Postgrad Med. 2010 Nov;122(6):98-106. doi: 10.3810/pgm.2010.11.2227.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are mainstays of the treatment of osteoarthritis (OA) but have dose- and age-related risks of gastrointestinal, cardiovascular, and renal adverse events (AEs). As a result, US and international guidelines recommend caution when prescribing oral NSAIDs, particularly in older patients and those with significant comorbidities. For OA of the hands and knees, topical NSAIDs provide efficacy similar to oral NSAIDs, with far less systemic distribution. Treatment-related cardiovascular, renal, and other serious AEs with topical NSAIDs have not been reported. At present, only 2 topical NSAIDs are approved in the United States for the treatment of OA: diclofenac sodium 1% gel for hand or knee OA and diclofenac sodium 1.5% in 45.5% dimethylsulfoxide solution for knee OA. Clinical trial data for these products have demonstrated efficacy superior to placebo or similar to oral diclofenac with AE profiles similar to placebo, except for application site reactions. In large double-blind trials, gastrointestinal AEs were infrequent and did not include ulcers, perforations, or bleeding. The purpose of this brief review is to examine the data from controlled double-blind trials evaluating the use of topical NSAIDs in patients with OA. Articles included were identified via a search of PubMed covering the period from January 1, 2005 through March 31, 2010. Reference lists from OA treatment guidelines and meta-analyses were reviewed for additional citations of importance.
非甾体抗炎药(NSAIDs)是治疗骨关节炎(OA)的主要药物,但存在剂量和年龄相关的胃肠道、心血管和肾脏不良事件(AE)风险。因此,美国和国际指南建议在开具口服 NSAIDs 时要谨慎,尤其是在老年患者和有严重合并症的患者中。对于手部和膝关节的 OA,局部 NSAIDs 提供的疗效与口服 NSAIDs 相似,但全身分布要少得多。局部 NSAIDs 与治疗相关的心血管、肾脏和其他严重 AE 尚未报道。目前,只有 2 种局部 NSAIDs 在美国被批准用于治疗 OA:用于手部或膝关节 OA 的双氯芬酸钠 1%凝胶和用于膝关节 OA 的双氯芬酸钠 1.5%在 45.5%二甲基亚砜溶液中。这些产品的临床试验数据表明,其疗效优于安慰剂或与口服双氯芬酸钠相似,AE 谱与安慰剂相似,除了应用部位反应。在大型双盲试验中,胃肠道 AE 很少见,不包括溃疡、穿孔或出血。本综述的目的是检查对照双盲试验中评估局部 NSAIDs 在 OA 患者中的使用的数据。通过对 2005 年 1 月 1 日至 2010 年 3 月 31 日期间 PubMed 的搜索确定了纳入的文章。还回顾了 OA 治疗指南和荟萃分析的参考文献列表,以获取其他重要的引用。