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正常阴道分娩后进行常规抗生素预防以降低产妇感染发病率。

Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity.

作者信息

Bonet Mercedes, Ota Erika, Chibueze Chioma E, Oladapo Olufemi T

机构信息

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland, CH-1211.

出版信息

Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD012137. doi: 10.1002/14651858.CD012137.pub2.

Abstract

BACKGROUND

Infectious morbidities contribute to considerable maternal and perinatal morbidity and mortality, including women at no apparent increased risk of infection. To reduce the incidence of infections, antibiotics are often administered to women after uncomplicated childbirth, particularly in settings where women are at higher risk of puerperal infectious morbidities.

OBJECTIVES

To assess whether routine administration of prophylactic antibiotics to women after normal (uncomplicated) vaginal birth, compared with placebo or no antibiotic prophylaxis, reduces postpartum maternal infectious morbidities and improves outcomes.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2017), LILACS, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (22 August 2017) and reference lists of retrieved studies.

SELECTION CRITERIA

We planned to include randomised or quasi-randomised trials evaluating the use of prophylactic antibiotics versus placebo or no antibiotic prophylaxis. Trials using a cluster-randomised design would have been eligible for inclusion, but we found none.In future updates of this review, we will include studies published in abstract form only, provided sufficient information is available to assess risks of bias. We will consider excluded abstracts for inclusion once the full publication is available, or the authors provide more information.Trials using a cross-over design are not eligible for inclusion in this review.

DATA COLLECTION AND ANALYSIS

Two review authors conducted independent assessment of trials for inclusion and risks of bias. They independently extracted data and checked them for accuracy, resolving differences in assessments by discussion. They evaluated methodological quality using standard Cochrane criteria and the GRADE approach.We present the summaries as risk ratios (RRs) and mean difference (MDs) using fixed- or random-effect models. For one primary outcome we found considerable heterogeneity and interaction. We explored further using subgroup analysis to investigate the effects of the randomisation unit. All review authors discussed and interpreted the results.

MAIN RESULTS

One randomised controlled trial (RCT) and two quasi-RCTs contributed data on 1779 women who had uncomplicated vaginal births, comparing different antibiotic regimens with placebo or no treatment. The included trials took place in the 1960s (one trial) and 1990s (two trials). The trials were conducted in France, the USA and Brazil. Antibiotics administered included: oral sulphamethoxypyridazine or chloramphenicol for three to five days, and intravenous amoxicillin and clavulanic acid in a single dose one hour after birth. We rated most of the domains for risk of bias as high risk, with the exception of reporting bias and other potential bias.The quality of evidence ranged from low to very low, based on the GRADE quality assessment, given very serious design limitations of the included studies, few events and wide confidence intervals (CIs) of effect estimates.We found a decrease in the risk of endometritis (RR 0.28, 95% CI 0.09 to 0.83, two trials, 1364 women,very low quality). However, one trial reported zero events for this outcome and we rate the evidence as very low quality. There was little or no difference between groups for the risk of urinary tract infection (RR 0.25, 95% CI 0.05 to 1.19, two trials, 1706 women,low quality), wound infection after episiotomy (reported as wound dehiscence in the included trials) (RR 0.78, 95% CI 0.31 to 1.96, two trials, 1364 women, very low quality) and length of maternal hospital stay in days (MD -0.15, 95% CI -0.31 to 0.01, one trial, 1291 women, very low quality). Cost of care in US dollar equivalent was 2½ times higher in the control group compared to the group receiving antibiotics prophylaxis (USD 3600: USD 9000, one trial, 1291 women). There were few or no differences between treated and control groups for adverse effects of antibiotics (skin rash) reported in one woman in each of the two trials (RR 3.03, 95% CI 0.32 to 28.95, two trials, 1706 women, very low quality). The incidence of severe maternal infectious morbidity, antimicrobial resistance or women's satisfaction with care were not addressed by any of the included studies.

AUTHORS' CONCLUSIONS: Routine administration of antibiotics may reduce the risk of endometritis after uncomplicated vaginal birth. The small number and nature of the trials limit the interpretation of the evidence for application in practice, particularly in settings where women may be at higher risk of developing endometritis. The use of antibiotics did not reduce the incidence of urinary tract infections, wound infection or the length of maternal hospital stay. Antibiotics are not a substitute for infection prevention and control measures around the time of childbirth and the postpartum period. The decision to routinely administer prophylactic antibiotics after normal vaginal births needs to be balanced by patient features, childbirth setting and provider experience, including considerations of the contribution of indiscriminate use of antibiotics to raising antimicrobial resistance. Well-designed and high-powered randomised controlled trials would help to evaluate the added value of routine antibiotic administration as a measure to prevent maternal infections after normal vaginal delivery.

