国产米诺膦酸片治疗绝经后骨质疏松症的随机、双盲、安慰剂对照多中心临床研究  

A randomized double-blinded placebo-controlled clinical trial of minodronate tablet in postmenopausal Chinese women with osteoporosis

作　　者：彭超[1] 田融[2] 李玲[3] 朱亦堃[4] 李淑英[5] 叶山东[6] 贺良[7] 牛佳鹏[8] 章秋[9] 周应芳[1] Peng Chao;Tian Rong;Li Ling;Zhu Yikun;Li Shuying;Ye Shandong;He Liang;Niu Jiapeng;Zhang Qiu;Zhou Yingfang(Department of Obstetrics and Gynecology,Peking University First Hospital,Beijing 100034,China;Department of Orthopedics,Tianjin People′s Hospital,Tianjin 300121,China;Department of Endocrinology,Shengjing Hospital of China Medical University,Shenyang 110004,China;Department of Endocrinology,The Second Hospital of Shanxi Medical University,Taiyuan 030001,China;Department of Endocrinology,Tianjin Medical University General Hospital,Tianjin 300052,China;Department of Endocrinology,Anhui Provincial Hospital,Hefei 230001,China;Department of Orthopedics,Beijing Jishuitan Hospital,Beijing 100035,China;Department of Endocrinology,The Affiliated Hospital of Qingdao University,Qingdao 266003,China;Department of Endocrinology,First Affiliated Hospital of Anhui Medical University,Hefei 230022,China)

机构地区：[1]北京大学第一医院妇产科,北京100034 [2]天津市人民医院骨科,天津300121 [3]中国医科大学附属盛京医院内分泌科,沈阳110004 [4]山西医科大学第二医院内分泌科,太原030001 [5]天津医科大学总医院内分泌科,天津300052 [6]安徽省立医院内分泌科,合肥230001 [7]北京积水潭医院骨科,北京100035 [8]青岛大学附属医院内分泌科,青岛266003 [9]安徽医科大学第一附属医院内分泌科,合肥230022

出　　处：《中华妇产科杂志》2022年第5期346-351,共6页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的评价国产米诺膦酸片治疗绝经后骨质疏松症患者的有效性和安全性。方法采用多中心、随机、双盲、平行对照研究,将262例绝经后骨质疏松症患者采用中央随机化分为试验组(130例)和对照组(132例),以碳酸钙D3咀嚼片为基础用药,试验组给予国产米诺膦酸片每天1 mg,对照组给予安慰剂每天1片,试验疗程共48周。观察两组患者治疗前后腰椎平均骨密度变化率、椎体骨折发生率以及不良事件和不良反应发生情况。结果治疗48周,受试者腰椎平均骨密度较基线的变化率,全分析集结果:试验组为(3.52±4.82)%,对照组为(2.00±5.74)%;符合方案分析集结果:试验组为(3.99±5.05)%,对照组为(2.07±6.20)%;在全分析集和符合方案分析集,两组分别比较,差异均有统计学意义(P均<0.05)。治疗48周,椎体骨折发生率对照组为2.3%(3/132),试验组为0.8%(1/130),差异无统计学意义(P>0.05)。用药48周不良事件发生率试验组与对照组分别为71.5%(93/130)、78.0%(103/132),不良反应发生率试验组与对照组分别为23.8%(31/130)、28.8%(38/132),两组分别比较,差异均无统计学意义(P均>0.05)。结论国产米诺膦酸片治疗绝经后骨质疏松症安全有效。Objective To verify the efficacy and safety of daily oral minodronate in postmenopausal women with established osteoporosis.Methods In this randomized,double-blinded,placebo-controlled trial,262 postmenopausal women were enrolled.Patients were randomized to receive daily oral minodronate 1 mg with supplements of 500 mg calcium and 200 U vitamin D3(n=130)or placebo(n=132)with daily supplements of 500 mg calcium and 200 U vitamin D3,for 48 weeks.The primary endpoint was the average bone mineral density(BMD)change in the lumbar vertebrae 48 weeks post-treatment.Secondary outcome measures was the incidence of vertebral fractures.Safety assessments included the rate of adverse events.Results At the end of 48 weeks treatment,the average BMD change rate from baseline were:full analysis set results:(3.52±4.82)%in the minodronate group and(2.00±5.74)%in the placebo group;per-protocol set results:(3.99±5.05)%in the minodronate group and(2.07±6.20)%in the placebo group;the differences were all significant(all P<0.05).Vertebral fracture occured in 3 patients(2.3%,3/132)in the placebo group,and 1 case(0.8%,1/130)in the minodronate group(P>0.05).The incidence of adverse events was 71.5%(93/130)in the minodronate group and 78.0%(103/132)in the placebo group(P>0.05).Conclusion Minodronate is effective and safe in the treatment of postmenopausal osteoporosis without severe side effects.

关 键 词：骨质疏松 绝经后 二膦酸盐类 随机对照试验 安慰剂 临床研究 

分 类 号：R580[医药卫生—内分泌]