[Translation] A randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial on the efficacy and safety of Shenxiong Jieyu Granule in the treatment of post-ischemic stroke depression (Qi deficiency and blood stasis combined with liver depression and fire syndrome)

缺血性中风后抑郁

[Translation]

Depression after ischemic stroke

Start Date17 Dec 2021

Sponsor / Collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

100 Clinical Results associated with Shenxiong Jieyu Granules

100 Translational Medicine associated with Shenxiong Jieyu Granules

100 Patents (Medical) associated with Shenxiong Jieyu Granules

Literatures (Medical) associated with Shenxiong Jieyu Granules

01 May 2024·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Network Meta-analysis of traditional Chinese medicine injections in treatment of chronic pulmonary heart disease].

Article

Author: Zhou, Ya-Bin ; Wang, Zhuo-Xi ; Ban, Ji-Fang ; Wang, He ; Qie, Rui

Based on the network Meta-analysis, the efficacy and safety of different traditional Chinese medicine(TCM) injections in the treatment of chronic pulmonary heart disease(CPHD) were systematically evaluated. CNKI, Wanfang, VIP, SinoMed, Web of Science, PubMed, EMbase, and Cochrane Library were searched to collect randomized controlled trial(RCT) of TCM injection in the treatment of CPHD from inception to October 1, 2023. The quality of the included studies was evaluated by the bias risk assessment tool recommended by the Cochrane systematic evaluation manual version 5.3. Stata 17.0 and RevMan 5.4 software were used for statistical analysis of the data. Finally, 103 RCTs were included, involving 9 332 patients and 13 kinds of TCM injections. Network Meta-analysis yielded the following results.(1)In terms of improving the total clinical effective rate, the top three intervention measures in SUCRA ranking are Shuxuetong Injection + conventional western medicine>Ligustrazine Injection + conventional western medicine>Xinmailong Injection + conventional western medicine.(2)In terms of reducing pulmonary artery pressure, the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine>Ligustrazine Injection + conventional western medicine>Shenmai Injection + conventional western medicine.(3)In terms of improving left ventricular ejection fraction(LVEF), the top three intervention measures in SUCRA ranking are Xinmailong Injection + conventional western medicine>Danhong Injection + conventional western medicine>Ginkgo Damo Injection + conventional western medicine.(4) In terms of reducing brain natriuretic peptide(BNP), the top three intervention measures in SUCRA ranking are Xinmailong Injection + conventional wes-tern medicine>Ginkgo Damo Injection + conventional western medicine>Danhong Injection + conventional western medicine.(5) In terms of increasing arterial oxygen partial pressure(PaO_2) and reducing arterial carbon dioxide partial pressure(PaCO_2), the top three intervention measures in SUCRA ranking are Shenxiong Glucose Injection + conventional western medicine>Shenmai Injection + conventional western medicine>Shenfu Injection + conventional western medicine.(6) In terms of improving arterial oxygen saturation(SaO_2), the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine>Xinmailong Injection + conventional western medicine>Shenmai Injection + conventional western medicine.(7) In terms of increasing the percentage of forced expiratory volume in the first second(FEV_1%), the top three intervention measures in SUCRA ranking are Shenfu Injection + conventional western medicine>Tanshinone Sodium Ⅱ_A Sulfonate Injection + conventional western medicine>Shenmai Injection + conventional western medicine.(8) In terms of increasing the proportion of forced expiratory volume to forced vital capacity in the first second(FEV_1/FVC), the top three intervention measures in SUCRA ranking are Salvia Miltiorrhiza Ligustrazine Injection + conventional western medicine>Shuxuetong Injection + conventional western medicine>Danhong Injection + conventional western medicine.(9) In terms of safety, neither the experimental group nor the control group experienced any serious adverse drug reactions during the treatment period. In summary, combining TCM injection with conventional western medicine treatment can improve the comprehensive efficacy of treating CPHD, reduce pulmonary artery pressure, and improve cardiopulmonary function and arterial blood gas levels. However, due to the limitations of the quality and quantity of research methodology included, the above conclusions need to be further validated by more well-designed and high-quality RCT.

