【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 in treatment of postmenopausal osteoporosis and the possibility of it to be exploited as a new clinical drug of traditional Chinese medicine (TCM). Methods:The study was designed as a randomized,double blind, double dummy and multi-center. The patients all received osteoform 250mg, bid as a fundamental drug.The patients separately received Jiangu granules, Gusongbao and placebo with the same dosage of 5g, bid. The whole treatment course was 6 months. The study enrolled 144 patients, according to intention to treat (ITT) principle, 48 patients in Jiangu group, 48 patients in Gusongbao group and 48 patients in placebo group. And finally 108 patients were available, according to per protocol set (PP) sample, 37 patients in Jiangu group, 36 patients in Gusongbao group and 35 patients in placebo group. The method of patient evaluation is the bone mineral density (BMD) including the spine, femoral neck and wards. Results:BMD increases significantly in the L2～L4 both in the Jiangu group and the Gusongbao group(Jiangu group:P=0.006,Gusongbao group:P=0.017). While the BMD in the femoral neck and wards have no significant improvement in all the three groups. There were no statistic differences in the changes of BMD among the three groups. Conclusion:Jiangu granules is an effective drug of TCM for osteoporosis and its efficacy is comparable to that of gusongbao. Both the two drugs can increase the BMD in the L2～L4 and maintain the BMD in the femoral neck and wards. Even the osteoform single can maintain the BMD in the three positions.更多还原