疑似肺炎球菌感染所致CAP患者进行10天治疗的疗效和安全性。文中给出了所鉴定病原体的详细信息、观察到的抗生素敏感性模式以及所获得的临床和微生物学结果。总共研究了84例患者,其中70例(83.3%)在试验结束时接受评估,以确定所接受治疗的疗效和安全性。29例患者(80.5%)的样本中发现革兰氏阳性菌。其中28例(77.7%)的病原体为肺炎链球菌。7例患者(19.4%)中发现革兰氏阴性菌,最常见的是3例患者(8.3%)感染流感嗜血杆菌。70例患者中有18例(25%)检测到非典型微生物存在,主要是肺炎支原体(n = 11),6例(8.5%)为混合感染。10株肺炎链球菌(35.7%)对青霉素敏感,2株(7.1%)高度耐药,16株(5z7.1%)中度耐药。治疗后末次访视时,莫西沙星的临床成功率为94.1%,阿莫西林为91.7%。该试验结果表明,拉丁美洲CAP患者中肺炎链球菌普遍存在且对青霉素敏感性降低。还揭示了非典型病原体的高发病率以及8.6%的患者存在混合感染。在制定拉丁美洲CAP经验性治疗方案时应考虑这些信息。

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