Mpimbaza Arthur, Ndeezi Grace, Staedke Sarah, Rosenthal Philip J, Byarugaba Justus
Makerere University, Department of Pediatrics and Child Health, Faculty of Medicine, PO Box 7072, Kampala, Uganda.
Pediatrics. 2008 Jan;121(1):e58-64. doi: 10.1542/peds.2007-0930.
Our goal was to compare the efficacy and safety of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children.
This was a single-blind, randomized clinical trial in which 330 patients were randomly assigned to receive buccal midazolam or rectal diazepam. The trial was conducted in the pediatric emergency unit of the national referral hospital of Uganda. Consecutive patients who were aged 3 months to 12 years and presented while convulsing or who experienced a seizure that lasted >5 minutes were randomly assigned to receive buccal midazolam plus rectal placebo or rectal diazepam plus buccal placebo. The primary outcome of this study was cessation of visible seizure activity within 10 minutes without recurrence in the subsequent hour.
Treatment failures occurred in 71 (43.0%) of 165 patients who received rectal diazepam compared with 50 (30.3%) of 165 patients who received buccal midazolam. Malaria was the most common underlying diagnosis (67.3%), although the risk for failure of treatment for malaria-related seizures was similar: 35.8% for rectal diazepam compared with 31.8% for buccal midazolam. For children without malaria, buccal midazolam was superior (55.9% vs 26.5%). Respiratory depression occurred uncommonly in both of the treatment arms.
Buccal midazolam was as safe as and more effective than rectal diazepam for the treatment of seizures in Ugandan children, although benefits were limited to children without malaria.
我们的目标是比较颊部咪达唑仑与直肠地西泮治疗乌干达儿童癫痫持续状态的疗效和安全性。
这是一项单盲随机临床试验，330例患者被随机分配接受颊部咪达唑仑或直肠地西泮治疗。该试验在乌干达国家转诊医院的儿科急诊科进行。年龄在3个月至12岁之间、惊厥发作时就诊或癫痫发作持续超过5分钟的连续患者，被随机分配接受颊部咪达唑仑加直肠安慰剂或直肠地西泮加颊部安慰剂治疗。本研究的主要结局是在10分钟内停止可见的癫痫活动，且在随后1小时内无复发。
165例接受直肠地西泮治疗的患者中有71例（43.0%）治疗失败，而165例接受颊部咪达唑仑治疗的患者中有50例（30.3%）治疗失败。疟疾是最常见的潜在诊断（67.3%），尽管与疟疾相关的癫痫发作的治疗失败风险相似：直肠地西泮为35.8%，颊部咪达唑仑为31.8%。对于没有疟疾的儿童，颊部咪达唑仑更具优势（55.9%对26.5%）。两个治疗组中呼吸抑制均罕见。
对于乌干达儿童癫痫的治疗，颊部咪达唑仑与直肠地西泮一样安全且更有效，尽管益处仅限于没有疟疾的儿童。
