Rane Manas A, Gitin Alexander, Fiedler Benjamin, Fiedler Lawrence, Hennekens Charles H
Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.
Graduate Medical Education Consortium (Bethesda Hospital, Boca Raton Regional Hospital, Delray Medical Center, St. Mary's Medical Center, West Boca Raton Hospital), Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.
J Cardiovasc Pharmacol Ther. 2020 Jan;25(1):3-6. doi: 10.1177/1074248419871902. Epub 2019 Aug 29.
Nonsteroidal anti-inflammatory drugs (NSAIDs) include aspirin, naproxen, diclofenac, and ibuprofen, as well as selective cyclooxygenase 2 inhibitors such as celecoxib. Their use is common, as well as their side effects which cause 100 000 hospitalizations and 17 000 deaths annually. Recently, the US Food and Drug Administration strengthened its warning about the risks of cardiovascular disease (CVD) attributed to nonaspirin NSAIDs.
When the sample size is large, randomization provides control of confounding not possible to achieve with any observational study. Further, observational studies and, especially, claims data have inherent confounding by indication larger than the small to moderate effects being sought.
While trials are necessary, they must be of sufficient size and duration and achieve high compliance and follow-up. Until then, clinicians should remain uncertain about benefits and risks of these drugs. Conclusions: Since the totality of evidence remains incomplete, health-care providers should consider all these aforementioned benefits and risks, both CVD and beyond, in deciding whether and, if so, which, NSAID to prescribe. The factors in the decision of whether and, if so, which NSAID to prescribe for relief of pain from inflammatory arthritis should not be limited to risks of CVD or gastrointestinal side effects but should also include potential benefits including improvements in overall quality of life resulting from decreases in pain or impairment from musculoskeletal pain syndromes. The judicious individual clinical decision-making about the prescription of NSAIDs to relieve pain based on all these considerations has the potential to do much more good than harm.
非甾体抗炎药（NSAIDs）包括阿司匹林、萘普生、双氯芬酸、布洛芬以及选择性环氧化酶2抑制剂如塞来昔布。它们的使用很普遍，其副作用每年导致10万例住院治疗和1.7万例死亡。最近，美国食品药品监督管理局加强了对非阿司匹林类NSAIDs所致心血管疾病（CVD）风险的警告。
当样本量很大时，随机分组能够控制混杂因素，这是任何观察性研究都无法做到的。此外，观察性研究，尤其是索赔数据，存在因适应证导致的固有混杂因素，其程度大于所寻求的小到中度效应。
虽然试验是必要的，但试验必须有足够的规模和持续时间，并实现高依从性和随访。在此之前，临床医生对于这些药物的益处和风险仍应持不确定态度。结论：由于证据总体仍不完整，医疗保健提供者在决定是否以及（如果是）开具哪种NSAID时，应考虑上述所有益处和风险，包括心血管疾病及其他方面的。决定是否以及（如果是）开具哪种NSAID以缓解炎性关节炎疼痛的因素不应仅限于心血管疾病风险或胃肠道副作用，还应包括潜在益处，如因疼痛减轻或肌肉骨骼疼痛综合征所致功能障碍改善而使总体生活质量提高。基于所有这些考虑，就NSAID处方以缓解疼痛进行明智的个体化临床决策，可能带来的益处远大于危害。
