二甲双胍在轻至中度溃疡性结肠炎患者中的辅助作用：一项随机对照研究。
The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study.
作者信息
Binsaleh Ammena Y, El-Haggar Sahar M, Hegazy Sahar K, Maher Maha M, Bahgat Monir M, Elmasry Thanaa A, Alrubia Sarah, Alsegiani Amsha S, Eldesoqui Mamdouh, Bahaa Mostafa M
机构信息
Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.
Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, Egypt.
出版信息
Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025.
BACKGROUND
Metformin, hypoglycemic medication, is recognized for its diverse properties and its capacity to influence the inflammatory pathways. Medications with anti-inflammatory and anti-oxidative characteristics have been demonstrated to be able to elicit and sustain remission in ulcerative colitis (UC), chronic inflammatory disorder of the bowel. Studies in both preclinical and clinical settings have looked into the several metabolic pathways via which metformin protects against UC.
AIM
To assess efficacy of metformin as adjunctive therapy in patients with mild to moderate UC.
METHODS
This clinical research was double-blinded, randomized, controlled, and involved 60 patients with mild to moderate UC. The participants were randomly assigned to one of two groups (n = 30). The control group was given 1 g of mesalamine three times a day (t.i.d.) for a period of 6 months (mesalamine group). The metformin group was given 500 mg of metformin twice daily and 1 g of mesalamine t. i.d. For a period of 6 months. Patients with UC were assessed by a gastroenterologist using the disease activity index (DAI) both at the beginning of treatment and 6 months thereafter. To evaluate the drug's biological efficacy, measurements of fecal calprotectin, serum C-reactive protein (CRP), interleukin 10 (IL-10), and nitric oxide (NO) were taken both before and after treatment.
STUDY OUTCOMES
Decrease in DAI and change in the level of measured serum and fecal markers.
RESULTS
The metformin group displayed a statistical reduction in DAI ( = 0.0001), serum CRP ( = 0.019), NO ( = 0.04), and fecal calprotectin ( = 0.027), as well as a significant increase in IL-10 ( = 0.04) when compared to the mesalamine group. There was a significant direct correlation between DAI and calprotectin (p < 0.0001, r = 0.551), and between DAI and CRP (p < 0.0001, r = 0.794). There was a significant negative correlation between DAI and IL-10 (p = 0.0003, r = 0.371).
CONCLUSION
Metformin may be an effective adjunct drug in management of patients with mild to moderate UC by decreasing DAI and other inflammatory markers that were involved in the pathogenesis of UC.
CLINICAL TRIAL REGISTRATION
identifier NCT05553704.
背景
二甲双胍作为一种降糖药物，因其具有多种特性以及影响炎症通路的能力而受到认可。具有抗炎和抗氧化特性的药物已被证明能够引发并维持溃疡性结肠炎（UC，一种肠道慢性炎症性疾病）的缓解。临床前和临床研究均探讨了二甲双胍预防UC的多种代谢途径。
目的
评估二甲双胍作为轻度至中度UC患者辅助治疗药物的疗效。
方法
这项临床研究采用双盲、随机、对照设计，纳入了60例轻度至中度UC患者。参与者被随机分为两组（每组n = 30）。对照组每天服用3次1g美沙拉嗪，持续6个月（美沙拉嗪组）。二甲双胍组每天服用2次500mg二甲双胍以及每天服用3次1g美沙拉嗪，持续6个月。由胃肠病学家在治疗开始时和6个月后使用疾病活动指数（DAI）对UC患者进行评估。为评估药物的生物学疗效，在治疗前后测量粪便钙卫蛋白、血清C反应蛋白（CRP）、白细胞介素10（IL - 10）和一氧化氮（NO）水平。
研究结果
DAI降低以及所测血清和粪便标志物水平的变化。
结果
与美沙拉嗪组相比，二甲双胍组的DAI（p = 0.0001）、血清CRP（p = 0.019）、NO（p = 0.04）和粪便钙卫蛋白（p = 0.027）有统计学意义的降低，以及IL - 10有显著升高（p = 0.04）。DAI与钙卫蛋白之间存在显著正相关（p < 0.0001，r = 0.551），DAI与CRP之间也存在显著正相关（p < 0.0001，r = 0.794）。DAI与IL - 10之间存在显著负相关（p = 0.0003，r = 0.371）。
结论
二甲双胍可能是治疗轻度至中度UC患者的有效辅助药物，可降低DAI以及参与UC发病机制的其他炎症标志物水平。
临床试验注册
标识符NCT05553704。
Zotero 插件