Trevisan Carlo L M, Carraro Andrea, Baldari Gemma L A
Orthopedic Department, Ospedale Bolognini Seriate ASST Bergamo Est, Seriate, Italy.
Azienda Sociosanitaria Ligure n. 3 (ASL3), Genoa, Italy.
Pain Ther. 2023 Oct;12(5):1149-1163. doi: 10.1007/s40122-023-00531-z. Epub 2023 Jun 14.
The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain.
A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner's clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator's satisfaction with the treatment was also assessed. Subjects initially took 1-2 capsules of the study treatment and then one or two soft capsules every 4-6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period.
A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated.
The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects' overall satisfaction with treatment more than 90%.
EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.
口服非甾体抗炎药（NSAIDs）用于急性肌肉骨骼疼痛时，应采用最低有效剂量并使用最短疗程，以尽量减少潜在的不良反应。本研究使用患者报告的结局指标，在现实生活环境中，对轻度至中度急性肌肉骨骼疼痛患者在短时间（3天）内使用低剂量双氯芬酸依泊胺12.5毫克软胶囊制剂（DHEP 12.5毫克胶囊）的治疗满意度、有效性和耐受性进行了评估。
在意大利8个地点的医院门诊科室/全科医生诊所对成年门诊患者进行一项前瞻性、开放标签的IV期临床研究。主要疗效变量是治疗开始后72±7小时的治疗满意度，使用疼痛治疗满意度量表（PTSS）的总体满意度问题进行评估，并通过经典描述性统计进行描述。次要目标是评估首次给药后及随时间推移的镇痛效果；疼痛缓解开始的时间和满意度、疼痛缓解的量和持续时间；随时间的疼痛强度差异；以及安全性和耐受性。还评估了研究者对治疗的满意度。受试者最初服用1-2粒研究药物胶囊，然后根据需要每4-6小时服用1或2粒软胶囊。任何24小时内服用的软胶囊不超过6粒。
共有182名受试者（平均年龄56.2岁；54.4%为女性）服用了≥1剂DHEP胶囊，并纳入全分析集。最常见的肌肉骨骼疾病是关节痛（39.0%）和腰痛（23.1%）。所有受试者均完成了研究，165/182名（90.7%，95%CI 0.86，0.95）受试者在首次给药后72±7小时对治疗感到满意或非常满意（主要疗效变量）。关于其他疗效参数的治疗满意度记录了相似的百分比。镇痛效果起效迅速，平均49.45分钟后疼痛完全缓解。研究者对总体治疗满意度的评分是92.9%。治疗耐受性良好。
低剂量（12.5或25毫克）口服双氯芬酸依泊胺软胶囊制剂对轻度至中度肌肉骨骼疼痛患者具有快速、有效和安全的镇痛活性，受试者对治疗的总体满意度超过90%。
欧洲药品管理局临床试验编号：2018-004886-15（研究18I-Fsg08）。2018年9月4日注册。
