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目的通过对随机和类随机对照试验的系统综述,评价NaFeEDTA改善铁缺乏的效果和安全性。方法通过检索电子数据库、手工检索相关期刊与书籍、收集灰色文献、查找会议摘要、联系相关领域专家、检索互联网,并通过查找参考文献和引文进行了全面的文献检索;使用Cochrane EPOC制定的标准对纳入研究的质量进行了评价;使用自行设计的表格提取了有关的数据;使用广义倒方差法对各结局的纳入研究进行了meta分析,通过亚组分析和meta回归调查了异质性的可能来源。结果在铁缺乏人群,NaFeEDTA可以使血红蛋白浓度增加12.14g/L(95%可信区间5.60-18.69;P<0.001),使血清铁蛋白浓度增加1.70μg/L(95%可信区间1.20-2.34;P=0.003)。亚组分析和meta回归提示更低的基线血红蛋白浓度、更高的干预剂量可能导致更大的血红蛋白浓度增加。结论NaFeEDTA可以显著改善铁缺乏人群的血红蛋白浓度和血清铁蛋白浓度,并且基线血红蛋白浓度越低、干预剂量越高,这种改善效果越大。未发现NaFeEDTA可能的有害效应。
Objective To evaluate the efficacy and safety of NaFeEDTA in improving iron deficiency through a systematic review of randomized and randomized controlled trials. The method by searching electronic databases, manual searches of relevant journals and books, collecting gray literature, look for conference abstracts, contact the relevant experts in the field to retrieve the Internet, and conducted a comprehensive literature search by looking for references and citations; using Cochrane EPOC criteria established for quality of the included studies were evaluated; using self-designed tables to extract data related to; the outcome of each of the included studies were meta-analysis using the generic inverse variance method, by subgroup analyzes and meta-regression investigating the possible source of heterogeneity . The results in iron deficiency population, NaFeEDTA hemoglobin concentration can be increased 12.14g / L (95% CI 5.60-18.69; P <0.001), serum ferritin concentrations increase 1.70μg / L (95% confidence interval 1.20-2.34 ; P = 0.003). Subgroup analyzes and meta-regression suggest lower baseline hemoglobin concentrations, and higher intervention doses may result in greater hemoglobin concentration increases. Conclusion NaFeEDTA can significantly improve hemoglobin concentration and serum ferritin concentration in iron-deficient population, and the lower the baseline hemoglobin concentration, the higher the intervention dose, the greater the improvement effect. No possible adverse effects of NaFeEDTA were found.