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一项比较剖宫产术前单次使用头孢唑林与头孢唑林加甲硝唑作为预防性抗生素的随机试验。

A randomised trial comparing preoperative administration of single-dose kefazolin to kefazolin plus metronidazole as prophylactic antibiotics at caesarean section.

机构信息

Obstetrics and Gynaecology Department, Kalafong Provincial Tertiary Hospital, Pretoria, South Africa.

Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Pretoria, South Africa.

出版信息

S Afr Med J. 2024 May 31;114(6):e1081. doi: 10.7196/SAMJ.2024.v114i6.1081.

Abstract

BACKGROUND

Caesarean section is a life-saving procedure which is associated with high rates of maternal and neonatal complications. It has been estimated that globally, 29.7 million births occur by caesarean section annually. The risk of postpartum infection is estimated to be five to ten times higher compared with normal vaginal delivery. Pregnancy-related sepsis was listed as a top-six cause of maternal mortality in the South African Saving Mothers report between 2017 and 2019. Multiple trials have been conducted in an attempt to optimise administration of prophylactic antibiotics in an effort to reduce postpartum infection and maternal sepsis, and current practice guidelines suggest that there is sufficient evidence that extended-spectrum antibiotics, in combination with kefazolin, result in reduction of postpartum infections.

OBJECTIVES

To investigate the effect of perioperative administration of kefazolin alone compared with kefazolin plus metronidazole on postpartum infection in women undergoing caesarean section at Kalafong Provincial Tertiary Hospital, Pretoria, South Africa.

METHOD

All patients undergoing emergency or elective caesarean section were randomised and then sequentially numbered in opaque sealed envelopes, which were placed in the caesarean section operating theatre. The intervention group received kefazolin and a sealed envelope with metronidazole. The control group received kefazolin and a sealed envelope with normal saline.

RESULTS

A total of 57/1 010 patients (5.64%) had surgical site infections, of which 27 (5.33%) were in the control group, and 30 (5.96%) were in the intervention group (p=0.66). Two patients in each arm (0.40% in the intervention arm and 0.39% in the control arm) underwent laparotomy procedures, while three women (0.60%) in the intervention arm and four women (0.79%) in the control arm underwent hysterectomy procedures. There were no statistically significant differences in all the measured secondary outcomes between the two groups.

CONCLUSION

The overall sepsis rate in this study was 5.64%. Postpartum infection is multifactorial and there are multiple factors that can be addressed in strengthening the sepsis care bundle. We do not recommend the addition of metronidazole to kefazolin as prophylaxis at caesarean section.

摘要

背景

剖宫产术是一种挽救生命的手术,但与产妇和新生儿并发症的发生率较高有关。据估计,每年全球有 2970 万婴儿通过剖宫产分娩。与正常阴道分娩相比,产后感染的风险估计要高 5 到 10 倍。2017 年至 2019 年期间,南非拯救母亲报告将妊娠相关败血症列为孕产妇死亡的六大原因之一。已经进行了多项试验,试图优化预防性抗生素的给药,以减少产后感染和产妇败血症,目前的实践指南表明,有足够的证据表明,联合头孢唑林使用广谱抗生素可减少产后感染。

目的

调查在南非比勒陀利亚卡拉冯省级三级医院行剖宫产术的妇女中,单独使用头孢唑林与头孢唑林加甲硝唑联合围手术期给药对产后感染的影响。

方法

所有行急诊或择期剖宫产术的患者均随机分组,并将其编号放入透明密封信封中,放置在剖宫产手术室。干预组接受头孢唑林和甲硝唑密封信封,对照组接受头孢唑林和生理盐水密封信封。

结果

共有 57/1010 例(5.64%)患者发生手术部位感染,其中对照组 27 例(5.33%),干预组 30 例(5.96%)(p=0.66)。每组各有 2 例患者(干预组 0.40%,对照组 0.39%)行剖腹手术,而干预组 3 例(0.60%)和对照组 4 例(0.79%)行子宫切除术。两组所有次要测量结果均无统计学差异。

结论

本研究的总体败血症发生率为 5.64%。产后感染是多因素的,有多个因素可以通过强化败血症护理包来解决。我们不建议在剖宫产时将甲硝唑加入头孢唑林作为预防用药。

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