IN VITRO STUDIES OF SURAMIN NEUROTOXICITY

苏拉明钠是一种有前途的化疗药物， 对前列腺癌和肾上腺癌有效。 它被用于 晚期D2前列腺癌患者的II期试验 在一个多中心试验中。 观察到的主要不良反应之一是， 初步试验是严重的周围神经病变。 在 研究提出，患者进入临床试验苏拉明 将进行前瞻性研究，以确定 周围神经损伤 灵敏定量技术 （神经病症状评分，神经功能障碍评分，计算机 辅助感觉检查，神经传导研究，针 肌电图和定量自主神经检查） 在基线和治疗期间间隔使用。 的 神经病变在纤维类别损失方面的特征， 纤维病理学（轴突变性与脱髓鞘）将被 通过神经活检研究确定。 每周血清评估 苏拉明将使神经病变的发展与 暴露于药物的持续时间和水平。 这种不利影响将 与肿瘤消退进行比较，以确定治疗窗口是否 存在. 那些发生神经病变的患者将被研究12年。 在停止治疗后的几个月内， 神经病变是可逆的。

Sodium suramin is a promising chemotherapeutic agent with possible efficacy against prostate and adrenal cancer. It is being used in phase II trials for patients with advanced D2 cancer of the prostate in a multicenter trial. One of the major adverse effects observed in preliminary trials was a severe peripheral neuropathy. In the studies proposed, patients entered into clinical trials of suramin will be studied prospectively to identify the appearance of peripheral nerve injury. Sensitive quantitative techniques (Neuropathy Symptom Score, Neurologic Disability Score, Computer Assisted Sensory Examination, Nerve Conduction Studies, Needle Electromyography, and Quantitative Autonomic Examination) will be used at baseline and at intervals during therapy. The characteristics of the neuropathy in terms of fiber class loss and fiber pathology (axonal degeneration versus demyelination) will be determined by study of nerve biopsy. Weekly estimation of serum suramin will allow correlation of development of neuropathy with duration and level of exposure to the drug. This adverse effect will be compared to tumor regression to determine if a therapeutic window exists. Those patients developing neuropathy will be studied for 12 months following cessation of therapy to determine whether the neuropathy is reversible.