多糖铁对比硫酸亚铁用于妊娠期贫血安全性的Meta分析

Meta-analysis of the safety of polysaccharide iron complex versus ferrous sulfate in the treatment of anemia during pregnancy

目的比较多糖铁与硫酸亚铁用于妊娠期贫血的安全性。方法计算机检索the Cochrane Library、PubMed、Embase、SinoMed、中国知网、维普网、万方数据库,收集多糖铁(试验组)对比硫酸亚铁(对照组)用于妊娠期贫血的随机对照试验(RCT),检索时限为建库起至2022年5月20日。筛选文献、提取资料及质量评价后,采用RevMan 5.3软件进行Meta分析、敏感性分析和发表偏倚分析。结果共纳入13项RCT,共计1318例患者。Meta分析结果显示,试验组患者的不良反应总发生率[RR=0.11,95%CI(0.06,0.18),P<0.00001]以及胃肠道不适[RR=0.08,95%CI(0.05,0.12),P<0.00001]、厌食恶心[RR=0.21,95%CI(0.09,0.54),P=0.001]、腹痛[RR=0.18,95%CI(0.04,0.78),P=0.02]、腹泻[RR=0.18,95%CI(0.04,0.79),P=0.02]、呕吐[RR=0.24,95%CI(0.06,0.89),P=0.03]、牙龈黑染[RR=0.09,95%CI(0.03,0.28),P<0.0001]发生率均显著低于对照组。敏感性分析结果显示,本研究所得结论较稳健。发表偏倚结果显示,本研究存在发表偏倚的可能性较大。结论多糖铁用于妊娠期贫血的安全性优于硫酸亚铁。

OBJECTIVE To compare the safety of polysaccharide iron complex and ferrous sulfate in the treatment of anemia during pregnancy.METHODS Retrieved from Cochrane Library,PubMed,Embase,SinoMed,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about polysaccharide iron complex(trial group)versus ferrous sulfate(control group)in the treatment of anemia during pregnancy were collected from the inception to May 20th,2022.After literature screening,data extraction and quality evaluation,meta-analysis,sensitivity analysis and publication bias analysis were conducted with RevMan 5.3 software.RESULTS A total of 13 RCTs were included,with a total of 1318 patients.Results of meta-analysis showed that the total incidence of adverse drug reactions(ADR)[RR=0.11,95%CI(0.06,0.18),P<000001],gastrointestinal adverse reactions[RR=0.08,95%CI(0.05,0.12),P<0.00001],anorexia and nausea[RR=0.21,95%CI(0.09,0.54),P=0.001],abdominal pain[RR=0.18,95%CI(0.04,0.78),P=0.02],diarrhea[RR=0.18,95%CI(0.04,0.79),P=0.02],vomiting[RR=0.24,95%CI(0.06,0.89),P=0.03]and gingival melanosis[RR=0.09,95%CI(0.03,0.28),P<0.0001]in the trial group were all significantly lower than the control group.The results of sensitivity analysis showed that the conclusions obtained in this study were relatively robust.The results of publication bias analysis indicated that there was a high possibility of publication bias in this study.CONCLUSIONS The polysaccharide iron complex is safer than ferrous sulfate for treatment of anemia during pregnancy.