研究动态
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Effects of oestradiol treatment on hot flushes in men undergoing androgen deprivation therapy for prostate cancer: a randomised placebo-controlled trial. 激素雌二醇治疗对于接受前列腺癌雄激素剥夺治疗的男性潮热的影响:一项随机安慰剂对照试验。

Effects of oestradiol treatment on hot flushes in men undergoing androgen deprivation therapy for prostate cancer: a randomised placebo-controlled trial.

发表日期:2022 Nov 01
作者: Nicholas Russell, Rudolf Hoermann, Ada S Cheung, Jeffrey D Zajac, Mathis Grossmann
来源: EUROPEAN JOURNAL OF ENDOCRINOLOGY

摘要:

大多数接受雄激素剥夺疗法(ADT)治疗前列腺癌的男性都会出现潮热症状。目前的治疗方法效果低或证据不足。很可能是雌二醇缺乏引起了这些潮热症状,而经皮雌二醇可能是一种有效的治疗方法。这是一个为期6个月的随机、安慰剂对照试验,假设雌二醇可以减少潮热发生率和强度,提高生活质量(QoL)。78名接受ADT的受试者随机分配到每天0.9毫克0.1%雌二醇凝胶或相符的安慰剂组。在基线、1个月、3个月和6个月时,通过7天日记评估潮热发生率和严重程度。使用验证问卷评估生活质量。雌二醇减少了每天的潮热发生率,均调差异(MAD)为每天-1.6次(95% CI:-2.7至-0.5;P = 0.04)。每周潮热记分的效果无显著差异,MAD为-19.6(95% CI:-35.5至-3.8;P = 0.11)。根据方案分析,E2显著减少了每天的潮热发生率,MAD为每天-2.2次(95% CI:-3.2至-1.1;P = 0.001),每周潮热记分MAD为-27.0(-44.7至-9.3;P = 0.02)。雌二醇对QoL没有显著影响。我们证实了使用雌二醇降低潮热发生率的临床效果的假设,适用于其他治疗无效的持续潮热症状的男性,但需要考虑乳腺效应和脂肪增多的风险。©欧洲内分泌学会。
Most men undergoing androgen deprivation therapy (ADT) for prostate cancer experience hot flushes. Current treatments have low or limited evidence of efficacy. It is likely that oestradiol depletion is the mediator of these hot flushes, and transdermal oestradiol might be an effective treatment.This is a 6-month randomised, placebo-controlled trial with the hypothesis that oestradiol would reduce hot flush frequency and intensity and improve quality of life (QoL).Seventy-eight participants receiving ADT were randomised to 0.9 mg of 0.1% oestradiol gel per day or matched placebo. Hot flush frequency and severity were assessed by 7-day diary at baseline, month 1, month 3, and month 6. QoL was assessed by validated questionnaire.Oestradiol reduced daily hot flush frequency, with a mean adjusted difference (MAD) of -1.6 hot flushes per day (95% CI: -2.7 to -0.5; P = 0.04). The effect on weekly hot flush score was non-significant, with a MAD -19.6 (95% CI: -35.5 to -3.8; P = 0.11). On per protocol analysis, E2 significantly reduced daily hot flush frequency, with a MAD of -2.2 hot flushes per day (95% CI: -3.2 to -1.1; P = 0.001), and weekly hot flush score, with a MAD of -27.0 (-44.7 to -9.3; P = 0.02). Oestradiol had no significant effect on QoL.We confirmed our hypothesis of a clinical effect of assignment to oestradiol to reduce hot flush frequency in men with castrate testosterone due to ADT. Transdermal oestradiol could be considered for men with burdensome hot flushes in whom other treatments have failed as long as the risk of breast effects and fat gain are considered.© European Society of Endocrinology.