Strippoli G F M, Navaneethan S D, Craig J C
NHMRC Centre for Clinical Research Excellence in Renal Medicine, Cochrane Renal Group, Centre for Kidney Research, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, Australia.
Cochrane Database Syst Rev. 2006 Oct 18(4):CD003967. doi: 10.1002/14651858.CD003967.pub2.
Anaemia affects 60% to 80% of patients with chronic kidney disease (CKD) reduces quality of life and is a risk factor for early death. Treatment options are blood transfusion, erythropoietin (EPO) and darbepoetin alfa. Recently higher haemoglobin (Hb) and haematocrit (HCT) targets have been widely advocated because of positive associations with improved survival and quality of life from observational studies.
To assess the benefits and harms of different Hb or HCT targets in CKD patients receiving any treatment for anaemia.
We searched The Cochrane Renal Group's specialised register, Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library) MEDLINE (from 1966), EMBASE (from 1980) and reference lists of retrieved articles. Date of most recent search: April 2006
Randomised controlled trials (RCTs) and quasi-RCTs comparing different Hb/HCT targets in patients with the anaemia of CKD.
Two reviewers independently assessed trial quality and extracted data. Statistical analyses were performed using the random effects model and results expressed as relative risks (RR) for dichotomous outcomes and weighted mean difference (MD) for continuous outcomes, with 95% confidence intervals (CI).
Twenty two trials (3707 patients) were included. Hb > or = 133 g/L was not associated with a reduction in the risk of all-cause mortality compared with 120 g/L in dialysis and pre-dialysis patients. In pre-dialysis patients, there was a significantly lower end of treatment creatinine clearance with Hb < 120 g/L compared to > 130 g/L (MD -4.17, 95% CI -6.33 to -2.02) but no significant difference in the risk of end-stage kidney disease (ESKD) (RR 1.05, 95% CI 0.50 to 2.22). Lower Hb targets resulted in an increased risk for seizures (RR 5.25, 95% CI 1.13 to 24.34) and a reduced risk of hypertensive episodes (RR 0.50, 95% CI 0.33 to 0.76). There were no significant differences in the risk of vascular access thrombosis.
AUTHORS' CONCLUSIONS: There was no significant difference in the risk of death for low (< 120 g/L) versus higher Hb targets (>133 g/L). Lower Hb targets were significantly associated with an increased risk for seizures but a reduced risk of hypertension. In general study quality was poor. There is a need for more adequately powered, well-designed and reported trials. Trials should be pragmatic, focusing on hard end-points (mortality, ESKD, major side effects) or outcomes which were previously not studied adequately (e.g. seizures, quality of life).
贫血影响60%至80%的慢性肾脏病（CKD）患者，降低生活质量，且是早期死亡的危险因素。治疗选择包括输血、促红细胞生成素（EPO）和阿法达贝泊汀。最近，由于观察性研究表明较高的血红蛋白（Hb）和血细胞比容（HCT）目标与改善生存和生活质量呈正相关，因此这些较高目标得到了广泛提倡。
评估接受任何贫血治疗的CKD患者中，不同Hb或HCT目标的益处和危害。
我们检索了Cochrane肾脏组的专业注册库、Cochrane对照试验中心注册库（CENTRAL，Cochrane图书馆）、MEDLINE（始于1966年）、EMBASE（始于1980年）以及检索到文章的参考文献列表。最近一次检索日期：2006年4月
比较CKD贫血患者不同Hb/HCT目标的随机对照试验（RCT）和半随机对照试验。
两名评价员独立评估试验质量并提取数据。采用随机效应模型进行统计分析，结果以二分类结局的相对风险（RR）和连续结局的加权均数差（MD）表示，并给出95%置信区间（CI）。
纳入22项试验（3707例患者）。与透析患者和透析前患者Hb为120 g/L相比，Hb≥133 g/L与全因死亡率降低无关。在透析前患者中，与Hb＞130 g/L相比，Hb＜120 g/L时治疗末期的肌酐清除率显著降低（MD -4.17，95%CI -6.33至-2.02），但终末期肾病（ESKD）风险无显著差异（RR 1.05，95%CI 0.50至2.22）。较低的Hb目标导致癫痫发作风险增加（RR 5.25，95%CI 1.13至24.34），高血压发作风险降低（RR 0.50，95%CI 0.33至0.76）。血管通路血栓形成风险无显著差异。
低Hb目标（＜120 g/L）与高Hb目标（＞133 g/L）相比，死亡风险无显著差异。较低的Hb目标与癫痫发作风险增加显著相关，但高血压风险降低。总体而言，研究质量较差。需要开展更多样本量充足、设计良好且报告规范的试验。试验应注重实际效果，关注硬性终点（死亡率、ESKD、主要副作用）或以前未充分研究的结局（如癫痫发作、生活质量）。
