度洛西汀可预防接受紫杉醇化疗的乳腺癌患者的神经病变(一项双盲随机试验)。
Duloxetine to prevent neuropathy in breast cancer patients under paclitaxel chemotherapy (a double-blind randomized trial).
发表日期:2024 Jul 08
作者:
Mahdi Aghili, Maryam Taherioun, Fatemeh Jafari, Mohaddeseh Azadvari, Marzieh Lashkari, Kasra Kolahdouzan, Reza Ghalehtaki, Alireza Abdshah
来源:
PHYSICAL THERAPY & REHABILITATION JOURNAL
摘要:
化疗引起的周围神经病变(CIPN)是乳腺癌患者的主要副作用之一,也是影响生活质量和减少剂量甚至停止治疗的主要原因。最广泛使用的化疗药物之一是“紫杉烷”。考虑到度洛西汀近年来已被用于治疗神经病,本研究旨在调查其预防紫杉烷相关神经病的有效性。这是一项针对 47 名患者的随机对照试验:24 名患者接受安慰剂,23 名患者接受每日 30 毫克的度洛西汀治疗。每个化疗周期注射紫杉醇后的第一周和第二周注射 60 毫克紫杉醇。患者客观症状(神经传导速度(NCV)值)和主观症状(视觉模拟量表,包括:神经病变、感觉异常、疼痛、冷敏感和麻木)、患者神经病变等级(根据不良事件通用术语标准计算) (CTCAE) v.5),并记录每个化疗周期前后并发症的存在情况。安慰剂组新发神经病变的发生率显着较高(度洛西汀组为 8/23,安慰剂组为 16/24,P = 0.029 )在 NCV 中,胫神经潜伏期(- 0.28% vs 19.87%,P = 0.006)、胫骨振幅(4.40% vs - 10.88%,P = 0.049)和正中神经潜伏期(8.72% vs 31.16%,P = 0.039) ;给予度洛西汀可显着降低化疗期间和 6 周后的神经病变评分 (P < 0.001)、疼痛评分 (P = 0.027);然而,对感觉异常、麻木、冷敏感性和其他 NCV 测量结果没有观察到显着影响。紫杉醇可引起神经病变,且持续时间较长。我们的研究表明度洛西汀是一种潜在的有效药物,可以预防主观和客观神经病变。© 2024。作者获得 Springer-Verlag GmbH 德国(Springer Nature 旗下公司)的独家许可。
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the major side effects and main reasons for affecting quality of life and dose reduction or even discontinuation of treatment in breast cancer patients. One of the most widely prescribed chemotherapies is the "taxanes." Considering that duloxetine has been used in treating neuropathies in recent years, this study aimed to investigate its effectiveness in preventing taxane-related neuropathy.This is a randomized controlled trial on 47 patients: 24 received a placebo and 23 received duloxetine at 30 mg daily in the first week following the injection of paclitaxel and 60 mg during the second week in each chemotherapy cycle. Patients objective (nerve conduction velocity (NCV) values) and subjective symptoms (visual analog scale including; neuropathy, paresthesia, pain, cold sensitivity, and numbness), the grades of the patients' neuropathy (calculated according to Common Terminology Criteria for Adverse Events (CTCAE) v.5), and the presence of complications, before and after each chemotherapy cycle, were recorded.The placebo group experienced significantly higher occurrences of new neuropathy (8/23 in duloxetine vs 16/24 in placebo, P = 0.029) in NCV by tibial nerve latency (- 0.28% vs 19.87%, P = 0.006), tibial amplitude (4.40% vs - 10.88%, P = 0.049), and median nerve latency (8.72% vs 31.16%, P = 0.039); administration of duloxetine significantly reduced the scores of neuropathies (P < 0.001), pain (P = 0.027), during chemotherapy, and 6 weeks later; however, no significant effect was observed on paresthesia, numbness, cold sensitivity, and other NCV measurements.Paclitaxel can cause neuropathy, lasting for a long time. Our study showed duloxetine is potentially an effective medication that can prevent subjective and objective neuropathy.© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.