摘要：据7月20日《美国医学会杂志》上的一则研究披露，用激素类似物曲普瑞林暂时性地抑制卵巢功能，可以降低乳腺癌妇女中由化疗诱发的早期绝经的发生。
大约有6%的罹患乳腺癌的妇女是在40岁之前被诊断出的，这些年轻患者中大多数会接受化疗、激素疗法或两者兼有的系统治疗。根据文章的背景资料介绍，化疗疗法与至少40%患者的长期停经（即没有月经）症状有关系。目前还没有防止由化疗诱导的卵巢功能衰竭的标准治疗策略。前期临床资料表明，用一种促性腺激素（由垂体腺分泌的激素）-释放激素（GnRH）类似物（一种化合物），在化疗期间可减少对化疗对卵巢的毒性。
意大利热那亚Istituto Nazionale per la Ricerca sul Cancro的Lucia Del Mastro, M.D.及其同事开展了一个3期临床实验，旨在评估由GnRH类似物曲普瑞林所诱导的暂时性抑制卵巢功能，对那些已经接受了补充性或新辅助化疗（即在乳腺癌手术之前施予的化疗）的年轻乳腺癌患者发生早期停经的功效。这一随机性的试验是2003年10月至2008年1月间，在意大利的16个城市中进行的，有281位病人被纳入到这项研究之中。这些患者是罹患乳腺癌I期至III期的绝经前妇女，她们是辅助化疗或新辅助化疗的人选。在化疗开始之前，患者被随机分配接受单一化疗或化疗结合曲普瑞林治疗，后者是在开始化疗之前至少一周时进行肌肉内注射，并在此后的化疗期内每4周肌肉内注射一次。
患者在如试验中所示的接受了治疗之后，研究人员发现，单一化疗组的早期停经发生率为25.9%，而在化疗结合曲普瑞林组治疗中则为8.9%，绝对差异为17%。需要治疗的数字（即：需要用曲普瑞林治疗以防止一个病人发生早期停经的病人数）为6。进一步的分析显示，只有曲普瑞林的治疗才与发生早期停经的风险的显著降低有关。病人的年龄和化疗的类型不会显著地影响该风险。（生物探索编辑）
曲普瑞林(TRIPTORELIN)
生物探索推荐英文论文摘要：
Effect of the Gonadotropin-Releasing Hormone Analogue Triptorelin on the Occurrence of Chemotherapy-Induced Early Menopause in Premenopausal Women With Breast Cancer
ABSTRACT
Context Premenopausal patients with breast cancer are at high risk of premature ovarian failure induced by systemic treatments, but no standard strategies for preventing this adverse effect are yet available.
Objective To determine the effect of the temporary ovarian suppression obtained by administering the gonadotropin-releasing hormone analogue triptorelin during chemotherapy on the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy.
Design, Setting, and Patients The PROMISE-GIM6 (Prevention of Menopause Induced by Chemotherapy: A Study in Early Breast Cancer Patients–Gruppo Italiano Mammella 6) study, a parallel, randomized, open-label, phase 3 superiority trial, was conducted at 16 sites in Italy and enrolled 281 patients between October 2003 and January 2008. The patients were premenopausal women with stage I through III breast cancer who were candidates for adjuvant or neoadjuvant chemotherapy. Assuming a 60% rate of early menopause in the group treated with chemotherapy alone, it was estimated that 280 patients had to be enrolled to detect a 20% absolute reduction in early menopause in the group treated with chemotherapy plus triptorelin. The intention-to-treat analysis was performed by including all randomized patients and using imputed values for missing data.
Interventions Before beginning chemotherapy, patients were randomly allocated to receive chemotherapy alone or combined with triptorelin. Triptorelin was administered intramuscularly at a dose of 3.75 mg at least 1 week before the start of chemotherapy and then every 4 weeks for the duration of chemotherapy.
Main Outcome Measure Incidence of early menopause (defined as no resumption of menstrual activity and postmenopausal levels of follicle-stimulating hormone and estradiol 1 year after the last cycle of chemotherapy).
Results The clinical and tumor characteristics of the 133 patients randomized to chemotherapy alone and the 148 patients randomized to chemotherapy plus triptorelin were similar. Twelve months after the last cycle of chemotherapy (last follow-up, August 18, 2009), the rate of early menopause was 25.9% in the chemotherapy-alone group and 8.9% in the chemotherapy plus triptorelin group, an absolute difference of −17% (95% confidence interval, −26% to −7.9%; P < .001). The odds ratio for treatment-related early menopause was 0.28 (95% confidence interval, 0.14 to 0.59; P < .001).
Conclusion The use of triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause.
KEYWORDS: breast neoplasms, chemotherapy, adjuvant, drug reaction, adverse, gonadotropin-releasing hormone, menopause, premature, menstrual cycle, ovarian failure, premature, premenopause, randomized trials, triptorelin.
