Ohta H, Komukai S, Sugimoto I, Fuyuki T, Makita K, Takamatsu K, Horiguchi F, Nozawa S
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo, Japan.
Maturitas. 1998 Jun 3;29(2):163-71. doi: 10.1016/s0378-5122(97)00090-x.
Menopause is associated with a rise in serum lipid concentrations. We compared a regimen of pravastatin alone with pravastatin and hormone therapy in postmenopausal women with hyperlipidemia.
We performed a double-blind, randomized, multicenter controlled study in postmenopausal women with hyperlipidemia. The women were randomly assigned to receive pravastatin alone (M group; n = 25) or pravastatin and hormone replacement therapy (HRT) (MC group; n = 32) for 12 weeks. Serum lipid and estrogen concentrations were measured at baseline and after 4 weeks and 12 weeks of treatment.
The two groups were similar with respect to baseline demographic characteristics such as age, height, and body weight. As compared with baseline, the total cholesterol (TC) concentration was 15.0% lower at 4 weeks and 17.7% lower at 12 weeks in the M group and 15.1% lower at 4 weeks and 18.3% lower at 12 weeks in the MC group. The low-density-lipoprotein cholesterol (LDL-C) concentration decreased by 25.0% at both 4 weeks and 12 weeks in the M group and by 26.8% at 4 weeks and 30.0% at 12 weeks in the MC group. Serum TC and LDL-C concentrations were significantly lower in the MC group than in the M group after 4 weeks of treatment, but there was no significant difference between the groups in serum lipid concentrations after 12 weeks. Pravastatin combined with HRT was therefore suggested to lower serum lipid concentrations earlier than pravastatin alone. There were no significant differences between the treatment groups in serum high-density-lipoprotein cholesterol concentrations or triglyceride concentrations after the initiation of therapy. In the MC group, there was a significant positive correlation between the percentage change in serum lipid concentrations and that in estrogen concentrations, suggesting that the HRT-induced rise in estrone (E1) as well as that in estradiol (E2) contributed an improved serum lipid profile. TC and E2, and LDL-C and serum E1 had significant negative correlation at 12 weeks and 4 weeks, respectively. Pravastatin had no apparent effect on endogenous estrogen levels and was not associated with any side effects, which confirmed that pravastatin is safe, either alone or in combination with HRT.
The combination of pravastatin and HRT in the management of hyperlipidemia in postmenopausal women is very useful therapeutically, because it additionally provides the broad benefits of HRT, without compromising the lipid lowering effects of either treatment.
绝经与血清脂质浓度升高有关。我们比较了单用普伐他汀与普伐他汀联合激素治疗在绝经后高脂血症女性中的疗效。
我们对绝经后高脂血症女性进行了一项双盲、随机、多中心对照研究。这些女性被随机分配接受单用普伐他汀（M组；n = 25）或普伐他汀联合激素替代疗法（HRT）（MC组；n = 32）治疗12周。在基线以及治疗4周和12周后测量血清脂质和雌激素浓度。
两组在年龄、身高和体重等基线人口统计学特征方面相似。与基线相比，M组4周时总胆固醇（TC）浓度降低15.0%，12周时降低17.7%；MC组4周时降低15.1%，12周时降低18.3%。M组4周和12周时低密度脂蛋白胆固醇（LDL-C）浓度均降低25.0%；MC组4周时降低26.8%，12周时降低30.0%。治疗4周后，MC组血清TC和LDL-C浓度显著低于M组，但治疗12周后两组血清脂质浓度无显著差异。因此，提示普伐他汀联合HRT比单用普伐他汀能更早降低血清脂质浓度。治疗开始后，治疗组间血清高密度脂蛋白胆固醇浓度或甘油三酯浓度无显著差异。在MC组，血清脂质浓度变化百分比与雌激素浓度变化百分比之间存在显著正相关，提示HRT诱导的雌酮（E1）和雌二醇（E2）升高有助于改善血清脂质谱。TC与E2以及LDL-C与血清E1分别在12周和4周时存在显著负相关。普伐他汀对内源性雌激素水平无明显影响，且未出现任何副作用，这证实了普伐他汀单用或与HRT联合使用都是安全的。
普伐他汀与HRT联合用于绝经后女性高脂血症的治疗非常有效，因为它额外提供了HRT的广泛益处，且不影响任何一种治疗的降脂效果。
