Shenqi Fuzheng Injection Reduces Cisplatin-Induced Kidney Injury via cGAS/STING Signaling Pathway in Breast Cancer Mice Model.

Background: Shenqi Fuzheng Injection (SQFZ) is a traditional Chinese medicine injection consists of extracts of Codonopsis pilosula and Astragalus mongholicus. Combining SQFZ with conventional chemotherapy may improve the therapeutic efficacy and reduce side-effects of chemotherapy. However, the mechanisms of SQFZ reducing cisplatin-induced kidney injury are still unclear. Methods: The main compounds of SQFZ were identified via UPLC-Q-TOF-MS technique. Using multiple databases to predict potential targets for SQFZ. We established a breast cancer model by injecting 4T1 cells into mice. Tumor growth and body weight were observed. Serum blood urea nitrogen (BUN), creatinine (CRE), and glutathione (GSH) levels were measured. The extent of their kidney injury was measured by hematoxylin-eosin staining (HE). Cell apoptosis was identified using Hoechst33258 staining, flow cytometry and TUNEL. We evaluated H2AX and stimulator of interferon genes (STING) expression by immunohistochemistry (IHC), and assessed apoptosis-associated proteins by Western blotting analysis. We also evaluated mitochondrial function. The secretion of the inflammatory cytokines in serum was observed using ELISA assay. The effect of the STING pathway in HK-2 renal tubular epithelial cells exposed to cisplatin alone or combined with SQFZ. Results: The potential targets of SQFZ on kidney injury mainly related to inflammatory responses, oxidation and antioxidant, apoptosis as well as IFN signaling pathway. Cisplatin significantly reduced animal weight, while there were no changes in the combination SQFZ and cisplatin. SQFZ counteracted cisplatin-induced BUN and CRE elevation. SQFZ ameliorated the oxidative stress induced by cisplatin. It diminished cisplatin-induced apoptosis and mitochondrial DNA damage and reversed cisplatin-induced cyclic guanosine monophosphate-adenosine monophosphate synthase (cGAS)/STING signaling pathway activation. It also improved the mitochondrial dysfunction induced by cisplatin. Conclusions: The results of the present study suggested that SQFZ effectively reduced cisplatin-induced kidney injury by inhibiting cGAS/STING signaling pathway.

Shenqi Fuzheng injection facilitates skeletal muscle mitophagy mediated by the ubiquitination of HIF-1α to ameliorate cancer-associated fatigue.

Cancer-related fatigue (CRF) significantly impacts the quality of life of cancer patients. This study investigates the therapeutic potential of Shenqi Fuzheng injection (SFI) in managing CRF, focusing on its mechanistic action in skeletal muscle. We utilized a CRF mouse model to examine the effects of SFI on physical endurance, monitoring activity levels, swimming times and rest periods. Proteomic analysis of the gastrocnemius muscle was performed using isobaric tags and liquid chromatography-tandem mass spectrometry to map the muscle proteome changes post-SFI treatment. Mitochondrial function in skeletal muscle was assessed via ATP bioluminescence assay. Furthermore, the regulatory role of the hypoxia inducible factor 1 subunit alpha (HIF-1α) signalling pathway in mediating SFI's effects was explored through western blotting. In CRF-induced C2C12 myoblasts, we evaluated cell viability (CCK-8 assay), apoptosis (flow cytometry) and mitophagy (electron microscopy). The study also employed pulldown, luciferase and chromatin immunoprecipitation assays to elucidate the molecular mechanisms underlying SFI's action, particularly focusing on the transcriptional regulation of PINK1 through HIF-1α binding at the PINK1 promoter region. Our findings reveal that SFI enhances physical mobility, reduces fatigue symptoms and exerts protective effects on skeletal muscles by mitigating mitochondrial damage and augmenting antioxidative responses. SFI promotes cell viability and induces mitophagy while decreasing apoptosis, primarily through the modulation of HIF-1α, PINK1 and p62 proteins. These results underscore SFI's efficacy in enhancing mitochondrial autophagy, thereby offering a promising approach for ameliorating CRF. The study not only provides insight into SFI's potential therapeutic mechanisms but also establishes a foundation for further exploration of SFI interventions in CRF management.

