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儿童急性细菌性脑膜炎短疗程每日单次头孢曲松单药治疗:一项瑞士多中心研究的结果。第一部分:临床结果。

Short course single daily ceftriaxone monotherapy for acute bacterial meningitis in children: results of a Swiss multicenter study. Part I: Clinical results.

作者信息

Martin E, Hohl P, Guggi T, Kayser F H, Fernex M

机构信息

Department of Medicine, Universitäts-Kinderklinik, Zürich, Switzerland.

出版信息

Infection. 1990 Mar-Apr;18(2):70-7. doi: 10.1007/BF01641418.

Abstract

In a prospective Swiss multicenter study, 119 children (aged three weeks to 15.5 years) with acute bacterial meningitis were treated with single daily doses of ceftriaxone (100 mg/kg on days one and two and 60 mg/kg thereafter). All patients were randomly assigned to either short course (four, six, seven days) or full course (eight, 12, 14 days) therapy depending on whether they had contracted meningococcal, Haemophilus influenzae type b or pneumococcal meningitis. Bacteriological cure was obtained in 92 children who fully completed the study and in all the 20 culture-positive of the 27 children secondarily excluded from the study for failure to meet all bacteriological and initial safety criteria for continuation in protocol (secondary exclusions). Complete clinical recovery was noted in 105 of 119 patients (88%) and was as frequent in the short course (91%) as in the full course (89%), and as in the secondary exclusion (81%) group. All patients survived. At follow-up examination three to six months after hospital discharge only seven infants and seven children (11.8%), mostly those with poor presentation on admission (p = 0.0012), showed residual neurological sequelae. Side effects of antibiotic therapy were minor but more frequent, albeit not statistically significant (p = 0.065), in children receiving the full course therapy. The results of this study suggest that short course treatment of acute bacterial meningitis in children with single daily ceftriaxone monotherapy is as efficacious as full course therapy and at least as well tolerated.

摘要

在一项前瞻性瑞士多中心研究中,119名急性细菌性脑膜炎患儿(年龄从3周至15.5岁)接受了每日单次剂量的头孢曲松治疗(第1天和第2天为100mg/kg,此后为60mg/kg)。所有患者根据感染的是脑膜炎球菌、b型流感嗜血杆菌还是肺炎球菌脑膜炎,被随机分配至短疗程(4、6、7天)或全疗程(8、12、14天)治疗。92名完全完成研究的患儿以及27名因未达到继续参与方案的所有细菌学和初始安全标准而被二次排除在研究之外的患儿(二次排除)中的20名培养阳性患儿获得了细菌学治愈。119名患者中有105名(88%)实现了完全临床康复,短疗程组(91%)、全疗程组(89%)和二次排除组(81%)的康复频率相当。所有患者均存活。在出院后三至六个月的随访检查中,只有7名婴儿和7名儿童(11.8%)出现了残留神经后遗症,这些患儿大多入院时病情较差(p = 0.0012)。抗生素治疗的副作用较小,但在接受全疗程治疗的儿童中更频繁,尽管无统计学意义(p = 0.065)。这项研究的结果表明,儿童急性细菌性脑膜炎采用每日单次头孢曲松单药短疗程治疗与全疗程治疗一样有效,且耐受性至少相同。

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