Stearns V, Isaacs C, Rowland J, Crawford J, Ellis M J, Kramer R, Lawrence W, Hanfelt J J, Hayes D F
Breast Cancer Program, Lombardi Cancer Center, Georgetown University School of Medicine, Washington, DC, USA.
Ann Oncol. 2000 Jan;11(1):17-22. doi: 10.1023/a:1008382706068.
Many breast cancer survivors suffer debilitating hot flashes. Estrogen, the drug of choice in perimenopausal women, is generally not recommenced to breast cancer survivors. Nonhormonal treatments are mostly disappointing. Anecdotal reports in our institution suggested that the selective serotonin-reuptake inhibitor, paroxetine hydrochloride, might be efficacious in alleviating hot flashes.
Thirty women with prior breast cancer who were suffering at least two hot flashes a day entered a single institution pilot trial to evaluate paroxetine's efficacy in reducing the frequency and severity of hot flashes. After completing daily diaries for one week on no therapy, the women received open-label paroxetine, 10 mg daily for one week, followed by four weeks of paroxetine, 20 mg daily. The women completed hot-flash daily diaries throughout the study period, and a health-related symptom-assessment questionnaire and a quality-of-life rating scale in the first and sixth week of the study.
Twenty-seven women completed the six-week study period. The mean reduction of hot flash frequency was 67% (95% confidence interval (95% CI): 56%-79%). The mean reduction in hot flash severity score was 75% (95% CI: 66%-85%). There was a statistically significant improvement in depression, sleep, anxiety, and quality of life scores. Furthermore, 25 (83%) of the study participants chose to continue paroxetine therapy at the end of study. The most common adverse effect was somnolence, resulting in drug discontinuation in two women, and dose reduction in two women. One woman discontinued drug due to anxiety.
Paroxetine hydrochloride is a promising new treatment for hot flashes in breast cancer survivors, and warrants further evaluation in a double-blind randomized placebo-controlled trial.
许多乳腺癌幸存者遭受令人虚弱的潮热。雌激素是围绝经期女性的首选药物，但一般不建议乳腺癌幸存者重新使用。非激素治疗大多令人失望。我们机构的轶事报告表明，选择性5-羟色胺再摄取抑制剂盐酸帕罗西汀可能对缓解潮热有效。
30名曾患乳腺癌且每天至少经历两次潮热的女性进入一项单机构试点试验，以评估帕罗西汀在降低潮热频率和严重程度方面的疗效。在无治疗情况下完成一周的每日日记后，这些女性接受开放标签的帕罗西汀治疗，每天10毫克，持续一周，随后四周每天20毫克。在整个研究期间，这些女性完成潮热每日日记，并在研究的第一周和第六周完成一份与健康相关的症状评估问卷和一份生活质量评分量表。
27名女性完成了为期六周的研究期。潮热频率的平均降低率为67%（95%置信区间（95%CI）：56%-79%）。潮热严重程度评分的平均降低率为75%（95%CI：66%-85%）。抑郁、睡眠、焦虑和生活质量评分有统计学上的显著改善。此外，25名（83%）研究参与者在研究结束时选择继续使用帕罗西汀治疗。最常见的不良反应是嗜睡，导致两名女性停药，两名女性减量。一名女性因焦虑停药。
盐酸帕罗西汀是一种有前景的治疗乳腺癌幸存者潮热的新疗法，值得在双盲随机安慰剂对照试验中进一步评估。
