西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进症有效性和安全性的系统评价

摘要

OBJECTIVE:To systematically review the efficacy and safety of cinacalcet in the treatment of hemodialysis pa-tients with secondary hyperparathyroidism,and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from Medline,Cochrane Library,EMBase and CBM,randomized controlled trials(RCT)about cinacalcet in the treatment of he-modialysis patients with secondary hyperparathyroidism (SHPT) were collected. Meta-analysis was performed by using Rev Man 5.3.5 software after data extract and quality evaluation by Cochrane systematic Rev Man 5.3.5. RESULTS:Totally 7 RCTs were en-rolled,involving 1 987 patients. Results of Meta-analysis showed cinacalcet can significantly reduce the rate of surgical parathyroid-ectomy[RR=0.23,95%CI(0.06,0.89),P=0.03],incidence of fracture[RR=0.26,95%CI(0.12,0.60),P=0.002] and increase the incidences of hypocalcemia[RR=9.81,95%CI(3.92,4.59),P<0.001],nausea[RR=1.97,95%CI(1.58,2.46),P<0.001] and vomit-ing[RR=1.91,95%CI(1.50,2.42),P<0.001],while it showed no significant effect on the the incidence of all-cause mortality and cardiovascular death. CONCLUSIONS:The clinical efficacy of cinacalcet in the treatment of hemodialysis patients with secondary hyperparathyroidism is good,but there are common adverse reactions such as nausea and vomiting,hypocalcemia.%目的：系统评价西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进症（SHPT）的有效性和安全性，为临床提供循证参考。方法：计算机检索Medline、Cochrane图书馆、EMBase和中国生物医学文献数据库（CBM）中关于西那卡塞治疗血液透析患者SHPT的随机对照试验（RCT），提取资料并评价质量后采用Cochrane协作组织提供的Rev Man 5.3.5统计软件进行Meta分析。结果：最终纳入7项RCT，合计1987例患者。Meta分析结果显示，相比对照组方案，在常规治疗基础上给予西那卡塞可以显著降低SHPT患者甲状旁腺切除率[RR＝0.23，95％CI（0.06，0.89），P＝0.03]、骨折发生率[RR＝0.26，95％CI（0.12，0.60），P＝0.002]，增加低钙血症发生率[RR＝9.81，95％CI（3.92，4.59），P＜0.001]、恶心发生率[RR＝1.97，95％CI（1.58，2.46），P＜0.001]和呕吐发生率[RR＝1.91，95％CI（1.50，2.42），P＜0.001]，而全因死亡率和心血管事件发生率的差异无统计学意义。结论：西那卡塞治疗血液透析患者SHPT临床疗效较好，但低钙血症、恶心、呕吐等不良反应较常见。