密骨颗粒联合阿仑膦酸钠维D3片治疗老年性骨质疏松症的多中心临床研究  

A pragmatic multicenter randomized controlled clinical study of Migu granules combined with alendronate sodium and Vitamin D3 tablets in the treatment of older osteoporosis

作　　者：童正一[1] 王国栋[1] 许金海[1] 叶洁[1] 闵鸿祥 夏烨[1] 沈琪幸 梅一南 方娅贝 王生宝[5] 范春兰[6] 王轶 董毅 王拥军[1,2] 莫文[1,2] 施杞[1,2] TONG Zhengyi;WANG Guodong;XU Jinhai;YE Jie;MIN Hongxiang;XIA Ye;SHEN Qixing;MEI Yinan;FANG Yabei;WANG Shengbao;FAN Chunlan;WANG Yi;DONG Yi;WANG Yongjun;MO Wen;Shi Qi(Department of Orthopedics,Longhua Hospital,Shanghai University of T.C.M,Shanghai 200032,China;Institute of Spine Disease,Shanghai University of T.C.M,Shanghai 200032,China;Qingpu District,T.C.M Hospital,Shanghai 201700,China;Peng Pu New Village Community Health Service Center,Jingan District,Shanghai 200040,China;Shang Gang Community Health Service Center,Pudong New District,Shanghai 201315,China;Nan Matou community health Service Center,Pudong New District,Shanghai 201204,China;Yang Jing community Health Service Center,Pudong New District,Shanghai 200135,China;Da Chang Society District Health Service Center,Baoshan District,Shanghai 201900,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]上海中医药大学脊柱病研究所,上海200032 [3]上海市青浦区中医医院,上海201700 [4]上海市静安区彭浦新村街道社区卫生服务中心,上海200040 [5]上海市浦东新区上钢社区卫生服务中心,上海201315 [6]上海市浦东新区南码头社区卫生服务中心,上海201204 [7]上海市浦东新区洋泾社区卫生服务中心,上海200135 [8]上海市宝山区大场社区卫生服务中心,上海201900

出　　处：《中国骨质疏松杂志》2021年第6期855-861,共7页Chinese Journal of Osteoporosis

基　　金：上海市卫生健康委员会项目[ZY3-LCPT-1-1003,ZYKC201701003,ZY(2018-2020)-FWTX-4002,ZY(2018-2020)-FWTX-2006,ZY(2018-2020)-FWTX-6024];上海市科学技术委员会项目(18401903200,19401901100);国家中医药管理局项目(2020年中医药传承创新平台建设)。

摘　　要：目的探讨密骨颗粒联合阿仑膦酸钠维D3片治疗骨质疏松症的临床疗效与安全性。方法随机将受试者分为试验组(n=109)和对照组(n=75),试验组给予密骨颗粒联合阿仑膦酸钠维D3片,对照组给予阿仑膦酸钠维D3片,疗程为12个月。分别于治疗前、治疗后6、12个月时行骨代谢、骨密度(bone mineral density,BMD)、血常规、肝肾功能等检查,并记录VAS与SF-36评分,观察受试者的不良反应。结果①12个月后,试验组和对照组受试者的腰椎BMD分别增加3.70%和4.18%,两组间比较差异无统计学意义(P>0.05);髋部BMD分别下降0.89%和17.02%,对照组下降更明显(P<0.05);②12个月,试验组和对照组受试者的PTH分别增加44.29%和72.03%,25(OH)D分别下降11.83%和9.29%,β-CTX分别下降32.25%和20.0%,PINP分别下降36.70%和58.95%,BGP分别下降22.82%和27.24%,ALP分别下降20.43%和25.97%,两组间比较差异有统计学意义(P<0.05);③两组受试者治疗后腰痛VAS评分均下降(P<0.05),组间比较差异有统计学意义(P<0.05)。治疗9、12个月后试验组SF-36PCS及MCS功能评分高于对照组,比较差异有统计学意义(P<0.05);④两组均未出现严重不良反应。结论密骨颗粒联合阿仑膦酸钠维D3片治疗骨质疏松症可以降低骨转换速度,同时还可以促进成骨,提升腰部骨密度,保持髋部骨密度,降低骨流失,降低患者躯体疼痛,改善生活质量。未出现不良反应与肝肾功能损害,具有较好的安全性。Objective To evaluate the effectiveness and safety of Migu granules combined with alendronate sodium and vitamin D3 tablets in the treatment of Osteoporosis.Methods The 6 Clinical centers were randomly divided into the treatment group(n=109)and the control group(n=75),The patients in the treatment group were treated with Migu granules combined with alendronate sodium and vitamin D3 tablets.alendronate sodium and vitamin D3 tablets were used in the control group,Patients received intervention for 12 months.Bone metabolism,bone mineral density(BMD),blood routine,liver and kidney function were examined before treatment,6 and 12 months after treatment,vas and SF-36 scores were recorded,and observed the adverse reactions.Results①After 12 months treatment,lumbar spine BMD in the experimental group and the control group increased 3.70%and 4.18%(P>0.05),Hip BMD decreased 0.89%and 17.02%,The difference between the two groups was statistically significant(P<0.05);②PTH in the experimental group and the control group increased 44.29%and 72.03%,25(OH)D decreased by 11.83%and 9.29%,β-CTX decreased by 32.25%and 20.0%,PINP decreased by 36.70%and 58.95%,BGP decreased by 22.82%and 27.24%,ALP decreased by 20.43%and 25.97%,the difference between the two groups was statistically significant(P<0.05);③The VAS scores of lumbar pain in the two groups decreased after treatment(P<0.05),but there was no significant difference between the two groups(P>0.05).SF-36 PCS and MCS in the treatment group were higher than those in the control group after 9 and 12 months treatment(P<0.05);④No serious adverse reactions occurred in the two groups.Conclusion Migu granules combined with alendronate D3 tablets in the treatment of osteoporosis can effectively reduce the rate of bone turnover,and also promote osteogenesis.It can increase the BMD of the lumbar spine,maintain the BMD of hip,reduce bone loss,reduce patient pain,improve the quality of life.There are no adverse reactions and liver and kidney damage,and it has good safety.

关 键 词：骨质疏松症 密骨颗粒 阿仑膦酸钠维D3片 实用性随机对照 临床研究 

分 类 号：R274[医药卫生—中医骨伤科学]