From the Department of Obstetrics and Gynecology, Lucile S. Packard Children's Hospital at Stanford, Stanford, California; Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, California; and Department of Pediatrics, Lucile S. Packard Children's Hospital at Stanford, Stanford, California.
Obstet Gynecol. 2010 Feb;115(2 Pt 1):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.
To assess whether daily gentamicin is as effective as 8-hour gentamicin for the treatment of intrapartum chorioamnionitis.
Women with a clinical diagnosis of chorioamnionitis between 32 and 42 weeks of gestation were randomly assigned in labor to receive either daily gentamicin (5 mg/kg intravenously (IV), then 2 placebo doses IV after 8 and 16 hours) or 8-hour gentamicin (2 mg/kg IV, then 1.5 mg/kg IV after 8 and 16 hours). Both groups received ampicillin (2 grams IV every 6 hours for a total of four doses). Patients who underwent cesarean delivery also received clindamycin (900 mg IV every 8 hours, for a total of three doses). The primary outcome was treatment success, defined by resolution of chorioamnionitis after 16 hours of treatment without development of endometritis. One hundred twenty-six patients were required to have 95% confidence that daily gentamicin is at worst 15% inferior to 8-hour dosing with an alpha of .05 and a beta of 0.2.
One hundred twenty-six women were enrolled, of whom 63 received daily gentamicin and 63 received 8-hour gentamicin. One patient was excluded from data analysis. Baseline maternal and obstetric characteristics were similar between groups except for longer mean duration of ruptured membranes in the 8-hour group (679+/-514 compared with 469+/-319 minutes; P =.03). Treatment success was equal between groups (94% daily gentamicin compared with 89% 8-hour gentamicin, P =.53). There were no differences in maternal or neonatal morbidities, including neonatal sepsis and newborn hearing screen.
Daily and 8-hour gentamicin appear equally effective for the treatment of intrapartum chorioamnionitis.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00185991.
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评估每日庆大霉素与 8 小时庆大霉素治疗产时绒毛膜羊膜炎的疗效。
在 32 至 42 周妊娠时，临床诊断为绒毛膜羊膜炎的女性在分娩时随机分为每日组（5mg/kg 静脉内（IV），然后在 8 小时和 16 小时后给予 2 次安慰剂 IV）或 8 小时组（2mg/kg IV，然后在 8 小时和 16 小时后给予 1.5mg/kg IV）。两组均接受氨苄西林（2g IV，每 6 小时一次，共 4 剂）。行剖宫产术的患者还接受克林霉素（900mg IV，每 8 小时一次，共 3 剂）。主要结局为治疗成功，定义为治疗 16 小时后绒毛膜羊膜炎缓解，无子宫内膜炎发生。需要 126 名患者，以 95%置信度确保每日庆大霉素的治疗效果至少比 8 小时庆大霉素差 15%，α 值为 0.05，β 值为 0.2。
共纳入 126 名女性，其中 63 名接受每日庆大霉素治疗，63 名接受 8 小时庆大霉素治疗。1 名患者被排除在数据分析之外。两组间的基线产妇和产科特征相似，除 8 小时组的中位胎膜破裂时间较长（679+/-514 分钟比 469+/-319 分钟；P=0.03）外。两组的治疗成功率相当（94%的每日庆大霉素与 89%的 8 小时庆大霉素，P=0.53）。两组的产妇和新生儿发病率无差异，包括新生儿败血症和新生儿听力筛查。
每日和 8 小时庆大霉素治疗产时绒毛膜羊膜炎的效果似乎相当。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00185991。
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