摘要

背景

感染性疾病导致了相当高的孕产妇及围产期发病率和死亡率,包括那些表面上感染风险未明显增加的女性。为降低感染发生率,抗生素常在无并发症的分娩后给予产妇,尤其是在产妇产褥期感染性疾病风险较高的环境中。

目的

评估与安慰剂或不进行抗生素预防相比,正常(无并发症)阴道分娩后对女性常规给予预防性抗生素是否能降低产后产妇感染性疾病的发生率并改善结局。

检索方法

我们检索了Cochrane妊娠与分娩组试验注册库(2017年8月31日)、拉丁美洲和加勒比卫生科学数据库、美国国立医学图书馆临床试验数据库、世界卫生组织国际临床试验注册平台(2017年8月22日)以及检索到的研究的参考文献列表。

入选标准

我们计划纳入评估预防性抗生素与安慰剂或不进行抗生素预防的随机或半随机试验。采用整群随机设计的试验本应符合纳入标准,但我们未找到此类试验。在本综述的未来更新中,若有足够信息可评估偏倚风险,我们将纳入仅以摘要形式发表的研究。一旦全文发表或作者提供更多信息,我们将考虑纳入之前排除的摘要。采用交叉设计的试验不符合本综述的纳入标准。

数据收集与分析

两位综述作者独立评估试验是否符合纳入标准及偏倚风险。他们独立提取数据并检查其准确性,通过讨论解决评估中的差异。他们使用Cochrane标准和GRADE方法评估方法学质量。我们使用固定效应或随机效应模型将汇总结果表示为风险比(RRs)和均值差(MDs)。对于一个主要结局,我们发现了相当大的异质性和交互作用。我们通过亚组分析进一步探讨,以研究随机化单位的影响。所有综述作者讨论并解释了结果。

主要结果

一项随机对照试验(RCT)和两项半随机试验纳入了1779例无并发症阴道分娩的女性的数据,比较了不同抗生素方案与安慰剂或不治疗的效果。纳入的试验分别在20世纪60年代(一项试验)和90年代(两项试验)进行。试验在法国、美国和巴西开展。使用的抗生素包括:口服磺胺甲氧嗪或氯霉素3至5天,以及出生后1小时静脉注射单剂量阿莫西林和克拉维酸。除报告偏倚和其他潜在偏倚外,我们将大多数偏倚风险领域评为高风险。基于GRADE质量评估,鉴于纳入研究存在非常严重的设计局限性、事件数少且效应估计的置信区间宽,证据质量从低到极低。我们发现子宫内膜炎风险降低(RR 0.28,95%CI 0.09至0.83,两项试验,1364名女性,极低质量)。然而,一项试验报告该结局的事件数为零,我们将证据评为极低质量。两组在尿路感染风险(RR 0.25,95%CI 0.05至1.19,两项试验,1706名女性,低质量)、会阴切开术后伤口感染(纳入试验中报告为伤口裂开)(RR 0.78,95%CI 0.31至1.96,两项试验,1364名女性,极低质量)以及产妇住院天数(MD -0.15,95%CI -0.31至0.01,一项试验,1291名女性,极低质量)方面几乎没有差异。与接受抗生素预防的组相比,对照组的护理费用以美元等效计算高出2.5倍(3600美元:9000美元,一项试验,1291名女性)。在两项试验中,每组各有一名女性报告了抗生素的不良反应(皮疹),治疗组和对照组之间几乎没有差异(RR 3.03,95%CI 0.32至28.95,两项试验,1706名女性,极低质量)。纳入的任何研究均未涉及严重孕产妇感染性疾病的发生率、抗菌药物耐药性或女性对护理的满意度。

作者结论

常规使用抗生素可能会降低无并发症阴道分娩后子宫内膜炎的风险。试验的数量少及性质限制了对证据在实际应用中的解释,尤其是在女性发生子宫内膜炎风险可能较高的环境中。使用抗生素并未降低尿路感染、伤口感染的发生率或产妇住院天数。抗生素不能替代分娩时及产后的感染预防和控制措施。在正常阴道分娩后常规给予预防性抗生素的决定需要综合考虑患者特征、分娩环境和医疗服务提供者的经验,包括考虑滥用抗生素对增加抗菌药物耐药性的影响。设计良好且样本量大的随机对照试验将有助于评估常规使用抗生素作为预防正常阴道分娩后产妇感染措施的附加价值。

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