骨康口服液治疗原发性骨质疏松症Ⅱ期临床试验观察

目的:观察骨康口服液对原发性骨质疏松症,中医分型为肾阳虚证的患者的治疗作用,并通过本临床试验观察骨康口服液治疗骨质疏松症的疗效,以及对相关实验室指标的影响,为进一步临床开发,运用提供理论依据。方法:纳入的患者分别用骨康口服液、仙灵骨葆做对照治疗,比较骨康口服液的疗效与安全性。结果:骨康口服液组和仙灵骨葆组都能显著改善肾阳虚证症候,提高腰椎L2~L4(均值)、股骨颈、Ward三角、大粗隆部位的骨密度,同时治疗组和对照组血、尿常规,肝、肾功能等各项生化指标的检测没有发生显著性改变。结论:本次临床研究表明,骨康口服液能有效地改善各项相关实验指标及缓解证候症状,有效的治疗原发性骨质疏松症。在服药过程当中,对肝、肾功能,血常规等相关安全性指标没有明显影响,是一种安全有效的用药途径,发挥了中医药的优势,为Ⅲ期临床试验提供了有效的试验数据,并为临床推广使用提供了有利的理论依据。

Observation of the Efficacy of GKKFY in Treating Primary Osteoporosis

Objective: To observe the effects of GKKFY in treating primary osteoporosis. Methods: Cases of primary osteoporosis were treated with GKKFY for 6 months, and the control group consisted with 120 patients treated with XLGB for 6 months. Results: The bone mineral density of lumber vertebra, inter, trouch and hip were increased and the bone pain was alleviated. The increase of the serum Ca2 was statistically significant and there was no statistically significant difference between the two groups. There were no statistically significant differences between the two groups of the serum P and the serum ALP. And the blood, urine routine and biochemical quota had no obvious change in both two groups. Conclusion: GKKFY has a constant effect on the patients of primary osteoporosis in this clinical practice: it can relieve the symptoms and improve physical signs and the related indexes of patients. It is a kind of safe medicine which can educe the preponderance of traditional chinese medicine and be worth applying to clinical use.