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一项关于口服辅酶Q10缓解新诊断乳腺癌患者自我报告的治疗相关疲劳的随机、双盲、安慰剂对照研究。

A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.

作者信息

Lesser Glenn J, Case Doug, Stark Nancy, Williford Susan, Giguere Jeff, Garino L Astrid, Naughton Michelle J, Vitolins Mara Z, Lively Mark O, Shaw Edward G

机构信息

Department of Internal Medicine, Section on Hematology and Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

出版信息

J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.

DOI:10.1016/j.suponc.2012.03.003
PMID:22682875
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3501550/
Abstract

BACKGROUND

Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

OBJECTIVES

We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

RESULTS

Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632).

CONCLUSIONS

Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

摘要

背景

辅酶Q10(CoQ10)是一种常见的抗氧化补充剂,具有已知的心脏保护作用和潜在的抗癌益处。

目的

我们对女性乳腺癌患者进行了一项口服CoQ10的随机、双盲、安慰剂对照研究,主要目的是确定CoQ10对自我报告的疲劳、抑郁和生活质量(QOL)的影响。方法符合条件的新诊断乳腺癌且计划接受辅助化疗的女性被随机分为口服300mg CoQ10或安慰剂,每种均与300IU维生素E联合,分为每日3次服用。治疗持续24周。在基线以及第8、16和24周时进行血液检查、QOL测量以及血浆CoQ10和维生素E水平检测。使用混合效应模型评估随时间变化的治疗结果差异。

结果

2004年9月至2009年3月期间,共招募了236名女性。治疗组在年龄(范围28 - 85岁)、病理分期(0期,91%;1期,8%;II期,1%)、种族(白人,87%;黑人,11%;西班牙裔,2%)和计划治疗方面均衡良好。CoQ10组和安慰剂组的基线CoQ10水平分别为0.70和0.73μg/mL;24周时的CoQ10水平分别为1.83和0.79μg/mL。在24周时,CoQ10组和安慰剂组在情绪状态疲劳问卷得分(最小二乘均值,7.08对8.24,P = 0.257)、慢性病治疗功能评估疲劳工具得分(37.6对37.6,P = 0.965)、癌症治疗功能评估乳腺癌量表得分(111.9对110.4,P = 0.577)或流行病学研究中心抑郁量表得分(11.6对12.3,P = 0.632)方面均无显著差异。

结论

补充常规剂量的CoQ10可使血浆CoQ10水平持续升高,但在治疗24周后并未改善自我报告的疲劳或生活质量。

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