Liao Yu-Hua, Yuan Jing, Jin Xue-Juan, Yang Ying-Zhen, Wang Zhao-Hui, Yu Miao, Tian Gang, Zhao De-Chao, Li Bin, Wu Wei-Feng, Chen Rui-Zhen, Han Hong-Yan, Xu Dongjie, Wei Jin, Yuan Hai-Tao
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Hubei Key Laboratory of Biological Targeted Therapy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Curr Med Sci. 2024 Dec;44(6):1081-1090. doi: 10.1007/s11596-024-2916-9. Epub 2024 Aug 28.
Qiliqiangxin (QLQX) capsule- a traditional Chinese medicine used for treating heart failure (HF), can modulate inflammatory cytokines in rats with myocardial infarction. However, its immune-regulating effect on dilated cardiomyopathy (DCM) remains unknown. The aim of this study was to investigate whether QLQX has a unique regulatory role in the imbalance of pro- and anti-inflammatory cytokines in patients with DCM.
The QLQX-DCM is a randomized- double-blind trial conducted at 24 tertiary hospitals in China. A total of 345 patients with newly diagnosed virus-induced DCM were randomly assigned to receive QLQX capsules or placebo while receiving optimal medical therapy for HF. The primary endpoints were changes in plasma inflammatory cytokines and improvements in left ventricular ejection fraction (LVEF) and left ventricular end-diastolic diameter (LVEDd) over the 12-month treatment.
At the 12-month follow-up, the levels of IFN-γ, IL-17, TNF-α, and IL-4 decreased significantly, while the level of IL-10 increased in both groups compared with baselines (all P<0.0001). Furthermore-these changes, coupled with improvements in LVEF, NT-proBNP and New York Heart Association (NYHA) functional classification, excluding the LVEDd in the QLQX group, were greater than those in the placebo group (all P<0.001). Additionally, compared with placebo, QLQX treatment also reduced all-cause mortality and rehospitalization rates by 2.17% and 2.28%, respectively, but the difference was not statistically significant.
QLQX has the potential to alleviate the imbalance of inflammatory cytokines in patients with DCM, potentially leading to further improvements in cardiac function when combined with anti-HF standard medications.
芪苈强心胶囊——一种用于治疗心力衰竭（HF）的中药，可调节心肌梗死大鼠的炎性细胞因子。然而，其对扩张型心肌病（DCM）的免疫调节作用尚不清楚。本研究旨在探讨芪苈强心胶囊对DCM患者促炎和抗炎细胞因子失衡是否具有独特的调节作用。
芪苈强心胶囊治疗扩张型心肌病（QLQX-DCM）是一项在中国24家三级医院进行的随机双盲试验。共有345例新诊断的病毒感染性DCM患者在接受HF最佳药物治疗的同时，随机分配接受芪苈强心胶囊或安慰剂治疗。主要终点是12个月治疗期间血浆炎性细胞因子的变化以及左心室射血分数（LVEF）和左心室舒张末期内径（LVEDd）的改善情况。
在12个月的随访中，两组患者的IFN-γ、IL-17、TNF-α和IL-4水平均较基线显著降低，而IL-10水平升高（均P<0.0001）。此外，这些变化以及LVEF、NT-proBNP和纽约心脏协会（NYHA）功能分级的改善情况（芪苈强心胶囊组不包括LVEDd）均大于安慰剂组（均P<0.001）。此外，与安慰剂相比，芪苈强心胶囊治疗还使全因死亡率和再住院率分别降低了2.17%和2.28%，但差异无统计学意义。
芪苈强心胶囊有可能缓解DCM患者炎性细胞因子的失衡，与抗HF标准药物联合使用时可能会进一步改善心功能。
