骨疏康冲剂防治原发性骨质疏松症的临床观察

目的：观察中药骨疏康冲剂（简称骨疏康）防治原发性骨质疏松症疗效及机理。方法：随机选择骨密度（BMD）低于同性别峰值骨量1个标准差且不伴合并症，未经防治的骨量减少及骨质疏松症患者197例；其中女性176例，自然绝经1年以上；男性21例，70岁以上。女性按本人自愿分为3组，观察组101例，口服骨疏康，每次1袋（12g），每日3次，并服用碳酸钙，每次300mg，每日2次，连续6个月；单钙组23例，口服骨疏康，每次1袋（12g），每日3次，并服用碳酸钙，每次300mg，每日2次，连续6个月；钙组23例，单服等量钙剂；空白对照组（简称空白组）52例，不服药物，用以观察骨量自然下降情况；男性均为观察组，服药同女性观察组。各组用药前、治疗6个月后检测L2－4BMD和骨代谢相关指标。结果：观察组（女、男）治疗6个月后BMD下降减缓，且较治疗前有增加，女性观察组有效率为91．1％，平均BMD增加3．1％；男性观察组有效率为95．2％，平均BMD增加3．9％；单钙组及空白组BMD均下降（1．8％）。观察组抗酒石酸盐酸性磷酸酶（TRAP）明显下降，雌二醇睾酮明显增加，高密度脂蛋白胆固醇升高。单钙组治疗后TRAP下降，其他指标差异无显著性。结论：骨疏康有增加性（雌、雄）激素、抑制骨吸收，减缓骨量丢失，增加BMD的作用，能有效地防治骨质疏松症。本药还能增加高密度脂蛋白胆固醇，对心血管疾病的防治有益。

Clinical Study on Effect of Gushukang Granule in Preventing and Treating Primary Osteoporosis

OBJECTIVE: To investigate the effect and mechanism of Gushukang granule (GSKG), a Chinese herbal preparation, in preventing and treating primary osteoporosis. METHODS: The total of 197 patients of osteoporosis, whose bone mineral density (BMD) was below 1 standard deviation of the peak bone mass of same sex, with no complications and had not been treated were selected. Among them, 176 were menopausal females for over 1 year and 21 males aged over 70. The females were voluntarily divided into three groups, the 101 cases in the observed group were treated with GSKG 12 g, three times a day and calcium carbonate 300 mg, twice a day, orally taken for 6 months; the 23 cases in the positive control group were treated with equal volume of calcium preparation alone and the 52 cases in the blank control group were untreated. All the males were treated in the same way as that in the observed group of female. The BMD level of lumbar vertebrae 2-4 and other related to indexes of bone were determined before and 6 months after treatment. RESULTS: BMD level in the two control groups lowered by 1.8% after 6 months. While in the observed group, BMD lowered slowly or even increased, after 6 months the average BMD increased by 3.1% in females and by 3.9% in males. The effective rate was 91.1% in females and 95.2% in males. After treatment, the levels of tartrate-resistant acid phosphate decreased, estradiol, testosterone and high density lipoprotein increased in the female observed group, while the obove-mentioned indexes unchanged in the control groups. CONCLUSION: GSKG has the effects in increasing sex hormones (both estrogen and androgen), inhibiting bone absorption, slowing down bone mass loss and elevating BMD, it could prevent and treat osteoporosis effectively. Besides, it could increase the level of high density lipoprotein so as to benefit prevention and treatment of cardiovascular diseases.