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舍曲林(左洛复)治疗早期乳腺癌服用他莫昔芬女性潮热的随机、双盲、安慰剂对照、交叉研究。

Randomized, double-blind, placebo-controlled, crossover study of sertraline (Zoloft) for the treatment of hot flashes in women with early stage breast cancer taking tamoxifen.

作者信息

Kimmick Gretchen G, Lovato James, McQuellon Richard, Robinson Emily, Muss Hyman B

机构信息

Wake Forest University School of Medicine, Comprehensive Cancer Center, Wake Forest University, Winston-Salem, North Carolina, USA.

出版信息

Breast J. 2006 Mar-Apr;12(2):114-22. doi: 10.1111/j.1075-122X.2006.00218.x.

DOI:10.1111/j.1075-122X.2006.00218.x
PMID:16509835
Abstract

We observed the relief of hot flashes in breast cancer survivors taking tamoxifen and treated with sertraline for depression. Our objective was to assess the effect of sertraline on the frequency and severity of hot flashes, mood status, and health-related quality of life. We used a randomized, double-blind, placebo-controlled, crossover study using 6 weeks of sertraline (50 mg each morning) versus placebo. Study participants were 62 breast cancer survivors from an oncology clinic in a tertiary care center on adjuvant tamoxifen reporting bothersome hot flashes. Patients were asked to keep a daily hot flash diary to record hot flash frequency and severity, from which hot flash scores (frequency x severity) were calculated. The Center for Epidemiologic Studies depression scale and Functional Assessment of Cancer Therapy--Breast (FACT-B) (at baseline, 6 weeks, and 12 weeks) were used to assess mood and quality of life. Sixty-two women were accrued. Forty-seven women (median age 53.9 years, range 36.6-77.1 years; 89% postmenopausal; 85.5% Caucasian) completed the first 6 weeks and 39 completed 12 weeks. The baseline daily hot flash frequency and score were 5.8 (standard deviation 4.1) and 11.5 (14.0), respectively. At the end of the first 6 weeks, hot flash frequency decreased by 50% in 36% of those taking sertraline compared to 27% taking placebo. In the crossover analysis, sertraline was significantly more effective than placebo: women crossing from placebo to sertraline had a decrease (-0.9 and -1.7) in hot flash frequency and score, whereas those crossing from sertraline to placebo had an increase (1.5 and 3.4) in hot flash frequency and score (p = 0.03 and 0.03). Forty-eight percent preferred the sertraline period, 11% preferred the placebo period, and 41% had no preference (p = 0.006). Measures of depression and quality of life were within normal range and did not change significantly within treatment groups. Sertraline decreases hot flashes in breast cancer survivors taking tamoxifen and women prefer sertraline to placebo. Further study of sertraline for the management of hot flashes is warranted.

摘要

我们观察了服用他莫昔芬且因抑郁症接受舍曲林治疗的乳腺癌幸存者潮热症状的缓解情况。我们的目的是评估舍曲林对潮热频率和严重程度、情绪状态以及健康相关生活质量的影响。我们采用了一项随机、双盲、安慰剂对照的交叉研究,比较为期6周的舍曲林(每天早晨50毫克)与安慰剂的效果。研究参与者为来自一家三级护理中心肿瘤门诊的62名乳腺癌幸存者,她们正在接受辅助性他莫昔芬治疗且有令人烦恼的潮热症状。要求患者每天记录潮热日记,以记录潮热频率和严重程度,并据此计算潮热评分(频率×严重程度)。使用流行病学研究中心抑郁量表和癌症治疗功能评估——乳腺癌量表(FACT - B)(在基线、6周和12周时)来评估情绪和生活质量。共招募了62名女性。47名女性(中位年龄53.9岁,范围36.6 - 77.1岁;89%为绝经后;85.5%为白种人)完成了前6周的研究,39名完成了12周的研究。基线时每日潮热频率和评分分别为5.8(标准差4.1)和11.5(14.0)。在最初6周结束时,服用舍曲林的患者中36%的潮热频率下降了50%,而服用安慰剂的患者中这一比例为27%。在交叉分析中,舍曲林比安慰剂显著更有效:从安慰剂组转至舍曲林组的女性潮热频率和评分有所下降(分别下降0.9和1.7),而从舍曲林组转至安慰剂组的女性潮热频率和评分有所上升(分别上升1.5和3.4)(p = 0.03和0.03)。48%的人更喜欢服用舍曲林的阶段,11%的人更喜欢服用安慰剂的阶段,41%的人没有偏好(p = 0.006)。抑郁和生活质量指标在正常范围内,且在各治疗组内没有显著变化。舍曲林可减轻服用他莫昔芬的乳腺癌幸存者的潮热症状,且女性更喜欢舍曲林而非安慰剂。有必要对舍曲林治疗潮热进行进一步研究。

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