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阴道内乳酸凝胶(Canesbalance)用于会阴切开术后愈合的初步研究:一项随机临床试验。

A Preliminary Study of Intravaginal Lactic Acid Gel (Canesbalance) for Post-Episiotomy Healing: A Randomized Clinical Trial.

作者信息

Brezeanu Dragos, Brezeanu Ana-Maria, Chirila Sergiu Ioachim, Tica Vlad

机构信息

Faculty of Medicine, Ovidius University of Constanta, 900573 Constanta, Romania.

County Clinical Emergency Hospital "Sf. Ap. Andrei", 900591 Constanta, Romania.

出版信息

Healthcare (Basel). 2025 Jul 1;13(13):1581. doi: 10.3390/healthcare13131581.

DOI:10.3390/healthcare13131581
PMID:40648604
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12249008/
Abstract

Episiotomy-related morbidity remains a substantial challenge in postpartum recovery, often affecting maternal quality of life. Given the crucial role of local microbiota and wound environment in perineal healing, intravaginal lactic acid gel emerges as a promising adjunctive therapy. To evaluate the effectiveness and safety of intravaginal lactic acid gel (Canesbalance, Bayer) in enhancing scar healing and reducing pain following mediolateral episiotomy. In this single-center randomized controlled trial, 100 postpartum women with mediolateral episiotomy were allocated to either a treatment group receiving intravaginal lactic acid gel (Canesbalance, Bayer) or a standard care group. Scar healing was assessed at 7 and 40 days postpartum using POSAS, VAS, and NRS scores; hematological parameters were also monitored. The lactic acid gel group demonstrated significantly greater reductions in scar severity and pain scores over time ( < 0.05), with no adverse hematological effects. Effect sizes (Cohen's d) were moderate to high for scar healing (d = 0.76) and pain reduction (VAS: d = 0.83; NRS: d = 0.79), indicating clinical relevance beyond statistical significance. Intravaginal application of lactic acid gel may offer a safe and effective strategy to enhance perineal wound healing and pain relief after episiotomy. Further large-scale studies are warranted to validate these promising findings and explore underlying mechanisms.

摘要

会阴切开术相关的发病率仍然是产后恢复中的一个重大挑战,常常影响产妇的生活质量。鉴于局部微生物群和伤口环境在会阴愈合中的关键作用,阴道内乳酸凝胶成为一种有前景的辅助治疗方法。为了评估阴道内乳酸凝胶(Canesbalance,拜耳公司)在促进侧切会阴切开术后瘢痕愈合和减轻疼痛方面的有效性和安全性。在这项单中心随机对照试验中,100名接受侧切会阴切开术的产后妇女被分配到接受阴道内乳酸凝胶(Canesbalance,拜耳公司)的治疗组或标准护理组。在产后7天和40天时,使用POSAS、VAS和NRS评分评估瘢痕愈合情况;还监测血液学参数。乳酸凝胶组随着时间的推移,瘢痕严重程度和疼痛评分显著降低(<0.05),且无不良血液学影响。对于瘢痕愈合(d = 0.76)和疼痛减轻(VAS:d = 0.83;NRS:d = 0.79),效应量(科恩d值)为中度到高度,表明除了统计学意义外还具有临床相关性。阴道内应用乳酸凝胶可能为促进会阴切开术后会阴伤口愈合和减轻疼痛提供一种安全有效的策略。有必要进行进一步的大规模研究来验证这些有前景的发现并探索潜在机制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c70/12249008/8cd4037e29ae/healthcare-13-01581-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c70/12249008/eb258ec1696b/healthcare-13-01581-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c70/12249008/8cd4037e29ae/healthcare-13-01581-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c70/12249008/eb258ec1696b/healthcare-13-01581-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c70/12249008/8cd4037e29ae/healthcare-13-01581-g002.jpg

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本文引用的文献

1
The Role of Lactic Acid in Episiotomy Wound Healing: A Systematic Review.乳酸在会阴切开术伤口愈合中的作用:一项系统评价
Healthcare (Basel). 2025 Apr 21;13(8):956. doi: 10.3390/healthcare13080956.
2
The "Ideal Birth": The Occurrence of Severe Perineal Lacerations, Related Factors and the Possibility of Identifying Patients at Higher Risk.“理想分娩”:严重会阴裂伤的发生情况、相关因素及识别高危患者的可能性
Healthcare (Basel). 2024 Dec 22;12(24):2584. doi: 10.3390/healthcare12242584.
3
Probiotics in Wound Healing.益生菌在伤口愈合中的作用。
Int J Mol Sci. 2024 May 24;25(11):5723. doi: 10.3390/ijms25115723.
4
Advancements in Regenerative Hydrogels in Skin Wound Treatment: A Comprehensive Review.再生水凝胶在皮肤创伤治疗中的研究进展:全面综述。
Int J Mol Sci. 2024 Mar 29;25(7):3849. doi: 10.3390/ijms25073849.
5
Postpartum care needs assessment: women's understanding of postpartum care, practices, barriers, and educational needs.产后护理需求评估:女性对产后护理的理解、实践、障碍和教育需求。
BMC Pregnancy Childbirth. 2023 Jul 7;23(1):502. doi: 10.1186/s12884-023-05813-0.
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Anti-inflammatory and wound healing properties of lactic acid bacteria and its peptides.乳酸菌及其肽的抗炎和伤口愈合特性。
Folia Microbiol (Praha). 2023 Jun;68(3):337-353. doi: 10.1007/s12223-022-01030-y. Epub 2023 Feb 13.
7
A Review of Episiotomy and Modalities for Relief of Episiotomy Pain.会阴切开术及缓解会阴切开术疼痛方法的综述
Cureus. 2022 Nov 17;14(11):e31620. doi: 10.7759/cureus.31620. eCollection 2022 Nov.
8
Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials.分娩期间的会阴按摩:随机对照试验的系统评价和荟萃分析
J Matern Fetal Neonatal Med. 2020 Mar;33(6):1051-1063. doi: 10.1080/14767058.2018.1512574. Epub 2018 Sep 19.
9
Selective versus routine use of episiotomy for vaginal birth.经阴道分娩时会阴切开术的选择性使用与常规使用
Cochrane Database Syst Rev. 2017 Feb 8;2(2):CD000081. doi: 10.1002/14651858.CD000081.pub3.
10
Variations in rates of severe perineal tears and episiotomies in 20 European countries: a study based on routine national data in Euro-Peristat Project.20个欧洲国家严重会阴撕裂和会阴切开术发生率的差异:一项基于欧洲围产期统计项目国家常规数据的研究
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