Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：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，也是影响患者生活质量和剂量减少甚至停止治疗的主要原因。紫杉烷类是处方最广泛的化疗药物之一。“考虑到近年来度洛西汀已被用于治疗神经病变，本研究旨在探讨其预防紫杉烷相关神经病变的有效性.
方法：这是一项针对47名患者的随机对照试验：在每个化疗周期中，在注射紫杉醇后的第一周，24名患者接受安慰剂，23名患者接受每日30mg的度洛西汀，在第二周接受60mg的度洛西汀。患者客观（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,冷灵敏度,和麻木)，患者神经病变的等级（根据不良事件通用术语标准（CTCAE）第5节计算），以及并发症的存在，在每个化疗周期之前和之后，被记录下来。
结果：安慰剂组出现新的神经病变（8/23度洛西汀比安慰剂16/24，通过胫神经潜伏期在NCV中P=0.029）（-0.28％vs19.87％，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%vs31.16%，P=0.039）；使用度洛西汀显着降低了神经病变的评分（P<0.001），疼痛（P=0.027），化疗期间,6周后，然而，对感觉异常没有显著影响，麻木,冷灵敏度,和其他NCV测量。
结论：紫杉醇可引起神经病变，持续很长时间。我们的研究表明，度洛西汀可能是一种有效的药物，可以预防主观和客观的神经病变。
方法：这是一项针对47名患者的随机对照试验：在每个化疗周期中，在注射紫杉醇后的第一周，24名患者接受安慰剂，23名患者接受每日30mg的度洛西汀，在第二周接受60mg的度洛西汀。患者客观（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,冷灵敏度,和麻木)，患者神经病变的等级（根据不良事件通用术语标准（CTCAE）第5节计算），以及并发症的存在，在每个化疗周期之前和之后，被记录下来。
结果：安慰剂组出现新的神经病变（8/23度洛西汀比安慰剂16/24，通过胫神经潜伏期在NCV中P=0.029）（-0.28％vs19.87％，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%vs31.16%，P=0.039）；使用度洛西汀显着降低了神经病变的评分（P<0.001），疼痛（P=0.027），化疗期间,6周后，然而，对感觉异常没有显著影响，麻木,冷灵敏度,和其他NCV测量。
结论：紫杉醇可引起神经病变，持续很长时间。我们的研究表明，度洛西汀可能是一种有效的药物，可以预防主观和客观的神经病变。