Cost-effectiveness of Kang Ai injection plus chemotherapy vs. Shenqi Fuzheng injection plus chemotherapy in the first-line treatment of advanced non-small cell lung cancer.

Objective: This study aimed to evaluate the cost-effectiveness of two Chinese patent medicines, including Kang Ai injection and Shenqi Fuzheng injection with each combined with platinum-based chemotherapy as the first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) in China. Methods: From Chinese healthcare system perspective, a three state Markov model with a cycle of 3 weeks and a 10-year horizon was constructed to derive the incremental cost-effectiveness ratio (ICER). Since only individual patient data of progression-free survival (PFS) of Kang Ai injection group can be obtained, we extrapolated median overall survival (mOS) of Kang Ai injection group and median progression-free survival (mPFS) and mOS of Shenqi Fuzheng injection group based on published literature and methods. Then survival curves were estimated by the method of declining exponential approximation of life expectancy (DEALE), which is based on the assumption that survival follows a declining exponential function. We performed one-way sensitivity analysis and probabilistic sensitivity analysis to test the robustness. Additionally, a scenario analysis was adopted to investigate the impact of using best-fitting distribution for PFS curve of Kang Ai injection group on the economic conclusion. Results: The base-case result indicated that Kang Ai injection group provided 0.217 incremental quality-adjusted life years (QALYs) at an incremental cost of $103.38 compared with Shenqi Fuzheng injection group. The ICER was $476.41/QALY, which was much lower than the willingness to pay threshold of one time the GDP per capita of China in 2022 ($12,070/QALY). Deterministic sensitivity analysis result showed that ICER was most sensitive to the changes in odds ratio (OR) value. The probabilistic sensitivity analysis confirmed the robustness of base-case analysis results. The scenario analysis result showed that by using Log-Normal distribution to fit the PFS curve of Kang Ai injection group and shortening the time horizon to 5 years, the ICER was $4,081.83/QALY, which was still much lower than the willingness to pay threshold. Conclusion: Kang Ai injection combined with platinum-based chemotherapy appeared to be more cost-effective for the treatment of advanced NSCLC than Shenqi Fuzheng injection combined with platinum-based chemotherapy.

Shenqi Fuzheng injection hinders non-small cell lung cancer cell growth by regulating the Bax/Bcl-2 signaling pathway.

INTRODUCTION: Lung cancer (LC) is the most common solid tumor and is currently considered the primary cause of cancer-related deaths worldwide. In clinical efficacy studies, it was not difficult to find that the combination of SFI and chemotherapy could improve the general condition of patients, reduce the side effects of chemotherapy drugs, and have a cooperative antitumor effect in NSCLC patients. However, whether SFI can be used as a novel antitumor drug is still unknown. METHODS: First, meta-analysis aimed to explore the efficacy of SFI in NSCLC patients, and SFI was identified by ultra-performance liquid chromatography‒mass spectrometry (UPLC‒MS). Cell proliferation, migration, and invasion were explored by Cell Counting Kit-8 (CCK-8), scratch healing, and Transwell assays, respectively. Cell cycle and apoptosis assays were performed by flow cytometry. Transcriptome sequencing analysis was performed in four NSCLC cell lines. Differential expression analysis was used to identify potential targets. Apoptosis-related protein levels were detected by Western blotting assays. The effects of SFI in NSCLC were further investigated by mouse xenografts. RESULTS: SFI could markedly improve the chemotherapy efficacy of NSCLC patients. The main active ingredients include flavonoids and terpenoids, which can effectively exert antitumor effects. SFI could not only inhibit tumor cell proliferation and cell migration/invasion but also regulate the cell cycle and promote tumor cell apoptosis. In NSCLC, SFI could enhance the transcription level of the CHOP gene, thereby upregulating the expression of the proapoptotic proteins Bax and caspase 3, and inhibiting the expression of the antiapoptotic protein Bcl-2. SFI hindered the growth of mouse NSCLC xenografts in vivo. CONCLUSIONS: SFI hindered tumor progression and might promote apoptosis by increasing the expression of Bax, caspase 3 and decreasing the level of Bcl-2 in NSCLC.

Network pharmacology-based investigation of the effects of Shenqi Fuzheng injection on glioma proliferation and migration via the SRC/PI3K/AKT signaling pathway.

