Child Health Division, Menzies School of Health Research, Darwin, NT, Australia.
Med J Aust. 2010 Jan 4;192(1):24-9. doi: 10.5694/j.1326-5377.2010.tb03396.x.
To compare the clinical effectiveness of single-dose azithromycin treatment with 7 days of amoxycillin treatment among Aboriginal children with acute otitis media (AOM) in rural and remote communities in the Northern Territory.
DESIGN, SETTING AND PARTICIPANTS: Aboriginal children aged 6 months to 6 years living in 16 rural and remote communities were screened for AOM. Those diagnosed with AOM were randomly allocated to receive either azithromycin (30 mg/kg as a single dose) or amoxycillin (50mg/kg/day in two divided doses for a minimum of 7 days). We used a double-dummy method to ensure blinding. Our study was conducted from 24 March 2003 to 20 July 2005.
Failure to cure AOM by the end of therapy; nasal carriage of Streptococcus pneumoniae and non-capsular Haemophilus influenzae (NCHi).
We followed 306 of 320 children (96%) allocated to the treatment groups. Single-dose azithromycin did not reduce (or increase) the risk of clinical failure (50% failure rate [82/165]) compared with amoxycillin (54% failure rate [83/155]) (risk difference [RD], - 4% [95% CI, - 15% to 7%]; P = 0.504). Compared with amoxycillin, azithromycin significantly reduced the proportion of children with nasal carriage of S. pneumoniae (27% v 63%; RD, - 36% [95% CI, - 47% to - 26%]; P < 0.001) and NCHi (55% v 85%; RD, - 30% [95% CI, - 40% to - 21%]; P < 0.001). Nasal carriage of S. pneumoniae with intermediate or full resistance to penicillin was lower (but not significantly so) in the azithromycin group (10% v 16%), but this group had significantly increased carriage of azithromycin-resistant S. pneumoniae (10% v 3%; RD, 7% [95% CI, 0.1% to 12%]; P = 0.001). Carriage of beta-lactamase-producing NCHi was about 5% in both groups.
Although azithromycin reduced nasal carriage of S. pneumoniae and NCHi, clinical failure was high in both treatment groups. The possibility of weekly azithromycin treatment in children with persistent AOM should be evaluated.
Australian Clinical Trials Registry ACTRN 12609000691246.
比较单次剂量阿奇霉素与 7 天阿莫西林治疗北领地农村和偏远社区土著儿童急性中耳炎（AOM）的临床疗效。
设计、地点和参与者：对居住在 16 个农村和偏远社区的 6 个月至 6 岁的土著儿童进行 AOM 筛查。那些被诊断患有 AOM 的儿童被随机分配接受阿奇霉素（30mg/kg 作为单次剂量）或阿莫西林（50mg/kg/天，分两次服用，至少 7 天）。我们使用双盲法确保了盲法。我们的研究于 2003 年 3 月 24 日至 2005 年 7 月 20 日进行。
治疗结束时未治愈 AOM；鼻咽携带肺炎链球菌和非荚膜流感嗜血杆菌（NCHi）。
我们随访了 306 名（96%）分配到治疗组的儿童中的 320 名。与阿莫西林相比，单次剂量阿奇霉素并未降低（或增加）临床失败的风险（50%的失败率[82/165]）（风险差异[RD]，-4%[95%CI，-15%至 7%]；P=0.504）。与阿莫西林相比，阿奇霉素显著降低了携带鼻咽部肺炎链球菌的儿童比例（27%对 63%）（RD，-36%[95%CI，-47%至-26%]）（P<0.001）和携带鼻咽部非荚膜流感嗜血杆菌的儿童比例（55%对 85%）（RD，-30%[95%CI，-40%至-21%]）（P<0.001）。对青霉素中介或完全耐药的肺炎链球菌的鼻咽携带率较低（但不显著），阿奇霉素组为 10%（16%），但该组对阿奇霉素耐药的肺炎链球菌携带率显著增加（10%对 3%）（RD，7%[95%CI，0.1%至 12%]）；P=0.001）。两组β-内酰胺酶产生的 NCHi 的携带率约为 5%。
尽管阿奇霉素降低了鼻咽部肺炎链球菌和 NCHi 的携带率，但两组的临床失败率均较高。每周用阿奇霉素治疗持续性 AOM 的儿童的可能性应进行评估。
澳大利亚临床试验注册 ACTRN 12609000691246。
