Abstract
Objective
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.
Methods
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.
Results
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.
Conclusion
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.
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Acknowledgements
We would like to acknowledge all the investigators at the 24 research sites for making data available for public use. All of them are members of the Chinese Myocarditis & Cardiomyopathy Cooperation Group, listed as follows: Yu-hua LIAO, Jing YUAN, Zhao-hui WANG, Miao YU (Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan); Xue-juan JIN, Ying-zhen YANG, Rui-zhen CHEN (Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai); Gang TIAN (Department of Cardiology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an); De-chao ZHAO (Department of Cardiology, The First Affiliated Hospital of Harbin Medical University, Harbin); Bao LI (Department of Cardiology, Shanxi Cardiovascular Hospital, Taiyuan); Bin LI (Department of Cardiology, Xiangyang Central Hospital, Xiangyang); Qiong-li ZHENG (Department of Cardiology, Wuhan Hospital of Integrated Traditional Chinese and Western Medicine, Wuhan); Yun-fei BIAN (Department of Cardiology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan); Wei-feng WU (Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanling); Qing-xian LI (Department of Cardiology, The Affiliated Hospital of Jining Medical College, Jining); Gang HU (Department of Cardiology, Jingzhou Central Hospital, Jingzhou); Jin XU (Department of Cardiology, Renji Hospital of Shanghai Jiaotong University, Shanghai); Hong-yan HAN (Department of Cardiology, Tianyou Hospital of Wuhan University of Science and Technology, Wuhan); Xin-li LI, Dong-jie XU (Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing); Jin WEI (Department of Cardiology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an); Ye GU (Department of Cardiology, Wuhan Puai Hospital, Wuhan); Bo YU (Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin); Hong-kao ZHANG (Department of Cardiology, Shiyan People’s Hospital, Shiyan); Jia-wang DING (Department of Cardiology, Yichang Central Hospital, Yichang); Jiny-ing ZHANG (Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou); Xiao-mei GUO (Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan); Jing WAN (Department of Cardiology, Zhongnan Hospital of Wuhan University, Wuhan); Hai-tao YUAN (Department of Cardiology, Shandong Provincial Hospital, Jinan); Chuan-yu GAO (Department of Cardiology, Henan Provincial People’s Hospital, Zhengzhou).
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A complete list of the Chinese Myocarditis & Cardiomyopathy Cooperation Group can be found in the Acknowledgements.
This work was supported by the Key Project of the National Twelfth Five-Year Research Program of China (No. 2011BAI11B00 and No. 2011BAI11B23).
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Liao, Yh., Yuan, J., Jin, Xj. et al. Qiliqiangxin Alleviates Imbalance of Inflammatory Cytokines in Patients with Dilated Cardiomyopathy: A Randomized Controlled Trial. CURR MED SCI (2024). https://doi.org/10.1007/s11596-024-2916-9
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DOI: https://doi.org/10.1007/s11596-024-2916-9