目的:本研究旨在探讨二甲双胍辅助治疗肥胖膝骨关节炎(OA)患者的疗效。考虑到它的抗炎和软骨保护作用。
方法:在本随机分组中,双盲,安慰剂对照研究,50例肥胖膝OA患者随机分为两组,二甲双胍组(n=25)口服二甲双胍500mgBID加塞来昔布200mg,每日一次,和安慰剂组(n=25),其中安慰剂片剂BID加塞来昔布200mg,每天一次,连续12周。软骨寡聚基质蛋白(COMP),I型胶原的C端交联端肽(CTX-1),和白细胞介素1-β(IL-1β)的血清水平,西安大略省和麦克马斯特大学关节炎指数(WOMAC)评分评估膝关节疼痛,刚度,基线和12周后的身体功能。
结果:经过12周的治疗,二甲双胍组的COMP水平显着降低,与安慰剂组相比,血清中的CTX-1和IL-1β(分别为p=0.0081,p=0.0106和p=0.0223)。此外,二甲双胍组的WOMAC总量表有显著改善(p<0.0001),特别是膝盖疼痛,刚度,与安慰剂组相比(分别为p<0.0001,p<0.0001和p<0.0001)。
结论:二甲双胍作为肥胖膝骨关节炎患者的辅助治疗可能对软骨降解和炎症有有益的作用,血清COMP显著下降,CTX-1和IL-1β水平。此外,二甲双胍可以改善临床结果,如WOMAC评分的显著提高所示。
结果:
■NCT05638893/2022年12月6日注册-回顾性。
OBJECTIVE: This study aimed at investigating the efficacy of metformin as adjuvant therapy for obese knee osteoarthritis (OA) patients, considering its anti-inflammatory and cartilage-protective effects.
METHODS: In this randomized, double-blind, placebo-controlled study, 50 obese knee OA patients were assigned randomly to two groups, the metformin group (n = 25) which was treated with metformin 500 mg orally BID plus celecoxib 200 mg orally once daily, and the placebo group (n = 25) which was treated with placebo tablets BID plus celecoxib 200 mg orally once daily for 12 weeks. Cartilage Oligomeric Matrix Protein (
COMP), C-terminal cross-linked telopeptide of type I collagen (CTX-1), and Interleukin 1-beta (IL-1β) serum levels were measured, while Western Ontario and McMaster Universities Arthritis Index (WOMAC) score assessed knee pain, stiffness, and physical function at baseline and after 12 weeks.
RESULTS: Following a 12-week treatment, the metformin group exhibited significantly reduced levels of
COMP, CTX-1, and IL-1β in the serum compared to the placebo group (p = 0.0081, p = 0.0106, and p = 0.0223, respectively). Furthermore, metformin group produced significant improvements in WOMAC total scale (p < 0.0001), specifically in knee pain, stiffness, and physical function compared to placebo group (p < 0.0001, p < 0.0001, and p < 0.0001, respectively).
CONCLUSIONS: Metformin as an adjuvant therapy in obese knee OA patients may have beneficial effects on cartilage degradation and inflammation, as evidenced by the significant decreases in serum
COMP, CTX-1, and IL-1β levels. Additionally, metformin may improve clinical outcomes, as shown by the significant improvements in WOMAC scores.
RESULTS: UNASSIGNED: NCT05638893/Registered December 6, 2022 - Retrospectively.