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红霉素-磺胺异恶唑与阿莫西林治疗儿童急性中耳炎的双盲、多剂量对照研究。

Erythromycin-sulfisoxazole vs amoxicillin in the treatment of acute otitis media in children. A double-blind, multiple-dose comparative study.

作者信息

Rodriguez W J, Schwartz R H, Sait T, Khan W N, Chhabra O P, Chang M J, Reddy S, Marks L A, Gold A J

出版信息

Am J Dis Child. 1985 Aug;139(8):766-70. doi: 10.1001/archpedi.1985.02140100028019.

DOI:10.1001/archpedi.1985.02140100028019
PMID:3895889
Abstract

A fixed combination of erythromycin ethylsuccinate and sulfisoxazole acetyl (erythromycin-sulfa) was compared with amoxicillin for the treatment of acute otitis media (AOM) in children. Of 145 patients studied, 76 boys and 69 girls were compliant and were evaluated for drug efficacy (72 amoxicillin, 73 erythromycin-sulfa). Based on otoscopic and tympanometric results, cure rates at ten to 14 days for AOM due to all organisms were 83% (63/72) for amoxicillin and 89% (65/73) for erythromycin-sulfa; for Haemophilus species (including mixed infections), they were 84% for amoxicillin (26/31) and 83% for erythromycin-sulfa (20/14). Cure rates for ampicillin-resistant Haemophilus were 1/1 for amoxicillin and 7/8 (88%) for erythromycin-sulfa; one patient (12%) had persistent AOM at day 10. Of the patients with AOM due to Streptococcus pneumoniae, 82% (29/35) in the amoxicillin-treated group and 98% (39/40) in the erythromycin-sulfa-treated group were cured. Patients with S pneumoniae as the initial infecting organism who were treated with amoxicillin had significantly more clinical recurrences then their erythromycin-sulfa-treated counterparts, 66% (8/12) vs 33% (3/9). There was no difference between treatment groups in recurrence rates for patients with Haemophilus as the initial infecting organism. On the treatment day indicated, the following number of patients had middle ear effusion: by days 10 to 14, 38% (27/72) amoxicillin-treated patients and 48% (35/73) erythromycin-sulfa-treated patients; by day 28, 10% (7/71) amoxicillin-treated patients and 16% (11/70) erythromycin-sulfa-treated patients. There were no significant differences in adverse reactions. The erythromycin-sulfa combination is safe and effective treatment for AOM, including ampicillin-resistant Haemophilus.

摘要

将琥乙红霉素和乙酰磺胺异恶唑的固定组合(红霉素 - 磺胺)与阿莫西林用于治疗儿童急性中耳炎(AOM)进行比较。在145名接受研究的患者中,76名男孩和69名女孩依从性良好,并对药物疗效进行评估(72名使用阿莫西林,73名使用红霉素 - 磺胺)。根据耳镜检查和鼓室图结果,所有病原体引起的AOM在10至14天的治愈率,阿莫西林组为83%(63/72),红霉素 - 磺胺组为89%(65/73);对于嗜血杆菌属(包括混合感染),阿莫西林组为84%(26/31),红霉素 - 磺胺组为83%(20/14)。对氨苄西林耐药的嗜血杆菌的治愈率,阿莫西林组为1/1,红霉素 - 磺胺组为7/8(88%);1名患者(12%)在第10天患有持续性AOM。在肺炎链球菌引起AOM的患者中,阿莫西林治疗组的治愈率为82%(29/35),红霉素 - 磺胺治疗组为98%(39/40)。以肺炎链球菌作为初始感染病原体接受阿莫西林治疗的患者,其临床复发率显著高于接受红霉素 - 磺胺治疗的患者,分别为66%(8/12)和33%(3/9)。以嗜血杆菌作为初始感染病原体的患者,治疗组之间的复发率没有差异。在指定的治疗日,以下数量的患者有中耳积液:在第10至14天,阿莫西林治疗组有38%(27/72)的患者,红霉素 - 磺胺治疗组有48%(35/73)的患者;在第28天,阿莫西林治疗组有10%(7/71)的患者,红霉素 - 磺胺治疗组有16%(11/70)的患者。不良反应方面没有显著差异。红霉素 - 磺胺组合是治疗AOM的安全有效方法,包括对氨苄西林耐药的嗜血杆菌感染。

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引用本文的文献

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Eur J Pediatr. 1991 Jun;150(8):534-46. doi: 10.1007/BF02072202.