西那卡塞对终末期肾病患者继发性甲状旁腺功能亢进影响的Meta分析

Efficacy of cinacalcet for end-stage renal disease patients with secondary hyperparathyroidism:a Meta-analysis

目的评价西那卡塞治疗终末期肾病患者继发性甲状旁腺功能亢进的有效性和安全性。方法纳入拟钙剂治疗终末期肾病患者继发性甲状旁腺功能亢进的随机对照研究。计算机检索MEDLINE(1966.1—2014.9)、OVID(1963.1—2014.9)、中文万方数据库(1996.1—2014.9)、CNKI(1979.1—2014.9)、Cochrane图书馆临床对照试验资料库。手工检索已发表或未发表的相关文献,包括会议摘要等。由2名评价员独立对纳入的文献进行质量评价和数据提取,用Rev Man5.2软件进行Meta分析。结果共纳入19项随机对照试验,共7 702例患者。Meta分析结果显示,西那卡塞与传统治疗方法相比,可以显著降低甲状旁腺素(WMD=-301.54μg/L,95%CI:-344.38^-258.7μg/L,P<0.05),降低血钙(WMD=-8.3 mg/L,95%CI:-9.1^-7.4 mg/L,P<0.05),降低血磷(WMD=-3.4 mg/L,95%CI:-4.6^-2.3 mg/L,P<0.05)。两组总体不良反应发生率相近(RR=1.03,95%CI:0.98~1.09,P>0.05)。西那卡塞组主要不良反应包括恶心(RR=2.05,95%CI:1.53~2.75,P<0.05),呕吐(RR=2.00,95%CI:1.78~2.23,P<0.05),腹泻(RR=1.15,95%CI:1.03~1.30,P<0.05),以及无症状的低钙血症(RR=7.60,95%CI:5.61~10.30,P<0.05),但均为短暂且不严重的不良反应。2组病死率相近(RR=0.97,95%CI:0.89~1.05,P>0.05)。结论西那卡塞抑制透析患者继发性甲状旁腺功能亢进,降低血钙和血磷,不增加病死率,但增加恶心、呕吐、腹泻和低钙血症的风险。

Objective To evaluate the efficacy and safety of cinacalcet on secondary hyperparathyroidism （SHPT） in patients with end-stage renal disease （ESRD）. Methods Patients with ESRD and SHPT for the treatment with calcimimetic agents were included in this study. MEDLINE （1996.1-2014.9）, OVID （1963.1-2014.9）, Chinese Wanfang database （1996.1-2014.9）, CNKI （1996.1-2014.9） and the clinical control test database of Cochrane Library were searched . Related literature, including published or unpublished papers, and meeting procedding were hand-searched. Quality assessment and data extraction were conducted by two independent investigators. Meta-analysis was conducted by RevMan 5.2. Results Nineteen randomized controlled trials involving 7 702 patients were included. The meta-analysis showed that compared with conventional therapy,cinacalcet can significantly decrease serum parathyroid hormone in dialysis patients [WMD=-301.54 μg/L, 95%CI：（-344.38）-（-258.7）μg/L, P〈0.05], decrease serum level of calcium [WMD=-8.3 mg/L, 95%CI：（-9.1）-（-7.4）mg/L, P〈0.05], and decrease serum level of phosphorus [WMD=-3.4 mg/L, 95%CI：（-4.6）-（-2.3） mg/L, P〈0.05]. The total incidence of adverse events was similar （RR=1.03, 95%CI：0.98-1.09, P〉0.05）. Cinacalcet increased nausea （RR =2.05, 95%CI ：1.53-2.75, P〈0.05）, vomiting （RR =2.00, 95%CI：1.78-2.23, P〈0.05）, diarrhea （RR=1.15, 95%CI：1.03-1.30, P〈0.05）, and asymptomatic hypocalcaemia （RR=7.60, 95%CI：5.61-10.30, P〈0.05）, but they were usually transient, and mild to moderate in severity. The mortality was similar （RR=0.97, 95%CI：0.89-1.05, P〉0.05）. Conclusion Results confirm that cinacalcet suppresses parathyroid hormone and decreases calcium and phosphorus in secondary hyperparathyroidism patients receiving dialysis. Cinacalcet increases risks of nausea, vomiting, diarrhea and hypocalcaemia,without increasing mortality.