人工虎骨粉胶囊治疗骨量低下与原发性骨质疏松症的多中心临床研究  

Multicenter clinical trial of artificial tiger bone capsules in the treatment of osteopenia and osteoporosis

作　　者：陈志刚[1] 梁志齐[1] 崔岩峥[1] 林华 雷闽湘[3] 沈霖 郝永强[5] 韩萍[6] 贺良[1] CHEN Zhi - gang;LIANG Zhi - qi;CUI Yan- zheng;LIN Hua;LEI Min - xiang;SHEN Lin;HAO Yong - qiang;HAN Ping;HE Liang(Clinical Trial Center, Beijing JishuitanHospital , Beijing 100035, China;Department of Orthopedics, Nanjing Drum Tower Hospital, Nanjing 210008, China;Department of Endocrinology,Xiangya Hospital, Central South University, Changsha 410008, China;Department of Orthopedics, Combination of Chinese Traditional and Western medicine, Wuhan Union Hospital, Tongji Medical College, Wuhan 430022, China;Department of Orthopedics, Shanghai Ninth People＇s Hospital, Shanghai Jiaotong University, Shanghai 200011, China;Department of Endocrinology, ShengiingHospital of China Medical University, Shenyang 110022, China)

机构地区：[1]北京积水潭医院临床试验中心,北京100035 [2]南京鼓楼医院骨科,南京210008 [3]中南大学湘雅医院内分泌科,长沙410008 [4]武汉同济医学院附属协和医院中西医结合骨科,武汉430022 [5]上海交通大学附属第九人民医院骨科,上海200011 [6]中国医科大学附属盛京医院内分泌科,沈阳110022

出　　处：《中国临床药理学杂志》2018年第13期1514-1516,1524,共4页The Chinese Journal of Clinical Pharmacology

基　　金：北京市人社部出国人员留学基金资助项目(J201202号)

摘　　要：目的观察人工虎骨粉胶囊治疗骨量低下与原发性骨质疏松症的临床疗效及安全性。方法入选120例受试者,并予以人工虎骨粉胶囊每次1.2 g,tid,口服,连续52周。用双能X线吸收仪(DXA)法测定骨密度(BMD),统计其临床疗效和药物不良反应的发生情况。结果与基线比较,治疗52周后腰椎(L2-L4)BMD提高1.15%,符合方案数据集(PPS)的总有效率为81.73%(85例/104例)。研究期间未出现明显与药物有关的药物不良反应。结论人工虎骨粉胶囊用于骨量低下与原发性骨质疏松症的治疗,可抑制BMD下降,但未能显著提高腰椎和和股骨颈的BMD,可有效缓解骨质疏松症的主要临床症状,从而改善患者生活质量,且安全性较高。Objective To observe the clinical efficacy and safety of artificial tiger bone capsules in the treatment of osteopenia and osteoporosis.Methods A total of 120 subjects were selected according to the inclusion criteria and treated with the artificial tiger bone capsule 1. 2 g per time for 52 weeks in 6 hospitals. The bone mineral density（ BMD） was measured by DXA at baseline and follow-up to statistic its clinical efficacy and the occurrence of adverse drug reactions. Results Compared with baseline,after 52 weeks of treatment,the BMD of lumbar spine（ L2-L4） increased by 1. 15%,the total clinical effective rate of PPS was 81. 73%（ 85 cases/104 cases）. There was no drug-related adverse drug reaction during the study. Conclusion The artificial tiger bone capsule could restrain the decline trend of BMD but failed to significantly improve the lumbar and femoral neck BMD. Besides,it could effectively alleviate the symptoms of osteoporosis to achieve the desired therapeutic goal,improve the quality of life of patients.

关 键 词：人工虎骨粉胶囊 骨量低下 骨质疏松 目标值 

分 类 号：R97[医药卫生—药品]