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补充益生菌对初产妇会阴切开伤口愈合的影响:一项三盲随机临床试验。

The effect of probiotic supplementation on episiotomy wound healing among primiparous women: a triple-blind randomized clinical trial.

机构信息

Student Research Committee, Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.

Department of Food Science and Technology, Faculty of Nutrition & Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

BMC Complement Med Ther. 2023 May 5;23(1):149. doi: 10.1186/s12906-023-03980-3.

Abstract

BACKGROUND

Probiotics increase the defense power of immune system and accelerate the wound healing process by anti-inflammatory mechanisms at the wound site. The present study aimed at evaluating the effect of Lactobacillus casei oral supplementation on episiotomy wound healing among primiparous women.

METHODS

This triple-blind randomized clinical trial was performed on 74 primiparous women delivered in Alzahra Hospital, Tabriz, Iran. Participants with mediolateral episiotomy (incision length equal to and less than 5 cm) were randomly assigned to the probiotic and placebo groups. The probiotic group received Lactobacillus casei 431 with 1.5 * 10 colony-forming unit /capsule once a day from the day after birth to 14 days. Wound healing as a primary outcome was measured by Redness, Edema, Ecchymosis, Discharge, Approximation and pain as a secondary outcome by the Visual Analogue Scale before discharge, 5 ± 1 and 15 ± 1 days after birth. The data were analyzed using independent t-test and repeated measures one way analysis of variance.

RESULTS

The mean (standard deviation: SD) score of wound healing in the probiotic group altered from 4.91(1.86) before discharge to 1.55 (0.99) during 5 ± 1 days after birth and reached to 0.95 (0.27) during 15 ± 1 days after birth. Further, the mean (SD) score of wound healing in the placebo group altered from 4.62 (1.99) before discharge to 2.80 (1.20) during 5 ± 1 days after birth and reached to 1.45(0.71) during 15 ± 1 days after birth (adjusted mean difference: -0.50, confidence interval 95%: -0.96 to -0.05, P = 0.03).

CONCLUSION

Lactobacillus casei oral supplementation is effective in healing episiotomy wounds. It is suggested to evaluate the effect of topical use of Lactobacillus casei on episiotomy repair and pain in further studies.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials (IRCT): IRCT20170506033834N7. Date of registration: 11/08/2021.

摘要

背景

益生菌通过在伤口部位发挥抗炎机制来提高免疫系统的防御能力,并加速伤口愈合过程。本研究旨在评估口服酪酸梭菌对初产妇会阴切开伤口愈合的影响。

方法

这项三盲随机临床试验在伊朗大不里士 Alzahra 医院对 74 名经会阴侧切(切口长度等于或小于 5 厘米)的初产妇进行。参与者被随机分配到益生菌和安慰剂组。益生菌组从产后第一天开始每天服用 1.5 * 10 菌落形成单位/胶囊的酪酸梭菌 431 一次,持续 14 天。主要结局为红肿、水肿、瘀斑、分泌物、接近度和疼痛,次要结局为出院前、产后 5 ± 1 天和 15 ± 1 天的视觉模拟量表评分。数据采用独立 t 检验和重复测量方差分析进行分析。

结果

益生菌组的伤口愈合评分从出院前的 4.91(1.86)降至产后 5 ± 1 天的 1.55 (0.99),并在产后 15 ± 1 天降至 0.95 (0.27)。此外,安慰剂组的伤口愈合评分从出院前的 4.62 (1.99)降至产后 5 ± 1 天的 2.80 (1.20),并在产后 15 ± 1 天降至 1.45(0.71)(调整平均差值:-0.50,95%置信区间:-0.96 至-0.05,P = 0.03)。

结论

口服酪酸梭菌对会阴切开伤口愈合有效。建议在进一步的研究中评估局部使用酪酸梭菌对会阴修复和疼痛的影响。

试验注册

伊朗临床试验注册中心(IRCT):IRCT20170506033834N7。注册日期:2021 年 8 月 11 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e47/10163808/ddd38c64b3c9/12906_2023_3980_Fig1_HTML.jpg

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