口服益生菌对妊娠期糖尿病女性血糖控制的影响：一项多中心、随机、双盲、安慰剂对照试验。
The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus-a multicenter, randomized, double-blind, placebo-controlled trial.
机构信息
Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel (Dr Nachum); Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel (Drs Nachum, Vitner, and Zipori).
Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel (Drs Perlitz, Harel, Soltsman, and Yefet); Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel (Drs Perlitz and Yefet).
出版信息
Am J Obstet Gynecol MFM. 2024 Jan;6(1):101224. doi: 10.1016/j.ajogmf.2023.101224. Epub 2023 Nov 12.
BACKGROUND
Gestational diabetes mellitus should be treated adequately to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with gestational diabetes mellitus. However, a major limitation of previous studies was that preprandial and especially postprandial glucose values, which are important predictors of pregnancy outcomes, were not studied.
OBJECTIVE
This study aimed to examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly preprandial and postprandial glucose values and pregnancy outcomes among women with gestational diabetes mellitus.
STUDY DESIGN
A multicenter prospective randomized, double-blind, placebo-controlled trial was conducted. Women newly diagnosed with gestational diabetes mellitus were randomly allocated into a research group, receiving 2 capsules of oral probiotic formula containing Bifidobacterium bifidum, B lactis, Lactobacillus acidophilus, L paracasei, L rhamnosus, and Streptococcus thermophilus (>6 × 10/capsule), and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control was evaluated by daily glucose charts. After 2 weeks, pharmacotherapy was started in case of poor glycemic control. The primary outcomes were the rate of women requiring medications for glycemic control and mean daily glucose charts after 2 weeks of treatment with the study products.
RESULTS
Forty-one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first 2 weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively (P=.35). The rate of women needing pharmacotherapy because of poor glycemic control after 2 weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively (P=.10). Mean preprandial and postprandial glucose levels throughout the study period were similar between the groups (P>.05). There were no differences in maternal and neonatal outcomes, including birthweight and adverse effect profile between the groups.
CONCLUSION
The oral probiotic product tested in this study did not affect glycemic control of women with gestational diabetes mellitus.
背景
妊娠糖尿病应充分治疗，以避免与母亲高血糖相关的并发症。先前有研究表明，益生菌补充剂可改善妊娠糖尿病患者的空腹血糖。然而，先前研究的一个主要局限性是没有研究餐前和尤其是餐后血糖值，这些值是妊娠结局的重要预测指标。
目的
本研究旨在探讨混合益生菌菌株对妊娠糖尿病患者血糖参数的影响，特别是餐前和餐后血糖值以及妊娠结局。
研究设计
进行了一项多中心前瞻性随机、双盲、安慰剂对照试验。新诊断为妊娠糖尿病的女性被随机分配到研究组，接受 2 粒含有双歧杆菌、乳双歧杆菌、嗜酸乳杆菌、副干酪乳杆菌、鼠李糖乳杆菌和嗜热链球菌（>6×10/capsule）的口服益生菌配方，以及对照组，接受 2 粒安慰剂（每天 2 粒）直至分娩。通过每日血糖图表评估血糖控制情况。2 周后，如果血糖控制不佳，则开始药物治疗。主要结局是需要药物治疗血糖控制的女性比例和使用研究产品治疗 2 周后平均每日血糖图表。
结果
分别对治疗组和安慰剂组的 41 名和 44 名女性进行了分析。在益生菌组和安慰剂组中，治疗前 2 周的平均每日血糖分别为 99.7±7.9 和 98.0±9.3 mg/dL，差异无统计学意义（P=.35）。在益生菌组和安慰剂组中，治疗 2 周后因血糖控制不佳需要药物治疗的女性比例分别为 24 名（59%）和 18 名（41%），差异无统计学意义（P=.10）。整个研究期间，两组间餐前和餐后血糖水平相似（P>.05）。两组间母婴结局和不良事件谱均无差异，包括出生体重和不良事件。
结论
本研究中测试的口服益生菌产品对妊娠糖尿病女性的血糖控制没有影响。
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