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德国脂蛋白分离术注册研究(DLAR)对降低升高的Lp(a)水平的治疗选择的影响。

Impact of the German Lipoprotein Apheresis Registry (DLAR) on therapeutic options to reduce increased Lp(a) levels.

作者信息

Schettler Volker J J, Neumann Class L, Peter Christian, Zimmermann Thomas, Julius Ulrich, Roeseler Eberhard, Heigl Franz

机构信息

Centre of Nephrology Göttingen GbR, An der Lutter 24, 37075, Göttingen, Germany,

出版信息

Clin Res Cardiol Suppl. 2015 Apr;10(Suppl 1):14-20. doi: 10.1007/s11789-015-0073-1.

Abstract

BACKGROUND

The German Lipoprotein Apheresis Registry (DLAR) has been initiated by members of the Nephrology Foundation (WiNe), the German association of kidney centres (DN), the German society of nephrology (DGfN) and additional medical associations taking part in the apheresis working group. Its goal is the introduction of a substantial database, suitable to provide statistical evidence for the assessment of extracorporeal procedures. Data have been added to the DLAR since October 2011. In this article, preliminary results are first reported.

METHODS AND RESULTS

Data are stored on a secured Internet platform. The recorded information comprises mean values and rates of change in lipid levels (cholesterol, triglyceride, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, lipoprotein(a) (Lp(a)) before and after apheresis therapy, blood/plasma volume, frequency and type of adverse effects, medication, vascular events, diagnoses and comorbidity. It is collected by participating apheresis centres from all over Germany. Up until October 2014, a total of 7946 lipoprotein apheresis (LA) treatments of 991 patients (787 with documented LDL-C and 688 with documented Lp(a) levels) via 96 medical accounts were documented and analysed. The current share of Lp(a) patients is 50.6 % (Lp(a) ≥ 60 mg/dl; n = 348/688). For both LDL-C and Lp(a), lowering rates exceeding 60 % have been observed. Likely in conjunction with these reduction rates, the preliminary analysis shows a 90 % decline in major adverse coronary events (MACE) as well as a decrease in major adverse non-coronary events (MANCE) by 69 %. As before, good tolerability and low rates of adverse effects (< 3 %) of LA therapy were found.

CONCLUSIONS

The available numbers suggest in parts very good response by the participating centres to the DLAR. Unfortunately, there are also centres that have not documented any patients so far or LA treatments at all. The benchmark values for reduction rates in lipoprotein concentration required by the directives of the German Federal Joint Committee (G-BA) have all been met. The decrease in MACE and MANCE rates currently observed is very promising. However, the comparably short runtime of the registry does not allow for high confidence in the current results. Certainly, reliable data will be extractable in the coming years. Given the high interest expressed by European neighbours, the extension of the registry to the European level should be a future goal for the DLAR as well.

摘要

背景

德国脂蛋白分离术登记处(DLAR)由肾脏病学基金会(WiNe)、德国肾脏中心协会(DN)、德国肾脏病学会(DGfN)以及参与血液分离术工作组的其他医学协会成员发起。其目标是建立一个大型数据库,以提供评估体外治疗的统计证据。自2011年10月起,数据已被录入DLAR。本文首次报告初步结果。

方法与结果

数据存储在一个安全的互联网平台上。记录的信息包括血液分离术治疗前后血脂水平(胆固醇、甘油三酯、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇、脂蛋白(a)[Lp(a)])的平均值和变化率、血液/血浆量、不良反应的频率和类型、药物治疗、血管事件、诊断结果和合并症。这些数据由德国各地参与的血液分离术中心收集。截至2014年10月,通过96个医疗账户记录并分析了991例患者的7946次脂蛋白分离术(LA)治疗(787例有记录的LDL-C水平,688例有记录的Lp(a)水平)。目前Lp(a)患者的比例为50.6%(Lp(a)≥60mg/dl;n = 348/688)。对于LDL-C和Lp(a),均观察到降低率超过60%。可能与这些降低率相关,初步分析显示主要不良冠状动脉事件(MACE)下降了90%,主要不良非冠状动脉事件(MANCE)下降了69%。与以往一样,LA治疗耐受性良好,不良反应发生率低(<3%)。

结论

现有数据表明,部分参与中心对DLAR的反应非常好。不幸的是,也有一些中心至今未记录任何患者或根本未记录LA治疗情况。德国联邦联合委员会(G-BA)指令要求的脂蛋白浓度降低率基准值均已达到。目前观察到的MACE和MANCE发生率下降非常有前景。然而,登记处相对较短的运行时间使得对当前结果的信心不足。当然,未来几年将能够提取可靠的数据。鉴于欧洲邻国表现出的高度兴趣,将登记处扩展到欧洲层面也应成为DLAR未来的目标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b95/4361719/90af84d1b6b2/11789_2015_73_Fig1_HTML.jpg

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