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小剂量柠檬酸盐抗凝对高胆固醇血症患者直接脂蛋白吸附(DALI 血液成分分离术)临床安全性和疗效的影响:一项前瞻性对照临床试验。

Effect of low-dose citrate anticoagulation on the clinical safety and efficacy of direct adsorption of lipoproteins (DALI apheresis) in hypercholesterolemic patients: a prospective controlled clinical trial.

作者信息

Bosch T, Heinemann O, Duhr C, Wendler T, Keller C, Fink E, Kirschner T, Klebert S, Samtleben W

机构信息

Nephrology Division, Medical Clinic I, Klinikum Grosshadern, University of Munich, Germany.

出版信息

Artif Organs. 2000 Oct;24(10):790-6. doi: 10.1046/j.1525-1594.2000.06647.x.

DOI:10.1046/j.1525-1594.2000.06647.x
PMID:11091168
Abstract

Direct adsorption of lipoproteins (DALI) is the first lipid apheresis system compatible with whole blood with the advantage of a very simple procedure. A mixture of heparin plus citrate (ACD-A) is used for the anticoagulation regimen (AR). A clinical, prospective, controlled crossover study was performed to test the safety and efficacy of low-dose citrate (LDC) anticoagulation in DALI. Five chronic DALI patients suffering from coronary heart disease and hypercholesterolemia underwent 3 DALI sessions each using the LDC anticoagulation regimen (60 IU heparin/kg body weight as initial bolus; 1:40 ACD-A: blood as perfusion). This was compared to 3 sessions per patient with the standard AR (bolus of 20 IU heparin/kg, 1:20 ACD-A as perfusion). Patient blood volumes (1.6; average of 7,040 ml) were treated with 750 ml adsorber gel per session at a blood flow rate of 60 ml/min. Mean LDL and Lp(a) reductions exceeded 60% with both AR. No clinical side effects were observed. Both AR controlled the coagulation well as evidenced by a sufficient prolongation of the partial prothrombin time (PTT) and activated clotting time as well as low thrombin-antithrombin (TAT) formation. Biocompatibility parameters exhibited favorable results (low activation of complement and cells, and only slight formation of C3a, C5a, beta-thromboglobulin, elastase, and TNF-alpha). The asymptomatic bradykinin generation was comparable in both study arms. LDC optimized the ionized calcium levels and pH in the efferent blood postadsorber. LDC anticoagulation was safe and effective, and may further improve the tolerance of DALI apheresis in hypercholesterolemic patients.

摘要

脂蛋白直接吸附法(DALI)是首个与全血兼容的血脂分离系统,其操作流程非常简单。肝素加枸橼酸盐(ACD-A)的混合物用于抗凝方案(AR)。开展了一项临床前瞻性对照交叉研究,以测试低剂量枸橼酸盐(LDC)抗凝在DALI中的安全性和有效性。五名患有冠心病和高胆固醇血症的慢性DALI患者每人接受3次DALI治疗,每次使用LDC抗凝方案(初始推注60 IU肝素/千克体重;以1:40的ACD-A与血液比例进行灌注)。将其与每位患者使用标准AR的3次治疗(推注20 IU肝素/千克,以1:20的ACD-A进行灌注)进行比较。每次治疗时,以60 ml/分钟的血流速度,用750 ml吸附剂凝胶处理患者血容量(1.6;平均7040 ml)。两种抗凝方案下,平均低密度脂蛋白(LDL)和脂蛋白(a)[Lp(a)]降低幅度均超过60%。未观察到临床副作用。两种抗凝方案均能很好地控制凝血,部分凝血活酶时间(PTT)和活化凝血时间充分延长以及凝血酶-抗凝血酶(TAT)生成量低即证明了这一点。生物相容性参数显示出良好结果(补体和细胞激活程度低,且仅轻微生成C3a、C5a、β-血小板球蛋白、弹性蛋白酶和肿瘤坏死因子-α)。两个研究组中无症状缓激肽生成情况相当。LDC优化了吸附器后流出血液中的离子钙水平和pH值。LDC抗凝安全有效,可能会进一步提高高胆固醇血症患者对DALI血液分离术的耐受性。

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