慢性心力衰竭伴铁缺乏患者补铁治疗有效性和安全性的Meta分析

目的：用Meta分析的方法评价慢性心力衰竭伴铁缺乏患者补铁治疗的有效性和安全性。方法：收集国内外关于慢性心力衰竭伴铁缺乏患者静脉铁剂治疗的随机对照临床试验（RCTs），按照纳入与排除标准筛选文献，评价文献质量并提取有效数据，对其有效性和安全性进行Meta分析。结果：共纳入相关英文研究8篇，方法学质量均较高。Meta分析结果显示：（1）有效性：①静脉注射和口服铁剂未明显升高血红蛋白的水平OR=0.71，95% CI（-0.08，1.50），P=0.08]，但能够显著提高血清铁OR=175.18，95% CI（118.54，231.83），P < 0.01]和转铁蛋白饱和度的水平OR=7.01，95% CI（4.16，9.86），P < 0.01]。②口服铁剂不能改善患者的峰值摄氧量（peak VO₂）OR=0.19，95% CI（-0.27，0.65），P=0.42]、N末端B型利钠肽原（NT-proBNP）OR=41.00，95% CI（-95.54，177.54），P=0.56]、堪萨斯城生存质量评分（KCCQ）OR=0.10，95% CI（-0.304，3.24），P=0.95]；而静脉应用铁剂能改善患者的peak VO₂OR=1.33，95% CI（0.60，2.06），P < 0.01]、NT-proBNPOR=-517.99，95% CI（-764.88，-271.11），P < 0.01]、KCCQOR=6.02，95% CI（2.62，9.43），P < 0.01]。（2）安全性：静脉注射和口服铁剂未增加不良事件的发生OR=0.98，95% CI（0.74，1.29），P=0.88]、全因死亡或因心血管事件住院OR=0.75，95% CI（0.42，1.33），P=0.32]、全因死亡OR=0.76，95% CI（0.43，1.35），P=0.34]或住院的发生OR=1.1，95% CI（0.49，2.51），P=0.82]。结论：CHF伴ID患者口服或静脉注射铁剂均具有良好的安全性。静脉注射铁剂有效性较口服铁剂更好。

Effects and safety of iron therapy in patients with chronic heart failure and iron deficiency: a meta-analysis of randomized controlled trials

OBJECTIVE To review the effects and safety of iron therapy in chronic heart failure with iron deficiency patients.METHODS Related randomized controlled clinical trials (RCTs) about iron therapy in chronic heart failure with iron deficiency patients were collected and selected according to inclusion and exclusion criterions.The effects and safety of iron therapy were compared by using the meta analysis.RESULTS Eight trials were included.The quality of the included studies was high.Efficacy:intravenous or oral iron could not increase the hemoglobin \OR=0.71,95%CI(-0.08,1.50),P=0.08],but improve the serum ferritin (SF)OR=175.18,95%CI(118.54,231.83),P<0.01] and transferrin saturation (TSAT); oral iron could not improve the peak VO₂OR=0.19,95%CI(-0.27,0.65),P=0.42],NT-proBNPOR=41.00,95%CI (-95.54,177.54),P=0.56],KCCQOR=6.02,95%CI (2.62,9.43),P<0.01],but intravenous iron increased those outcomesOR=1.33,95%CI (0.60,2.06),P<0.01],OR=-517.99,95%CI (-764.88,-271.11),P<0.01] andOR=6.02,95%CI (2.62,9.43),P<0.01].Safety:intravenous or oral iron did not increased adverse eventOR=0.98,95%CI (0.74,1.29),P=0.88],all-cause death or cardiovascular hospitalizationOR=0.75,95%CI (0.42,1.33),P=0.32],all-cause deathOR=0.76,95%CI (0.43,1.35),P=0.34],and hospitalizationOR=1.1,95%CI (0.49,2.51),P=0.82].CONCLUSION Both intravenous and oral iron preparations have good safety for patients with chronic heart failure combined iron deficiency.Intravenous iron is more effective than oral iron.