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每周一次电针预防早期乳腺癌女性患者紫杉烷诱导的周围神经病变的随机假对照试验性研究

Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.

作者信息

Greenlee Heather, Crew Katherine D, Capodice Jillian, Awad Danielle, Buono Donna, Shi Zaixing, Jeffres Anne, Wyse Sharon, Whitman Wendy, Trivedi Meghna S, Kalinsky Kevin, Hershman Dawn L

机构信息

Mailman School of Public Health, Columbia University, New York, NY, USA.

Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.

出版信息

Breast Cancer Res Treat. 2016 Apr;156(3):453-464. doi: 10.1007/s10549-016-3759-2. Epub 2016 Mar 25.

Abstract

To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25 % white, 25 % black, and 43 % Hispanic; 52 % had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, P = .86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (SEA 1.7 vs. EA 3.4, P = .03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (P = .04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.

摘要

为研究电针(EA)作为一种非药物干预措施,对接受紫杉烷化疗的乳腺癌患者预防或减轻化疗引起的周围神经病变(CIPN)的效果。计划接受紫杉烷治疗的I - III期乳腺癌女性被随机分为两组,一组接受每周12次的标准化真电针或假电针(SEA)治疗,并同时接受紫杉烷治疗。受试者在基线、第6周、12周和16周完成简短疼痛量表简表(BPI - SF)、癌症治疗功能评估 - 紫杉烷神经毒性子量表(FACT - NTX)及其他评估。共筛选了180名受试者,63名入组,48名完成了第16周的评估。平均年龄为50岁,其中25%为白人,25%为黑人,43%为西班牙裔;52%既往未接受过化疗。在第12周时,两组报告的BPI - SF最严重疼痛评分均值均有所增加,但两组间无均值差异(SEA组为2.8,EA组为2.6,P = 0.86)。到第16周时,SEA组恢复至基线水平,而EA组继续恶化(SEA组为1.7,EA组为3.4,P = 0.03)。在第16周时,EA组的BPI - SF最严重疼痛评分增加比SEA组高1.62分(P = 0.04)。在一项关于EA预防紫杉烷诱导的CIPN的随机、假对照试验中,第12周时两组在疼痛或神经病变方面无差异。值得关注的是,接受EA治疗的受试者比接受SEA治疗的受试者恢复得慢。未来的研究应关注EA用于治疗而非预防CIPN。

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