Cai Panpan, Tang Xiaohong, Qin Wei, Ji Ling, Li Zi
Division of Nephrology, West China Hospital of Sichuan University, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan Province, China.
Int Urol Nephrol. 2016 Apr;48(4):571-84. doi: 10.1007/s11255-015-1195-6. Epub 2016 Jan 9.
The goal of this systematic review is to evaluate the efficacy and safety of paricalcitol versus active non-selective vitamin D receptor activators (VDRAs) for secondary hyperparathyroidism (SHPT) management in chronic kidney disease (CKD) patients.
PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), clinicaltrials.gov (inception to September 2015), and ASN Web site were searched for relevant studies. A meta-analysis of randomized controlled trials (RCTs) and quasi-RCTs that assessed the effects and adverse events of paricalcitol and active non-selective VDRA in adult CKD patients with SHPT was performed using Review Manager 5.2.
A total of 10 trials involving 734 patients were identified for this review. The quality of included trials was limited, and very few trials reported all-cause mortality or cardiovascular calcification without any differences between two groups. Compared with active non-selective VDRAs, paricalcitol showed no significant difference in both PTH reduction (MD -7.78, 95% CI -28.59-13.03, P = 0.46) and the proportion of patients who achieved the target reduction of PTH (OR 1.27, 95% CI 0.87-1.85, P = 0.22). In addition, no statistical differences were found in terms of serum calcium, episodes of hypercalcemia, serum phosphorus, calcium × phosphorus products, and bone metabolism index.
Current evidence is insufficient, showing paricalcitol is superior to active non-selective VDRAs in lowering PTH or reducing the burden of mineral loading. Further trials are required to prove the tissue-selective effect of paricalcitol and to overcome the limitation of current research.
本系统评价的目的是评估帕立骨化醇与活性非选择性维生素D受体激活剂(VDRAs)在慢性肾脏病(CKD)患者继发性甲状旁腺功能亢进(SHPT)管理中的疗效和安全性。
检索了PubMed、EMBASE、Cochrane对照试验中央注册库(CENTRAL)、clinicaltrials.gov(建库至2015年9月)以及美国肾脏病学会网站以查找相关研究。使用Review Manager 5.2对评估帕立骨化醇和活性非选择性VDRAs对成年CKD合并SHPT患者的影响及不良事件的随机对照试验(RCTs)和半随机对照试验进行荟萃分析。
本评价共纳入10项试验,涉及734例患者。纳入试验的质量有限,很少有试验报告全因死亡率或心血管钙化情况,两组之间无差异。与活性非选择性VDRAs相比,帕立骨化醇在降低甲状旁腺激素(PTH)方面无显著差异(平均差-7.78,95%置信区间-28.59至13.03,P = 0.46),且在达到PTH目标降低值的患者比例方面也无显著差异(比值比1.27,95%置信区间0.87至1.85,P = 0.22)。此外,在血清钙、高钙血症发作次数、血清磷、钙磷乘积和骨代谢指标方面未发现统计学差异。
目前证据不足,表明帕立骨化醇在降低PTH或减轻矿物质负荷方面并不优于活性非选择性VDRAs。需要进一步试验以证明帕立骨化醇的组织选择性作用并克服当前研究的局限性。