基于中医学“治未病”理论研究密骨颗粒治疗骨量减少的多中心临床试验  

A Pragmatic Multi-Centered Randomized Controlled Trial: Intervention of Osteopenia with the Use of Migu Granule Based on the Theory of “Preventive Treatment of Disease” in Chinese Medicine

作　　者：许金海[1] 王国栋[1] 叶洁[1] 马传凤 夏烨[1] 沈琪幸 闵鸿祥 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] Xu Jinhai;Wang Guodong;Ye Jie;Ma Chuanfeng;Xia Ye;Shen Qixing;Mei Yinan;Fang Yabei;Wang Shengbao;Fan Chunlan;Wang Yi;Dong Yi;Wang Yongjun;Mo Wen;Shi Qi(Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Institute of Spine Disease,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Qingpu District TCM Hospital,Shanghai 201700,China;Pengpu New Village Community Health Service Center,Shanghai 200040,China;Pudong New District Shanggang Community Health Service Center,Shanghai 201315,China;Pudong New District Nan Matou Community Health Service Center,Shanghai 201204,China;Pudong New District Yangjing Community Health Service Center,Shanghai 200135,China;Baoshan District Dcichang Community Health Service Center,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：《世界科学技术-中医药现代化》2019年第11期2436-2442,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：上海市申康项目(16CR3074B):健腰密骨颗粒治疗骨量减少性腰痛的多中心临床研究,负责人:叶洁;上海市卫计委项目(ZY3-LCPT-1-1003):上海市骨退行性病中医临床研究基地建设,负责人:莫文;国家自然科学基金委员会(81603635):芪麝丸调控NF-kB介导COX-2/PGE2信号通路降低根性神经痛的作用机制,负责人:叶洁;上海市科委项目(16401930600):筋痹颗粒异病同治慢性筋骨病的随机双盲、双糢拟、平行对照临床研究,负责人:叶洁;上海市卫计委项目(ZYKC201701003):骨质疏松症社区-综合医院防治网络的运作与远程互动管理,负责人:莫文;上海市卫计委项目(ZY(2018-2020)-FWTX-4002):上海市中医骨伤科联盟建设,负责人:莫文;上海市卫计委项目(20164Y81):脊柱骨盆矢状位平衡对腰椎间盘突出症发病的影响及功能锻炼的干预作用,负责人:许金海.

摘　　要：目的探讨密骨颗粒治疗骨量减少的有效性及临床应用的安全性。方法采用实用性随机对照方法,将6家分中心分为试验组和对照组,试验组给予密骨颗粒,对照组给予钙尔奇D,疗程为12个月,治疗前、治疗后6、12月时行骨代谢、骨密度、血常规、肝肾功能等检查,并记录VAS与SF-36评分,观察患者的不良反应。结果①两组患者腰椎BMD值治疗前后无变化;试验组髋部BMD在治疗12月时优于对照组(P <0.05)。②两组患者骨代谢比较,PTH、β-CTX、BGP、S-Ca与治疗前比较均有上升(P <0.05),组间比较差异无统计学意义(P> 0.05);25-羟维生素D(25-Hydroxyvitamin D,25-OH-D)治疗6、12月均有下降(P <0.05);PINP试验组无变化,对照组在治疗后6、12月均有下降(P <0.05);ALP两组治疗前后均无变化(P>0.05);试验组S-P在治疗后12月时升高(P <0.05),对照组无明显变化(P> 0.05)。③两组患者治疗后6、9、12月腰痛VAS评分均下降(P <0.05),组间比较差异均无统计学意义(P> 0.05)。试验组在治疗9、12月后患者的SF-36PCS及MCS功能评分高于对照组,差异有统计学意义(P <0.05);④两组均未出现严重不良反应。结论密骨颗粒可以增加髋骨骨量,减少骨量丢失,降低患者躯体疼痛,提高患者的生活质量,并且有较好的安全性。Objective To evaluate the effectiveness and side-effect of treatment with Migu Granules for treatment of osteopenia. Methods The 6 clinical centers were divided into a treatment group(n=118) and a control group(n=73). The patients in the treatment group were treated with Migu Granule. Calcium D 600 was used in the control group. Patients received intervention for 6-months, and follow-up were conducted every 3 months and changes in VAS, SF-36 were recorded. Tests for changes in Bone Mass Density(BMD), bone metabolism indicators, blood routine test, liver and kidney function were carried out on the 6 th,12 thmonth into intervention. Results ①There was no change in lumbar spine BMD before and after treatment in the 2 groups. The hip BMD in the treatment group was higher than that in the control group at 12 months after treatment(P < 0.05). ② PTH, beta-CTX, BGP and S-Ca in the 2 groups increased in 6 months and 12 months after treatment(P < 0.05), but there was no significant difference between the 2 groups at different time points(P > 0.05);25-hydroxyvitamin D decreased in 6 months and 12 months after treatment(P < 0.05);PINP in the treatment group was not significantly changed, while that in the control group was significantly decreased in 6 months and 12 months after treatment(P < 0.05);ALP in the 2 groups had no change before and after treatment(P > 0.05);S-P in the treatment group increased in 12 months after treatment(P < 0.05), while that in the control group had no significant change(P > 0.05). ③The VAS scores of lumbar back pain in the 2 groups decreased after treatment in 6, 9 and 12 months(P < 0.05), but there was no significant difference between the 2 groups at different time points(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 2 groups. Conclusion Migu Granule can prevent the loss of bone mass in patients with osteopenia, improve physical pain and improve the

关 键 词：骨量减少 健腰密骨颗粒 实用性随机对照 临床研究 

分 类 号：R2-031[医药卫生—中西医结合]