Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Clin Orthop Surg. 2013 Jun;5(2):145-51. doi: 10.4055/cios.2013.5.2.145. Epub 2013 May 15.
This study evaluated the effects of Beraprost sodium (Berasil) on subjective leg symptoms in patients with peripheral arterial disease caused by diabetes mellitus.
Ninety-four diabetic patients with peripheral arterial disease were treated with Beraprost in a fixed-dose, prospective, multicenter, cohort study. Beraprost (40 µg) was administered orally 3 times daily (120 µg/day) for 12 weeks. We developed a new disease-specific symptom questionnaire, which evaluated the effect of peripheral arterial disease on leg discomfort in daily life and assessed therapeutic responses to treatment. Patients were asked for their subjective assessment of symptoms on a written questionnaire before treatment and after 12 weeks of therapy.
There was significant improvement in all estimated subjective symptoms (burning, coldness, edema, exertional pain, stabbing, and paresthesias) in the lower extremities at 12 weeks (p < 0.001). There were 18 patients with neuropathy in whom significant improvement was noted for 6 subjective symptoms at 12 weeks (p < 0.05). Adverse events considered to be drug-related were observed in 4 patients (4.3%), all of which were mild and resolved with discontinuation of the medication.
Beraprost is effective as a treatment for improving various subjective symptoms in the lower extremities, such as burning, coldness, edema, exertional pain, stabbing, and paresthesias, in diabetic patients with peripheral arterial disease.
本研究评估了贝前列素钠（贝拉唑）对糖尿病性外周动脉疾病患者下肢主观症状的影响。
94 例糖尿病合并外周动脉疾病患者采用贝前列素钠进行固定剂量、前瞻性、多中心、队列研究。贝前列素钠（40μg）每日口服 3 次（120μg/天），疗程 12 周。我们开发了一种新的疾病特异性症状问卷，用于评估外周动脉疾病对日常生活中下肢不适的影响，并评估治疗反应。患者在治疗前和治疗 12 周后分别通过书面问卷对症状进行主观评估。
12 周时，所有下肢估计的主观症状（烧灼感、寒冷感、水肿、运动性疼痛、刺痛和感觉异常）均有显著改善（p<0.001）。18 例伴有神经病变的患者，6 种主观症状在 12 周时显著改善（p<0.05）。4 例（4.3%）患者认为与药物相关的不良事件，均为轻度，停药后缓解。
贝前列素钠可有效改善糖尿病性外周动脉疾病患者下肢各种主观症状，如烧灼感、寒冷感、水肿、运动性疼痛、刺痛和感觉异常。
