多糖铁复合物治疗肾性贫血的有效性和安全性的meta分析

目的 系统评价多糖铁复合物（polysaccharide iron complex，PIC）治疗肾性贫血的有效性及安全性，为临床提供循证参考。方法 计算机检索PubMed、Embase、Cochrane Library、CNKI、WanFang Data和CBM等数据库，查找PIC对比其他口服铁剂治疗肾性贫血的随机对照试验文献，检索时限均为建库至2018年5月。由2位研究员按纳入与排除标准独立进行文献筛选、资料提取和偏倚风险评价，后采用ReMan5.3软件进行meta分析。结果 共纳入7项研究，包括642例患者（试验组354例，对照组288例）。Meta分析结果显示：与硫酸亚铁/琥珀酸亚铁相比，PIC治疗肾性贫血的临床有效性（P=0.02）、显效性（P<0.000 01）更好；PIC能明显改善患者的血红蛋白（P=0.02）、血清铁蛋白（P=0.009）、转铁蛋白饱和度（P<0.000 01）、红细胞压积（P=0.002）和红细胞（P=0.04）各项实验室指标；PIC的不良事件更少：恶心/呕吐（P<0.000 01）、腹痛/烧灼感（P=0.000 1）、便秘/腹泻（P=0.000 2）。结论 与硫酸亚铁/琥珀酸亚铁相比，PIC治疗肾性贫血具有更好的临床疗效及安全性。

Efficacy and Safety of Polysaccharide Iron Complex in the Treatment of Renal Anemia: A Meta-analysis

OBJECTIVE To systematically evaluate the efficacy and safety of polysaccharide iron complex for patients with renal anemia. METHODS PubMed, Embase, Cochrane Library, CNKI, WanFang Data and CBM were searched from their inception to May 2018. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.RESULTS A total of 7 RCTs involving 642 patients (354 patients in the test group and 288 patients in the control group) with renal anemia were included. The meta-analysis results showed that:compared with ferrous sulfate/ferrous succinate, the effective rate(P=0.02) and significant effective rate(P<0.000 01) of renal anemia in PIC were higher. PIC significantly increased hematocrit(P=0.02), serum ferritin(P=0.009), transferrin saturation(P<0.000 01), hematocrit(P=0.002), red blood cell(P=0.04). adverse reactions of PIC were rare and mild:nausea/vomiting(P<0.000 01), abdominal pain/burning sensation(P=0.000 1), constipation/diarrhea(P=0.000 2).CONCLUSION Compared with ferrous sulfate/ferrous succinate, polysaccharide iron complex is effective and safe in the treatment of renal anemia.