Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, often debilitating side effect of several chemotherapeutic agents, particularly taxanes and platinum compounds. Current management strategies remain limited, with few agents demonstrating consistent efficacy. Our aim was to evaluate the efficacy and safety of a novel topical cream containing 1% amitriptyline and 0.5% ketamine in alleviating CIPN symptoms in oncology patients. Methods: A prospective observational study was conducted at Barzilai Medical Center following the approval of the local ethics committee. Thirty-seven patients (30 females, 7 males; age 40–75) with CIPN following taxane or platinum-based chemotherapy were treated with a topical cream applied three times daily for 28 weeks. Pain intensity was assessed using the Visual Analog Scale (VAS). Inclusion and exclusion criteria were strictly applied to ensure a homogenous cohort. Results: Initial mean VAS was 7 (range 6–10), which decreased to a final mean VAS of 3 (range 1–7). Two patients withdrew from the study, and 27 out of 35 evaluable patients (77.14%) reported significant symptoms relief. A statistically significant reduction in pain scores (p= 0.00005) was seen in our study. Only mild, transient erythema was reported as a side effect. Conclusions: This is the first clinical evaluation of a topical combination with new concentrations of amitriptyline and ketamine for CIPN. The results suggest this formulation offers a safe and effective option for symptomatic relief. Larger randomized controlled trials and exploration of transdermal delivery systems are warranted to validate these findings and optimize treatment outcomes.
背景：化疗所致周围神经病变（CIPN）是多种化疗药物（尤其是紫杉烷类和铂类化合物）常见且常致衰弱的副作用。目前的管理策略仍有限，鲜有药物能展现持续疗效。本研究旨在评估含1%阿米替林和0.5%氯胺酮的新型外用乳膏缓解肿瘤患者CIPN症状的有效性和安全性。方法：经当地伦理委员会批准后，在巴尔齐莱医疗中心开展了一项前瞻性观察研究。37例接受紫杉烷类或铂类化疗后出现CIPN的患者（女性30例，男性7例；年龄40-75岁）接受外用乳膏治疗，每日三次，持续28周。采用视觉模拟评分法（VAS）评估疼痛强度。研究严格执行纳入与排除标准以确保队列同质性。结果：初始平均VAS评分为7分（范围6-10分），最终降至平均3分（范围1-7分）。2例患者退出研究，35例可评估患者中有27例（77.14%）报告症状显著缓解。研究观察到疼痛评分具有统计学显著降低（p=0.00005）。仅报告轻度短暂性红斑作为副作用。结论：本研究首次对含新型浓度配比的阿米替林-氯胺酮外用复方制剂治疗CIPN进行临床评估。结果表明该制剂为症状缓解提供了安全有效的选择。需开展更大规模的随机对照试验并探索透皮给药系统，以验证这些发现并优化治疗结果。
肿瘤(癌症)患者之家