氨氯地平、赖诺普利和瑞舒伐他汀治疗代谢综合征合并非酒精性脂肪性肝病患者的安全性和有效性

[Safety and Efficacy of Amlodipine, Lisinopril and Rosuvastatin Therapy in Patients With Metabolic Syndrome and Nonalcoholic Fatty Liver Disease].

作者信息

Baranova E I, Berezina A V, Melioranskaya E I, Polyakova E A

机构信息

1I.P. Pavlov First St.-Petersburg State Medical University, St.-Petersburg, Russia; 2Almazov Federal North-West Medical Research Centre, St.-Petersburg, Russia.

出版信息

Kardiologiia. 2015 Oct;55(10):68-75. doi: 10.18565/cardio.2015.10.68-75.

DOI:10.18565/cardio.2015.10.68-75

PMID:28294798

Abstract

AIM

To evaluate the efficacy and safety of amlodipin, lisinopril and rosuvastatin therapy in metabolic syndrome and high cardiovascular risk patients with nonalcoholic fatty liver disease (NAFLD).

PATIENTS AND METHODS

6 months randomized study of fixed combination of amlodipin and lisinopril with or without rosuvastatin of 20 patients with 2 grade of arterial hypertension, dyslipidemia with metabolic syndrome and nonalcoholic fatty liver disease (NAFLD). Efficacy and safety was revealed: office BP, ABPM, NAFLD Fibrosis scale, insulin resistance index (HOMA-IR), serum lipids were measured basically and after 6 months of therapy.

RESULTS

6 months amlodipin and lisinopril therapy results: office BP decreased from 153,4+/-2,9/83,3+/-2,5 to 131,0+/-2,4/79,9+/-4,5 mm Hg (=0,001, for systolic BP).159/91 to 132/77 mm Hg. 24-hours BP decreased from 153,6+/-3,6/89,5+/-3,2 to 127,1+/-3,0/73,5+/-2,9 (=0,002); in 85% of patients BP normalized. Low density lipoprotein cholesterol (LDL-C) decreased lower 2.5 mmol/l in all patients and lower 1.8 mmol/l in 45% patients on rosuvastatin therapy. Before therapy 3 patients had elevated ALT levels, after 6 months therapy all patients had normal levels of ALT and AST. ALT decreased from 33,7+/-4,3 to 23,2+/-3,5 U/l (=0,01). Alkaline phosphatase decreased from 65,4+/-4,1 to 51,1+/-6,9 U/l (=0,02), gamma glutamyl transpeptidase level was stable. NAFLD Fibrosis index revealed fibrosis and was stable -0,9+/-0,2 and -0,9+/-0,2 (>0,05). HOMA-IR decreased from 4.2+/-0,4 to 2,9+/-0,4 (=0,02).

DISCUSSION

Some antihypertensive drugs and statins can be hepatotoxic especially in patients with metabolic syndrome and NAFLD. Antihypertensive drugs and statins with minimal liver metabolism can be preferable in NAFLD patients.

CONCLUSION

Amlodipin, lisinopril and rosuvastatin therapy is effective and safe in patients with metabolic syndrome of high cardiovascular risk and liver steatosis.

摘要

目的

评估氨氯地平、赖诺普利和瑞舒伐他汀治疗代谢综合征以及心血管风险高且患有非酒精性脂肪性肝病（NAFLD）患者的疗效和安全性。

患者与方法

对20例患有2级动脉高血压、伴有代谢综合征的血脂异常以及非酒精性脂肪性肝病（NAFLD）的患者进行为期6个月的随机研究，使用氨氯地平和赖诺普利的固定组合，联合或不联合瑞舒伐他汀。观察疗效和安全性：在治疗前及治疗6个月后，主要测量诊室血压、动态血压监测、NAFLD纤维化评分、胰岛素抵抗指数（HOMA-IR）、血脂。

结果

氨氯地平和赖诺普利治疗6个月的结果：诊室血压从153.4±2.9/83.3±2.5降至131.0±2.4/79.9±4.5 mmHg（收缩压P = 0.001），从159/91降至132/77 mmHg。24小时血压从153.6±3.6/89.5±3.2降至127.1±3.0/73.5±2.9（P = 0.002）；85%的患者血压恢复正常。所有患者的低密度脂蛋白胆固醇（LDL-C）均降至2.5 mmol/l以下，45%接受瑞舒伐他汀治疗的患者降至1.8 mmol/l以下。治疗前3例患者ALT水平升高，治疗6个月后所有患者的ALT和AST水平均正常。ALT从33.7±4.3降至23.2±3.5 U/l（P = 0.01）。碱性磷酸酶从65.4±4.1降至51.1±6.9 U/l（P = 0.02），γ-谷氨酰转肽酶水平稳定。NAFLD纤维化指数显示纤维化且保持稳定，分别为-0.9±0.2和-0.9±0.2（P>0.05）。HOMA-IR从4.2±0.4降至2.9±0.4（P = 0.02）。