摘要
目的系统评价使用骨肽注射液治疗原发性骨质疏松症的有效性。方法依据Meta分析要求,在CBM、CNKI、PubMed、Springer、Embase databases、Cochrane Library、维普、万方、中国科技论文统计与分析网、专利数据库等网站上进行检索,纳入以骨肽注射剂作为主要干预措施治疗原发性骨质疏松症临床试验的研究文献,检索年限从建库至2018年8月,检索资料由两名研究人员独立进行提取,若有分歧,则由第三方协助并解决;采用Review Manager 5.3、Stata/IC 15.0、R语言对有效性、骨密度进行系统评价。结果最终纳入20篇文献,受试者共2 230人,有6篇文献报道了不良反应;有16篇文献报道了总有效率Chi^2=16.98,I^2=12%,P=0.32>0.1;OR=6.17,95%CI(4.74,8.04),P<0.01,差异有统计学意义。经漏斗图分析、Egger、Begg’s检验表明不存在明显发表偏倚;有10篇文献报道了用药后骨密度的变化情况,发现治疗后的腰椎骨密度异质性较大,采用亚组分析、Galbraith异质性检验分析以及Meta回归分析来寻找异质性来源;有6篇文献报道了治疗后髋部骨密度分析情况,SMD=0.18,95%CI(0.02,0.34),Z=2.20,P=0.03<0.05,其差异具有统计学意义。结论骨肽注射剂对治疗原发性骨质疏松症着实有效,安全性较高。
Objective To systematically evaluate the efficacy of ossotide injection in the treatment of primary osteoporosis. Methods According to meta-analysis requirements, data in CBM, CNKI, PubMed, Springer, Embase databases, Cochrane Library, Chinese technical paper statistics and analysis, and patent databases were searched. The clinical studies on the treatment of primary osteoporosis with ossotide injection as the main intervention measure were enrolled from database founded to August 2018. All the information was extracted independently by two researchers and assisted and resolved by a third party if there gets some disagreement. The effectiveness and bone mineral density(BMD) were evaluated systematically by using the software named Review Manager 5.3, Stata/IC 15.0 and R language. Results Twenty literatures were finally included, and a total of 2,230 subjects are enrolled. Adverse reactions were reported in6 studies. The total effective rate was reported in 16 literatures, Chi^2=16.98, I^2=12%, P=0.32>0.1, OR=6.17, 95% CI(4.74,8.04), P<0.01, and the difference was statistically significant. Funnel plot, Egger, and Begg’s test showed no obvious publication bias. The changes of BMD after taking the medication were reported in 10 literatures, showing that the heterogeneity of BMD of lumbar vertebrae after treatment is greater. Subgroup analysis, Galbraith heterogeneity test analysis, and Meta regression analysis were used to find the sources of heterogeneity. There were 6 literatures that reported the BMD analysis of the hip, SMD=0.18, 95% CI(0.02,0.34), Z=2.20, P=0.03<0.05, and the difference was statistically significant. Conclusion Ossotide injection is effective and safe in the treatment of primary osteoporosis.
作者
杨杰
孙宇
陈崇民
YANG Jie;SUN Yu;CHEN Chongmin(Liaoning University of Traditional Chinese Medicine,Shenyang 110000;Shenyang Hospital of Orthopedics,Shenyang 110000,China)
出处
《中国骨质疏松杂志》
CAS
CSCD
北大核心
2019年第5期721-732,共12页
Chinese Journal of Osteoporosis
