中国组织工程研究

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    下一篇

口服阿伦膦酸钠联合注射用骨肽治疗原发性骨质疏松症的Meta分析

林基勇1,黄 兰1,梁凤珍1,尚昱志1,张青槐2,方 刚2,庞宇舟2   

  1. 1广西中医药大学研究生学院,广西壮族自治区南宁市 530001;2广西中医药大学,广西壮族自治区南宁市  530001
  • 出版日期:2019-04-28 发布日期:2019-04-28
  • 通讯作者: 庞宇舟,教授,博士生导师,广西中医药大学,广西壮族自治区南宁市 530001
  • 作者简介:林基勇,男,1988年生,广东省揭阳市人,广西中医药大学在读硕士,主要从事中医药、民族医药临床与药物的研究。
  • 基金资助:

    国家自然科学基金资助项目(81460765,81674097),项目负责人:庞宇舟;广西中医药大学岐黄工程高层次人才团队培育项目资助(2018005),项目负责人:方刚

Combination of alendronate sodium tablets and ossotide for injection for primary osteoporosis: a meta-analysis  

Lin Jiyong1, Huang Lan1, Liang Fengzhen1, Shang Yuzhi1, Zhang Qinghuai2, Fang Gang2, Pang Yuzhou2   

  1. 1Graduate School of Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China; 2Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China
  • Online:2019-04-28 Published:2019-04-28
  • Contact: Pang Yuzhou, Professor, Doctoral supervisor, Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China
  • About author:Lin Jiyong, Master candidate, Graduate School of Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China
  • Supported by:

    the National Natural Science Foundation of China, No. 81460765 and 81674097 (to PYZ); the Qihuang Engineering High-level Talent Team Training Project of Guangxi University of Chinese Medicine, No. 2018005 (to FG)

摘要:

文章快速阅读:

文题释义:

循证医学:循证医学的核心思想是在医疗决策中将临床证据、个人经验与患者的实际状况和意愿三者相结合。临床证据主要来自大样本的随机对照临床试验(randomized controlled trial,RCT)和系统性评价(systematic review)或荟萃分析(meta-analysis)。
偏倚:测量学中偏倚是指一切测量值对真值的偏离。包括测量仪器的不准,样本过小,试验设计不合理,分配或分组不均衡,抽样未随机,测量者有主观倾向等。医学研究中偏倚是指在临床研究中,研究结果总是会或多或少的偏离真实情况,这种偏离称之为误差(error)。在不同的学科中对偏倚的解释差别不大,统指与目标有所偏离的意思。
 
摘要
背景:阿伦膦酸钠联合注射用骨肽治疗原发性骨质疏松症临床运用较多,但缺乏足够的循证医学依据。
目的:系统评价口服阿伦膦酸钠联合注射用骨肽治疗原发性骨质疏松症的疗效及安全性。
方法:检索发表在Cochrane、Web of Science、PubMed、CBM、中国知网(CNKI)、万方数据库(“wanfang”Data)、维普中文科技期刊全文数据库(VIP)从2008年8月到2018年8月15日期间公开发表的相关文献,由2名评价者对相关文献进行筛选、数据提取及质量评价,采用Review manager 5.3软件对纳入文献进行Meta分析。
结果与结论:①13个RCTs共1 579例患者纳入研究,其中试验组792例(采用阿仑膦酸钠片+注射用骨肽+碳酸钙D3片或阿仑膦酸钠片+注射用骨肽治疗),对照组787例(采用阿仑膦酸钠片+碳酸钙D3片或碳酸钙D3片治疗)。Meta分析结果显示,队列效应量OR值为5.67,95%CI为[4.02,8.00],两组疗效比较差异有显著性意义(P < 0.000 01);治疗组有效率(94.44%) > 对照组有效率(74.97%),口服阿伦膦酸钠联合注射用骨肽治疗原发性骨质疏松症的综合疗效明显优于对照组;②口服阿伦膦酸钠联合注射用骨肽可能具有提升原发性骨质疏松症治疗效果的作用,但受到目前纳入文献质量较低、临床研究随机方法描述不够具体及多数临床研究缺乏随访等因素的局限,口服阿伦膦酸钠联合注射用骨肽治疗原发性骨质疏松症的疗效还需进一步验证。

中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱骨折;内固定;数字化骨科;组织工程
ORCID: 0000-0003-4592-324X(林基勇)

关键词: 阿伦膦酸钠联合注射用骨肽, 原发性骨质疏松症, 骨肽, 随机对照, Meta分析, 组织构建

Abstract:

BACKGROUND: Alendronate combined with injection of ossotide has been extensively applied in the treatment of primary osteoporosis, but there is still lack of evidence-based medicine.

OBJECTIVE: To systematically evaluate the efficacy and safety of alendronate combined with injection of ossotide for primary osteoporosis.
METHODS: Cochrane, Web of Science, PubMed, CBM, CNKI, WanFang, and VIP databases were retrieved for the articles published from August 2008 to August 15, 2018. Literature screening, data extraction, and quality evaluation were conducted by two reviewers. Meta-analysis was undergone on Review manager 5.3 software.
RESULTS AND CONCLUSION: (1) Thirteen randomized controlled trials involving 1 579 patients were included, including trial group (n=792, alendronate sodium tablets + ossotide for injection + calcium carbonate and vitamin D3 tablets, or alendronate sodium tablets + ossotide for injection) and control group (n=787, alendronate sodium tablets + calcium carbonate and vitamin D3 tablets, or calcium carbonate and vitamin D3 tablets). The results of meta-analysis showed that the OR value of cohort effect was 5.67, and 95%CI was [4.02, 8.00]. The efficacy between two groups was differently different (P < 0.000 01). The effective rate in the trial group (94.44%) was higher than that in the control group (74.97%). The total curative efficacy of alendronate sodium tablets combined with ossotide for injection in the treatment of primary osteoporosis was significantly superior to the control group. (2) Alendronate sodium tablets combined with ossotide for injection can improve the curative efficacy in the treatment of primary osteoporosis. However, due to the low quality of literature, unclear clinical trial randomized methods, and follow-up deficiency, the treatment outcome of the combination of alendronate sodium tablets and ossotide for injection for primary osteoporosis still needs a further investigation.

Key words: Diphosphonates, Osteoporosis, Meta-Analysis, Tissue Engineering

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