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碳酸镧治疗透析患者高磷血症的疗效和耐受性:一项系统评价和随机对照试验的荟萃分析。

Efficacy and tolerability of lanthanum carbonate in treatment of hyperphosphatemia patients receiving dialysis--a systematic review and meta-analysis of randomized controlled trials.

机构信息

The First Clinical Medical College, Lanzhou University , China.

出版信息

Curr Med Res Opin. 2014 Jan;30(1):99-108. doi: 10.1185/03007995.2013.838551. Epub 2013 Oct 9.

DOI:10.1185/03007995.2013.838551
PMID:24063635
Abstract

OBJECTIVE

To evaluate the efficacy and tolerability of lanthanum carbonate (LC) in the treatment of hyperphosphatemia in dialysis patients.

METHOD

Multiple databases were used to recruit the published clinical randomized controlled trials (RCTs) comparing LC with placebo for hyperphosphatemia in dialysis patients from inception to March 2013. Results were expressed using standardized mean difference (SMD) for continuous variables and pooled odd ratios (OR) for dichotomous outcomes. Study quality was assessed according to Cochrane Handbook 5.1 guidelines and statistical analysis was performed using RevMan 5.2 software.

RESULTS

A total of 950 patients in seven placebo-controlled RCTs were included. Results showed that LC could effectively controlled hyperphosphatemia compared with placebo (SMD -1.06, 95% CI -1.27- -0.86, P < 0.00001). The proportion of subjects reaching the target in the LC group was higher than that in the placebo group (OR 6.88, 95% CI 4.39-10.78, P < 0.00001). LC-treated patients showed less change in serum PTH and Ca × Pi product from baseline compared to the placebo group (SMD -0.21, 95% CI -0.48-0.06, P = 0.007; SMD -0.90, 95% CI -1.13- -0.66, P < 0.00001, respectively). LC-treated patients experienced more side-effects, like vomiting and nausea, than controls (OR 3.10, 95% CI 1.35-7.08, P = 0.007; OR 2.74, 95% CI 1.22-6.19, P = 0.02, respectively). But overall, the incidence of drug-related adverse events was similar between placebo- and LC-treated patients (OR 1.21, 95% CI 0.66-2.22, P = 0.54).

CONCLUSION

In the treatment of hyperphosphatemia in dialysis patients, LC is well tolerated and more effective than placebo during short-term trials. Furthermore, it helps to maintain PTH and Ca × Pi product levels within recommended ranges. LC is an ideal choice for second-line treatment of hyperphosphatemia after therapy failure or other contraindication for calcium agents. Its long-term security still needs further research.

摘要

目的

评估碳酸镧(LC)治疗透析患者高磷血症的疗效和耐受性。

方法

检索多个数据库,收集 2013 年 3 月前发表的比较 LC 与安慰剂治疗透析患者高磷血症的随机对照临床试验(RCT)。采用标准化均数差(SMD)表示连续性变量,合并比值比(OR)表示二分类变量。根据 Cochrane 手册 5.1 评价研究质量,采用 RevMan 5.2 软件进行统计分析。

结果

共纳入 7 项安慰剂对照 RCT 的 950 例患者。结果显示,LC 可有效控制高磷血症,与安慰剂相比差异有统计学意义(SMD -1.06,95% CI -1.27~-0.86,P<0.00001)。LC 组达标率高于安慰剂组(OR 6.88,95% CI 4.39~10.78,P<0.00001)。与安慰剂组相比,LC 组治疗后患者的血清甲状旁腺素和钙磷乘积变化较小(SMD -0.21,95% CI -0.48~0.06,P=0.007;SMD -0.90,95% CI -1.13~-0.66,P<0.00001)。LC 组较安慰剂组更易发生不良反应,如呕吐和恶心(OR 3.10,95% CI 1.35~7.08,P=0.007;OR 2.74,95% CI 1.22~6.19,P=0.02)。但总体上,两组药物相关不良反应发生率相似(OR 1.21,95% CI 0.66~2.22,P=0.54)。

结论

在短期研究中,LC 治疗透析患者高磷血症的耐受性良好,疗效优于安慰剂,且有助于维持 PTH 和钙磷乘积在推荐范围内。LC 是治疗高磷血症失败或存在钙制剂应用禁忌后的二线药物,其长期安全性仍需进一步研究。

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