A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors.
A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors.
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DOI：
10.1007/s00520-014-2158-7
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发表时间：
2014-07
影响因子：
3.1
通讯作者：
Morrow, Gary R.
中科院分区：
文献类型：
--
作者：
Gewandter, Jennifer S.;Mohile, Supriya G.;Heckler, Charles E.;Ryan, Julie L.;Kirshner, Jeffrey J.;Flynn, Patrick J.;Hopkins, Judith O.;Morrow, Gary R.
化疗诱导的周围神经病变（CIPN）发生在高达70%的患者接受某些类型的化疗药物。FDA尚未批准CIPN的治疗方法。这项多中心、III期、随机、双盲、安慰剂对照试验的目的是研究2%氯胺酮加4%阿米替林乳膏（KA乳膏）减少化疗诱导的周围神经病变（CIPN）的疗效。入组了至少1个月前完成化疗并患有CIPN（≥4/10）的癌症幸存者（N=462）。CIPN使用7天日记的平均评分进行评估，该日记要求患者在基线和干预后6周的11点数字评定量表上对过去24小时内的平均“手部和脚部疼痛，麻木或刺痛”进行评分。使用ANCOVA测量6周CIPN的差异，影响包括基线CIPN、KA治疗组和既往紫杉烷治疗（Y/N）。KA治疗对6周CIPN评分无影响（校正平均差异=-0.17，p = 0.363）。这项研究表明，2%氯胺酮加4%阿米替林乳膏不会减少癌症幸存者的CIPN症状。
Chemotherapy-induced peripheral neuropathy (CIPN) occurs in as high as 70% of patients receiving certain types of chemotherapy agents. The FDA has yet to approve a therapy for CIPN. The aim of this multicenter, phase III, randomized, double-blind, placebo-controlled trial was to investigate the efficacy of 2% ketamine plus 4% amitriptyline cream (KA cream) for reducing chemotherapy-induced peripheral neuropathy (CIPN). Cancer survivors who completed chemotherapy at least one month prior and had CIPN (≥4 out of 10) were enrolled (N=462). CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average “pain, numbness, or tingling in [their] hands and feet over the past 24 hours” on an 11-point numeric rating scale at baseline and 6-weeks post intervention. ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN, KA treatment arm, and previous taxane therapy (Y/N). The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference = −0.17, p = 0.363). This study suggests that two percent ketamine plus 4% amitriptyline cream does not decrease CIPN symptoms in cancer survivors.
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