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比较分析甲状旁腺素与其他维生素 D 受体激动剂在血液透析患者中的疗效和安全性:系统评价和荟萃分析 15 项随机对照试验。

A comparative analysis of the efficacy and safety of paricalcitol versus other vitamin D receptor activators in patients undergoing hemodialysis: A systematic review and meta-analysis of 15 randomized controlled trials.

机构信息

Hemodialysis Room, The Fourth Central Hospital of Baoding City, Baoding, Hebei, China.

Administration Department, The Fourth Central Hospital of Baoding City, Baoding, China.

出版信息

PLoS One. 2020 May 29;15(5):e0233705. doi: 10.1371/journal.pone.0233705. eCollection 2020.

Abstract

Paricalcitol, a new vitamin D receptor activator (VDRA), is reported to be more effective than other VDRAs in reducing calcium and phosphorus levels in patients undergoing hemodialysis. However, the efficacy and safety of paricalcitol remain controversial. This analysis compares paricalcitol with other VDRAs in patients undergoing hemodialysis. We searched the Cochrane Library, PubMed, EMBASE, Web of Science, and CNKI up to April 22, 2019. Standardized mean difference (SMD), risk ratio (RR) and 95% confidence interval (CI) values were estimated to compare the outcomes of the groups. Two reviewers extracted data and assessed trial quality independently. All statistical analyses were performed using the standard statistical procedures of RevMan 5.2 and Stata 12.0. Fifteen studies (N = 110,544) were included in this meta-analysis. Of these studies, 11 were randomized controlled trials (RCTs) and 4 were non-randomized studies of interventions (NRSIs). Patients receiving paricalcitol experienced better overall survival (OS) than patients receiving other VDRAs, with a pooled hazard ratio of 0.86 (95% CI 0.80-0.91; P < 0.00001). Intact parathyroid hormone (iPTH) levels were significantly reduced in the paricalcitol group compared to the group receiving other VDRAs, with a pooled SMD of -0.53 (95% CI -0.89- -0.16; P = 0.004). There was a significant increase in serum calcium levels from baseline in the paricalcitol group compared to the other VDRAs group when limiting the analysis to RCTs, with a pooled SMD of 2.14 (95% CI 0.90-3.38; P = 0.0007). Changes in serum calcium levels were significantly lower in the paricalcitol group when the analysis was limited to NRSIs, with a pooled SMD of -0.85 (95% CI -1.34--0.35; P = 0.0008). The NSRI analysis also showed a significant reduction in serum phosphorus levels in the paricalcitol group, with a pooled SMD of -0.57 (95% CI -1.00--0.13; P = 0.01). No significant differences were observed in the incidence of hypercalcemia, hyperphosphatemia, or adverse events. Generally, paricalcitol seems superior to other VDRAs in reducing mortality and iPTH levels in patients undergoing hemodialysis. However, the comparative effectiveness of paricalcitol in reducing serum calcium and phosphorus levels needs further exploration. No significant difference was found in the rate of adverse events.

摘要

帕立骨化醇是一种新型维生素 D 受体激动剂(VDRA),据报道,在接受血液透析的患者中,它比其他 VDRA 更能有效降低钙和磷水平。然而,帕立骨化醇的疗效和安全性仍存在争议。本分析比较了帕立骨化醇与血液透析患者的其他 VDRA。我们检索了 Cochrane 图书馆、PubMed、EMBASE、Web of Science 和中国知网,截至 2019 年 4 月 22 日。使用标准化均数差(SMD)、风险比(RR)和 95%置信区间(CI)值来比较组间的结局。两名评审员独立提取数据并评估试验质量。所有统计分析均使用 RevMan 5.2 和 Stata 12.0 的标准统计程序进行。这项荟萃分析纳入了 15 项研究(N=110544)。其中 11 项为随机对照试验(RCTs),4 项为干预性非随机研究(NRSIs)。与接受其他 VDRA 的患者相比,接受帕立骨化醇治疗的患者总生存率(OS)更好,合并风险比为 0.86(95%CI 0.80-0.91;P<0.00001)。与接受其他 VDRA 的患者相比,帕立骨化醇组的完整甲状旁腺激素(iPTH)水平显著降低,SMD 为-0.53(95%CI-0.89- -0.16;P=0.004)。当将分析仅限于 RCT 时,与其他 VDRA 组相比,帕立骨化醇组的血清钙水平从基线开始显著升高,SMD 为 2.14(95%CI 0.90-3.38;P=0.0007)。当分析仅限于 NRSIs 时,帕立骨化醇组的血清钙水平变化显著较低,SMD 为-0.85(95%CI-1.34--0.35;P=0.0008)。NRSI 分析还显示帕立骨化醇组血清磷水平显著降低,SMD 为-0.57(95%CI-1.00--0.13;P=0.01)。高钙血症、高磷血症或不良事件的发生率无显著差异。总体而言,帕立骨化醇似乎优于其他 VDRA,可降低血液透析患者的死亡率和 iPTH 水平。然而,帕立骨化醇在降低血清钙和磷水平方面的比较效果仍需进一步探索。不良事件发生率无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f56d/7259607/f43422fe509c/pone.0233705.g001.jpg

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