度洛西汀对日本化疗引起的周围神经病变患者的疗效：一项初步随机试验。
Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial.
作者信息
Hirayama Yasuo, Ishitani Kunihiko, Sato Yasushi, Iyama Satoshi, Takada Kohichi, Murase Kazuyuki, Kuroda Hiroyuki, Nagamachi Yasuhiro, Konuma Yuichi, Fujimi Akihito, Sagawa Tamotsu, Ono Kaoru, Horiguchi Hiroto, Terui Takeshi, Koike Kazuhiko, Kusakabe Toshiro, Sato Tsutomu, Takimoto Rishu, Kobune Masayoshi, Kato Junji
机构信息
Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan.
Division of Palliative Care, Higashi Sapporo Hospital, Sapporo, Japan.
出版信息
Int J Clin Oncol. 2015 Oct;20(5):866-71. doi: 10.1007/s10147-015-0810-y. Epub 2015 Mar 12.
BACKGROUND
Chemotherapy-induced peripheral neuropathy (CIPN) is difficult to manage. A phase III trial conducted in the United States demonstrated that duloxetine was effective for CIPN caused by taxane and platinum-based chemotherapy. No randomized trial of duloxetine for CIPN has been conducted in Japan.
METHODS
In this open-label, randomized, crossover study, eligible patients were randomized to Group A or Group B. Group A received duloxetine 20 mg/day orally for the first week and 40 mg/day for the next 3 weeks. Group B received vitamin B12 (VB12) 1.5 mg/day orally for 4 weeks. After a 2- to 4-week washout period, treatment was crossed over for another 4 weeks. The severity of numbness and pain was assessed using a visual analog scale (VAS).
RESULTS
Thirty-four patients were enrolled. Obvious decreases in the mean VAS scores for numbness and pain were observed for the periods of duloxetine administration. Significant differences were observed between the duloxetine-first (Group A) and the VB12-first (Group B) groups with respect to numbness (p = 0.03) and pain (p = 0.04) at 4 weeks after administration. Fatigue was observed in six of the 34 participants (17.6 %).
CONCLUSIONS
Our data suggests that duloxetine has a beneficial effect on CIPN caused by oxaliplatin, paclitaxel, vincristine, or bortezomib in Japanese patients.
背景
化疗引起的周围神经病变（CIPN）难以处理。在美国进行的一项III期试验表明，度洛西汀对由紫杉烷和铂类化疗引起的CIPN有效。在日本尚未进行过度洛西汀治疗CIPN的随机试验。
方法
在这项开放标签、随机、交叉研究中，符合条件的患者被随机分为A组或B组。A组在第一周口服度洛西汀20毫克/天，接下来3周为40毫克/天。B组口服维生素B12（VB12）1.5毫克/天，持续4周。在2至4周的洗脱期后，治疗交叉进行另外4周。使用视觉模拟量表（VAS）评估麻木和疼痛的严重程度。
结果
共纳入34例患者。在度洛西汀给药期间，观察到麻木和疼痛的平均VAS评分明显下降。给药4周后，在麻木（p = 0.03）和疼痛（p = 0.04）方面，度洛西汀优先组（A组）和VB12优先组（B组）之间观察到显著差异。34名参与者中有6名（17.6%）出现疲劳。
结论
我们的数据表明，度洛西汀对日本患者由奥沙利铂、紫杉醇、长春新碱或硼替佐米引起的CIPN有有益作用。
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