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

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

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:(1)13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。

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.