He Wu, Cui Guanglin, Chen Juan, Chen Manhua, Li Rui, Wang Luyun, Yu Ting, Li Gen, Jiang Jiangang, Wang Dao Wen
Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095# Jiefang Ave, Wuhan, 430030, China.
Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Wuhan, 430000, China.
BMC Med. 2025 Aug 8;23(1):467. doi: 10.1186/s12916-025-04301-w.
Chronic inflammatory cardiomyopathy (infl-CMP) is a long-term sequela caused by the chronicity of acute myocarditis, especially fulminant myocarditis (FM). Hydroxychloroquine (HCQ) may benefit these patients by inhibiting the excessive inflammatory response.
In this multicenter, randomized trial, we evaluated the efficacy and safety of HCQ in patients with chronic infl-CMP after FM. The primary outcome of the trial was a composite of the cardiovascular outcomes of time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker, or implantable cardioverter defibrillator implantation. Secondary outcomes were changes in left ventricular ejection fraction (LVEF), left ventricular internal diastolic diameter (LVIDd), plasma levels of high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein (hs-CRP), and erythrocyte sedimentation rate (ESR) from baseline to 12 months.
Fifty patients were randomized to receive HCQ combined with prednisolone (PDN) or PDN monotherapy for 12 months. Compared to PDN monotherapy, HCQ combined with PDN therapy reduced the primary composite outcome [hazard ratio (HR) = 0.28, 95% confidence interval (CI) = 0.11-0.71] and had significant changes in the increase of LVEF and the decrease of LVIDd, hs-cTnI, NT-proBNP, and hs-CRP in patients with infl-CMP. No serious drug-related adverse events were recorded in either group, indicating an acceptable safety profile. Furthermore, HCQ combined with PDN significantly reduced the levels of 16 plasma cytokines to levels comparable to healthy controls.
Twelve months of HCQ combined with PDN therapy significantly improved the prognosis and heart function, inhibited inflammation, and had acceptable safety in patients with infl-CMP after FM.
ClinicalTrials.gov identifier: NCT05961202.
慢性炎症性心肌病（infl-CMP）是急性心肌炎，尤其是暴发性心肌炎（FM）慢性化导致的长期后遗症。羟氯喹（HCQ）可能通过抑制过度的炎症反应使这些患者受益。
在这项多中心随机试验中，我们评估了HCQ对FM后慢性infl-CMP患者的疗效和安全性。试验的主要结局是心血管死亡或心脏移植时间、因心力衰竭住院或心肌炎复发、永久性起搏器或植入式心律转复除颤器植入等心血管结局的综合指标。次要结局是从基线到12个月时左心室射血分数（LVEF）、左心室内径舒张末期（LVIDd）、血浆高敏心肌肌钙蛋白I（hs-cTnI）、N末端B型利钠肽原（NT-proBNP）、高敏C反应蛋白（hs-CRP）和红细胞沉降率（ESR）的变化。
50例患者被随机分配接受HCQ联合泼尼松龙（PDN）或PDN单药治疗12个月。与PDN单药治疗相比，HCQ联合PDN治疗降低了主要综合结局[风险比（HR）=0.28，95%置信区间（CI）=0.11-0.71]，并且infl-CMP患者的LVEF增加以及LVIDd、hs-cTnI、NT-proBNP和hs-CRP降低有显著变化。两组均未记录到严重的药物相关不良事件，表明安全性可接受。此外，HCQ联合PDN显著降低了16种血浆细胞因子水平，使其与健康对照相当。
HCQ联合PDN治疗12个月可显著改善FM后infl-CMP患者的预后和心脏功能，抑制炎症，且安全性可接受。
ClinicalTrials.gov标识符：NCT05961202。
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