泛美研究：一项多中心、双盲、随机、非劣效性研究，比较扑热息痛与非甾体抗炎药治疗急性肌肉骨骼创伤。

The PanAM study: a multi-center, double-blinded, randomized, non-inferiority study of paracetamol versus non-steroidal anti-inflammatory drugs in treating acute musculoskeletal trauma.

机构信息

Department of Anaesthesiology; Academic Medical Center, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.

出版信息

BMC Emerg Med. 2013 Nov 20;13:19. doi: 10.1186/1471-227X-13-19.

DOI:10.1186/1471-227X-13-19

PMID:24256450

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4225513/

Abstract

BACKGROUND

Acute musculoskeletal trauma, including strains, sprains or contusions, occur frequently. Pain management is a crucial component of treatment. However, there is no convincing evidence which drug is superior in managing pain in these patients. The aim of the PanAM Study is to compare analgesic efficacy of three strategies of pain management: paracetamol, diclofenac, or a combination of both in patients with acute musculoskeletal trauma.

METHODS/DESIGN: The PanAM Study is a multi-center, double blind randomized controlled trial with non-inferiority design. Included are adult patients presenting to an academic, urban Emergency Department or to a General Practice with acute, blunt, traumatic limb injury. In total, 547 patients will be included using a predefined list of exclusion criteria, to be allocated by randomization to treatment with paracetamol + placebo diclofenac, diclofenac + placebo paracetamol or paracetamol + diclofenac. The hypothesis is that paracetamol will not be inferior to treatment with diclofenac, or the combination of both. Primary outcome will be between-group differences in decrease in pain, measured with Numerical Rating Scales at baseline and at 90 minutes after study drug administration. Secondary outcomes are Numerical Rating Scales at 30 and 60 minutes and measured frequently during three consecutive days after discharge; occurrence of adverse effects; patient satisfaction and an analysis of quality of life and cost-effectiveness. Recruitment started July 2013 and is expected to last a year.

DISCUSSION

With this multi-center randomized clinical trial we will investigate whether treatment with paracetamol alone is not inferior to diclofenac alone or a combination of both drugs in adult patients with acute musculoskeletal trauma. The main relevance of the trial is to demonstrate the benefits and risks of three commonly used treatment regimens for musculoskeletal trauma. Data that lead to the prevention of severe Non-Steroidal Anti-Inflammatory Drugs-related adverse effects might be gathered.

TRIAL REGISTRATION

Dutch Trial Register (http://www.trialregister.nl): NTR3982.EudraCT database (http://www.clinicaltrialsregister.eu): 201300038111.

摘要

背景

急性肌肉骨骼创伤，包括拉伤、扭伤或挫伤，经常发生。疼痛管理是治疗的关键组成部分。然而，目前没有令人信服的证据表明哪种药物在治疗这些患者的疼痛方面更优。PanAM 研究的目的是比较三种疼痛管理策略的镇痛效果：对乙酰氨基酚、双氯芬酸或两者的联合治疗急性肌肉骨骼创伤患者。

方法/设计：PanAM 研究是一项多中心、双盲、随机对照非劣效性临床试验。纳入标准为：患有急性、钝性、创伤性肢体损伤的成年患者，就诊于学术型城市急诊部或普通诊所。根据预先设定的排除标准，共纳入 547 例患者，通过随机分组，分别接受对乙酰氨基酚+安慰剂双氯芬酸、双氯芬酸+安慰剂对乙酰氨基酚或对乙酰氨基酚+双氯芬酸治疗。假设对乙酰氨基酚的镇痛效果不劣于双氯芬酸或两者的联合治疗。主要结局为使用数字评分量表（NRS）在基线和研究药物给药后 90 分钟测量的疼痛减轻程度的组间差异。次要结局为 30 分钟和 60 分钟时的 NRS 评分以及出院后连续三天内的频繁测量结果；不良反应的发生情况；患者满意度以及对生活质量和成本效益的分析。该研究于 2013 年 7 月开始招募，预计持续一年。