唑来膦酸注射液治疗糖尿病性骨质疏松疗效以及安全性Meta分析

Meta-analysis on Zoledronic Acid Injection for Treatment of Diabetic Osteoporosis

目的:评价唑来膦酸注射液治疗糖尿病性骨质疏松(Diabetic Osteoporosis,DO)的临床疗效及安全性。方法:依据Meta分析要求,对CBM、CNKI、PubMed、Springer、Embase Databases、Cochrane Library、中国科技论文统计与分析网、专利数据库等进行检索,纳入以唑来膦酸注射液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对有效性、骨密度进行系统评价。结果:最终纳入12篇文献,受试者共1034例。Meta分析结果显示,治疗组各项血液指标[包括血钙、血磷、血清I型胶原C末端肽(s-CTX)、抗酒石酸酸性磷酸酶(TRACP-5b)、血清骨钙素蛋白(BGP)]显著优于对照组,差异具有统计学意义。治疗组不同部位的视觉模拟评分(VAS)、骨密度值(腰椎、股骨颈、股骨大转子、华氏三角区)的改善情况显著优于对照组,差异有统计学意义。6篇文献发现明确的唑来膦酸注射液引起的药品不良反应,且对症治疗后症状均可消失。结论:唑来膦酸注射液对治疗DO有一定疗效,且具有一定安全性,但还需更多高质量的RCT进行分析才能对其疗效及安全性得出肯定性结论。

Objective:To systematically evaluate the efficacy of Zoledronic Acid Injection in the treatment of diabetic osteoporosis.Methods:According to Meta-analysis requirements,papers were searched in CBM,CNKI,PubMed,Springer,Embase Databases,Cochrane Library,Chinese Technical Paper Statistics and Analysis,Patent Databases,etc,and brought into clinical studies on the treatment of primary diabetic osteoporosis with Zoledronic Acid Injection as the main intervention measure from database founded to August 2018.All the information were 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)are evaluated systematically by using the Review Manager 5.3.Results:12 references were finally included,and a total of 1034 subjects were enrolled.Meta-analysis showed that the treatment group in the blood of the indicators(including blood calcium,blood phosphorus,s-CTX,TRACP-5 b,BGP)significantly better than the control group,the difference had statistical meaning.The improvement of visual analogue score(VAS),bone mineral density(lumbar spine,femoral neck,femur big rotor and Fahrenheit triangle)in different parts of the treatment group was significantly better than that of the control group,and the difference was statistically justified.The adverse drug reactions caused by Zoledronic Acid Injection were found in 6 literatures,and symptoms disappeared after symptomatic treatment.Conclusion:Zoledronic Acid Injection has a certain effect on the treatment of DO,and has a certain degree of safety,but more high-quality RCTs are needed for analysis to reach a positive conclusion on its efficacy and safety.