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Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee

机译:曲安奈德乙酰缓释药:膝骨关节炎疼痛的审查。

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摘要

Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta®) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. Although the therapeutic effects from IA corticosteroids are typically short-lived, triamcinolone acetonide ER is formulated in poly (lactic-co-glycolic acid) (PLGA) microspheres that slowly release triamcinolone acetonide in the synovium, enabling their prolonged presence in the joint. This reduces systemic exposure and lessens corticosteroid-related systemic adverse reactions, such as blood glucose elevations. In a 24-week, randomized, phase III clinical trial, triamcinolone acetonide ER 32 mg significantly improved mean average daily pain intensity in patients with knee OA relative to placebo, and pain, stiffness and physical function (according to WOMAC criteria) relative to placebo and triamcinolone acetonide crystalline suspension (CS). Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo. Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.
机译:曲安奈德丙酮缓释(ER)32毫克(Zilretta ®)已在美国获准用于治疗膝关节骨关节炎(OA)疼痛,并以5毫升的单一关节腔给药(IA)注射。尽管IA皮质类固醇的治疗作用通常是短暂的,但曲安奈德ER是在聚乳酸-乙醇酸(PLGA)微球中配制的,该微球在滑膜中缓慢释放曲安奈德,从而使其在关节中可以长期存在。这减少了全身暴露,并减轻了皮质类固醇相关的全身不良反应,例如血糖升高。在一项为期24周的随机III期临床试验中,曲安奈德ER 32毫克相对于安慰剂显着改善了膝OA患者的平均每日平均疼痛强度,相对于安慰剂而言,其疼痛,僵硬和身体功能(根据WOMAC标准)和曲安奈德丙酮晶体悬浮液(CS)。曲安奈德ER的耐受性一般良好,其耐受性与曲安奈德CS和安慰剂相似。单臂IIIb期研究的结果表明,曲安奈德ER的重复给药可能与初次注射相似,对软骨或关节结构的其他方面无害。因此,曲安奈德ER扩大了可用于治疗膝盖OA疼痛的治疗选择。

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