Albany Medical Center, Albany, NY, USA.
Curr Med Res Opin. 2011 Jul;27(7):1315-27. doi: 10.1185/03007995.2011.568058. Epub 2011 May 12.
To conduct a systematic review of evidence supporting the efficacy and safety profiles of nonsteroidal anti-inflammatory drugs (NSAIDs) introduced in the last decade for the treatment of patients with osteoarthritis (OA), including their analgesic effects, ability to improve function, and adverse event profiles relative to current standards of care.
Systematic search of the literature for NSAIDs approved by the FDA (2000-2010).
One new orally-administered NSAID molecule (meloxicam), two orally-administered NSAID formulations (naproxen plus lansoprazole; oxycodone/ibuprofen), and three topical NSAID formulations (diclofenac patch, gel, and solution) were approved by the FDA (2000-2010). A systematic literature review found evidence to support efficacy in treating patients with OA for all agents except oxycodone/ibuprofen, which has not been studied in this patient population, although ibuprofen and immediate-release oxycodone have been studied individually for OA pain. Evidence quality was inconsistent, with several agents lacking long-term, controlled trials against active comparators, and functional end points inconsistently met. Although low-dose meloxicam and naproxen plus lansoprazole offer a reduced risk of adverse gastrointestinal (GI) events, cardiovascular and renal risks remain similar to traditional oral NSAID therapy. Further, only lower doses of meloxicam appear to carry a reduced risk of GI events. Diclofenac patch, gel, and solution preparations offer the potential for reduced GI, cardiovascular, and renal adverse events. The level of evidence available to support the efficacy and safety of these agents for long-term treatment of patients with OA differs, with some having only short-term trials, while others have longer-duration trials with active comparators.
By expanding the treatment armamentarium, newly-approved NSAID agents may improve the ability of clinicians to tailor analgesic therapy for their diverse patient populations and to achieve realistic functional improvements. The comparisons in this article were limited to drugs that received approval after 2000 and should be considered accordingly.
对过去十年间被引入治疗骨关节炎(OA)患者的非甾体抗炎药(NSAIDs)的疗效和安全性进行系统评价,包括其镇痛效果、改善功能的能力以及与当前治疗标准相关的不良事件概况。
对 FDA 批准的 NSAIDs(2000-2010 年)进行系统文献检索。
有一个新的口服 NSAIDs 分子(美洛昔康)、两种口服 NSAIDs 制剂(萘普生加兰索拉唑;羟考酮/布洛芬)和三种局部用 NSAIDs 制剂(双氯芬酸贴剂、凝胶和溶液)被 FDA 批准(2000-2010 年)。一项系统文献回顾发现,除了尚未在该患者人群中进行研究的羟考酮/布洛芬外,所有药物在治疗 OA 患者方面都有疗效证据,尽管布洛芬和即释羟考酮已分别用于 OA 疼痛的研究。证据质量不一致,一些药物缺乏针对活性对照的长期对照试验,并且功能终点不一致。尽管低剂量美洛昔康和萘普生加兰索拉唑降低了不良胃肠道(GI)事件的风险,但心血管和肾脏风险与传统口服 NSAID 治疗相似。此外,只有较低剂量的美洛昔康似乎降低了 GI 事件的风险。双氯芬酸贴剂、凝胶和溶液制剂具有降低 GI、心血管和肾脏不良事件的潜力。这些新批准的 NSAIDs 药物在长期治疗 OA 患者方面的疗效和安全性的证据水平不同,一些只有短期试验,而另一些则有与活性对照的长期试验。
通过扩大治疗手段,新批准的 NSAID 药物可能会提高临床医生为其多样化患者群体定制镇痛治疗的能力,并实现现实的功能改善。本文中的比较仅限于 2000 年后获得批准的药物,因此应相应考虑。