Loprinzi C L, Dueck A C, Khoyratty B S, Barton D L, Jafar S, Rowland K M, Atherton P J, Marsa G W, Knutson W H, Bearden J D, Kottschade L, Fitch T R
Division of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
Ann Oncol. 2009 Mar;20(3):542-9. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6.
Hot flashes represent a significant problem in men undergoing androgen deprivation therapy.
Via a prospective, double-blind, placebo-controlled clinical trial, men with hot flashes, on a stable androgen deprivation therapy program for prostate cancer, received a placebo or gabapentin at target doses of 300, 600, or 900 mg/day. Hot flash frequencies and severities were recorded daily during a baseline week and for 4 weeks while the patients took the study medication.
In the 214 eligible patients who began the study drug on this trial, comparing the fourth treatment week to the baseline week, mean hot flash scores decreased in the placebo group by 4.1 units and in the three increasing dose gabapentin groups by, 3.2, 4.6, and 7.0 units. Comparing the three combined gabapentin arms to the placebo arm did not result in significant hot flash differences. Wilcoxon rank-sum P values for change in hot flash scores and frequencies after 4 weeks of treatment were 0.10 and 0.02, comparing the highest dose gabapentin arm to the placebo arm, respectively. The gabapentin was well tolerated in this trial.
These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.
潮热是接受雄激素剥夺治疗的男性面临的一个重大问题。
通过一项前瞻性、双盲、安慰剂对照临床试验，对患有潮热且正在接受稳定的前列腺癌雄激素剥夺治疗方案的男性，给予安慰剂或加巴喷丁，目标剂量分别为300、600或900毫克/天。在基线期的一周以及患者服用研究药物的4周期间，每天记录潮热的频率和严重程度。
在本试验中开始服用研究药物的214名符合条件的患者中，将第四个治疗周与基线周进行比较，安慰剂组的平均潮热评分下降了4.1个单位，三个加巴喷丁剂量递增组分别下降了3.2、4.6和7.0个单位。将三个加巴喷丁组与安慰剂组进行比较，潮热方面未出现显著差异。治疗4周后，将最高剂量加巴喷丁组与安慰剂组相比，潮热评分和频率变化的Wilcoxon秩和P值分别为0.10和0.02。在本试验中，加巴喷丁耐受性良好。
这些结果支持加巴喷丁可在一定程度上减轻与雄激素消融相关的血管舒缩功能障碍男性的潮热症状。
