Carpenter Janet S, Storniolo Anna Maria, Johns Shelley, Monahan Patrick O, Azzouz Faouzi, Elam Julie L, Johnson Cynthia S, Shelton Richard C
Indiana University, 1111 Middle Drive NU340D, Indianapolis, Indiana 46202, USA.
Oncologist. 2007 Jan;12(1):124-35. doi: 10.1634/theoncologist.12-1-124.
Although venlafaxine reduces self-reported hot flashes, no data have established the drug's impact on physiologically documented hot flashes. Two randomized, double-blind, placebo-controlled crossover trials examined the efficacy of two doses of venlafaxine in relation to physiological and self-reported hot flashes and other outcomes, including negative affect, fatigue, sleep, and quality of life.
57 breast cancer survivors in the low-dose study; 20 in the high-dose study.
university cancer clinics in the Southeast and Midwest.
37.5 mg of venlafaxine (low-dose study) or 75 mg of venlafaxine (high-dose study).
hot flash frequency (physiological monitor, diary, and event marker), hot flash severity (diary), hot flash bother (diary), and questionnaires for hot flash impact on daily life, negative affect, fatigue, sleep, and quality of life.
Subjective but not physiological hot flash measures showed placebo effects. Venlafaxine resulted in modest decreases in hot flashes, but only hot flash interference improved differentially at the higher dose. The timing of venlafaxine's effects on hot flashes varied by dose. Only women with a > or =50% decrease in physiological hot flashes experienced significant improvement in fatigue, sleep quality, and quality of life. Although side effects were mild, most patients discontinued venlafaxine long-term.
Although venlafaxine resulted in modest and acute reductions in hot flashes with few side effects, it may not be tolerable to some patients long-term. At least 50% relief in physiological hot flashes may be needed for patients to demonstrate improvement in other outcomes, including decreased fatigue, improved sleep, and improved quality of life.
尽管文拉法辛可减少自我报告的潮热症状，但尚无数据证实该药对经生理记录的潮热症状的影响。两项随机、双盲、安慰剂对照的交叉试验研究了两种剂量的文拉法辛在生理和自我报告的潮热症状及其他结果（包括负面影响、疲劳、睡眠和生活质量）方面的疗效。
低剂量研究中有57名乳腺癌幸存者；高剂量研究中有20名。
东南部和中西部的大学癌症诊所。
37.5毫克文拉法辛（低剂量研究）或75毫克文拉法辛（高剂量研究）。
潮热频率（生理监测仪、日记和事件标记）、潮热严重程度（日记）、潮热困扰程度（日记），以及关于潮热对日常生活影响、负面影响、疲劳、睡眠和生活质量的问卷。
主观潮热测量指标（而非生理潮热测量指标）显示出安慰剂效应。文拉法辛可使潮热症状适度减轻，但仅在高剂量时潮热干扰有差异地得到改善。文拉法辛对潮热症状的影响时间因剂量而异。只有生理潮热症状减少≥50%的女性在疲劳、睡眠质量和生活质量方面有显著改善。尽管副作用较轻，但大多数患者长期停用了文拉法辛。
尽管文拉法辛可使潮热症状适度且急性减轻，副作用较少，但对一些患者来说长期可能无法耐受。患者可能需要生理潮热症状至少减轻50%，才能在其他结果方面有所改善，包括减轻疲劳、改善睡眠和提高生活质量。