01 Feb 2024·Journal of Pharmaceutical and Biomedical Analysis

Analysis of compatibility mechanism of shenxiong glucose injection after multiple dosing based on differences of PK-PD correlation and cytochrome P450 enzyme

Article

Author: Liu, Chunhua ; Liu, Ting ; Huang, Yong ; Li, Rong ; Zhang, Jingya ; Sun, Jia ; Li, Yongjun ; Lu, Yuan

Shenxiong glucose injection (SGI) containing a water extract from the roots of Danshen and Ligustrazine hydrochloride, is the main drug used for the prevention and treatment of acute myocardial ischemia (AMI) in China. Based on the characteristics of drug clinical applications, this study aims to uncover the compatibility mechanism of SGI by investigating pharmacokinetic (PK) and pharmacodynamic (PD) differences between Danshen glucose injection (DGI), Ligustrazine glucose injection (LGI) and SGI groups after multiple dosing during the pathological state from the perspective of metabolic enzymes. Compared to the LGI group, the absorption (C_max) and exposure (AUC) of ligustrazine increased significantly, and the protein expression of CYP1A2, CYP2C11 and CYP3A2 in the SGI group decreased significantly. Furthermore, the PK and PD experimental data for Danshen and ligustrazine in AMI rats were fitted to obtain a PK-PD binding model with three components. PK-PD parameter analysis showed that in the SGI group the IC50 values of ligustrazine and danshensu on AST, CK-MB, cTn-I and the IC₅₀ values of rosmarinic acid on AST and CK-MB were lower than the DGI or LGI group. It is speculated that Danshen inhibited CYP1A2, CYP2C11 and CYP3A2 mediating the metabolism of ligustrazine and decreased the expression of these three isozymes, which further affected the in vivo process of ligustrazine. Moreover, the combination of Danshen and ligustrazine could have better regulating effect on AST, CK-MB and cTn-I. This preliminary study has provided a scientific basis for understanding the compatibility mechanism of SGI from the viewpoint of the regulation of CYP enzymes in the PK-PD model.

01 May 2022·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Mechanism of Shenxiong Glucose Injection against myocardial ischemia-reperfusion injury based on network pharmacology and molecular docking].

Article

Author: Nie, Hong ; Li, Chang-Jian ; Ma, Xian-Peng

Based on network pharmacology and molecular docking, the mechanism of danshensu and tetramethylpyrazine, the main active components of Shenxiong Glucose Injection(SGI), against myocardial ischemia-reperfusion injury(MIRI) was explored. Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP), GeneCards, and Online Mendelian Inheri-tance in Man(OMIM) were used to search the targets of the active components and the disease, and the common targets were screened. The "drug-component-disease-target" network was constructed by Cytoscape, and the protein-protein interaction network was established by STRING, followed by Gene Ontology(GO) term and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment by R software. AutoDock Vina was employed for the molecular docking between active components and core targets. A total of 15 potential targets of danshensu and tetramethylpyrazine against MIRI were screened out, involving the major GO terms of cyclooxyge-nase pathway, extracellular matrix binding, and antioxidant activity, and the main pathways of platelet activation and regulation of lipolysis in adipocytes. Danshensu and tetramethylpyrazine can form stable conformations with core targets prostaglandin G/H synthase 2(PTGS2), vascular endothelial growth factor A(VEGFA), and acetylcholinesterase(ACHE) with low binding energy. This study reflects the multi-component, multi-target, multi-pathway, and synergistic action characteristics of SGI, which provides a theoretical re-ference for further clarifying the anti-MIRI mechanism of SGI.

100 Deals associated with Shenxiong Jieyu Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder	Phase 2	CN	Xiyuan Hospital of China Academy of Chinese Medical Sciences	17 Dec 2021
Ischemic stroke	Phase 2	CN	Xiyuan Hospital of China Academy of Chinese Medical Sciences	17 Dec 2021

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