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瑞舒伐他汀/氨氯地平与阿托伐他汀/氨氯地平在随机对照试验中的应用后高敏C反应蛋白显著降低的预测因素——亚组分析

Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials.

作者信息

Park Chun Muk, Jung Hae Won

机构信息

Department of Cardiology, Daegu Catholic Medical Center, 33 Duryugongwonro 17-gil, Nam-gu, Daegu 42472, Republic of Korea.

出版信息

J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363.

DOI:10.3390/jcm14103363
PMID:40429358
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12112149/
Abstract

There are no clear predictors of high-sensitivity C-reactive protein (hsCRP) reductions following the use of antihypertensives and statins. Also, there are no clear data on the effect of BMI on hsCRP changes following the use of antihypertensives and statins. Therefore, we sought to identify predictors of significant hsCRP reduction after the use of rosuvastatin (RSV)/amlodipine (AML) and atorvastatin (ATV)/AML. We included 237 patients from 21 institutions in the Republic of Korea. Patients were randomly assigned to one of three treatment groups: RSV 10 mg/AML 5 mg; RSV 20 mg/AML 5 mg; or ATV 20 mg/AML 5 mg. Multivariate logistic regression analysis was performed to evaluate the predictors for hsCRP responders (hsCRP reduction ≥ 40% after 8 weeks). We also compared baseline hsCRP levels and their changes after 8 weeks between obese patients ( = 153) and nonobese patients ( = 84). Baseline hsCRP ≥ 2 mg/dL and RSV 20 mg/AML 5 mg were independent predictors of hsCRP responders. Their median hsCRP % change rates were -53.11% and -40.0%, respectively. Normal weight, pre-obesity, and obesity were not independent predictors of hsCRP responders. The median hsCRP % reduction rates among normal weight, pre-obese, and obese patients were less than 40% in all groups, and the differences between each group were not significant (-20.0% vs. -33.33 vs. -23.08%, = 0.289). In patients with ATV, RSV/AML polypill, baseline hsCRP ≥ 2 mg/dL, and baseline RSV 20 mg/AML 5 mg were independent predictors of a significant hsCRP reduction. BMI was not associated with hsCRP reduction (Clinical trial: NCT03951207).

摘要

在使用抗高血压药物和他汀类药物后,尚无高敏C反应蛋白(hsCRP)降低的明确预测指标。此外,关于体重指数(BMI)对使用抗高血压药物和他汀类药物后hsCRP变化的影响,也没有明确的数据。因此,我们试图确定使用瑞舒伐他汀(RSV)/氨氯地平(AML)和阿托伐他汀(ATV)/AML后hsCRP显著降低的预测指标。我们纳入了韩国21家机构的237例患者。患者被随机分配到三个治疗组之一:RSV 10 mg/AML 5 mg;RSV 20 mg/AML 5 mg;或ATV 20 mg/AML 5 mg。进行多因素逻辑回归分析以评估hsCRP应答者(8周后hsCRP降低≥40%)的预测指标。我们还比较了肥胖患者(n = 153)和非肥胖患者(n = 84)的基线hsCRP水平及其8周后的变化。基线hsCRP≥2 mg/dL和RSV 20 mg/AML 5 mg是hsCRP应答者的独立预测指标。它们的hsCRP中位数变化率分别为-53.11%和-40.0%。正常体重、肥胖前期和肥胖并非hsCRP应答者的独立预测指标。所有组中正常体重、肥胖前期和肥胖患者的hsCRP中位数降低率均小于40%,且各组之间的差异不显著(-20.0%对-33.33对-23.08%;P = 0.289)。在使用ATV、RSV/AML复方制剂、基线hsCRP≥2 mg/dL以及基线RSV 20 mg/AML 5 mg的患者中,hsCRP显著降低的独立预测指标。BMI与hsCRP降低无关(临床试验:NCT03951207)。

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本文引用的文献

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Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia.一项随机、多中心、平行、开放性的 4 期研究,旨在比较瑞舒伐他汀/氨氯地平复方制剂与阿托伐他汀/氨氯地平复方制剂在伴有血脂异常的高血压患者中的疗效和安全性。
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