Lewis David F, Adair C David, Robichaux Alfred G, Jaekle Ronald K, Moore Jodi A, Evans Arthur T, Fontenot M Todd
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Kentucky Chandler Medical Center, Lexington, USA.
Am J Obstet Gynecol. 2003 Jun;188(6):1413-6; discussion 1416-7. doi: 10.1067/mob.2003.382.
The purpose of this study was to determine whether 3 days of broad-spectrum antibiotic therapy, which is intended to prolong latency in patients with preterm premature rupture of membranes, is comparable to 7 days of therapy.
Patients with preterm premature rupture of membranes at three separate study sites were asked to participate in this intent-to-treat, prospective, randomized trial. They were assigned randomly to either 3 or 7 days of ampicillin-sulbactam (3 g intravenously every 6 hours). The primary outcome of interest was the latency period from membrane rupture to delivery.
Forty-two individuals were enrolled in each group. No difference was noted in the latency interval between the two groups (3 days, 214 +/- 225 hours, vs 7 days, 229 +/- 218 hours). A significantly higher number of patients in the 3-day group completed therapy (80.1% vs 47.6%, P =.003). No other parameters were significantly different between the two groups. No adverse events or trends were noted in either group.
There appears to be no difference in the latency period between 3 and 7 days of ampicillin-sulbactam antibiotic therapy. More patients are needed to exclude a type II error.
本研究旨在确定旨在延长胎膜早破患者潜伏期的3天广谱抗生素治疗是否与7天治疗效果相当。
在三个不同研究地点的胎膜早破患者被邀请参与这项意向性治疗的前瞻性随机试验。他们被随机分配接受3天或7天的氨苄西林-舒巴坦治疗（每6小时静脉注射3克）。主要关注的结果是从胎膜破裂到分娩的潜伏期。
每组招募了42名个体。两组之间的潜伏期没有差异（3天，214±225小时， vs 7天，229±218小时）。3天治疗组完成治疗的患者数量显著更高（80.1%对47.6%，P = 0.003）。两组之间的其他参数没有显著差异。两组均未观察到不良事件或趋势。
氨苄西林-舒巴坦抗生素治疗3天和7天的潜伏期似乎没有差异。需要更多患者以排除II类错误。
