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左卡尼汀改善血液透析伴左心室肥厚患者的心脏功能:一项随机对照试验。

Levocarnitine Improves Cardiac Function in Hemodialysis Patients With Left Ventricular Hypertrophy: A Randomized Controlled Trial.

机构信息

Department of Nephrology, Keiai Hospital, Tokyo, Japan.

Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.

出版信息

Am J Kidney Dis. 2016 Feb;67(2):260-70. doi: 10.1053/j.ajkd.2015.09.010. Epub 2015 Oct 23.

Abstract

BACKGROUND

Levocarnitine deficiency in hemodialysis patients is common. Although the effect of levocarnitine therapy on uremic anemia has been studied in small trials, its effects on cardiac function remain unclear.

STUDY DESIGN

Multicenter, prospective, open-label, parallel, randomized, controlled trial.

SETTING & PARTICIPANTS: Patients undergoing maintenance hemodialysis with carnitine deficiency (free carnitine plasma concentration < 40μmol/L) enrolled in 3 hemodialysis centers.

INTERVENTION

Random assignment to treatment for 12 months with oral levocarnitine therapy at a dose of 20mg/kg/d or control group (no levocarnitine therapy).

OUTCOMES & MEASUREMENTS: Cardiac function was assessed by echocardiography. The primary end point was change in ejection fraction from baseline at the end of the study. Secondary end points included changes in left ventricular mass index and clinical parameters from baseline at the end of the study.

RESULTS

222 patients were randomly assigned, of whom 148 patients (levocarnitine group, n=75; control group, n=73) were analyzed. Ejection fraction increased from baseline to the end of the study in the levocarnitine group by 5.43% (95% CI, 4.53%-6.32%), but not in the control group (change, -0.14%; between-group difference, 5.57% [95% CI, 4.48%-6.66%]; P<0.001). Left ventricular mass index decreased from baseline to the end of the study in the levocarnitine group (change of -8.89 [95% CI, -11.7 to -6.09] g/m(2)), but not in the control group (change of 1.62g/m(2); between-group difference, 10.50 [95% CI, 7.51 to 13.60] g/m(2); P<0.001). Levocarnitine therapy reduced N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and improved the erythropoietin responsiveness index, whereas no such effects were observed in the control group.

LIMITATIONS

Not a double-blinded study.

CONCLUSIONS

Levocarnitine therapy is useful for hemodialysis patients with carnitine deficiency; these patients may benefit from such therapy, with amelioration of cardiac function and reduction of left ventricular mass index.

摘要

背景

左旋肉碱缺乏症在血液透析患者中很常见。尽管小样本试验已经研究了左旋肉碱治疗对尿毒症性贫血的作用,但对其对心脏功能的影响仍不清楚。

研究设计

多中心、前瞻性、开放标签、平行、随机、对照试验。

设置和参与者

在 3 个血液透析中心接受维持性血液透析且肉碱缺乏(游离肉碱血浆浓度<40μmol/L)的患者入组。

干预

随机分配接受 12 个月的口服左卡尼汀治疗,剂量为 20mg/kg/d,或对照组(不给予左卡尼汀治疗)。

结局和测量

通过超声心动图评估心脏功能。主要终点是研究结束时与基线相比射血分数的变化。次要终点包括研究结束时与基线相比左心室质量指数和临床参数的变化。

结果

222 名患者被随机分配,其中 148 名患者(左卡尼汀组,n=75;对照组,n=73)进行了分析。左卡尼汀组的射血分数从基线增加到研究结束时增加了 5.43%(95%CI,4.53%-6.32%),而对照组则没有(变化,-0.14%;组间差异,5.57%[95%CI,4.48%-6.66%];P<0.001)。左心室质量指数从基线到研究结束时在左卡尼汀组下降(变化-8.89[95%CI,-11.7 至-6.09]g/m2),而对照组没有(变化 1.62g/m2;组间差异,10.50[95%CI,7.51 至 13.60]g/m2;P<0.001)。左卡尼汀治疗降低了 N 端脑钠肽前体(NT-proBNP)水平并改善了促红细胞生成素反应指数,而对照组则没有观察到这些作用。

局限性

不是双盲研究。

结论

左卡尼汀治疗对肉碱缺乏的血液透析患者有用;这些患者可能受益于这种治疗,心脏功能得到改善,左心室质量指数降低。

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