Wientzen R, Prestidge C B, Kramer R I, McCracken G H, Nelson J D
Am J Dis Child. 1980 Dec;134(12):1134-8. doi: 10.1001/archpedi.1980.02130240018007.
To determine the effect of antimicrobial therapy on acute pulmonary exacerbations in cystic fibrosis, a randomized, double-blind trial of tobramycin and placebo was carried out. Clinical responses were satisfactory in all 11 children given tobramycin and in seven of 11 given placebo. Two patients in the placebo group died. No patient given placebo had improved results on pulmonary function studies, whereas improvement of 15% or more occurred in four of the six patients given tobramycin who could cooperate with the testing. Quantitative cultures of sputum showed a decrease of 1 logarithm or greater in Pseudomonas sp concentrations in six of seven patients in the tobramycin group and in two of eight in the placebo group. No difference in staphylococcal colonization was found. Several features indicate that children with severer disease were randomly assigned to the placebo group; nevertheless, the trend toward improved response in patients given tobramycin suggests that empirical therapy with antibiotics is beneficial for patients with acute pulmonary exacerbations in cystic fibrosis.
为了确定抗菌治疗对囊性纤维化急性肺部加重的影响，进行了一项关于妥布霉素和安慰剂的随机双盲试验。在接受妥布霉素治疗的所有11名儿童以及接受安慰剂治疗的11名儿童中的7名中，临床反应令人满意。安慰剂组有两名患者死亡。接受安慰剂治疗的患者在肺功能研究中均未取得改善，而在接受妥布霉素治疗且能配合测试的6名患者中，有4名患者肺功能改善了15%或更多。痰液定量培养显示，妥布霉素组7名患者中的6名以及安慰剂组8名患者中的2名，其假单胞菌属浓度下降了1个对数或更多。在葡萄球菌定植方面未发现差异。有几个特征表明病情较重的儿童被随机分配到了安慰剂组；然而，接受妥布霉素治疗的患者反应改善的趋势表明，经验性使用抗生素对囊性纤维化急性肺部加重的患者有益。
