Jenoure P, Segesser B, Lühti U, Gremion G
Rennbahn Clinic for Orthopaedic and Sport Medicine, Muttenz, Switzerland.
Drugs Exp Clin Res. 1993;19(3):125-31.
Diclofenac HEP plaster was tested in an open study in the treatment of different traumatic sport and overload injuries, to confirm the results of efficacy and tolerability already shown in other clinical studies. A total of 101 patients were assigned to treatment and were eligible for the evaluation of results at the end of a 14-day treatment period. The average score of spontaneous pain, assessed by means of a verbal scale and a visual analogical scale, showed a clear difference in pain rating between the beginning and end of treatment. In general 60% pain reduction was observed. The difference in analgesic activity was already apparent on the 7th day of treatment (-28%). The reduction of pain was confirmed by changes in another subjective sign related to the injury: provoked pain. This symptom decreased in a manner comparable to spontaneous pain: 61% pain reduction after 2 weeks of treatment. Global assessment of efficacy, performed by the investigator at the end of treatment, showed the clear therapeutic activity of local treatment with diclofenac HEP plaster. Satisfactory results were obtained and only 18% of the patients (most of them with chronic and persistent pain) experienced ineffective pain relief at the end of the 2-week treatment. The beneficial effects of diclofenac HEP plaster on pain are confirmed by the patients' assessment, since almost identical scores were obtained. It is striking that the overall tolerance of diclofenac HEP plaster, applied topically twice a day for 2 weeks, was "good" or "excellent" in the 101 patients treated. Any side effect was reported on the patient's card and all the patients completed the study.
双氯芬酸HEP贴剂在一项开放性研究中用于治疗不同的运动创伤和超负荷损伤，以证实其他临床研究中已显示的疗效和耐受性结果。共有101名患者被分配接受治疗，并在14天治疗期结束时符合结果评估条件。通过言语量表和视觉模拟量表评估的自发疼痛平均评分显示，治疗开始和结束时的疼痛评分有明显差异。总体上观察到疼痛减轻了60%。在治疗第7天，镇痛活性的差异已经很明显（-28%）。与损伤相关的另一个主观体征——激发痛的变化证实了疼痛的减轻。这种症状的减轻方式与自发痛相似：治疗2周后疼痛减轻61%。研究者在治疗结束时进行的总体疗效评估显示，双氯芬酸HEP贴剂局部治疗具有明显的治疗活性。获得了满意的结果，在2周治疗结束时，只有18%的患者（大多数为慢性持续性疼痛患者）疼痛缓解无效。患者的评估证实了双氯芬酸HEP贴剂对疼痛的有益作用，因为获得了几乎相同的评分。值得注意的是，在接受治疗的101名患者中，每天局部应用双氯芬酸HEP贴剂2周，其总体耐受性为“良好”或“优秀”。任何副作用都记录在患者卡片上，所有患者均完成了研究。