ETHNOPHARMACOLOGICAL RELEVANCE: In the clinic, Shenqi Fuzheng Injection (SFI) is used as an adjuvant for cancer chemotherapy. However, the molecular mechanism is unclear. AIM OF THE STUDY: We screened potential targets of SFI action on gliomas by network pharmacology and performed experiments to validate possible molecular mechanisms against gliomas. MATERIALS AND METHODS: We consulted relevant reports on the SFI and glioma incidence from PubMed and Web of Science and focused on the mechanism through which the SFI inhibits glioma. According to the literature, two primary SFI components-Codonopsis pilosula (Franch.) Nannf. and Astragalus membranaceus (Fisch.) Bunge-have been found. All plant names have been sourced from "The Plant List" (www.theplantlist.org). The cell lines U87, T98G and GL261 were used in this study. The inhibitory effects of SFI on glioma cells U87 and T98G were detected by CCK-8 assay, EdU, plate cloning assay, scratch assay, Transwell assay, immunofluorescence, flow cytometry and Western blot. A subcutaneous tumor model of C57BL/6 mice was constructed using GL261 cells, and the SFI was evaluated by HE staining and immunohistochemistry. The targets of glioma and the SFI were screened using network pharmacology. RESULTS: A total of 110 targets were enriched, and a total of 26 major active components in the SFI were investigated. There were a total of 3,343 targets for gliomas, of which 79 targets were shared between the SFI and glioma tissues. SFI successfully prevented proliferation and caused cellular S-phase blockage in U87 and T98G cells, thus decreasing their growth. Furthermore, SFI suppressed cell migration by downregulating EMT marker expression. According to the results of the in vivo tests, the SFI dramatically decreased the development of tumors in a transplanted tumour model. Network pharmacological studies revealed that the SRC/PI3K/AKT signaling pathway may be the pathway through which SFI exerts its anti-glioma effects. CONCLUSIONS: The findings revealed that the SRC/PI3K/AKT signaling pathway may be involved in the mechanism through which SFI inhibits the proliferation and migration of glioma cells.

The role of Shenqi Fuzheng injection as adjuvant therapy for breast cancer: an overview of systematic reviews and meta-analyses.

BACKGROUND: Breast cancer (BC) is the most frequent malignancy in the world. Chemotherapy (CT) is a common treatment for BC but is accompanied by toxicity and side effects. Shenqi Fuzheng Injection (SFI) is an adjuvant therapy with promising results in improving efficacy and reducing toxicity in clinical studies. This overview of systematic reviews and meta-analysis (SRs/MAs) aimed to summarize the benefits and evaluate the quality of evidence supporting SFI adjuvant as CT for BC. METHODS: A systematic search for SRs/MAs of randomized controlled trials (RCTs) on SFI treatment for BC was performed by searching PubMed, Web of Science, EMbase, Cochrane Library, CNKI, Wanfang, VIP, and SinoMed databases from inception to October 1, 2022. The quality of SRs/MAs was evaluated using AMSTAR-2, PRISMA 2020, ROBIS, and GRADE by two reviewers. The corrected covered area (CCA) was used to quantify the degree of duplication of the original SRs/MAs. Finally, quantitative analysis of RCTs was conducted using RevMan 5.4 software. This study was registered with PROSPERO, CRD42022377290. RESULTS: Six SRs/MAs including 61 RCTs with 5593 patients were included in this study. Studies were published between 2015 and 2019, the original RCTs ranged from 7-49, with sample sizes ranging from 336-1989. The quantitative meta-analysis found that adjuvant CT of SFI improved the clinical response rate (RR=1.37, 95% CI=1.28, 1.46; P<0.00001) and the KPS score (RR=1.66, 95% CI 1.54, 1.79, P<0.00001) of patients with BC. In terms of immune function, CD3+ (SMD=1.51, 95% CI 0.91, 2.10; P<0.00001), CD4+ (SMD=1.87, 95% CI 1.18, 2.56; P<0.00001), CD4+/CD8+ (SMD=0.86, 95% CI 0.48, 1.23; P<0.00001), and NK cell levels (SMD=0.94, 95% CI 0.63, 1.24; P<0.00001) in the adjuvant CT group SFI were better than those with CT alone. Adverse reactions following SFI adjuvant CT showed reduced incidence of leukopenia (RR=0.53, 95% CI 0.46, 0.62; P<0.00001) and gastrointestinal reactions (RR=0.48, 95% CI 0.39, 0.58; P<0.00001). However, the GRADE results showed 'very low' to 'moderate' evidence for the 42 outcomes, without high-quality evidence supporting them, limited mainly by deficiencies in the design of RCTs (42/42, 100.00%), inconsistency (19/42, 45.24%), publication bias (41/42, 97.62%), and inaccuracy (3/42, 7.14%). The unsatisfactory results of AMSTAR-2, PRISMA 2020, and ROBIS were limited to lack of registration of study protocols, explanation of inclusion basis of RCTs, description of funding sources for the included studies, incomplete search strategy and screening process, addressing heterogeneity and sensitivity, and reporting potential conflicts of interest. CONCLUSION: Adjuvant CT with SFI for BC had better benefits and a lower risk of adverse events. The methodology and quality of the evidence are generally low, highlighting a need of greater attention during study implementation. More objective and high-quality studies are needed to verify the efficacy of adjuvant CT with SFI in clinical decision-making for BC.

