Palomba S, Affinito P, Tommaselli G A, Nappi C
Department of Gynecology and Obstetrics, University of Naples Federico II, Italy.
Fertil Steril. 1998 Jul;70(1):111-8. doi: 10.1016/s0015-0282(98)00128-9.
To evaluate the effects of tibolone therapy in association with GnRH-a on uterine leiomyomata, on climacteric-like symptoms, on bone metabolism, and on the lipid profile.
A prospective, randomized, double-blind, placebo-controlled, clinical trial.
Department of Gynecology and Obstetrics, University of Naples "Federico II," Naples, Italy.
PATIENT(S): Fifty women with symptomatic uterine leiomyomata.
INTERVENTION(S): Six months of treatment with leuprolide acetate (3.75 mg every 28 days IM) combined with daily placebo tablets (group A) or with 2.5-mg of tibolone per os (group B).
MAIN OUTCOME MEASURE(S): Uterine and uterine leiomyomata sizes, lumbar spine bone mineral density, biochemical markers of bone metabolism, lipid profile, and myoma-related symptoms were measured at baseline and after 6 months of treatment. Daily symptom diary in which hot flushes and vaginal bleeding episodes were recorded.
RESULT(S): No differences between the 2 groups in uterine and uterine leiomyomata size and myoma-related symptoms were detected. After 6 months of treatment, there were statistically significant changes from baseline in bone mineral density and in biochemical markers of bone metabolism in group A but not in group B. Vasomotor symptoms were significantly lower in group B than in group A. There was a statistically significant increase (P<.01) in serum total cholesterol, high-density lipoprotein cholesterol, and triglycerides in group A after 6 months of treatment in comparison with baseline values. The difference in serum total cholesterol and triglyceride levels after 6 months of treatment in group B was not statistically significant in comparison with baseline values, but was statistically significant in comparison with group A values (P<.01). In group B, levels of high-density lipoprotein cholesterol were significantly lower after 6 months of therapy in comparison with baseline values and in comparison with group A values (P<.01). There were no statistically significant changes at baseline and after 6 months of treatment in the level of low-density lipoprotein cholesterol in either group.
CONCLUSION(S): Administration of tibolone in association with GnRH-a reduces vasomotor symptoms and prevents bone loss, without compromising the therapeutic efficacy of GnRH-a alone.
评估替勃龙联合促性腺激素释放激素激动剂（GnRH-a）治疗对子宫肌瘤、更年期样症状、骨代谢及血脂谱的影响。
一项前瞻性、随机、双盲、安慰剂对照的临床试验。
意大利那不勒斯“费德里科二世”大学妇产科。
50例有症状的子宫肌瘤女性。
醋酸亮丙瑞林（每28天肌肉注射3.75毫克）联合每日安慰剂片治疗6个月（A组）或联合口服2.5毫克替勃龙治疗6个月（B组）。
在基线及治疗6个月后测量子宫及子宫肌瘤大小、腰椎骨密度、骨代谢生化标志物、血脂谱及肌瘤相关症状。记录潮热和阴道出血发作情况的每日症状日记。
两组在子宫及子宫肌瘤大小和肌瘤相关症状方面未检测到差异。治疗6个月后，A组骨密度和骨代谢生化标志物与基线相比有统计学显著变化，而B组无。B组血管舒缩症状显著低于A组。治疗6个月后，A组血清总胆固醇、高密度脂蛋白胆固醇和甘油三酯与基线值相比有统计学显著升高（P<0.01）。B组治疗6个月后血清总胆固醇和甘油三酯水平与基线值相比无统计学显著差异，但与A组值相比有统计学显著差异（P<0.01）。在B组，治疗6个月后高密度脂蛋白胆固醇水平与基线值及A组值相比显著降低（P<0.01）。两组低密度脂蛋白胆固醇水平在基线及治疗6个月后均无统计学显著变化。
替勃龙联合GnRH-a给药可减轻血管舒缩症状并预防骨质流失，且不影响GnRH-a单独的治疗效果。
