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帕米膦酸治疗对肾移植术后早期骨密度的临床疗效及安全性:一项随机对照试验的荟萃分析

Clinical efficacy and safety of pamidronate therapy on bone mass density in early post-renal transplant period: a meta-analysis of randomized controlled trials.

作者信息

Wang Zijie, Han Zhijian, Tao Jun, Lu Pei, Liu Xuzhong, Wang Jun, Wu Bian, Huang Zhengkai, Yin Changjun, Tan Ruoyun, Gu Min

机构信息

Department of urology, the first affiliated hospital of Nanjing Medical University, Nanjing, China.

出版信息

PLoS One. 2014 Sep 29;9(9):e108106. doi: 10.1371/journal.pone.0108106. eCollection 2014.

Abstract

INTRODUCTION

The overall effect of pamidronate on bone mass density (BMD) in the early renal transplant period varies considerably among studies. The effects of pamidronate on graft function have not been determined.

MATERIALS AND METHODS

A comprehensive search was conducted in PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase independently by two authors. Randomized controlled trials of pamidronate evaluating bone loss in the first year of renal transplantation were included. Methods reported in the "Cochrane Handbook for Systematic Reviews of Interventions 5.0.2" were used to evaluate changes of lumbar spine and femoral neck BMD, and serum creatinine, calcium and intact parathyroid hormone (iPTH) levels. Fixed or random effect models were used as appropriate.

RESULTS

Six randomized trials evaluating 281 patients were identified. One hundred forty-four were treated with pamidronate and 137 were control patients. Administration of pamidronate was associated with significant reduction of bone loss in the lumbar spine, compared to the control group (standardized mean difference (SMD)  = 24.62 [16.25, 32.99]). There was no difference between the pamidronate treated and control femoral neck BMD (SMD  = 3.53 [-1.84, 8.90]). A significant increase in the serum creatinine level of the intervention group was seen, compared to the control group. The serum calcium and iPTH of the pamidronate and control groups were not different after 1 year (serum creatinine: SMD  = -3.101 [-5.33, -0.89]; serum calcium: SMD  = 2.18 [-0.8, 5.16]; serum iPTH: SMD  = 0.06 [-0.19, 0.31]). Heterogeneity was low for serum calcium and iPTH and high for serum creatinine.

CONCLUSIONS

This meta-analysis demonstrated the beneficial clinical efficacy of pamidronate on BMD with no association with any alteration in graft function during the first year of renal transplantation. Significant heterogeneity precludes the conclusion of the relationship between serum creatinine and pamidronate.

摘要

引言

在早期肾移植阶段,帕米膦酸盐对骨密度(BMD)的总体影响在不同研究中差异很大。帕米膦酸盐对移植肾功能的影响尚未确定。

材料与方法

两位作者分别在PubMed、Cochrane对照试验中心注册库(CENTRAL)和Embase中进行了全面检索。纳入了评估肾移植第一年骨质流失的帕米膦酸盐随机对照试验。采用《Cochrane干预措施系统评价手册5.0.2》中报告的方法评估腰椎和股骨颈骨密度以及血清肌酐、钙和完整甲状旁腺激素(iPTH)水平的变化。根据情况使用固定效应或随机效应模型。

结果

确定了6项评估281例患者的随机试验。144例接受帕米膦酸盐治疗,137例为对照患者。与对照组相比,帕米膦酸盐治疗与腰椎骨质流失显著减少相关(标准化均数差(SMD)=24.62 [16.25, 32.99])。帕米膦酸盐治疗组和对照组的股骨颈骨密度无差异(SMD = 3.53 [-1.84, 8.90])。与对照组相比,干预组血清肌酐水平显著升高。1年后,帕米膦酸盐组和对照组的血清钙和iPTH无差异(血清肌酐:SMD = -3.101 [-5.33, -0.89];血清钙:SMD = 2.18 [-0.8, 5.16];血清iPTH:SMD = 0.06 [-0.19, 0.31])。血清钙和iPTH的异质性较低,血清肌酐的异质性较高。

结论

这项荟萃分析表明,帕米膦酸盐在肾移植第一年对骨密度具有有益的临床疗效,且与移植肾功能的任何改变无关。显著的异质性妨碍了得出血清肌酐与帕米膦酸盐之间关系的结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70e8/4180498/502318da868a/pone.0108106.g001.jpg

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