Quella S K, Loprinzi C L, Sloan J, Novotny P, Perez E A, Burch P A, Antolak S J, Pisansky T M
Department of Biostatistic, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Urol. 1999 Jul;162(1):98-102. doi: 10.1097/00005392-199907000-00024.
Hot flashes may be a significant clinical problem in men undergoing androgen deprivation therapy with gonadotropin releasing hormone analogues, oral antiandrogens and/or surgical bilateral orchiectomy. Anecdotal information suggests that a low dose of the relatively new antidepressant venlafaxine may abrogate this clinical problem. We developed the current pilot trial to investigate further whether venlafaxine alleviates hot flashes in such men.
The study included men in whom substantial hot flashes were associated with androgen deprivation therapy. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period when no therapy was given for hot flashes, as well as for the next 4 weeks when study participants received 12.5 mg. venlafaxine orally twice daily. Questionnaires completed during the 4 weeks ofvenlafaxine therapy also documented data on potential drug toxicity.
Of the 16 evaluable patients who completed the study 10 (63%) had a greater than 50% decrease in hot flash score, as determined using the formula, frequency x severity, by week 4 of treatment versus the baseline week. Median weekly hot flash scores decreased 54% from baseline during week 4 of venlafaxine therapy. Average incidence of severe and very severe hot flashes was reduced from 2.3 daily at baseline to 0.6 daily at study end (p = 0.003). Therapy was generally well tolerated.
Venlafaxine hydrochloride appears to represent an efficacious new method for alleviating hot flashes in men undergoing androgen ablation therapy. Further evaluation of this compound for alleviating hot flashes is indicated.
潮热可能是接受促性腺激素释放激素类似物、口服抗雄激素药物和/或双侧睾丸切除术进行雄激素剥夺治疗的男性患者的一个重要临床问题。轶事性信息表明，低剂量的相对较新的抗抑郁药文拉法辛可能消除这一临床问题。我们开展了当前的试点试验，以进一步研究文拉法辛是否能缓解此类男性患者的潮热。
该研究纳入了因雄激素剥夺治疗而出现明显潮热的男性患者。在为期1周的基线期，当未针对潮热进行治疗时，以及在接下来的4周，研究参与者每天口服12.5mg文拉法辛两次时，通过每日日记问卷收集潮热数据。在文拉法辛治疗的4周内完成的问卷还记录了潜在药物毒性的数据。
在完成研究的16例可评估患者中，10例（63%）在治疗第4周时潮热评分较基线周下降超过50%，潮热评分采用频率×严重程度的公式计算。在文拉法辛治疗的第4周，每周潮热评分中位数较基线下降了54%。严重和非常严重潮热的平均发生率从基线时的每日2.3次降至研究结束时的每日0.6次（p = 0.003）。该治疗总体耐受性良好。
盐酸文拉法辛似乎是缓解接受雄激素剥夺治疗男性潮热的一种有效新方法。有必要对该化合物缓解潮热的效果做进一步评估。
