低剂量复方尼尔雌醇片和替勃龙对老年女性生命质量和糖脂代谢影响的比较

Comparison of the effects between low dosage of compound nylestriol tablet and tibolone replacement on quality of life and glucolipid metabolism of the aged females

目的观察低剂量复方尼尔雌醇片(尼尔雌醇0.5mg/片,左炔诺酮0.15mg/片)和替勃龙治疗对老年女性生命质量(QOL)和糖脂代谢的影响。方法将145例患骨质疏松的老年女性随机分为3组:复方尼尔雌醇组(0.5片/次,1次/w,52例),替勃龙组(1.25mg/次,隔日1次,53例),安慰剂组(40例),均干预治疗1年。用SF-36量表在基线、治疗0.5、1年时测量患者QOL;用全自动生化仪测定各组治疗前后空腹血糖(FBS)、血脂〔甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)〕及高敏C反应蛋白(hs-CRP)的值;用红外线扫描及B超监测乳腺,用B超测量子宫内膜厚度,观察对象以日记方式记录阴道出血、乳房胀痛等情况。结果①对同一指标不同时间点的差值进行比较,显示复方尼尔雌醇组和替勃龙组,△T0.5年-0、△T1年-0的总体健康、躯体疼痛、心理健康和精力较安慰剂组有显著性差异,二治疗组间以上指标无显著差异(P>0.05)。多变量方差分析结果显示:3个时间点患者QOL差异显著(F=5.78,P<0.001);3个治疗方案间患者QOL差异有显著性(F=3.92,P<0.05)。②各组治疗前后FBS、TG、TC、LDL均无差异(P>0.05);复方尼尔雌醇组、替勃龙组治疗后较治疗前HDL显著上升(P<0.05);替勃龙组治疗后较治疗前CRP显著下降(P<0.05)。③治疗前后子宫内膜和乳腺体层厚度的变化在各组间无显著差异(P>0.05)。结论低剂量复方尼尔雌醇或替勃龙替代治疗1年均能有效改善老年女性患者QOL,同时未损害糖脂代谢,也未发现子宫内膜和乳腺病变的增加。

Objective To observe the effects of low dosage of compound nylestriol tablet（CNT,containing nilestriol 0. 5 mg plus L- norethisterone l. 5 mg per tablet） and tibolone replacement on quality of life（QOL） and glucolipid metabolism of the aged females. Methods 145 aged female patients with osteoporosis were randomly divided into three groups and observed for one year：group CNT （52 cases, 1/2 tablet,once a week） ,group tibolone （53 cases, 1.25 rag, once every 2 days） and placebo-control group （40 cases）. QOL was surveyed by SF-36 at baseline, half a year and 1 year after treatment. Their concentrations of fast blood sugar （FBS） , triglyeride （ TG ） , total cholesterol （TC） ,low-density lipoprotein（LDL）, high-density lipoprotein （HDL） and high-sensitivity C-reactive protein （hs-CRP） were measured by Hitachi 7600-020 Clinical Analyzer. The breast glandular section thickness was measured by proximal-infrared scanning and mammary ultra- sonography. The thickness of uterus＇s endometrial were measured by ultrasonography. Their symptoms and feelings such as vaginal bleeding and spargosis et al were recorded in dairy by the patients themselves. Results Compared with baseline value, the difference of general health,bodily pain,mental health and vitality at 1/2 year （ ATI/2 r.,r~） and 1 year （ ATI~~,r.0 ） in group CNT and tibolon increased signifi- cantly,but not in control group. Neither was that between group CNT and tibolon. By multivariate ANOVA,signifieant statistical difference of the patients＇ QOL was found among 3 different groups （ F = 3.92,P 〈 0. 05 ） and also among 3 different time （ F = 5.78,P 〈 0. 001 ）. There were no significant changes between pro- and post-treatment concentration of FBS, TG, TC and LDL in all three groups, but that of HDL in group group CNT and tibolon increased significantly after 1 year treatment（ P 〈 0. 05） ,at the same time CRP decreased significantly in group tibolon （P 〈 0. 05 ）. After treatment the changes of the thickness of endometria and breast glandular seetion had no significant differences between three groups. Conclusions Replacement with low dosage of CNT or tibolon for 1 year can improve the aged females＇ QOL without damaging the glucolipid metabolism or changing the thickness of endometrial or breast glandular section.