Hans-Georg Predel, Andrew C Leary, Roger Imboden, Ralph-Steven Wedemeyer, Bruno M Giannetti
{"title":"醋酸乙酯70 mg药膏治疗钝性外伤后急性扭伤、拉伤或挫伤的疗效和耐受性的随机安慰剂对照试验","authors":"Hans-Georg Predel, Andrew C Leary, Roger Imboden, Ralph-Steven Wedemeyer, Bruno M Giannetti","doi":"10.1007/s40122-025-00764-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).</p><p><strong>Methods: </strong>In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).</p><p><strong>Results: </strong>A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.</p><p><strong>Conclusion: </strong>In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.</p><p><strong>Registration: </strong>2021-003778-30 (EudraCT number).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1461-1472"},"PeriodicalIF":3.3000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484470/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Randomized Placebo-Controlled Trial of the Efficacy and Tolerability of Etofenamate 70 mg Medicated Plaster for the Treatment of Pain in Acute Sprains, Strains or Bruises of the Soft Tissues Following Blunt Trauma.\",\"authors\":\"Hans-Georg Predel, Andrew C Leary, Roger Imboden, Ralph-Steven Wedemeyer, Bruno M Giannetti\",\"doi\":\"10.1007/s40122-025-00764-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).</p><p><strong>Methods: </strong>In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).</p><p><strong>Results: </strong>A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. 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A Randomized Placebo-Controlled Trial of the Efficacy and Tolerability of Etofenamate 70 mg Medicated Plaster for the Treatment of Pain in Acute Sprains, Strains or Bruises of the Soft Tissues Following Blunt Trauma.
Introduction: Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).
Methods: In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).
Results: A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.
Conclusion: In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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