Alirocumabum在一家多学科医院中的实践:一项开放,非比较性前瞻性研究的结果
https://doi.org/10.47093/2218-7332.2020.11.4.15-22
摘要
目的
在实际临床实践中评估在患有动脉粥样硬化血脂异常的患者中使用Alirocumabum的疗效和安全性。
材料和方法
一项前瞻性,非对照研究研究了92例(61名男性;平均年龄59.8±9.6岁)患有动脉粥样硬化血脂异常且未能达到目标脂质水平的患者。Alirocumabum的剂量为150 mg,每2周一次,皮下注射,持续3个月。主要终点是达到低密度脂蛋白胆固醇的目标水平。此外,还评估了脂蛋白(a)和高密度脂蛋白胆固醇的水平。为了评估安全性,检查了肝试验,肌酐水平和血糖,已经研究了副作用。为了检验统计假设,使用了配对t检验和威尔克森符号秩检验。
结果
3个月后,治疗中观察到低密度脂蛋白胆固醇的降低有统计学意义:1.45 [0.99;2.14] vs 最初的3.00 mmol / l [2.17;3.81](p <0.0001);中位数下降幅度为–47%[–25;–65]; 40名(43%)患者达到低密度脂蛋白胆固醇的目标水平。3个月后,发现高密度脂蛋白胆固醇增加。治疗时,其水平为1.36±0.41 vs最初的1.31±0.38 mmol / L(p <0.01)。在基线> 30 mg / dL的21例患者中重新测量了脂蛋白(a)的浓度:3个月后,统计学上显着降低。67 [46; 155] vs 85mg/dl[58; 187](p <0.001)。肝功能检查,肌酐和空腹血糖指标没有明显变化。 没有记录到副作用和不良反应。
结论
在实际的临床实践中,三个月后。 用Alirocumabum治疗后,观察到低密度脂蛋白胆固醇水平显着下降,43%的患者达到了目标水平,脂蛋白(a)水平显着下降,高密度脂蛋白胆固醇升高。
关于作者
A. O. Bueverov俄罗斯联邦
Alexey O. Bueverov, Dr. of Sci. (Medicine), Professor, Leading Researcher of the Hepatology Department, 61/2, bld 1, Shchepkina str., Moscow, 129110;
Deputy Chairman of the Board, Bolshaya Akademicheskaya str., 39, Moscow, 125008
+7 (916) 678-43-94
P. O. Bogomolov
俄罗斯联邦
Pavel O. Bogomolov, Cand. of Sci. (Medicine), Scientific Head of the Department of Hepatology, 61/2, bld 1, Shchepkina str., Moscow, 129110;
Chairman of the Board, Bolshaya Akademicheskaya str., 39, Moscow, 125008
A. A. Kucherov
俄罗斯联邦
Alexey A. Kucherov, Head of the Cardiology Department of the Clinic,
Bolshaya Akademicheskaya str., 39, Moscow, 125008
V. E. Syutkin
俄罗斯联邦
Vladimir E. Syutkin, Dr. of Sci. (Medicine), leading researcher in the liver transplantation department,
Bolshaya Sukharevskaya sq., 3, Moscow, 129090
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