摘要
目的比较小剂量的性激素治疗方案(HT)对健康的绝经后妇女总的效果,同时观察中药-坤泰胶囊的临床作用,以期寻找防治绝经后骨丢失的优化方案。方法本研究为随机、开放、平行对照的临床试验,时间1年。征集2002年4月至2003年3月在北京协和医院就诊的41～65岁的绝经后妇女136例,分4组:A组:戊酸雌二醇1.0mg/d+醋甲羟孕酮(MPA)2mg/d;B组:结合型雌激素(倍美力)0.45mg/d+MPA2mg/d;C组:7-甲异炔诺酮(利维爱)1.25mg/d;D组:坤泰胶囊4粒日3次口服。同时各组研究对象均加服元素钙400mg/d和维生素D200IU/d。监测治疗前后腰椎(L2-4)、股骨颈的骨密度(BMD)、骨代谢指标和血脂水平的变化,及Kupperman评分、副反应的发生情况。结果用药期间,无一例研究对象发生临床骨折。L2-4BMD在4个组的改变率分别为:(2.91±3.58)%、(2.44±3.20)%、(2.48±3.43)%、(-0.97±3.50)%,HT组间差别无显著性,而D组显著低于其他组(P<0.01),而股骨颈BMD的变化各组间差别无显著性(P>0.05)。Kupperman评分的下降在治疗后的任何时点HT组均优于D组。血脂的改变在HT组各有差别,出血、乳胀的发生A组和B组相似,多于C组,D组最少。结论3种临床常用的小剂量HT方案对绝经后健康妇女的疗效相似,而副反应和对血脂的影响不尽相同。中药坤泰不能阻止绝经后骨量的丢失,但在一定程度上能改善绝经症状。
Objective To compare the general effects of different low-dose regimens of hormone therapy （HT） and a formulation of Chinese herbs, which could be helpful to find the optimal regimen for prevention of bone loss in postmenopausal women. Methods Applied with l-year, open-labeled, randomized, clinical trial design, eligible postmenopausal women aged between 41 to 65 years were assigned into 4 groups. Group A： Estradiol valerate （E2V） I mg ＋ Medroxyprognsterone acetate （MPA） 2mg/d; Group B： Premarin 0.45mg ＋ MPA2mg/d; Group C： Tibolone 1.25mg/d; Group D： Chinese formulated products （ Kuntai capsule） 4# t. i.d. Each subject took element calcium 400mg/d and vitamin D 200 IU/d concomitantly. BMD on lumbar 2-4 and femoral neck as well as blood lipids profile was measured before and after treatment. Kupperman scores and side effects such as irrugnlar vaginal bleeding and mastalgia were also recorded. Results No clinical fracture occurred during the trial. Changes of BMD of spine were （2.913.58）%, （2.44 ±3.20）%, （2.48±3.43）%, （-0.97 ±3.50）%, respectively, with insignificant difference among HT groups, butin group Dit was significantly lower than the others（P〈0.01）, and that of femoral neck did not show statistical difference （P 〉0. 05）. The decrease of Kupperman scores was more distinct in HT groups than in Group D. Blood lipid profiles changed differently among groups. Incidence of side-effects such as bleeding and tenderness of breast were less in Group C and D. Conclusion The general efficacies of three HT regimens in healthy postmenopausal Chinese women seem similar, but side-effects occur less in group C. Chinese formulated herbs（Kuntai） products can not prevent postmenopausal bone loss, but alleviate menopausal symptoms at some extent.
出处
《中国实用妇科与产科杂志》
CAS
CSCD
北大核心
2007年第3期184-188,共5页
Chinese Journal of Practical Gynecology and Obstetrics
基金
国家科技部十五科技攻关计划课题(2001BA702B03)
