头孢曲松与复方新诺明治疗急性中耳炎的比较。大波士顿中耳炎研究小组。

Comparison of ceftriaxone and trimethoprim-sulfamethoxazole for acute otitis media. Greater Boston Otitis Media Study Group.

作者信息

Barnett E D, Teele D W, Klein J O, Cabral H J, Kharasch S J

机构信息

Maxwell Finland Laboratory for Infectious Diseases, Boston City Hospital, MA 02118, USA.

出版信息

Pediatrics. 1997 Jan;99(1):23-8. doi: 10.1542/peds.99.1.23.

DOI:10.1542/peds.99.1.23

PMID:8989332

Abstract

OBJECTIVE

The purpose of this prospective, randomized, single-blind trial was to assess the clinical efficacy of a single intramuscular dose of ceftriaxone compared with 10 days of oral trimethoprim-sulfamethoxazole (TMP-SMZ) in treating acute otitis media (AOM).

METHODS

Children aged 3 months through 3 years diagnosed with AOM (signs of acute illness plus evidence of middle-ear effusion) were randomized to treatment with either a single intramuscular dose of ceftriaxone (maximum dose of 50 mg/kg) or 10 days of oral trimethoprim-sulfamethoxazole (8 mg of TMP and 40 mg of SMZ/kg/day in two divided doses). Children were evaluated at scheduled visits on days 3, 14, and 28, and the parents were telephoned on day 5. Children were assessed as cured, improved, or failed on day 3, and as cured or failed on days 14 and 28. Children ill at other times during the study period were, if possible, seen and assessed by the study team.

RESULTS

Of 596 children enrolled during the study period, 484 were evaluable. Characteristics of evaluable subjects did not differ significantly by drug. On day 3, 223/241 children in the ceftriaxone group (92.5%) and 231/243 (95.1%) in the TMP-SMZ group were cured or improved. On day 14, 158/197 (80.2%) in the ceftriaxone group and 174/212 (82.1%) in the TMP-SMZ group were cured. On day 28, 108/136 (79.4%) in the ceftriaxone group and 124/155 (80%) in the TMP-SMZ group were cured. Persistence of middle-ear fluid did not differ between groups at day 14 (55% in the ceftriaxone group vs 47% in the TMP-SMZ group; P = .16) or at day 28 (39% vs 43%; P = .48). Pain at the injection site persisting at day 3 occurred in 8.4% of children receiving ceftriaxone. New diarrhea was more common in the ceftriaxone group (23.6% vs 9.2%; P < .001).

CONCLUSION

A single intramuscular dose of ceftriaxone is comparable in clinical efficacy to 10 days of oral TMP-SMZ for treatment of AOM.

摘要

目的

本前瞻性、随机、单盲试验的目的是评估单次肌内注射头孢曲松与口服10天甲氧苄啶-磺胺甲恶唑（TMP-SMZ）治疗急性中耳炎（AOM）的临床疗效。

方法

年龄在3个月至3岁之间、诊断为AOM（有急性疾病体征及中耳积液证据）的儿童被随机分为两组，一组接受单次肌内注射头孢曲松（最大剂量50mg/kg），另一组接受口服10天甲氧苄啶-磺胺甲恶唑（8mg TMP和40mg SMZ/kg/天，分两次服用）。在第3天、第14天和第28天进行定期随访评估患儿情况，并在第5天给家长打电话。在第3天评估患儿为治愈、好转或未愈，在第14天和第28天评估为治愈或未愈。在研究期间其他时间患病的儿童，研究团队尽可能对其进行诊治和评估。

结果

在研究期间纳入的596名儿童中，484名可进行评估。可评估受试者的特征在两组药物之间无显著差异。在第3天，头孢曲松组241名儿童中有223名（92.5%）、TMP-SMZ组243名儿童中有231名（95.1%）治愈或好转。在第14天，头孢曲松组197名中有158名（80.2%）、TMP-SMZ组212名中有174名（82.1%）治愈。在第28天，头孢曲松组136名中有108名（79.4%）、TMP-SMZ组155名中有124名（80%）治愈。在第14天（头孢曲松组55% vs TMP-SMZ组47%；P = ）或第28天（39% vs 43%；P = ），两组中耳积液持续存在情况无差异。在第3天，接受头孢曲松治疗的儿童中有8.4%注射部位疼痛持续存在。头孢曲松组新出现腹泻更为常见（23.6% vs 9.2%；P < 0.001）。