新一代静脉拟钙剂治疗继发性甲状旁腺功能亢进疗效的Meta分析  

Meta-analysis of the efficacy of a new generation of intravenous calcimimetic agent in the treatment of secondary hyperparathyroidism

作　　者：张菊红 李莹[1] ZHANG Ju-hong;LI Ying(Department of Nephrology,First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]重庆医科大学附属第一医院肾脏内科,重庆400016

出　　处：《中国血液净化》2024年第12期896-900,共5页Chinese Journal of Blood Purification

摘　　要：目的评价新一代静脉拟钙剂伊特卡塞肽治疗继发性甲状旁腺功能亢进的疗效和不良反应。方法计算机检索2024年5月前发表在中国知网、万方数据库、PubMed、Embase、Cochrane library上关于伊特卡塞肽治疗继发性甲状旁腺功能亢进透析患者的随机对照试验或队列研究。使用RevMan 5.3软件进行Meta分析。结果共纳入14篇文献,15项试验,总样本量9628例。伊特卡塞肽治疗组血清甲状旁腺激素水平降低30%的有效率高于对照组(空白对照组:RR=8.440,95%CI:6.515~10.935,P<0.001;西那卡塞组:RR=1.131,95%CI:1.040~1.229,P=0.004;维生素D受体激动剂组:RR=4.272,95%CI:2.259~8.081,P<0.001)。伊特卡塞肽治疗组能提高血磷达标率(RR=1.122,95%CI:1.049~1.205,P=0.001)、降低血清成纤维细胞生长因子23水平(治疗时间<1年:MD=-0.563,95%CI:-0.713~-0.413,P<0.001;治疗时间≥1年:MD=-2.108,95%CI:-2.405~-1.812,P<0.001);在血钙达标率(RR=0.910,95%CI:0.778~1.064,P=0.240)、药物持续性(RR=1.439,95%CI:0.903~2.292,P=0.120)方面无统计学差异。不良反应方面:伊特卡塞肽治疗组的症状性低血钙发生率高于对照组(RR=2.890,95%CI:1.915~4.361,P<0.001);恶心事件发生率高于空白对照组(RR=1.747,95%CI:RR=1.150~2.652,P=0.009),低于口服用药组(RR=0.769,95%CI:0.611~0.969,P=0.030)。结论新一代静脉拟钙剂剂伊特卡塞肽能更好的降低血清甲状旁腺激素水平,改善高磷血症、减少恶心症状及降低血清成纤维细胞生长因子23水平,而引起的低血钙不良反应升高。Objective To evaluate the efficacy and adverse reactions of etelcalcetide in the treatment of secondary hyperparathyroidism in hemodialysis patients.Methods Randomized controlled trials or cohort studies on Etelcalcetide in the treatment of secondary hyperparathyroidism(SHPT)in dialysis patients published before May 2024 were searched in CNKI,Wanfang Database,PubMed,Embase and Cochrane library.Meta-analysis was performed by the software RevMan 5.0.Results A total of 14 articles were included,including 15 experiments,with a total sample size of 9628 cases.Meta-analysis showed that Etelcalcetide was more effective in reducing PTH level by 30%than the control group(Blank control group:RR=8.440,95%CI:6.515~10.935,P<0.001;Cinacalcet group:RR=1.131,95%CI:1.040~1.229,P=0.004;Vitamin D receptor agonist group:RR=4.272,95%CI:2.259~8.081,P<0.001),improving serum phosphate compliance rate(RR=1.122,95%CI:1.049~1.205,P=0.001)and decreasing the level of serum fibroblast growth factor(FGF-23)(treatment time<1 year:MD=-0.563,95%CI:-0.713~-0.413,P<0.001;treatment duration≥1 year:MD=-2.108,95%CI:-2.405~-1.812,P<0.001),while no statistical differences in the rate of serum calcium compliance(RR=0.910,95%CI:0.778~1.064,P=0.240)and drug persistence(RR=1.439,95%CI:0.903~2.292,P=0.120).In terms of adverse events,the incidence of symptomatic hypocalcemia was higher in Etelcalcetide group than in control group(RR=2.890,95%CI:1.915~4.361,P<0.001),and the incidence of nausea in Etelcalcetide group was higher than that in blank control group(RR=1.747,95%CI:1.150~2.652,P=0.009),which was lower than that in oral medication group(RR=0.769,95%CI:0.611~0.969,P=0.030),while no significant difference in the incidence of vomiting.Conclusion Etelcalcetide,a new generation of intravenous calcimimetic agent,has more advantages in reducing PTH level,improving hyperphosphatemia and reducing FGF-23 level,but it increased the incidence of hypocalcemia.

关 键 词：伊特卡塞肽 慢性肾脏病 继发性甲状旁腺功能亢进 

分 类 号：R453[医药卫生—治疗学]