强骨胶囊治疗原发性骨质疏松症有效性和安全性的Meta分析  

Clinical outcomes and safety of Qianggu(强骨)capsules for treatment of primary osteoporosis:a meta-analysis

作　　者：杜国庆[1] 潘富伟 王玉鹏 石金玉 李正言[1] 廉由之 陆洁航 章振林[3] 詹红生[1] DU Guoqing;PAN Fuwei;WANG Yupeng;SHI Jinyu;LI Zhengyan;LIAN Youhi;LU Jiehang;ZHANG Zhen-lin;ZHAN Hongsheng(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Baoshan Hospital of Integrated Traditional Chinese and W esterm Medicine,Shanghai 201999,China;The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University,Shanghai 200233,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]上海市宝山区中西医结合医院,上海201999 [3]上海交通大学附属第六人民医院,上海200233

出　　处：《中医正骨》2023年第8期31-36,共6页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：《中成药治疗优势病种临床应用指南》标准化项目第三批优势病种指南子课题(SATCM-2015-BZ402-042);全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号);上海市2020年度“科技创新行动计划”医学创新研究专项项目(20MC1920600)。

摘　　要：目的:系统评价强骨胶囊治疗原发性骨质疏松症(primary osteoporosis,POP)的有效性和安全性。方法:应用计算机检索中国生物医学文献服务系统、万方数据库、中国知网、维普网、PubMed、Medline、Cochrane Library、Embase,筛选强骨胶囊治疗POP的随机对照试验,试验组采用强骨胶囊或强骨胶囊联合常规疗法治疗,对照组采用常规疗法治疗。采用Cochrane偏倚风险评估工具对纳入研究的文献进行质量评估,采用RevMan5.3软件进行Meta分析。结果:共检索到1434篇文献,通过逐层筛选最终纳入9篇文献,均为中文文献。Meta分析结果显示,2组腰椎骨密度、临床有效率、不良反应发生率比较,差异均无统计学意义[SMD=0.25,95%CI(-0.15,0.65),P=0.210;RR=1.10,95%CI(0.96,1.26),P=0.160;OR=1.53,95%CI(0.82,2.85),P=0.180],试验组股骨颈骨密度高于对照组[SMD=0.44,95%CI(0.16,0.71),P=0.002],骨痛积分低于对照组[MD=-1.00,95%CI(-1.50,-0.51),P=0.000]。结论:现有的证据表明,单独应用强骨胶囊或在常规疗法基础上联合应用强骨胶囊治疗POP,与单独应用常规疗法相比,在改善腰椎骨密度、临床综合疗效和安全性方面作用相当,但前者在缓解骨痛、改善股骨颈骨密度方面优于后者。Objective:To systemalically review the elinical outcomes and safey of Qianggu(强骨,QG)capsules in trealmenl of pimary osteporosis(P0P).Methods:All the randomized controlled trial(RCT)articles about QG capsules for treatment of POP included from da-tabase establishing to September 30,2022 were retrieved from Chinese Biomedical Literalure Service System,Wanfang Database,China Na tional Knowledge Intemet,Vip Database,PubMed,Medline,Cochrane Library and Embase through compuler.The paients in experimental group were treated with oral application of QG capsules or combination of oral application of QG capsules with conventional therapies,while the ones in control group with conventional thenapies alone.The methodological quality of researches in the articles was evaluated by using Cochrane bias risk assessment tools,and then a Meta-analysis was conducted by using RevMan5.3 software.Results:One thousand four hundred and hirty-four articles were searched out.Afer screening,9 Chinese articles(803 patients)were included in the final analysis.443 patients in experimental group and 360 ones in control group.The results of Meta-analys is revealed that there was no statistical difference in bone mineral density(BMD)of lumbar vertebrae,elinical eficacey alte and incidence male of adverse reactions between the 2 groups(SMD=0.25,95%CI(-0.15,0.65),P=0.210;RR=1.10,95%CI(0.96,1.26),P=0.160;0R=1.53.95%CI(0.82,2.85),P=0.180),while the BMD of femoral neck was higher,the bone pain score was lower in experimental group compared to control group(SMD=0.44,95%CI(0.16,0.71),P=0.002;MD=-1.0095%CI(-1.50,-0.51),P=0.000).Conclusion:Available evidences suggest that oral application of QG capsules alone or combination of oral application of QG capsules with conventional therapy is similar to conventional ther-apy alone in improving BMD of lumbar vertebrae,total clinical curative efects and safety in trealment of POP,however,the fommer is better than the later in relieving bone pain and improving BMD of fenoral neck.

关 键 词：骨质疏松 强骨胶囊 专题Meta分析 有效性 安全性 

分 类 号：R259[医药卫生—中西医结合]