柠檬酸铁治疗慢性肾脏病患者的疗效及安全性的Meta分析

    Efficacy and safety of ferric citrate for patients with chronic kidney disease:a Meta-analysis

    • 摘要: 目的 评价柠檬酸铁治疗慢性肾脏病(chronic kidney disease,CKD)患者合并缺铁性贫血和高磷血症的疗效及安全性。方法 计算机检索PubMed、Embase、Medline、Cochrane Library、Ovid、CNKI、CBM、万方及维普数据库从建库至2020年3月关于柠檬酸铁治疗CKD的随机对照试验。依据Cochrane协作网的风险偏倚评估对纳入的文献进行质量评价,使用RevMan 5.3软件对疗效及不良反应进行Meta分析。结果 共纳入13篇文献,2146例患者,按照是否接受透析治疗,分为透析依赖的CKD患者(dialysis-dependent CKD,DD-CKD)和非透析依赖的CKD患者(non-dialysis dependent chronic kidney disease,NDD-CKD),两组均与对照组(安慰剂或积极治疗)对比,试验组的患者血红蛋白水平高于对照组DD-CKD:(MD=0.52,95%CI:0.18~0.87,P=0.003)、NDD-CKD:(MD=0.73,95%CI:0.53~0.93,P<0.001)。在NDD-CKD患者中,能有效降低血磷水平(MD=-0.65,95%CI:-0.960~-0.33,P<0.001);在DD-CKD患者中,两组差异无统计学意义(MD=-0.64,95%CI:-1.50~0.20,P=0.14),但与安慰剂对比柠檬酸铁能显著降低血磷水平(MD=-2.17,95%CI:-2.43~-1.91,P<0.001)。此外,柠檬酸铁还可以提高患者铁蛋白水平,降低患者成纤维细胞生长因子-23(fibroblast growth factor-23,FGF-23)水平。腹泻是柠檬酸铁最常见的不良反应,但与对照组相比差异无统计学意义(P>0.05)。结论 柠檬酸铁可有效治疗CKD患者的缺铁性贫血、高磷血症,短期内无明显严重不良反应,但其远期并发症及不良反应尚需要更多的临床试验加以验证。

       

      Abstract: Objective To evaluate the efficacy and safety of ferric citrate for chronic kidney disease(CKD) patients with iron deficiency anemia and hyperphosphatemia. Methods Randomized controlled trials on the treatment of CKD with ferric citrate were retrieved from the databases of PubMed,Embase,MedLine,Cochrane Library,Ovid,CNKI,CBM,WanFang and Weipu from the inceptions until March 2020. According to the risk bias assessments of Cochrane Collaboration,the quality of included literature was evaluated and RevMan 5.3 software utilized for a Meta-analysis of efficacy and adverse reactions. Results A total of 13 articles involving 2,146 patients were included. According to whether or not receiving dialysis,they were divided into two groups of dialysis-dependent CKD(DD-CKD) and non-dialysis-dependent CKD(NDD-CKD). Both groups were compared with control group(placebo or active treatment). The hemoglobin level of patients in test group was higher than that of control group DD-CKD:(MD=0.52,95%CI:0.18~0.87,P=0.003),NDD-CKD:(MD=0.73,95%CI:0.53~0.93,P<0.001). It could effectively reduce serum phosphorus level in NDD-CKD patients(MD=-0.65,95%CI:-0.960~-0.33,P<0.001);in DD-CKD patients,there was no significant inter-group difference(MD=-0.64,95%CI:-1.50~0.20,P=0.14). As compared with placebo,ferric citrate could significantly reduce blood phosphorus level(MD=-2.17,95%CI:-2.43~-1.91,P<0.001). In addition,ferric citrate elevated ferritin level and lowered FGF-23 level. Diarrhea was the most common adverse reaction of ferric citrate. However,the difference was not statistically significant as compared with control group(P>0.05). Conclusion Ferric citrate can effectively treat iron deficiency anemia and hyperphosphatemia in CKD patients. There are no obvious serious short-term adverse reactions. However,its long-term complications and side effects should be further verified by more clinical trials.

       

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