一项关于使用覆盖解脲脲原体的广谱抗生素进行预防性治疗以降低剖宫产术后子宫内膜炎发生率的随机临床试验。

Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis.

作者信息

Andrews William W, Hauth John C, Cliver Suzanne P, Savage Karen, Goldenberg Robert L

机构信息

Department of Obstetrics and Gynecology, Center for Research in Women's Health, University of Alabama at Birmingham, Birmingham, Alabama 35249-7333, USA.

出版信息

Obstet Gynecol. 2003 Jun;101(6):1183-9. doi: 10.1016/s0029-7844(03)00016-4.

DOI:10.1016/s0029-7844(03)00016-4

PMID:12798523

Abstract

OBJECTIVE

To determine if extended spectrum prophylactic antibiotic treatment (with efficacy against Ureaplasma urealyticum) reduces post-cesarean delivery clinical endometritis.

METHODS

After cord clamping at cesarean delivery, subjects received prophylaxis with cefotetan. Subjects were then simultaneously randomized (double blind) to receive doxycyline plus azithromycin versus placebo. Post-cesarean delivery endometritis was defined clinically as fever of 100.4F or higher with one or more supporting clinical signs or a physician diagnosis of endometritis plus the absence of a nonpelvic source of fever.

RESULTS

A total of 597 women were enrolled, 301 in the doxycycline/azithromycin group and 296 in the placebo group. The study population was 56% black, 25.5 +/- 6.2 years of age, and 43% nulliparous. The groups were similar (P >.05) for black race, parity, maternal age, and most risk factors for post-cesarean delivery endometritis. The frequency of post-cesarean delivery endometritis (16.9% versus 24.7%, P =.020), wound infections (0.8% versus 3.6%, P =.030), and a combination of these two outcomes (19.0% versus 27.8%, P =.019) were significantly lower in the doxycycline/azithromycin group compared with the placebo-treated group. The doxycycline/azithromycin versus placebo groups were dissimilar for maternal leukocytosis (24.9% versus 12.5%, P =.042) and frequency of classic uterine incision (7.6% versus 12.5%, P =.048). Adjusting for these factors did not alter the risk ratio for post-cesarean delivery endometritis in the active versus placebo-treated group (relative risk 0.65, 95% confidence interval 0.43, 0.98). Length of stay was longer in the placebo group overall (104 +/- 56 versus 95 +/- 32 hours, P =.016) and among women with endometritis (146 +/- 52 versus 127 +/- 46 hours, P =.047).

CONCLUSION

Extended spectrum prophylactic antibiotic treatment (with presumed efficacy against U urealyticum) given to women undergoing cesarean delivery at term shortens hospital stay and reduces the frequency of post-cesarean delivery endometritis and wound infections.

摘要

目的

确定延长谱预防性抗生素治疗（对解脲脲原体有效）是否能降低剖宫产术后临床子宫内膜炎的发生率。

方法

剖宫产时脐带结扎后，受试者接受头孢替坦预防用药。然后将受试者同时随机分组（双盲），分别接受强力霉素加阿奇霉素或安慰剂。剖宫产术后子宫内膜炎的临床定义为体温达到或高于100.4°F，伴有一项或多项支持性临床体征，或医生诊断为子宫内膜炎且无盆腔外发热源。

结果

共纳入597名女性，强力霉素/阿奇霉素组301名，安慰剂组296名。研究人群中56%为黑人，年龄25.5±6.2岁，43%为初产妇。两组在种族、产次、产妇年龄以及剖宫产术后子宫内膜炎的大多数危险因素方面相似（P>.05）。与安慰剂治疗组相比，强力霉素/阿奇霉素组剖宫产术后子宫内膜炎的发生率（16.9%对24.7%，P =.020）、伤口感染率（0.8%对3.6%，P =.030）以及这两种情况的合并发生率（19.0%对27.8%，P =.019）均显著更低。强力霉素/阿奇霉素组与安慰剂组在产妇白细胞增多症（24.9%对12.5%，P =.042）和经典子宫切口发生率（7.6%对12.5%，P =.048）方面存在差异。对这些因素进行校正后，活性药物治疗组与安慰剂治疗组剖宫产术后子宫内膜炎的风险比未改变（相对风险0.65，95%置信区间0.43, 0.98）。总体而言，安慰剂组的住院时间更长（104±56小时对95±32小时，P =.016），子宫内膜炎女性患者中也是如此（146±52小时对127±46小时，P =.047）。