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氨苄西林/舒巴坦与头孢替坦预防高危患者剖宫产术后感染的随机双盲试验

Ampicillin/sulbactam versus cefotetan for the prevention of infection following cesarean delivery in high-risk patients: a randomized double-blind trial.

作者信息

Bracero L A

机构信息

Department of Obstetrics and Gynecology, New York Medical College, Westchester County Medical Center, Valhalla, USA.

出版信息

Gynecol Obstet Invest. 1997;44(1):21-5. doi: 10.1159/000291403.

DOI:10.1159/000291403
PMID:9251949
Abstract

The objective of this study was to compare the efficacy and safety of a single intravenous dose of 1 g ampicillin plus 0.5 g sulbactam to a single intravenous dose of 1 g cefotetan in the prevention of postoperative infection following cesarean delivery in high-risk patients. In this single-center comparative study, women who were to undergo cesarean delivery and who were at high risk of developing postoperative infection were randomized into two treatment groups. At the time the umbilical cord was clamped, one group was treated intravenously with 1 g ampicillin plus 0.5 g sulbactam, and the other was treated intravenously with 1 g cefotetan. The two groups were evaluated for evidence of postoperative infections and adverse experiences. A total of 170 women who were at high risk of developing postoperative infection following cesarean delivery (87 in the ampicillin/sulbactam group and 83 in the cefotetan group) were analyzed. Successful prophylaxis, absence of any infection including absence of febrile morbidity with no other symptoms, was reported in 69 of 87 (79%) patients receiving ampicillin/sulbactam and in 60 of 83 (72%) patients receiving cefotetan. One patient in each group had an infection at the incision site. There were no statistically significant differences in the rates of endometritis or urinary tract infections. The mean duration of hospitalization was 5.5 days for patients receiving ampicillin/sulbactam and 5.7 days for patients receiving cefotetan. A single intravenous dose of the combination of ampicillin/sulbactam was as safe and effective as a single intravenous dose of cefotetan when administered for the prevention of infections following cesarean delivery in patients at high risk of developing postoperative morbidity. Both antibiotics were safe and well tolerated with no unusual or unexpected events.

摘要

本研究的目的是比较单次静脉注射1g氨苄西林加0.5g舒巴坦与单次静脉注射1g头孢替坦在预防高危患者剖宫产术后感染方面的疗效和安全性。在这项单中心对照研究中,计划进行剖宫产且有术后感染高风险的女性被随机分为两个治疗组。在脐带结扎时,一组静脉注射1g氨苄西林加0.5g舒巴坦,另一组静脉注射1g头孢替坦。对两组进行术后感染证据和不良事件评估。共分析了170例剖宫产术后有感染高风险的女性(氨苄西林/舒巴坦组87例,头孢替坦组83例)。接受氨苄西林/舒巴坦治疗的87例患者中有69例(79%)报告预防成功,即无任何感染,包括无发热性疾病且无其他症状;接受头孢替坦治疗的83例患者中有60例(72%)如此。每组各有1例患者出现切口部位感染。子宫内膜炎或尿路感染的发生率无统计学显著差异。接受氨苄西林/舒巴坦治疗的患者平均住院时间为5.5天,接受头孢替坦治疗的患者为5.7天。对于有术后发病高风险的患者,在剖宫产术后预防感染时,单次静脉注射氨苄西林/舒巴坦组合与单次静脉注射头孢替坦同样安全有效。两种抗生素均安全且耐受性良好,未出现异常或意外事件。

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