补肾壮骨颗粒与联合激素替代疗法对骨代谢生化指标的影响

摘要

背景:女性进入绝经期后,机体内分泌发生变化,雌激素水平开始下降,引起一系列综合征候群,表明绝经后妇女性激素与钙、磷等骨代谢生化指标有着密切的关系.目的:观察补肾壮骨颗粒对绝经早期妇女性激素及钙、磷骨代谢生化指标的影响.设计:完全随机、双肓法分组研究.地点和对象:实验由解放军广州军区广州总医院普通内科和广州越秀区妇幼保健院门诊共同完成,对象为两家医院门诊绝经早期就诊妇女132例.方法:将132例患者按随机数字表法分成补肾壮骨组63例及替代疗法组69例,分别给予补肾壮骨颗粒和尼尔雌醇和安宫黄体酮口服.治疗前后行性激素及钙、磷代谢等骨代谢生化指标的检测.主要观察指标:性激素水平,钙、磷代谢生化指标变化.结果:治疗半年后,补肾壮骨组和替代疗法组雌二醇(E2)(pmol/L)分别为158.71±39.72,189.15±36.71,碱性磷酸酶(μkat/L)分别为1070±136,1119±136,均显著上升(t=2.002～2.712,P＜0.05);尿钙/肌酐比值分别为(Ca/Cr)0.14±0.21,0.15±0.23,呈显著下降(t=2.135～2.164,P＜0.05),各指标两组比较差异无显著性意义(t=0.121,P＜0.05)结论:补肾壮骨颗粒有类激素作用,使雌激素及碱性磷酸酶升高,是防治绝经后性激素紊乱、骨代谢改变的高效、安全的中药制剂.%BACKGROUND: The changes of endocrine system and the descent of estrogen levels start in women since menopause, which would cause a series of syndromes and indicate that there are close relationships between menopausal women and, sex hormones and the biochemical indexes of bone metabolism,such as calcium and phosphorus, etc..OBJECTIVE: To observe the effect of bushenzhuanggu granule(tonifying the kidney-yang and strengthening bone) on the biochemical indexes of bone metabolism, such as calcium and phosphorus in menopausal forepart women.DESIGN: A complete randomized double-blinded grouping study was conducted.SETTINGS and PARTICIPANTS: The study was completed in the Department of General Medicine, Guangzhou General Hospital of Guangzhou Military Commond and Maternal and Child Care Hospital of Yuexiu District in Guangzhou. The subjects were 132 out-patient women in early menopause hospitalised in the two hospitals.METHODS: The 132 women were randomly divided into bushenzhuanggu group(granule group) with 63 women and replacement therapy group(control group) with 69 women, which were taken with bushenzhuanggu granule and,nilestriol and medroxyprogesterone acetate(MPA) orally, respectively. The sex hormones and and biochemical indexes of bone metabolism, such as calcium and phosphorus were assayed before and after treatment.MAIN OUTCOME MEASURES: Sex hormones levels, the changes of biochemical indexes, such as calcium and phosphorus.RESULTS: After 6-month treatment, estradiol(E2) (pmol/L) of granule group and control group were 158.71 ±39.72 and 189.15 ±36.71 respectively, and the ALP (μkat/L) were 1 070 ± 136 and 1119 ± 136 respectively with significant increases(t=2.002-2.712, P ＜ 0.05) .The ratios of urinary calcium to creatinine(Ca/Cr) were 0. 14 ±0.21 and 0. 15 ±0. 33 respectively with significant decreases( t = 2. 135 - 2. 164, P ＜ 0.05) .There were no significant differences in the comparisons of the indexes between two groups( t =0. 121, P ＞ 0.05).