【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。更多还原

【Abstract】 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 multicenter 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 Gusongbao in treating postmenopausal osteoporosis and they both could increase BMD in vertebral bodies in combination with Osteoform.The administration of Osteoform alone could maintain BMD.更多还原