淫羊藿总黄酮治疗原发性骨质疏松症患者骨密度和骨代谢指标的变化

背景: 既往动物实验表明，淫羊藿总黄酮能有效抑制雌激素相关的骨丢失，但是相关的临床报道较少。目的：观察淫羊藿总黄酮对原发性骨质疏松症患者骨密度的影响。设计、时间及地点：随机双盲，阳性对照临床试验，病例来自2005-06/2007-09华中科技大学同济医学院附属协和医院门诊。对象：选择原发性骨质疏松症患者64例，男11例，女53例。方法：64例患者随机分为治疗组和对照组，每组32例，治疗组给予淫羊藿总黄酮 0.45 g/次，3次/d，口服治疗；对照组给予骨疏康颗粒10 g/次，2次/d，口服治疗，疗程均为6个月。主要观察指标：①两组患者治疗前后腰椎(L1~L4)，股骨颈，Ward’s三角，大转子和左髋的骨密度变化。②两组患者治疗前后血清钙、磷和碱性磷酸酶的变化。结果：64例原发性骨质疏松症患者均进入结果分析。①治疗组腰椎骨密度明显高于对照组(P < 0.05)，其他部位两组骨密度相比，差异无显著性意义(P > 0.05)。与治疗前相比，治疗组骨密度无明显改变(P > 0.05)，对照组腰椎，股骨颈，大转子和髋部骨密度明显降低(P < 0.05，P < 0.01)。②两组血钙水平均较治疗前明显升高(P < 0.05)，两组间比较无明显差异(P > 0.05)；治疗组血磷和血碱性磷酸酶水平与治疗前相比无明显变化(P > 0.05)。结论：淫羊藿总黄酮治疗能有效抑制原发性骨质疏松症患者骨密度降低。

Effects of epimedium total flavonoids on bone mineral density and bone metabolism-related indices in

BACKGROUND: Previous animal experiments have shown that epimedium total flavonoids can exhibit preventive effects on estrogen-related bone loss, but few data are available in clinical research. OBJECTIVE: To investigate the effects of pimedium total flavonoids on bone mineral density (BMD) in primary osteoporosis.DESIGN, TIME AND SETTING: A randomized, double-blinded, positively controlled clinical observation was performed at the Department of Traditional Chinese Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology between June 2005 and September 2007. PARTICIPANTS: A total of 64 patients with primary osteoporosis consisting of 11 males and 53 females were included in this study.METHODS: All patients were randomly and evenly assigned into a treatment group and a control group. The treatment group was orally administered epimedium total flavonoids, 0.45 g once, three times daily, for a total of 6 months. Simultaneously, the control group was orally administered Gushukang, 10 g once, twice daily, for a total of 6 months. MAIN OUTCOME MEASURES: BMD in the sites of lumbar vertebrae (L1-4), neck of femur, Wards triangle, greater trochanter, and left hip was measured, and simultaneously serum levels of calcium, phosphorus, and alkaline phosphatase (ALP) were detected prior to and after treatment in each group.RESULTS: All 64 patients with primary osteoporosis were included in the final analysis. The BMD in the lumbar vertebrae (L1-4) was significantly higher in the treatment group than in the control group (P < 0.05) and there was no significant difference in BMD in other sites between the two groups (P > 0.05). Compared with prior to drug application, BMD in the treatment group did not present obvious change after epimedium total flavonoids application, while in the control group, BMD in the sites of lumbar vertebrae (L1-4), neck of femur, Wards triangle, and greater trochanter was significantly decreased (P < 0.01-0.05). After drug application, serum level of calcium was significantly increased in each group, compared with prior to drug application (P < 0.05), and no significant difference existed between the treatment and control groups (P > 0.05). In the treatment group, serum levels of phosphorus and ALP did not alter significantly compared with prior to epimedium total flavonoids application (P > 0.05). CONCLUSION: Epimedium total flavonoids exhibit effective effects on the maintenance of BMD in primary osteoporosis.