Third Department of Internal Medicine, Nagoya University School of Medicine, Nagoya, JapanDepartment of Metabolism and Endocrinology, Chubu Rosai Hospital, Nagoya, Japan.
Clin Drug Investig. 2004;24(11):671-80. doi: 10.2165/00044011-200424110-00006.
To evaluate the effects of fidarestat (SNK-860) on vibration perception threshold, as measured by C64 quantitative tuning fork (64Hz) analysis, as well as its effects on subjective symptoms in patients with diabetic polyneuro-pathy.
Open-label, prospective study conducted at 12 hospitals in the central area of Honshu, Japan.
Fidarestat was administered at a dosage of 1mg once daily after breakfast for 28 weeks.
Vibration perception threshold of upper and lower extremities was determined using a C64 quantitative tuning fork, and measured at baseline and after 12 and 28 weeks of treatment. Subjective symptoms, including numbness, spontaneous pain and hypoaesthesia, were evaluated every 4 weeks.
Subjective symptoms were evaluated in 22 patients, and vibration perception threshold data were available for 19 patients. Vibration perception threshold at baseline was negatively correlated with the severity of the following subjective symptoms: numbness in the upper limbs, and numbness, coldness and hot flushes, smarting pain causing difficulty walking and hypoaesthesia in the lower limbs. During treatment with fidarestat, vibration perception threshold increased significantly in the upper (p = 0.0017) and lower (p = 0.0001) limbs. The following symptoms were also significantly improved: severity of numbness in the lower limbs, heaviness in the foot, coldness and hot flushes in the lower limbs, smarting pain causing difficulty walking, sensation as if walking on sand, sensation as if walking on an uneven road, spontaneous pain in the lower limbs, and dizziness. Adverse events occurred in four patients.
Administration of fidarestat after breakfast was effective in significantly alleviating some symptoms of diabetic polyneuropathy. The C64 quantitative tuning fork analysis is useful in the diagnosis of diabetic polyneuropathy, and as a measure of the severity of the neuropathological symptoms of this condition.
评估法地司他（SNK-860）对振动感觉阈值的影响，采用 C64 定量音叉（64Hz）分析进行测量，以及其对糖尿病多发性神经病患者主观症状的影响。
在日本本州中部的 12 家医院进行的开放性、前瞻性研究。
法地司他在早餐后每天 1 次，1mg 剂量治疗 28 周。
采用 C64 定量音叉测定上、下肢振动感觉阈值，分别在基线和治疗 12、28 周时测量。每 4 周评估一次主观症状，包括麻木、自发性疼痛和感觉减退。
22 例患者评估了主观症状，19 例患者有振动感觉阈值数据。基线时的振动感觉阈值与以下主观症状的严重程度呈负相关：上肢麻木，下肢麻木、发冷、热感、刺痛导致行走困难和感觉减退。用法地司他治疗期间，上肢（p = 0.0017）和下肢（p = 0.0001）的振动感觉阈值均显著增加。以下症状也显著改善：下肢麻木严重程度、下肢沉重感、下肢发冷和热感、刺痛导致行走困难、行走时有踏沙感、行走时有不平坦感、下肢自发性疼痛和头晕。4 例患者发生不良事件。
早餐后给予法地司他治疗可显著缓解糖尿病多发性神经病的某些症状。C64 定量音叉分析有助于诊断糖尿病多发性神经病，并可作为评估该疾病神经病理症状严重程度的一种方法。
