PDF(Pubmed)
Abstract：
BACKGROUND: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders.
OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains.
METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0.
RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC.
CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains.
BACKGROUND: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).
OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains.
METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0.
RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC.
CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains.
BACKGROUND: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).
摘要：
背景：肌肉骨骼疾病是缺勤的重要原因。临床实践指南建议使用非甾体抗炎药（NSAIDs）治疗I-II级宫颈扭伤。已经使用了硫胺素+吡哆醇+氰钴胺维生素的组合，单独和与NSAIDs联合使用，肌肉骨骼疾病的疼痛和炎症。
目的：本研究的目的是证明右酮洛芬的镇痛协同作用，和维生素硫胺素+吡哆醇+氰钴胺的组合在固定剂量组合（FDC）中用于治疗由I-II级宫颈扭伤引起的急性疼痛。
方法：我们进行了多中心，prospective,随机化，双盲,IIIb期临床研究比较两个治疗组：（1）右酮洛芬25毫克/维生素B（硫胺素100毫克，吡哆醇50mg和氰钴胺0.50mg）在FDC（两种或更多种活性成分组合在一个单一的剂型）与（2）右酮洛芬25mg单药治疗（单一药物治疗特定的疾病），口服一个胶囊或片剂，每8小时7天。最终意味着，平均变化,和疼痛感知的百分比变化(使用视觉模拟评分[VAS]测量)与基线进行比较。P值<0.05被认为是统计学上显著的。使用SPSS软件进行分析，v.29.0.
结果：与单药治疗相比，从FDC治疗的第三天开始观察到疼痛强度的统计学显着降低（-3.1±-1.5和-2.6±-1.1cm，分别)使用VAS(p=0.011)测量。关于残疾程度，使用NorthwickPark颈部疼痛问卷（NPQ），在最终测量中观察到统计学差异(7.5%，四分位数间距[IQR]2.5，10.5；vs.7.9%，IQR5.0,13.8;p=0.028)。使用FDC时报告的不良事件比例较低。
结论：右酮洛芬/硫胺素+吡哆醇+氰钴胺维生素的FDC与右酮洛芬单药治疗I-II级宫颈扭伤患者的疼痛相比，显示出更好的疗效和更好的安全性。
背景：NCT05001555，注册于2021年7月29日（https://clinicaltrials.gov/study/NCT05001555）。
目的：本研究的目的是证明右酮洛芬的镇痛协同作用，和维生素硫胺素+吡哆醇+氰钴胺的组合在固定剂量组合（FDC）中用于治疗由I-II级宫颈扭伤引起的急性疼痛。
方法：我们进行了多中心，prospective,随机化，双盲,IIIb期临床研究比较两个治疗组：（1）右酮洛芬25毫克/维生素B（硫胺素100毫克，吡哆醇50mg和氰钴胺0.50mg）在FDC（两种或更多种活性成分组合在一个单一的剂型）与（2）右酮洛芬25mg单药治疗（单一药物治疗特定的疾病），口服一个胶囊或片剂，每8小时7天。最终意味着，平均变化,和疼痛感知的百分比变化(使用视觉模拟评分[VAS]测量)与基线进行比较。P值<0.05被认为是统计学上显著的。使用SPSS软件进行分析，v.29.0.
结果：与单药治疗相比，从FDC治疗的第三天开始观察到疼痛强度的统计学显着降低（-3.1±-1.5和-2.6±-1.1cm，分别)使用VAS(p=0.011)测量。关于残疾程度，使用NorthwickPark颈部疼痛问卷（NPQ），在最终测量中观察到统计学差异(7.5%，四分位数间距[IQR]2.5，10.5；vs.7.9%，IQR5.0,13.8;p=0.028)。使用FDC时报告的不良事件比例较低。
结论：右酮洛芬/硫胺素+吡哆醇+氰钴胺维生素的FDC与右酮洛芬单药治疗I-II级宫颈扭伤患者的疼痛相比，显示出更好的疗效和更好的安全性。
背景：NCT05001555，注册于2021年7月29日（https://clinicaltrials.gov/study/NCT05001555）。
