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Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).

ABSTRACT: Background:Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase. Methods:A total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment. The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment. The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores. Results:After 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05). The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05). The incidence of adverse events and other safety indices showed no significant differences between the two groups. Conclusion:SFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients' quality of life without any significant AEs compared with the conventional therapy alone.

SUBMITTER: Wang X

PROVIDER: S-EPMC6413379 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).

Wang Xianliang X Zhao Zhiqiang Z Mao Jingyuan J Du Tinghai T Chen Yuanping Y Xu Hao H Liu Nan N Wang Xiaolong X Wu Jianguang J Li Rong R Xu Yong Y Zhao Yingqiang Y Wang Lei L He Jingsong J Zhang Junhua J Zhai Jingbo J Zhao Guoyuan G Hou Yazhu Y Wang Shuai S Liu Chunxiang C

Evidence-based complementary and alternative medicine : eCAM 20190225

<h4>Background</h4>Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase.<h4>Methods</h4>A total of 160 patients exper ...[more]

PMID: 30930952

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Project description:Background: Idiopathic pulmonary fibrosis (IPF) is disease with high mortality, and its effective treatment is limited. Shenfu injection is a traditional Chinese medicine which can improve circulation and protect cells. In this study, we aimed to investigate the feasibility and mechanism of Shenfu injection in the treatment of IPF. Methods: The components and targets of Shenfu injection were mainly retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) database. The targets of Shenfu injection were standardized by UniProt database. The Genecards and OMIM databases was used to search for IPF-related genes. The Venn diagram of gene intersection was drawn using the OmicStudio tools, and the protein-protein interaction network was visualized using the Cytoscape 3.7.2 software. Moreover, the metascape online software was applied to explore the enriched Gene Ontology (GO) terms and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways, and the Cytoscape 3.7.2 software was used to construct the target-pathway network. Molecular docking was used to visualize the interactions between the main active compounds and targeted proteins. Animal experiments were performed to validate the effects and mechanisms of Shenfu injection. Results: We obtained 46 co-targets of Shenfu injection and IPF. Among the hub target genes, several genes with important functions were enriched, including TNF, IL-6, IL-1B, TP53, JUN, CASP3 and CASP8. The pathway enrichment analysis for the hub target genes identified pathways in infection/inflammation, apoptosis and cancer. Molecular docking results showed that the main active compound Ginsenoside Re had high affinity to the core target proteins. These results suggested that Shenfu injection may have a positive effect in the treatment of IPF. Consistent with this finding, animal experiments showed that Shenfu injection significantly reduced pulmonary fibrosis in a mouse model with inhibition of apoptosis and inflammation by downregulating IL-1β, caspase-3 and phosphorylated NF-κB. Conclusion: Our results demonstrated that Shenfu injection efficiently alleviate bleomycin-induced pulmonary fibrosis through multi-targets in inflammation-, apoptosis- and cancer-related pathways, which provided first evidence and reference to the feasibility of Shenfu injection in the treatment of IPF.

Dataset Information

Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).

Publications

Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).

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