Sekercioglu Nigar, Busse Jason W, Mustafa Reem A, Guyatt Gordon H, Thabane Lehana
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada.
The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Canada.
Syst Rev. 2016 Jan 4;5:2. doi: 10.1186/s13643-015-0177-1.
Chronic kidney disease-mineral and bone disorders (CKD-MBD) have been associated with poor health outcomes, including diminished quality and length of life. Standard management for CKD-MBD includes phosphate-restricted diet, active vitamin D, vitamin D analogs, and phosphate binders. Persistently elevated parathyroid hormone (PTH) levels may require the addition of Cinacalcet hydrochloride (cinacalcet) which sensitizes calcium receptors on the parathyroid glands. The objective of this systematic review is to compare the effect of cinacalcet versus standard treatment in patients with CKD-MBD.
METHODS/DESIGN: Data sources will include MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and Web of Science from 1996 to June 2015. Teams of two reviewers will, independently and in duplicate, screen titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstract data and assess risk of bias in eligible trials. We will calculate the effect estimates (risk ratios or mean differences) and 95 % confidence intervals, as well as statistical measures of variability in results across studies using random effect models for patient-important and intermediate outcomes. We will use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence about estimates of effect on an outcome-by-outcome basis. We will present our results with a GRADE summary table.
Our review will explore the effect of cinacalcet versus standard treatment in patients with CKD-MBD. The results of this systematic review will help guide management of this patient population, and identify targets for future research.
PROSPERO CRD42015020318 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015020318.
慢性肾脏病 - 矿物质和骨异常（CKD - MBD）与不良健康结局相关，包括生活质量下降和寿命缩短。CKD - MBD的标准管理措施包括限磷饮食、活性维生素D、维生素D类似物和磷结合剂。甲状旁腺激素（PTH）水平持续升高可能需要加用盐酸西那卡塞（西那卡塞），它可使甲状旁腺上的钙受体敏感化。本系统评价的目的是比较西那卡塞与标准治疗对CKD - MBD患者的疗效。
方法/设计：数据来源将包括1996年至2015年6月的MEDLINE、EMBASE、Cochrane对照试验注册库和科学引文索引。由两名评审员组成的团队将独立且重复地筛选标题和摘要以及可能符合条件的全文报告，以确定其是否符合条件，随后提取数据并评估符合条件试验中的偏倚风险。我们将计算效应估计值（风险比或均值差）和95%置信区间，以及使用随机效应模型对患者重要结局和中间结局进行跨研究结果变异性的统计测量。我们将采用GRADE（推荐分级、评估、制定与评价）方法逐个结局地对效应估计的证据质量进行评级。我们将通过GRADE汇总表展示结果。
我们的评价将探讨西那卡塞与标准治疗对CKD - MBD患者的疗效。本系统评价的结果将有助于指导该患者群体的管理，并确定未来研究的目标。
PROSPERO CRD42015020318 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID = CRD42015020318
