van Walsem Anneloes, Pandhi Shaloo, Nixon Richard M, Guyot Patricia, Karabis Andreas, Moore R Andrew
Mapi, De Molen 84, 3995, AX, Houten, The Netherlands.
Novartis Pharma AG, Lichtstrasse 35, CH-4002, Basel, Switzerland.
Arthritis Res Ther. 2015 Mar 19;17(1):66. doi: 10.1186/s13075-015-0554-0.
There is argument over the benefits and risks of drugs for treating chronic musculoskeletal pain. This study compared the efficacy, safety, and tolerability of diclofenac, ibuprofen, naproxen, celecoxib, and etoricoxib for patients with pain caused by osteoarthritis (OA) or rheumatoid arthritis (RA).
A systematic literature review used Medline and EMBASE to identify randomised controlled trials. Efficacy outcomes assessed included: pain relief measured by visual analogue scale (VAS); Western Ontario McMaster Universities Arthritis Index (WOMAC) VAS or WOMAC Likert scale; physical functioning measured by WOMAC VAS or Likert scale; and patient global assessment (PGA) of disease severity measured on VAS or 5-point Likert scale. Safety outcomes included: Antiplatelet Trialists' Collaboration (APTC), major cardiovascular (CV) and major upper gastrointestinal (GI) events, and withdrawals. Data for each outcome were synthesized by a Bayesian network meta-analysis (NMA). For efficacy assessments, labelled doses for OA treatment were used for the base case while labelled doses for RA treatment were also included in the sensitivity analysis. Pooled data across dose ranges were used for safety.
Efficacy, safety, and tolerability data were found for 146,524 patients in 176 studies included in the NMA. Diclofenac (150 mg/day) was likely to be more effective in alleviating pain than celecoxib (200 mg/day), naproxen (1000 mg/day), and ibuprofen (2400 mg/day), and similar to etoricoxib (60 mg/day); a lower dose of diclofenac (100 mg/day) was comparable to all other treatments in alleviating pain. Improved physical function with diclofenac (100 and 150 mg/day) was mostly comparable to all other treatments. PGA with diclofenac (100 and 150 mg/day) was likely to be more effective or comparable to all other treatments. All active treatments were similar for APTC and major CV events. Major upper GI events with diclofenac were lower compared to naproxen and ibuprofen, comparable to celecoxib, and higher than etoricoxib. Risk of withdrawal with diclofenac was lower compared to ibuprofen, similar to celecoxib and naproxen, and higher than etoricoxib.
The benefit-risk profile of diclofenac was comparable to other treatments used for pain relief in OA and RA; benefits and risks vary in individuals and need consideration when making treatment decisions.
关于治疗慢性肌肉骨骼疼痛药物的益处和风险存在争议。本研究比较了双氯芬酸、布洛芬、萘普生、塞来昔布和依托考昔对骨关节炎（OA）或类风湿关节炎（RA）引起疼痛患者的疗效、安全性和耐受性。
通过系统文献综述，使用Medline和EMBASE检索随机对照试验。评估的疗效指标包括：用视觉模拟量表（VAS）测量的疼痛缓解情况；西安大略和麦克马斯特大学关节炎指数（WOMAC）VAS或WOMAC李克特量表；用WOMAC VAS或李克特量表测量的身体功能；以及用VAS或5点李克特量表测量的患者对疾病严重程度的整体评估（PGA）。安全性指标包括：抗血小板试验协作组（APTC）、主要心血管（CV）和主要上消化道（GI）事件以及退出研究情况。每个指标的数据通过贝叶斯网络荟萃分析（NMA）进行综合分析。对于疗效评估，基础病例使用OA治疗的标记剂量，敏感性分析中也纳入了RA治疗的标记剂量。安全性分析使用了不同剂量范围的汇总数据。
NMA纳入的176项研究中，共146,524例患者有疗效、安全性和耐受性数据。双氯芬酸（150毫克/天）在缓解疼痛方面可能比塞来昔布（200毫克/天）、萘普生（1000毫克/天）和布洛芬（2400毫克/天）更有效，与依托考昔（60毫克/天）相似；较低剂量的双氯芬酸（100毫克/天）在缓解疼痛方面与所有其他治疗相当。双氯芬酸（100和150毫克/天）在改善身体功能方面大多与所有其他治疗相当。双氯芬酸（100和150毫克/天）的PGA可能比所有其他治疗更有效或相当。所有活性治疗在APTC和主要CV事件方面相似。双氯芬酸的主要上消化道事件低于萘普生和布洛芬，与塞来昔布相当，高于依托考昔。双氯芬酸的退出风险低于布洛芬，与塞来昔布和萘普生相似，高于依托考昔。
双氯芬酸的获益风险情况与用于OA和RA疼痛缓解的其他治疗相当；个体的获益和风险各不相同，在做出治疗决策时需要考虑。