Energy preservation for skeletal muscles: Shenqi Fuzheng injection prevents tissue wasting and restores bioenergetic profiles in a mouse model of chemotherapy-induced cachexia.

BACKGROUND: Energy deficiency is the characteristic of chemotherapy-induced cachexia (CIC) which is manifested by muscle wasting. glycolysis, tricarboxylic acid (TCA) cycle, and lipid metabolism are central to muscle bioenergy production, which is vulnerable to chemotherapy during cancer treatment. Recent investigations have spotlighted the potential of Shenqi Fuzheng injection (SQ), a Chinese proprietary medicine comprising Radix Codonopsis and Radix Astragali, in alleviating CIC. However, the specific effects of SQ on muscle energy metabolism remains less explored. PURPOSE AND METHODS: Here, we integrated transcriptomics, spatial metabolomics, gas chromatography-mass spectrometry targeted quantitative analysis, and transmission electron microscopy techniques, combined with Seahorse live-cell metabolic analysis to reveal the changes in genes and pathways related to energy metabolism in the CIC model and SQ's protective effects at molecular and functional levels. RESULTS: Our data showed that chemotherapeutic agents caused glycolysis imbalance, which further leads to metabolic derangements of TCA cycle intermediates. SQ maintained glycolysis balance by facilitating pyruvate fluxing to mitochondria for more efficient bioenergy production, which involved a dual effect on promoting functions of mitochondrial pyruvate dehydrogenase complexes and inhibiting lactate dehydrogenase for lactate production. As a result of the sustained pyruvate level achieved by SQ administration, glycolysis balance was maintained, which further led to the preservation of mitochondrial integrity and function of electron transport chain, thereby, ensuring the normal operation of the TCA cycle and the proper synthesis of adenosine triphosphate (ATP). The above results were further validated using the Seahorse live-cell assay. CONCLUSION: In conclusion, our study highlights SQ as a promising strategy for CIC management, emphasizing its ability to harmonize the homeostasis of the muscle bioenergetic profile. Beyond its therapeutic implications, this study also offers a novel perspective for the development of innovative treatments in the realm of herbal medicine.

Shenqi Fuzheng Injection Combined With Chemotherapy for Gastric Cancer: An Overview of Systematic Reviews and Meta-Analyses.

