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西红花苷对糖尿病患者的影响:一项安慰剂对照、三盲临床试验。

Effect of crocin on diabetic patients: A placebo-controlled, triple-blinded clinical trial.

机构信息

Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Clin Nutr ESPEN. 2022 Aug;50:255-263. doi: 10.1016/j.clnesp.2022.05.006. Epub 2022 May 18.

DOI:10.1016/j.clnesp.2022.05.006
PMID:35871933
Abstract

OBJECTIVE

The purpose of this study was to evaluate the effect of Saffron and its active ingredient, crocin, as a natural antioxidant in the treatment of type II diabetes.

METHODS

A total of 150 uncontrolled type 2 (non-insulin-dependent) diabetic patients were selected based on inclusion criteria, randomly divided into three groups (crocin, saffron and placebo) for three months' clinical trial. Fasting blood glucose (FBS), insulin level, glycosylated hemoglobin (HbA1c), lipid profile, kidney and liver function tests were performed before and three months after the study. The patients were followed every two weeks for possible clinical side effects.

RESULTS

Our results showed that after three months of treatment with crocin and saffron, FBS reduction was significant in all groups (P-value < 0.05). In addition, reduction of HbA1c was significant in the crocin and saffron groups compared to placebo group. Comparison between groups showed that treatment with crocin and saffron led to a significant reduction in HbA1c than placebo, and FBS level significantly reduced only in crocin compared to saffron and placebo groups. In addition, changes in lipid profile were not significant in any of the three groups. Also, there was no significant difference in liver and liver parameters in all three groups. Inter-group comparison of insulin levels showed significant difference only between the saffron and placebo groups.

CONCLUSION

Crocin can be effective in controlling the level of FBS and HbA1c in patients with type 2 diabetes.

摘要

目的

本研究旨在评估藏红花及其活性成分藏红花酸作为天然抗氧化剂治疗 2 型糖尿病的效果。

方法

根据纳入标准,选择了 150 名未经控制的 2 型(非胰岛素依赖型)糖尿病患者,随机分为三组(藏红花酸组、藏红花组和安慰剂组),进行为期三个月的临床试验。在研究前后分别进行空腹血糖(FBS)、胰岛素水平、糖化血红蛋白(HbA1c)、血脂谱、肝肾功能检查。每两周对患者进行随访,以了解可能出现的临床副作用。

结果

我们的结果表明,在接受藏红花酸和藏红花治疗三个月后,所有组的 FBS 降低均有统计学意义(P 值均<0.05)。此外,藏红花酸组和藏红花组的 HbA1c 降低与安慰剂组相比有统计学意义。组间比较显示,藏红花酸和藏红花治疗组的 HbA1c 降低明显优于安慰剂组,FBS 水平仅在藏红花酸组与安慰剂组和藏红花组相比显著降低。此外,三组的血脂谱变化均不显著。三组的肝肾功能参数也无显著差异。胰岛素水平的组间比较仅显示藏红花组和安慰剂组之间有显著差异。

结论

藏红花酸可有效控制 2 型糖尿病患者的 FBS 和 HbA1c 水平。

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