藏红花（番红花）补充剂对2型糖尿病患者氧化应激、炎症指标以及肾和肝功能参数的影响：一项采用GRADE分级的随机临床试验系统评价和荟萃分析

Effect of Saffron (Crocus sativus) Supplementation on Oxidative Stress, Inflammatory Indices, and Renal and Liver Function Parameters in Patients With Type 2 Diabetes Mellitus: A GRADE-Assessed Systematic Review and Meta-analysis of Randomized Clinical Trials.

作者信息

Mafi Alireza, Mokhtari Zeinab, Hosseini Elham, Alimohammadi Mina, Aarabi Mohammad Hosein, Askari Gholamreza

机构信息

Nutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan 81746-73461, Iran.

Department of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan 81746-73461, Iran.

出版信息

Nutr Rev. 2025 Jun 1;83(6):971-987. doi: 10.1093/nutrit/nuae121.

DOI:10.1093/nutrit/nuae121

PMID:39657222

Abstract

CONTEXT

Clinical investigation has shown that the addition of saffron or crocin to standard antidiabetic medications improves a patient's metabolic profile, oxidative stress (OS), and inflammatory response. Despite a large number of studies examining the impact of saffron supplementation on OS, inflammation, and renal and liver function parameters, no systematic review or meta-analysis has been conducted to compile the outcomes in patients with type 2 diabetes mellitus (T2DM).

OBJECTIVE

The current systematic review and meta-analysis was performed to investigate the effect of saffron or crocin intake on OS, inflammation, and renal and liver function parameters in patients with T2DM.

DATA SOURCES

Online databases including PubMed, Scopus, ISI Web of Science, and Cochrane Library were searched up to December 2023.

DATA EXTRACTION

The mean differences and their respective SDs were extracted. Using a random-effects model, the pooled data were calculated as standardized mean difference (SMD) with 95% CI.

DATA ANALYSIS

17 eligible randomized controlled trials were included in this meta-analysis. The pooled findings showed that saffron supplementation remarkably decreased the levels of tumor necrosis factor-α (SMD: -0.37; 95% CI: -0.69 to -0.05; I2 = 40.77%, P = .15), interleukin-6 (IL-6) (SMD: -0.38; 95% CI: -0.65 to -0.10; I2 = 0%, P = .68), and malondialdehyde (MDA) (SMD: -0.36; 95% CI: -0.65 to -0.07; I2= 20.51%, P = .02) compared with the control. In addition, based on subgroup analyses, taking ≥100 mg of saffron daily in individuals with T2DM reduced the serum levels of IL-6 (SMD: -0.50; 95% CI: -0.90 to -0.10; I2 = 0%, P = .50) and MDA (SMD: -0.36; 95% CI: -0.68 to -0.03; I2 = 0, P = .97). Furthermore, the level of alanine transaminase was decreased (SMD: -0.43; 95% CI: -0.73 to -0.12; I2 = 0, P = .66) with a treatment period of <60 days of saffron or crocin supplementation.

CONCLUSION

Larger studies with more follow-up and higher doses of both saffron and crocin are needed in order to understand the efficacy and safety of these herbs for long-term use as routine therapies.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO registration no. CRD42023458119.

摘要

背景

临床研究表明，在标准抗糖尿病药物中添加藏红花或藏红花素可改善患者的代谢状况、氧化应激（OS）和炎症反应。尽管有大量研究探讨了补充藏红花对氧化应激、炎症以及肾脏和肝脏功能参数的影响，但尚未进行系统评价或荟萃分析来汇总2型糖尿病（T2DM）患者的相关结果。

目的

进行本次系统评价和荟萃分析，以研究摄入藏红花或藏红花素对T2DM患者氧化应激、炎症以及肾脏和肝脏功能参数的影响。

数据来源

检索了截至2023年12月的在线数据库，包括PubMed、Scopus、ISI科学网和Cochrane图书馆。

数据提取

提取平均差值及其各自的标准差。采用随机效应模型，将汇总数据计算为标准化平均差值（SMD）及95%置信区间。

数据分析

本荟萃分析纳入了17项符合条件的随机对照试验。汇总结果显示，与对照组相比，补充藏红花可显著降低肿瘤坏死因子-α水平（SMD：-0.37；95%置信区间：-0.69至-0.05；I² = 40.77%，P = 0.15）、白细胞介素-6（IL-6）水平（SMD：-0.38；95%置信区间：-0.65至-0.10；I² = 0%，P = 0.68）和丙二醛（MDA）水平（SMD：-0.36；95%置信区间：-0.65至-0.07；I² = 20.51%，P = 0.02）。此外，基于亚组分析，T2DM患者每日服用≥100mg藏红花可降低血清IL-6水平（SMD：-0.50；95%置信区间：-0.90至-0.10；I² = 0%，P = 0.50）和MDA水平（SMD：-0.36；95%置信区间：-0.68至-0.03；I² = 0，P = 0.97）。此外，补充藏红花或藏红花素治疗期<60天时，丙氨酸转氨酶水平降低（SMD：-0.43；95%置信区间：-0.73至-0.12；I² = 0，P = 0.66）。