碳酸镧治疗慢性肾脏病高磷血症的系统评价再评价

Lanthanum Carbonate in the Treatment of Chronic Kidney Disease with Hyperphosphatemia:An Overview of Systematic Reviews

目的再评价碳酸镧治疗慢性肾脏病高磷血症的系统评价的方法学偏倚以及结论的可靠程度。方法计算机检索Pub Med、EMbase、The Cochrane Library、PROSPERO、CNKI、CBM、Wan Fang Data和VIP数据库,搜集碳酸镧治疗慢性肾脏病高磷血症的系统评价和Meta分析,检索时间均为建库至2016年8月31日。由2位研究者独立筛选文献并提取资料,采用AMSTAR工具评价纳入研究的方法学质量,并运用GRADE方法对系统评价的结局指标进行证据质量分级。结果最终纳入8个系统评价,包含3个主要结局指标。8个系统评价均对纳入原始研究进行了方法学质量评价:1个采用Jadad量表,7个采用Cochrane偏倚风险评估工具。AMSTAR评价结果显示:纳入的4个系统评价属于高质量,另外4个为中等质量。GRADE分级结果显示:对于血磷水平,与安慰剂相比,3个系统评价的证据质量分别为中、低、极低;与碳酸钙/传统磷结合剂相比,4个系统评价的证据质量分别为低、低、低、极低;与司维拉姆相比,1个系统评价的证据质量为低。对于血钙水平,与安慰剂相比,3个系统评价的证据质量分别为高、中、极低;与碳酸钙/传统磷结合剂相比,5个系统评价的证据质量分别为低、低、低、极低、极低;与司维拉姆组相比,1个系统评价的证据质量为极低。对于血清i PTH水平,与安慰剂相比,3个系统评价的证据质量分别为中、低、极低;与碳酸钙/传统磷结合剂相比,5个系统评价的证据质量分别为中、低、低、极低、极低;与司维拉姆相比,1个系统评价的证据质量为低。结论当前针对碳酸镧治疗慢性肾脏病高磷血症的系统评价的方法学质量总体不高,结论的证据水平普遍较低。在药物安全性尤其是消化系统不良事件发生方面尚存在争议,需要大量的高质量试验来证明其长期使用的安全性。临床医生在使用这些证据进行临床决策时尚需谨慎。

Objectives To evaluate the methodological bias and the reliability of the conclusions of systematic reviews （SRs） of lanthanum carbonate in the treatment of chronic kidney disease with hyperphosphatemia. Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library, PROSPERO, CNKI, CBM, WanFang Data and VIP to collect systematic reviews and meta-analysis about lanthanum carbonate in the treatment of chronic kidney disease with hyperphosphatemia from inception to August 31st, 2016. Two reviewers independently screened literature and extracted data, then AMSTAR tool was used to assess the methodological quality of included studies and the GRADE tool was used to grade the evidence quality of outcome measures included in the SRs. Results A total of eight relevant SRs were included and containing three main outcome measures. The assessment results of AMSTAR tool suggested that： four SRs were of high quality, and the other four were of medium quality. GRADE results showed： for serum phosphorus level, compared with placebo, the quality of the evidence of three SRs were medium, low and very low; compared with calcium carbonate or conventional phosphorus binder, four SRs were low, low, low and very low; compared with sevelamer, one SR was low. For serum calcium level, compared with placebo, the quality of the evidence of three SRs were high, medium and low, respectively; compared with calcium carbonate or conventional phosphorus binder, five SRs were low, low, low, very low and very low; compared with sevelamer, one SR was very low. For serum iPTH level, compared with placebo, the quality of the evidence of three SRs were medium, low and very low; compared with calcium carbonate or conventional phosphorus binder, five SRs were medium, low, low, very low and very low; compared with sevelamer, one SR was low. Conclusion At present, methodological quality assessment for the treatment of hyperphosphatemia in chronic kidney disease with lanthanum carbonate is generally not high and the level of evidence for the conclusion is generally low. In drug safety, especially in the occurrence of adverse events of the digestive system is still controversial, and a large amount of high quality experimental is needed to demonstrate the safety of its long-term use. Clinicians need to be cautious in using these evidence to make clinical decisions.