Efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis： a meta-analysis

ZHAN Hedao; YAO Jiangling; CUI Hongwang

doi:10.6039/j.issn.1001-0408.2023.11.19

您当前的位置：

首页 >

文章列表页 >

Efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis： a meta-analysis

更新时间：2023-06-09

- Efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis： a meta-analysis
- ZHONGGUO YAOFANG Vol. 34, Issue 11, Pages: 1384-1388(2023)
- 作者机构：
  
  海南医学院第一附属医院急诊和创伤外科，海口　570102
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.11.19
  CLC： R681;R979.1+9
- Published：15 June 2023，
  
  Received：20 October 2022，
  
  Revised：15 March 2023，
扫描看全文
詹和道,姚江凌,崔红旺.地诺单抗对比双膦酸盐类治疗骨质疏松有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(11):1384-1388.

ZHAN Hedao,YAO Jiangling,CUI Hongwang.Efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis： a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(11):1384-1388.
詹和道,姚江凌,崔红旺.地诺单抗对比双膦酸盐类治疗骨质疏松有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(11):1384-1388. DOI： 10.6039/j.issn.1001-0408.2023.11.19.

ZHAN Hedao,YAO Jiangling,CUI Hongwang.Efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis： a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(11):1384-1388. DOI： 10.6039/j.issn.1001-0408.2023.11.19.

摘要

目的

系统评价地诺单抗对比双膦酸盐类治疗骨质疏松的有效性和安全性，为临床治疗提供循证参考。

方法

计算机检索PubMed、Embase、Medline、the Cochrane Library、中国期刊全文数据库、中文科技期刊数据库、万方数据库，检索时限为2012年1月－2022年12月，收集地诺单抗（试验组）对比双膦酸盐类（对照组）治疗骨质疏松的随机对照试验，对纳入的临床研究进行资料提取后，采用Cochrane系统评价手册5.1.0版进行质量评价，采用RevMan 5.3软件进行Meta分析。

结果

共纳入6项研究，共计3 145例患者。Meta分析结果显示，试验组患者腰椎骨密度改善程度 [MD＝1.78，95%CI（1.13，2.43），

＜0.000 01]、股骨颈骨密度改善程度[MD＝1.26，95%CI（1.08，1.45），

＜0.000 01]、全髋骨密度改善程度[MD＝1.16，95%CI（0.93，1.39），

＜0.000 01]均显著优于对照组；试验组患者治疗6个月后Ⅰ型胶原C末端肽水平[MD＝－0.09，95%CI（－0.16，－0.02），

＝0.01]、12个月后Ⅰ型前胶原N末端肽水平[MD＝－9.07，95%CI（－11.22，－6.92），

＜0.001]均显著高于对照组。两组患者治疗12个月后骨折发生率[OR＝1.02，95%CI（0.67，1.54），

＝0.92]、不良反应发生率[OR＝0.99，95%CI（0.67，1.46），

＝0.97]比较，差异无统计学意义。

结论

地诺单抗对比双膦酸盐治疗骨质疏松在提高骨密度、改善骨代谢方面更具有优势。

Abstract

OBJECTIVE

To systematically evaluate the efficacy and safety of denosumab versus bisphosphonates in the treatment of osteoporosis， and to provide evidence-based reference for clinical treatment.

METHODS

Randomized controlled trials （RCTs） about denosumab （trial group） versus bisphosphonates （control group） in the treatment of osteoporosis were retrieved from PubMed， Embase， Medline， the Cochrane Library， Chinese Journal Fulltext Database， Chinese Science and Technology Journal Database， Wanfang database from January 2012 to December 2022. After the data extraction of included clinical studies， the quality of included studies was evaluated with Cochrane Handbook for Systematic Review 5.1.0， and meta-analysis was performed by using RevMan 5.3 software.

RESULTS

A total of 6 RCTs were included， involving 3 145 patients. Meta-analysis showed that the improvement rate of lumbar bone mineral density （BMD） [MD＝1.78， 95%CI（1.13， 2.43），

＜0.000 01]， femoral neck BMD [MD＝1.26， 95%CI （1.08， 1.45），

＜0.000 01] and total hip BMD [MD＝1.16，95%CI（0.93，1.39），

＜0.000 01] in trial group were significantly better than control group. C-terminal telopeptide of type Ⅰ collagen after 6 months [MD＝－0.09， 95%CI （－0.16，－0.02），

＝0.01] and N-terminal propeptide of type Ⅰ collagen after 12 months [MD＝－9.07， 95%CI （－11.22，－6.92），

＜0.001] in trial group were significantly higher than control group. There was no statistical difference in the fracture incidence rate after 12 months [OR＝1.02， 95%CI （0.67，1.54），

＝0.92] and the incidence of adverse reaction [OR＝0.99， 95%CI （0.67，1.46），

＝0.97] between 2 groups.

