大蒜片预防早产的随机临床试验

IF 1 Q4 PHARMACOLOGY & PHARMACY Jundishapur Journal of Natural Pharmaceutical Products Pub Date : 2023-08-08 DOI:10.5812/jjnpp-137008
S. Niroomanesh, Zeinab Shaker Ardakani, M. Shirazi, F. Haghollahi, M. Shariat, G. Amin, MirFarbod Hojati Bagheri
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引用次数: 0

摘要

背景:早产是新生儿死亡和发病的重要原因之一。关于大蒜在预防早产方面的作用,几乎没有证据。目的:探讨大蒜片预防早产的作用。方法:这是一项双盲临床试验。本研究纳入了537名妊娠第16至26周有先兆早产史(妊娠第37周前分娩)的单胎孕妇。参与者被随机分为干预组(n=272)和对照组(n=265)。干预组每24小时接受一次大蒜片(500mg/天),持续10周,每周肌肉注射250mg孕酮,直到36周或分娩时间。对照组接受安慰剂片加250mg肌肉注射孕酮(每周至36周)。主要结果是早产(胎龄<37周)的发生率。定量变量用频率和百分比表示,并使用卡方检验或Fisher精确检验对小样本量进行比较。数值数据以平均值和标准差表示。我们使用Kolmogorov-Smirnov检验来确定数据分布的正态性。之后,使用独立T Student检验研究了连续变量与正态分布的关系,并使用非参数Mann-Whitney检验研究了无正态分布连续变量。多元逻辑回归分析估计了不同变量的相互作用和混杂效应。结果:445例足月分娩(82.9%),92例早产(17.1%)。干预组17例(6.3%)和对照组75例(28.3%)发生早产(P<0.001),研究组(干预组或对照组)是早产的唯一预测因素(or-3.6,CI:95%:1.98-6.5,P<0.001)。大蒜片似乎对预防早产有效。
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The Effect of Garlic Tablet for Preventing Preterm Labor: A Randomized Clinical Trial
Background: One of the important causes of neonatal mortality and morbidity is preterm birth. There is little evidence about the role of garlic in preventing preterm labor. Objectives: This study aimed to investigate the role of garlic tablets in preventing premature birth. Methods: This is a double-blind clinical trial. Five hundred and thirty-seven singleton pregnant women in the 16th to 26th week of pregnancy with a history of threatened preterm delivery (delivery before the 37th week of pregnancy) were included in this study. The participants were randomly divided into intervention (n = 272) and control groups (n = 265). The intervention group received garlic tablets (500 mg/day) every 24 hours for 10 weeks and 250 mg intramuscular progesterone every week until 36 weeks or delivery time. The control group received placebo tablets plus 250 mg intramuscular progesterone (every week until 36 weeks). The primary outcome was the incidence of Preterm delivery (gestational age < 37 weeks). Quantitative variables were expressed as frequency and percentage and compared using the chi-square or Fisher exact test with a small sample size. Numerical data were presented as mean and standard deviation. We used the Kolmogorov-Smirnov test to determine the normality of the data distribution. After that, the relationships of continuous variables with normal distribution were investigated using the Independent T Student test, and continuous variables without normal distribution were investigated with the non-parametric Mann-Whitney test. Multivariate logistic regression analysis estimated different variables' interaction and confounding effects. Results: Four hundred and forty-five had term delivery (82.9%), and 92 (17.1%) had preterm delivery. Seventeen participants in the intervention group (6.3%) and 75 (28.3%) in the control group had preterm delivery (P < 0.001). By considering preterm labor as dependent and other independent variables, the study group (intervention or control) was the only predictor of preterm labor (OR-3.6, CI: 95%: 1.98 - 6.5, P < 0.001). Conclusions: The results showed that the combined treatment of oral garlic tablets and intramuscular progesterone significantly prolonged pregnancy or improved outcomes. Garlic tablets seem to be effective in preventing preterm birth.
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