卡托普利、辛伐他汀和左旋肉碱作为 1 型糖尿病患儿心脏保护药物的疗效比较：一项随机对照试验。

Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial.

机构信息

Pediatric Department, Tanta University Hospital, Tanta, Egypt.

Clinical Pathology Department, Tanta University, Egypt.

出版信息

Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.

DOI:10.1017/S1047951121000226

PMID:33536102

Abstract

OBJECTIVES

To assess the efficacy and safety of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus on different echocardiographic parameters, electrocardiographic parameter, lipid profile, and carotid intima-media thickness.

METHODS

This randomised controlled trial was conducted on 100 children with type 1 diabetes mellitus for more than 3 years during the period from September 2018 to June 2020. Fifty healthy children of matched age and sex served as a control group. The patients were randomly assigned into four groups (25 children each): no-treatment group who received no cardioprotective drug, simvastatin group who received simvastatin (10-20 mg/day), captopril group who received captopril (0.2 mg/kg/day), and L-carnitine group who received L-carnitine (50 mg/kg/day) for 4 months. Lipid profile, serum troponin I, carotid intima-media thickness, and echocardiographic examinations were performed on all included children before and after the treatment.

RESULTS

Total cholesterol and low-density lipoprotein were signiﬁcantly decreased in children who received simvastatin or L-carnitine. Triglycerides significantly decreased only in children who received simvastatin. High-density lipoprotein significantly increased in simvastatin and L-carnitine groups only. Serum troponin I decreased significantly in all the three treatment groups. Carotid intima-media thickness showed no significant change in all treatment groups. Echocardiographic parameters significantly improved in simvastatin, L-carnitine, and captopril groups.

CONCLUSION

Captopril, simvastatin, and L-carnitine have a significant beneficial effect on cardiac functions in children with type 1 diabetes mellitus. However, only simvastatin and L-carnitine have a beneficial effect on the lipid profile. The drugs were safe and well tolerated.Clinical trial registration: The clinical trial was registered at www.clinicaltrial.gov (NCT03660293).

摘要

目的

评估卡托普利、辛伐他汀和左旋肉碱作为 1 型糖尿病患儿的心脏保护药物，通过不同的超声心动图参数、心电图参数、血脂谱和颈动脉内膜中层厚度来评估其疗效和安全性。

方法

本随机对照试验纳入了 100 名 1 型糖尿病患儿，这些患儿的糖尿病病史均超过 3 年，试验时间为 2018 年 9 月至 2020 年 6 月。同期选择 50 名年龄和性别相匹配的健康儿童作为对照组。将患者随机分为四组（每组 25 名患者）：未接受心脏保护药物治疗的对照组、接受辛伐他汀（10-20mg/d）治疗的辛伐他汀组、接受卡托普利（0.2mg/kg/d）治疗的卡托普利组和接受左旋肉碱（50mg/kg/d）治疗的左旋肉碱组，所有患儿均接受为期 4 个月的治疗。所有患儿在治疗前后均进行血脂谱、血清肌钙蛋白 I、颈动脉内膜中层厚度和超声心动图检查。