Loprinzi C L, Michalak J C, Quella S K, O'Fallon J R, Hatfield A K, Nelimark R A, Dose A M, Fischer T, Johnson C, Klatt N E
Department of Oncology, Mayo Clinic, Rochester, Minn. 55905.
N Engl J Med. 1994 Aug 11;331(6):347-52. doi: 10.1056/NEJM199408113310602.
Vasomotor hot flashes are a common symptom in women during menopause and in men who have undergone androgen-deprivation therapy for prostate cancer. Although treatment with estrogens in women and androgens in men can attenuate these symptoms, these hormones may be contraindicated in women with breast cancer and in men with prostate cancer. Pilot trials have suggested that the progestational agent megestrol acetate can ameliorate hot flashes in both groups of patients.
The patients included 97 women with a history of breast cancer and 66 men with prostate cancer who had undergone androgen-deprivation therapy. All patients had experienced bothersome hot flashes (median number per day at base line, 6.1 for the women and 8.4 for the men). After a one-week pretreatment observation period, the patients received megestrol acetate (20 mg twice daily) for four weeks, followed by placebo for four weeks, or vice versa in a double-blind manner as determined by pretreatment randomization. The patients documented the frequency and severity of hot flashes in daily symptom diaries.
After four weeks, hot flashes were reduced by 21 percent in the group receiving placebo first and by 85 percent in the group receiving megestrol acetate first (P < 0.001). An intention-to-treat analysis of data for all eligible treated patients showed that 74 percent of the megestrol acetate group, as compared with 20 percent of the placebo group, had a decrease of 50 percent or more in the frequency of hot flashes during the first four weeks (P < 0.001). The degree of efficacy was similar in men and women. The only side effect was withdrawal menstrual bleeding in women, generally occurring one to two weeks after the megestrol acetate had been discontinued.
Low-dose megestrol acetate is well tolerated and can substantially decrease the frequency of hot flashes in women and men.
血管舒缩性潮热是绝经后女性以及接受前列腺癌雄激素剥夺治疗的男性的常见症状。尽管女性使用雌激素、男性使用雄激素治疗可减轻这些症状，但这些激素可能对乳腺癌女性患者和前列腺癌男性患者有禁忌。初步试验表明，孕激素醋酸甲地孕酮可改善两组患者的潮热症状。
患者包括97例有乳腺癌病史的女性和66例接受过雄激素剥夺治疗的前列腺癌男性。所有患者均经历过令人烦恼的潮热（基线时女性每天潮热中位数为6.1次，男性为8.4次）。经过为期一周的预处理观察期后，患者接受醋酸甲地孕酮（每日2次，每次20 mg）治疗4周，随后接受4周安慰剂治疗，或根据预处理随机分组以双盲方式反过来进行治疗。患者在每日症状日记中记录潮热的频率和严重程度。
4周后，先接受安慰剂治疗组的潮热减少了21%，先接受醋酸甲地孕酮治疗组的潮热减少了85%（P<0.001）。对所有符合条件的治疗患者的数据进行意向性分析显示，醋酸甲地孕酮组74%的患者在最初4周内潮热频率降低了50%或更多，而安慰剂组为20%（P<0.001）。男性和女性的疗效程度相似。唯一的副作用是女性停药后出现月经出血，一般在停用醋酸甲地孕酮后1至2周发生。
低剂量醋酸甲地孕酮耐受性良好，可大幅降低女性和男性潮热的频率。
