低剂量复方尼尔雌醇片和替勃龙治疗老年女性骨质疏松症有效性和安全性的对比研究  

Contrast study of validity and safety of low dosage of complex prescription nilestriol tablets and tibolone in treatment of the elderly women with osteoporosis

作　　者：龙利民[1] 刘幼硕[1] 张红[1] 王田琪[1] 黄武[1] 王艳娇[1] 王翼[1] 李霞[1] 

机构地区：[1]中南大学湘雅二医院老年病科,湖南长沙410011

出　　处：《中国老年学杂志》2007年第16期1574-1577,共4页Chinese Journal of Gerontology

基　　金：中央保健委员会保健专项资金科研项目(2002-湘B026)

摘　　要：目的对比观察低剂量复方尼尔雌醇片(每片含尼尔雌醇0.5mg,左炔诺酮0.15mg,每周口服1/2片)和低剂量替勃龙(商品名:利维爱,1.25mg,隔日1次)治疗老年女性骨质疏松的有效性和安全性。方法筛选出166例老年女性骨质疏松患者(≥60岁),采用随机、均衡方法分为3组,145例完成试验。其中服用低剂量复方尼尔雌醇治疗(A组)52例,服用低剂量替勃龙治疗(B组)53例,安慰剂对照(C组)40例。干预1年,治疗前、后观察骨密度(BMD)、新发骨折、骨代谢生化指标、红外线扫描及B超监测乳腺、B超测量子宫体积及子宫内膜厚度、宫颈制片作阴道细胞除片检查、以日记方式记录阴道流血及乳房胀痛情况。结果共145例完成研究,各组退出率无显著差异;3组1年治疗中均无新骨折发生,2个治疗组治疗前后BMD无显著变化,且两组间BMD的变化无差别,而安慰剂对照组BMD较治疗前显著下降;各组用药前、后血、尿常规及肝肾功能均无异常,未发现子宫内膜病变,子宫内膜和乳腺体层厚度的变化在各组间无显著性差异;2个治疗组主要副作用是乳胀;3组患者治疗1年中均无阴道流血。结论低剂量复方尼尔醇片与低剂量替勃龙在1年治疗期内对于老年女性骨质疏松的效果和安全性类似,可以有效阻断其BMD的进一步下降,对乳腺和子宫内膜的安全性较高。Objective To observe the validity and safety of low dosage of complex prescription nilestriol tablets （0. 5 mg nilestriol, 0. 15 mg levonorgestrel per tablet, 0. 5 tablet per week, orally） and tibolone （Livial, 1.25 mg, once every other day） in treatment of the elderly women with osteoporosis. Methods 166 women aged ≥60 years with osteoporosis were randomly and averagely into 3 groups. Of 145 cases completed experiment, there were 52 in nilestriol group, 53 in tibolone group, 40 in placebo group with intervention for 1 year. Bone mineral density （BMD）, new onset of bone fracture, biochemical indicators of bone metabolism were observed before and after intervention. Mammary gland was monitored by infrascan and ultrasound. Uterine volume and endometrium thickness were measured by ultrasound. Cervix smears were prepared for vaginal cell examination. Vaginal bleeding and gas pains of breast were recorded by diary. Results 145 cases completed experiment, there was no difference in exiting rate from every group. There was no new onset of bone fracture within one year in three groups. BMD had no significant difference before and after intervention between nilestriol group and tibolone group, but BMD after intervention was decreased than that after intervention in placebo group. There were no differences in blood and urine routine and hepatic and renal function, no pathological changes in endometrium before and after intervention in each group. There was no significant difference in endometrium and mammary gland layer thickness among three groups. Main side effect in nilestriol group and tibolone group was gas pains of breast. There was no vaginal bleeding in 1 ydar after intervention in three groups. Conclusions Low dosage of complex prescription nilestriol tablets has similar effect and safety in treatment of the elderly women with osteoporosis as low dosage of tibolone, could effectively block the decrease in BMD, presenting the higher safety to mammary gland and endometrium.

关 键 词：骨质疏松 老年女性 雌激素 孕激素 尼尔雌醇 替勃龙 骨密度 

分 类 号：R592[医药卫生—老年医学]