肌肉注射长效醋酸甲羟孕酮与口服甲地孕酮用于控制乳腺癌患者绝经后潮热：一项随机研究。

Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients: a randomized study.

作者信息

Bertelli G, Venturini M, Del Mastro L, Bergaglio M, Sismondi P, Biglia N, Venturini S, Porcile G, Pronzato P, Costantini M, Rosso R

机构信息

Medical Oncology, S. Croce General Hospital, Cuneo, Italy.

出版信息

Ann Oncol. 2002 Jun;13(6):883-8. doi: 10.1093/annonc/mdf151.

DOI:10.1093/annonc/mdf151

PMID:12123333

Abstract

BACKGROUND

Hot flashes are frequent in postmenopausal breast cancer patients, especially when treated with tamoxifen. Estrogen replacement therapy is the most effective treatment for hot flashes, but its use is controversial in breast cancer survivors. Progestins may offer a good alternative for the control of hot flashes in this setting; in particular, oral megestrol acetate has been proven effective in a randomized, placebo-controlled clinical trial. With the aim of further improving these results, we have designed a randomized study comparing oral megestrol acetate with depot intramuscular (i.m.) medroxyprogesterone acetate (MPA) for the control of hot flashes in postmenopausal patients with a history of breast cancer.

PATIENTS AND METHODS

Seventy-one postmenopausal patients were randomized to receive an i.m. injection of depot MPA 500 mg on days 1, 14 and 28, or oral megestrol acetate 40 mg daily for 6 weeks. Patients recorded daily the number and severity of their hot flashes; response was defined as a > or =50% decrease in the number and severity of hot flashes.

RESULTS

At week 6, hot flashes were reduced by 86% on average in the whole group of patients, without significant differences between the two progestins. Response was obtained by 75 and 67% of patients receiving MPA or megestrol, respectively (P = 0.5). Responders were followed to assess maintenance of response (without further treatment), which was significantly better with i.m. MPA: in this group, 89% of responders still showed a benefit at week 24, compared with 45% in the megestrol group (P = 0.03).

CONCLUSIONS

Our study shows that a short cycle of i.m. depot MPA injections provides significant and long-lasting relief from postmenopausal hot flashes in patients with a history of breast cancer, offering an alternative to estrogen replacement therapy or prolonged administration of oral megestrol.

摘要

背景

潮热在绝经后乳腺癌患者中很常见，尤其是在接受他莫昔芬治疗时。雌激素替代疗法是治疗潮热最有效的方法，但其在乳腺癌幸存者中的使用存在争议。孕激素可能是控制这种情况下潮热的一个很好的替代方法；特别是，口服甲地孕酮已在一项随机、安慰剂对照的临床试验中被证明有效。为了进一步改善这些结果，我们设计了一项随机研究，比较口服甲地孕酮与醋酸甲羟孕酮长效肌内注射剂（MPA）对有乳腺癌病史的绝经后患者潮热的控制效果。

患者和方法

71名绝经后患者被随机分为两组，一组在第1、14和28天接受500mg醋酸甲羟孕酮长效肌内注射，另一组每天口服40mg甲地孕酮，持续6周。患者每天记录潮热的次数和严重程度；反应定义为潮热次数和严重程度减少≥50%。

结果

在第6周时，整个患者组的潮热平均减少了86%，两种孕激素之间无显著差异。接受MPA或甲地孕酮治疗的患者中，分别有75%和67%获得了反应（P = 0.5）。对有反应者进行随访以评估反应的维持情况（不再接受进一步治疗），醋酸甲羟孕酮长效肌内注射组明显更好：在该组中，89%的有反应者在第24周时仍有获益，而甲地孕酮组为45%（P = 0.03）。