近日，丹麦赫尔列夫医院Kathrine Perslev团队研究了在会阴切开术或二度撕裂术中使用预防性抗生素后感染和伤口裂开的风险（REPAIR研究）。这一研究成果于2025年10月29日发表在国际顶尖学术期刊《英国医学杂志》上。

为了探讨预防性抗生素对会阴切开或二度撕裂术后创面并发症的影响，研究组在丹麦首都地区的一所大学医院进行了一项单中心、双盲、安慰剂对照随机试验。参与者都是在2023年3月到12月间注册的。所有初步临床会诊于2023年3月至2024年1月进行，所有长期随访会诊于2024年3月至11月进行。该研究仅报道第一次咨询的数据。参与者为在分娩时连续招募442名外阴切开术或二度撕裂的妇女。排除标准包括治疗过敏（或与相关抗生素交叉反应的风险），分娩24小时内使用抗生素，非丹麦语，剖腹产或会阴切开术延长。

一个计算机生成的程序将参与者随机分为三剂阿莫西林（500毫克）和克拉维酸（125毫克）或安慰剂，从产后6小时内开始，每8小时重复一次。产后4至14天进行随访。医生、指导委员会和参与者都是双盲的。观察指标为伤口并发症（主要结局）和临床相关伤口并发症（次要结局）。

这项研究按计划于2024年12月结束。433名妇女完成了随访，并被纳入初步分析。总体伤口并发症（抗生素47/218,22%；安慰剂62/215,29%；P=0.10）无显著差异，风险差异为7.2%(95%可信区间（CI） 15.4% ~ 0.8%)，相对风险为0.75（0.54 ~ 1.04）。对于临床相关的伤口并发症，治疗组发生率明显减少（19/218,9% vs 36/215, 17%； P=0.01），风险差异为8.0% (95% CI为14.3% ~ 1.8%)，相对危险度为0.52（0.31 ~ 0.88）。对于临床相关的伤口并发症，需要治疗的数量为12例（95% CI 7 ~ 56）。探索性结果显示，治疗组自我评估的健康状况更好，接受的额外抗生素治疗更少，裂开患者的平均伤口裂开更小。未发生严重不良反应。

研究结果表明，尽管对整体伤口并发症没有明显影响，但预防性抗生素显著降低了会阴切开术和二级撕裂妇女出现临床相关伤口并发症的风险，应在产后护理中予以考虑。

附：英文原文

Title: Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial

Author: Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jang

Issue&Volume: 2025/10/29

Abstract:

Objective To evaluate the effect of prophylactic antibiotics on the risk of wound complications after episiotomy or second degree tear.

Design Single centre, double blind, placebo controlled randomised trial.

Setting One university hospital in the Capital Region of Denmark. Participants were enrolled between March and December 2023. All initial clinical consultations were conducted between March 2023 and January 2024, and all long term follow-up consultations were conducted between March and November 2024. This article reports only data from the first consultation.

Participants 442 women with episiotomies or second degree tears were consecutively recruited at delivery. Exclusion criteria included treatment allergy (or risk of cross reactivity with related antibiotics), antibiotic use within 24 hours of delivery, non-Danish speakers, caesarean section, or episiotomy extension.

Intervention A computer generated program randomised participants to either three doses of amoxicillin (500 mg) with clavulanic acid (125 mg) or placebo starting within six hours post partum and repeated at eight hour intervals. Follow-up was conducted four to 14 days post partum. Physicians, the steering committee, and participants were blinded.

Main outcome measures Wound complications (primary outcome) and clinically relevant wound complications (secondary outcome).

Results The study ended as planned, in December 2024. 433 women completed follow-up and were included in the primary analysis. No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10), with a risk difference of 7.2% (95% confidence interval (CI) 15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04). For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of 8.0% (95% CI 14.3% to 1.8%) and a relative risk of 0.52 (0.31 to 0.88). For clinically relevant wound complications, the number needed to treat was 12 (95% CI 7 to 56). Exploratory outcomes show that the treatment group reported better self-evaluated health, received fewer additional antibiotic treatments, and had smaller average wound dehiscence among patients with dehiscence. No serious adverse reactions occurred.

Conclusion Although no significant effect was seen for overall wound complications, prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears and should be considered in postpartum care.

DOI: 10.1136/bmj-2025-084312

Source: https://www.bmj.com/content/391/bmj-2025-084312