CONCLUSIONS

Denosumab has more advantages in improving BMD and bone metabolism， compared with bisphosphonates.

关键词

骨质疏松地诺单抗双膦酸盐骨密度骨代谢Meta分析

Keywords

dinomumabbisphosphonatesbone mineral densitybone metabolismmeta-analysis

references

中华医学会，中华医学会杂志社，中华医学会全科医学分会，等. 原发性骨质疏松症基层诊疗指南：2019年[J]. 中华全科医师杂志，2020，19（4）：304-315.

王琳琳，李虎虎，戴永娜. 骨质疏松症流行病学与中药新药研发机遇研究[J]. 中国处方药，2022，20（9）：1-4.

MCCLATCHEY K D. Musculoskeletal conditions affect millions[J]. Arch Pathol Lab Med，2004，128（4）：480.

DRAKE M T，CLARKE B L，KHOSLA S. Bisphosphonates：mechanism of action and role in clinical practice[J]. Mayo Clin Proc，2008，83（9）：1032-1045.

LACEY D L，BOYLE W J，SIMONET W S，et al. Bench to bedside：elucidation of the OPG-RANK-RANKL pathway and the development of denosumab[J]. Nat Rev Drug Discov，2012，11（5）：401-419.

中国老年学学会骨质疏松委员会骨质疏松诊断标准学科组. 中国人原发性骨质疏松症诊断标准：试行[J]. 中国骨质疏松杂志，1999，5（1）：1-3.

刘海宁，吴昊，姚灿，等. Meta分析中连续性数据的深度提取方法[J]. 中国循证医学杂志，2017，17（1）：117-121.

RECKNOR C，CZERWINSKI E，BONE H G，et al. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy：a randomized open-label trial[J]. Obstet Gynecol，2013，121（6）：1291-1299.

NAKAMURA T，MATSUMOTO T，SUGIMOTO T，et al. Clinical trials express：fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis：denosumab fracture intervention randomized placebo controlled trial （DIRECT）[J]. J Clin Endocrinol Metab，2014，99（7）：2599-2607.

ROUX C. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy：efficacy and safety results from a randomized open-label study[J]. Bone，2014，58：48-54.

MILLER P D，PANNACCIULLI N，BROWN J P，et al. Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonates[J]. J Clin Endocrinol Metab，2016，101（8）：3163-3170.

NIIMI R，KONO T，NISHIHARA A，et al. Efficacy of switching from teriparatide to bisphosphonate or denosumab：a prospective，randomized，open-label trial[J]. JBMR Plus，2018，2（5）：289-294.

ANASTASILAKIS A D，POLYZOS S A，GKIOMISI A，et al. Denosumab versus zoledronic acid in patients pre- viously treated with zoledronic acid[J]. Osteoporos Int，2015，26（10）：2521-2527.

李辉，谢兴文，李宁，等. 细胞因子在骨质疏松症中的作用及中医药干预研究进展[J]. 中国实验方剂学杂志，2021，27（18）：227-233.

COSMAN F，DE BEUR S J，LEBOFF M S，et al. Clinician’s guide to prevention and treatment of osteoporosis[J]. Osteoporos Int，2014，25（10）：2359-2381.

QASEEM A，FORCIEA M A，MCLEAN R M，et al. Treatment of low bone density or osteoporosis to prevent fractures in men and women：a clinical practice guideline update from the American College of Physicians[J]. Ann Intern Med，2017，166（11）：818-839.

BARON R，FERRARI S，RUSSELL R G. Denosumab and bisphosphonates：different mechanisms of action and effects[J]. Bone，2011，48（4）：677-692.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Effects of ivabradine on vascular endothelial function in patients with coronary artery disease： a meta-analysis

Meta-analysis about ADRB1 Arg389Gly polymorphism on the efficacy of bisoprolol

Meta-analysis of efficacy and safety of aspirin versus other anticoagulants in the prevention of thromboembolism after orthopedic surgery

Meta-analysis of the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea

Systematic review and meta-analysis of health state utility for global patients with hemophilia

Related Author

CHEN Congling

YANG Xian

WU Han

YING Jiachen

ZHANG Ruobin

LAN Xi

ZHANG Jinping

ZHANG Tianqi

Related Institution

Dept. of Cardiology， Nanjing Drum Tower Hospital

School of Basic Medicine and Clinical Pharmacy， China Pharmaceutical University

Dept. of Pharmacy， Nanjing Drum Tower Hospital

Dept. of Pharmacy， Beijing Hospital/National Center of Gerontology/Institute of Geriatric Medicine， Chinese Academy of Medical Science/Beijing Key Laboratory of Assessment for Clinical Risk and Individual Application of Drugs

Dept. of Cardiology， General Hospital of Eastern Theater Command

Address：8/F,129 Daping Main Street,Yuzhong District,Chongqing 400042,P.R.China
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