碳酸镧治疗维持性血液透析患者高磷血症有效性和安全性的系统评价

目的系统评价碳酸镧治疗维持性血液透析患者高磷血症的疗效和安全性。方法计算机检索MEDLINE(1996～2006．4)、EMbase(1996-2006．4)、Cochrane图书馆临床对照试验资料库(2006年第1期)和中国生物医学文献数据库(1996～2006．4)、中文科技期刊全文数据库(1996-2006．4)、中文学术期刊全文数据库(1996～2006．4)。手工检索已发表或未发表的相关文献,包括会议摘要等。检索无语种限制。纳入碳酸镧与安慰剂或传统磷结合剂比较治疗维持性血液透析患者高磷血症的随机对照试验。由两名评价员独立评价纳入研究的质量和提取资料,并用RevMan 4．2．8软件进行Meta分析。结果共纳入6个试验。Meta分析结果显示,碳酸镧与安慰剂相比,在治疗维持性血液透析患者高磷血症疗效方面两组间差异有统计学意义[OR=4．74, 95％CI(2．66,8．45),P<0．0001],两组间总的不良反应发生情况差异无统计学意义[OR=1．23,95％CI(0．74,2．04),P=0．42];碳酸镧与传统磷结合剂相比,降低血磷水平的疗效差异无统计学意义[OR=0．97,95％CI(0．74, 1．27),P=0．81],但碳酸镧治疗组血钙水平低于传统磷结合剂,两组间总的不良反应发生情况无明显差异。结论碳酸镧治疗可能对终末期肾脏疾病维持性血液透析患者高磷血症有效,且其高钙血症发生率低于传统磷结合剂,但证据强度不高。尚需要大样本、长疗程的研究为碳酸镧治疗终末期肾脏疾病患者的高磷血症有效性和安全性提供进一步的证据。

A Systematic Review of Lanthanum Carbonate for Hyperparathyroidism in Dialysis Patients

Objective To assess the efficacy and safety of Lanthanum Carbonate for hyperparathyroidism in dialysis patients. Methods We searched MEDLINE (1996 to April 2006); EMBASE (1996 to April 2006); Cochrane Central Register of Controlled Trials (Issue 1, 2006); CBM disc; VIP and CNKI. We also checked the references of relevant studies. Randomized controlled trials (RCTs) comparing Lanthanum Carbonate with placebo and standard therapy were eligible for inclusion. Quality assessment and data extraction were done by two reviewers independently. Meta-analysis was conducted using The Cochrane Collaboration's RevMan 4.2.8. Results Six RCTs were included. Lanthanum Carbonate was found to be more effective than placebo in treating hyperparathyroidism of dialysis patients (OR 4.74, 95%CI 2.66 to 8.45; P<0.0001) and the incidence of all drug-related adverse events was similar between Lanthanum Carbonate and placebo-treated group (OR 1.23, 95%CI 0.74 to 2.04; P=0.42). The metaanalysis also showed that the efficacy of treating hyperparathyroidism of dialysis patients was similar between Lanthanum Carbonate and conventional phosphate binders (OR 0.97, 95%CI 0.74 to 1.27; P=0.81) and the incidence of all drug-related adverse events was also similar (OR 1.29, 95%CI 0.62 to 2.47; P=0.49); However, serum calcium level was lower in the Lanthanum Carbonate group than in the conventional phosphate binders group. Conclusion Lanthanum Carbonate is effective and well-tolerated in treating hyperparathyroidism of dialysis patients with end-stage renal disease(ESRD). The incidence of hypercalcemia induced by Lanthanum Carbonate is significantly lower than that of the conventional phosphate binders. However, more large-scale, randomized, double-blinded trials are required to investigate the long-term safety and efficacy of Lanthanum Carbonate.