Currie D C, Garbett N D, Chan K L, Higgs E, Todd H, Chadwick M V, Gaya H, Nunn A J, Darbyshire J H, Cole P J
Department of Thoracic Medicine, National Heart and Lung Institute, London.
Q J Med. 1990 Aug;76(280):799-816.
Thirty-eight patients with bronchiectasis and daily expectoration of purulent sputum despite conventional antibiotic courses were randomly allocated to receive a sachet of amoxycillin (3 g) or matched placebo twice daily for 32 weeks in a double-blind study. Nine patients (four amoxycillin, five placebo) were withdrawn from the study treatment; the response of the two patients (both on amoxycillin) withdrawn within the first six weeks was not assessed. The pretreatment characteristics of the two groups were similar. Independent assessment of overall response based on patients' diary cards showed that a higher proportion improved in the amoxycillin group (11 of 17) than in the placebo group (four of 19; p = 0.02). Patients in the amoxycillin group spent significantly less time confined to bed and away from work during treatment. The frequency of exacerbations during the study treatment phase was similar in the two groups but they were less severe than before study treatment in the amoxycillin group. There was a greater reduction in purulent sputum volume between exacerbations during the study treatment in the amoxycillin group to 20 per cent of pretreatment volume than in the placebo group (88 per cent of pretreatment volume, p = 0.008), although the concentrations of Haemophilus spp. in sputum between exacerbations was similar in the two groups. Adverse effects experienced were minor except in one patient (amoxycillin) withdrawn after developing a rash and in six patients (three amoxycillin, three placebo) who had diarrhoea lasting more than one week necessitating withdrawal of two patients (one amoxycillin, one placebo) from study treatment. Sputum and stool cultures collected regularly during the study showed no important changes in the bacterial flora in either group. Prolonged higher-dose antibiotic therapy in these patients with severe purulent bronchiectasis significantly reduced the host (patient) inflammatory response to colonizing microorganisms and reduced morbidity.
在一项双盲研究中，38例患有支气管扩张且尽管接受了常规抗生素疗程但仍每日咳出脓性痰的患者被随机分配，每天两次接受一袋阿莫西林（3克）或匹配的安慰剂治疗，为期32周。9例患者（4例接受阿莫西林，5例接受安慰剂）退出了研究治疗；未评估在前六周内退出的2例患者（均接受阿莫西林治疗）的反应。两组的预处理特征相似。根据患者的日记卡对总体反应进行的独立评估显示，阿莫西林组（17例中的11例）改善的比例高于安慰剂组（19例中的4例；p = 0.02）。阿莫西林组的患者在治疗期间卧床和缺勤的时间明显减少。在研究治疗阶段，两组的病情加重频率相似，但阿莫西林组的病情加重程度比研究治疗前轻。与安慰剂组相比，阿莫西林组在研究治疗期间病情加重之间脓性痰量减少幅度更大，降至预处理量的20%，而安慰剂组为预处理量的88%（p = 0.0。尽管两组病情加重之间痰液中嗜血杆菌属的浓度相似。除1例出现皮疹后退出研究的患者（接受阿莫西林治疗）以及6例腹泻持续超过一周的患者（3例接受阿莫西林治疗，3例接受安慰剂治疗）外，所经历的不良反应均较轻微，其中2例患者（1例接受阿莫西林治疗，1例接受安慰剂治疗）因腹泻而退出研究治疗。研究期间定期采集的痰液和粪便培养显示，两组的细菌菌群均无重要变化。对这些患有严重脓性支气管扩张的患者进行延长的高剂量抗生素治疗可显著降低宿主（患者）对定植微生物的炎症反应并降低发病率。
