Mara Z. Vitolins, Leah Griffin, Bart Frizzel, Glenn J. Lesser, Michelle Naughton, and Edward G. Shaw, Wake Forest School of Medicine; Dawn Moose, Novant Health, Winston-Salem; James E. Radford Jr, Hendersonville Hematology/Oncology, Hendersonville, NC; W. Vic Tomlinson, AnMed Health, Anderson, SC; Jacqueline Vuky, Virginia Mason Medical Center, Seattle, WA; and Paul T. Adams, National Surgical Adjuvant Breast and Bowel Project, Genesys Regional Medical Center, Flint, MI.
J Clin Oncol. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30.
Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men.
Eligible androgen-deprived men were randomly assigned to one of four daily regimens (2 × 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate.
In all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL.
In androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.
大约 80%的去雄激素男性会出现热潮红。针对缓解男性热潮红的干预研究较少。
符合条件的去雄激素男性被随机分配到四种每日方案(2×2 析因设计)中,持续 12 周:乳清蛋白粉和安慰剂丸、文拉法辛和乳清蛋白粉、大豆蛋白粉和安慰剂丸或文拉法辛和大豆蛋白粉。主要终点是热潮红症状严重程度评分(HFSSS),定义为热潮红次数乘以严重程度。次要终点是生活质量(QoL),采用癌症治疗前列腺功能评估量表进行评估。
共有 120 名年龄在 46 至 91 岁的男性参与。大多数为白人(78%)和超重或肥胖(83%)。毒性极小。文拉法辛或大豆蛋白单独或联合使用均对 HFSSS 无显著影响。大豆蛋白而非文拉法辛改善了 QoL 测量指标。
在去雄激素男性中,文拉法辛和大豆蛋白均不能有效减少热潮红。对女性减少热潮红有效的干预措施在男性中不一定有效。