他汀类药物对慢性肾脏疾病患者的作用：随机对照研究

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他汀类药物对慢性肾脏疾病患者的作用：随机对照研究的荟萃分析和荟萃回归分析
Effects of statins in patients with chronic kidney disease: meta-analysis and meta-regression of randomised controlled trials
Abstract
Objective To analyse the benefits and harms of statins in patients with chronic kidney disease (pre-dialysis, dialysis, and transplant populations).
目的：分析他汀类药物对慢性肾脏疾病患者（透析前、透析和肾脏移植人群）的益处和害处。
Design Meta-analysis.
荟萃分析设计
Data sources Cochrane Central Register of Controlled Trials, Medline, Embase, and Renal Health Library (July 2006).
数据来源：urces Cochrane Central Register of Controlled Trials, Medline, Embase, and Renal Health Library (截止2006年7月).
Study selection Randomised and quasi-randomised controlled trials of statins compared with placebo or other statins in chronic kidney disease.
研究选择：慢性肾脏疾病患者中他汀类药物与安慰剂或其它他汀类药物比较的随机和半随机对照研究。
Data extraction and analysis Two reviewers independently assessed trials for inclusion, extracted data, and assessed trial quality. Differences were resolved by consensus. Treatment effects were summarised as relative risks or weighted mean differences with 95% confidence intervals by using a random effects model.
数据获取和分析：两个研究者独立评价研究是否入选、获取数据病评价研究的质量。Differences were resolved by consensus。治疗效果采用相对危险度和加权均数差（采用随机效应模型的95％可信区间）概括。
Results Fifty trials (30 144 patients) were included. Compared with placebo, statins significantly reduced total cholesterol (42 studies, 6390 patients; weighted mean difference –42.28 mg/dl (1.10 mmol/l), 95% confidence interval –47.25 to –37.32), low density lipoprotein cholesterol (39 studies, 6216 patients; –43.12 mg/dl (1.12 mmol/l), –47.85 to –38.40), and proteinuria (g/24 hours) (6 trials, 311 patients; –0.73 g/24 hour, –0.95 to –0.52) but did not improve glomerular filtration rate (11 studies, 548 patients; 1.48 ml/min (0.02 ml/s), –2.32 to 5.28). Fatal cardiovascular events (43 studies, 23 266 patients; relative risk 0.81, 0.73 to 0.90) and non-fatal cardiovascular events (8 studies, 22 863 patients; 0.78, 0.73 to 0.84) were reduced with statins, but statins had no significant effect on all cause mortality (44 studies, 23 665 patients; 0.92, 0.82 to 1.03). Meta-regression analysis showed that treatment effects did not vary significantly with stage of chronic kidney disease. The side effect profile of statins was similar to that of placebo. Most of the available studies were small and of suboptimal quality; mortality data were provided by a few large trials only.
结果：共50项研究（30144例患者）入选。与安慰剂比较，他汀类药物显著降低总胆固醇(42 项研究, 6390例患者; 加权均数差 –42.28 mg/dl (1.10 mmol/l), 95% 可信区间 –47.25 ～ –37.32)、低密度脂蛋白胆固醇(39 项研究, 6216 例患者; –43.12 mg/dl (1.12 mmol/l), –47.85 ～ –38.40)和蛋白尿(6 项研究, 311 例患者; –0.73 g/24 hour, –0.95～–0.52)，但并没有增加肾小球滤过率(11 项研究, 548例患者; 1.48 ml/min (0.02 ml/s), –2.32 ～5.28)。他汀类药物降低致死性心血管事件(43 项研究, 23 266例患者;相对危险度 0.81, 0.73～0.90)和非致死性心血管事件(8 项研究, 22 863 例患者; 0.78, 0.73 ～ 0.84)，但他汀类药物对全因死亡没有影响(44 项研究, 23 665 例患者; 0.92, 0.82 ～1.03)。荟萃回归分析显示治疗作用在慢性肾脏疾病不同阶段之间没有显著的差异。他汀类药物的副作用与安慰剂类似。大多数可获取的研究都是小样本研究而且质量不是最佳；仅有较少的大规模以研究提供死亡数据）。
Conclusion Statins significantly reduce lipid concentrations and cardiovascular end points in patients with chronic kidney disease, irrespective of stage of disease, but no benefit on all cause mortality or the role of statins in primary prevention has been established. Reno-protective effects of statins are uncertain because of relatively sparse data and possible outcomes reporting bias.
结论：他汀类药物显著降低慢性肾脏疾病患者血脂水平和心血管终点事件，与疾病阶段无关，但对全因死亡没有益处或者说用于一级预防的地位尚未确立。由于数据相对零星可能存在报道偏倚，他汀类药物的肾脏保护作用并不确定。

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