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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: After the woman enters the menopause period, the body endocrine change, the estrogen level begins to decline, causes a series of syndrome group, indicated that the sex hormone of the postmenopausal women and the calcium, phosphorus and so on the metabolism of bone metabolism has the close relation. Objective: To observe the effect of Bushen Zhuanggu granule on the sex hormone, calcium and phosphorus metabolism in early menopause women. Design: Completely randomized, double-blind method study. Location and Subject: The experiment was performed by the General Internal Medicine of Guangzhou General Hospital of Guangzhou Military Region of Guangzhou and the Outpatient of Maternal and Child Health Hospital of Yuexiu District of Guangzhou. The object was 132 outpatient visits of the early menopause women in two hospitals. Methods: 132 patients were divided into three groups based on random number table: Bushenzhuanggu group (n = 63) and replacement therapy group (n = 69). Bushen Zhuanggu granules and nylestriol were respectively given orally. Pre and post-treatment of sex hormones and calcium, phosphorus metabolism and other biochemical markers of bone metabolism testing. MAIN OUTCOME MEASURES: Changes in sex hormone levels, biochemical indicators of calcium and phosphorus metabolism. Results: After six months’ treatment, the estradiol (E2) (pmol / L) of Bushen Zhuanggu group and the replacement therapy group were 158.71 ± 39.72 and 189.15 ± 36.71, respectively. The alkaline phosphatase (μkat / L) was 1070 ± 136, (T = 2.002 ~ 2.712, P <0.05). The ratios of urinary calcium to creatinine were (Ca / Cr) 0.14 ± 0.21 and 0.15 ± 0.23, respectively, showing a significant decrease (t = 2.135-2.164, P <0.05), there was no significant difference between the two groups (t = 0.121, P <0.05) .Conclusion: Bushen Zhuanggu granules have hormones effect, estrogen and alkaline phosphatase increased, is the prevention and treatment of postmenopausal Sex hormone disorders, changes in bone metabolism, efficient, safe preparation of Chinese medicine.