健骨颗粒治疗绝经后骨质疏松症随机对照双盲双模拟多中心临床试验  

Jiangu Granules in Treatment of Postmenopausal Osteoporosis:a Randomized,Double-blind,Double Dummy,Multicenter Clinical Trial

作　　者：熊炎昊[1] 藤蔚然[2] 刘涛[1] 符诗聪[1] 顾品芳[2] 傅文彧[3] 李飞跃[1] 施荣庭[3] 奚小冰[1] 张凤华[3] 王毓兴[1] 唐旭升[1] 胡大佑[1] 李舸[3] 李中伟[3] 张昊[1] 高峰[1] 杜宁[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院伤科,上海200025 [2]上海交通大学医学院附属新华医院伤科 [3]上海市伤骨科研究所

出　　处：《中国中医骨伤科杂志》2008年第4期17-19,21,共4页Chinese Journal of Traditional Medical Traumatology & Orthopedics

摘　　要：目的:考察健骨颗粒治疗妇女绝经后骨质疏松症的疗效,评价其有无开发成治疗绝经后骨质疏松症中药新药的可能性。方法:随机、双盲、双模拟、多种心研究方法。受试者均服用乐力钙250mgbid作为基础用药,再分别服用健骨颗粒5gBid、骨松宝颗粒5gBid、安慰剂颗粒5gBid,共6m。意向性数据集(ITT)样本144例,其中健骨颗粒组48例,骨松宝组48例,空白组48例。符合方案数据集(PP)样本108例,其中健骨颗粒组37例,骨松宝组36例,空白组35例。评价指标为脊柱、股骨颈及Wards区骨密度改善情况。结果:L2-L4骨密度治疗后骨松宝组及健骨颗粒组较治疗前都有增加(骨松宝组P=0.017,健骨颗粒组P=0.006),安慰剂治疗前后骨密度无明显变化;股骨颈及Wards区骨密度各组均无明显增加。三组间骨密度改善情况变化无统计学差异。结论:健骨颗粒和骨松宝对妇女绝经后骨质疏松的治疗作用相似,与乐力钙胶囊联用均能改善椎体骨密度。单独使用乐力钙胶囊能维持骨密度。Objective： To evaluate the efficacy of Jiangu granules （JG） in treatment of postmenopausal osteoporosis and the possibility of JG to be exploited as a new clinical drug of traditional Chinese medicine. Methods： A randomized, double-blind, double dummy and muhicenter trial was conducted. One hundred and forty-four patients were enrolled according to intention to treat （ITT） principle and randomly divided into Jiangu group, Gusongbao group and placebo group with 48 cases for each. All patients received osteoform （250mg, twice a day） as a fundamental drug. Meanwhile, they were respectively administered JG, Gusongbao and placebo at the same dose of 5g twice daily for 6 months. Finally, 108 cases were assessable by per protocol set （PPS） analysis, 37 patients in Jiangu group, 36 in Gusongbao group and 35 in placebo group. The improvements in bone mineral density （BMD） of spine, femoral neck and wards were measured as indexes of curative effect. Results： After the treatment, BMD in lumbar 2 to 4 （L2-L4） increased significantly in Jiangu and Gusongbao group （P=0. 006, P=0. 017, respectively） compared with before treatment while no obvious changes were observed in placebo group. BMD in the femoral neck and wards showed no significant improvements in each group and there were no statistical differences in the changes of BMD among the three groups. Conclusion： JG possessed similar therapeutic effect to Gusong- bao in treating postmenopausal osteoporosis and they both could increase BMD in vertebral bodies in combination with Os- teoform. The administration of Osteoform alone could maintain BMD.

关 键 词：健骨颗粒 骨松宝 乐力钙胶囊 绝经后骨质疏松 骨密度 临床试验 

分 类 号：R681.05[医药卫生—骨科学] R969.4[医药卫生—外科学]