BACKGROUND: Gastric cancer (GC) is a prevalent malignant tumor of the digestive tract. Chemotherapy (CT) is the primary treatment for GC, but it is accompanied by toxic side effects. Several systematic reviews and meta-analyses (SRs/MAs) on the combination of Shenqi Fuzheng injection (SFI) with CT for GC have been published; however, the conclusions have been inconsistent. This overview of SRs/MAs aims to assess the effectiveness and safety of SFI for GC, establishing a dependable foundation for its clinical application. METHODS: We utilized 7 databases, namely PubMed, Embase, Cochrane Library, CNKI, Wanfang, VIP, and SinoMed, to conduct our search. The retrieval period spanned from inception to August 2023. The methodological quality, bias risk, reporting quality, and evidence quality of the SRs/MAs were assessed using the evaluation tools AMSTAR-2, ROBIS, PRISMA 2020, and GRADE, respectively. Subsequently, the randomized controlled trials (RCTs) included in the SRs/MAs were quantitatively analyzed through the implementation of RevMan 5.4 software. RESULTS: Eleven SRs/MAs were included in this study, comprising 54 RCTs involving a total of 9539 patients with GC. The studies covered the period from 2012 to 2021, with the number of original RCTs per study ranging from 3 to 20 and sample sizes ranging from 159 to 1413. The methodological quality of all 11 SRs/MAs was assessed as low or very low, and the quality of evidence was determined to range from moderate to very low. The comprehensive quantitative meta-analysis revealed that the combination of SFI with CT improved the objective response rate (ORR) (RR = 1.30, 95% CI = [1.21, 1.41], P < .00001) and disease control rate (DCR) (RR = 1.13, 95% CI = [1.09, 1.18], P < .00001) in GC patients, without heterogeneity observed among the studies. In comparison with CT alone, SFI combined with CT also demonstrated improvements in the Karnofsky performance status (KPS) (RR = 1.36, 95% CI = [1.25, 1.49], P < .00001) and CD4+/CD8+ level (RR = 1.16, 95% CI = [0.87, 1.46], P < .00001) of patients. In terms of adverse reactions, the combination therapy of SFI with CT was associated with a reduced incidence of gastrointestinal reactions (RR = 0.67, 95% CI = [0.58, 0.78], P < .00001) and neurotoxicity (RR = 0.64, 95% CI = [0.50, 0.81], P = .0002). CONCLUSIONS: SFI combined with CT can enhance the clinical effectiveness and enhance the quality of life in patients with GC, while minimizing adverse reactions. Nonetheless, the evaluation of overall quality remains deficient, thus restricting the reliability and stability of the conclusions. High-quality, large-sample RCTs remain crucial for establishing dependable clinical evidence. SYSTEMATIC REVIEW REGISTRATION: INPLASY20239004.

Effectiveness and safety of Shenqi Fuzheng injection combined with platinum-based chemotherapy for treatment of advanced non-small cell lung cancer: a systematic review and meta-analysis.

Objective: To evaluate the efficacy and safety of Shenqi Fuzheng Injection (SFI) combined with platinum-based chemotherapy (PBC) for the treatment of advanced non-small cell lung cancer (NSCLC). Methods: Seven electronic databases, including CNKI and Wanfang, were comprehensively searched to screen randomized controlled trials (RCTs) until May 1, 2022. The quality of each trial was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions, and systematic reviews were conducted according to the PRISMA guidelines. Statistical analysis was performed using Review Manager 5.3, and the results were expressed as relative risk (RR) and 95% confidence interval (95% CI). The primary outcome measures were objective response rate (ORR) and disease control rate (DCR). The secondary outcome measures were quality of life and toxicity. Subgroup analysis was performed according to the number of days of SFI single-cycle treatment and combined PBC regimen. Results: A total of 44 RCTs involving 3475 patients were included in the study. The meta-analysis results showed that, compared with PBC alone, SFI combined with PBC significantly improved the ORR (RR = 1.27, 95% CI = 1.18-1.37, P < 0.00001), DCR (RR = 1.12, 95% CI = 1.08-1.15, P < 0.00001), and quality of life (RR = 1.41, 95% CI = 1.31-1.52, P < 0.00001). It also reduced chemotherapy-induced hemoglobin reduction (RR = 0.57, 95% CI = 0.48-0.67, P < 0.00001), leukopenia (RR = 0.61, 95% CI = 0.53-0.71, P < 0.00001), thrombocytopenia (RR = 0.62, 95% CI = 0.55-0.70, P < 0.00001), and simple bone marrow suppression (RR = 0.55, 95% CI = 0.41-0.73, P < 0.0001). Nausea and vomiting (RR = 0.63, 95% CI = 0.52-0.77, P < 0.00001), diarrhea (RR = 0.48, 95% CI = 0.37-0.64, P < 0.00001), and simple digestive tract reactions (RR = 0.63, 95% CI = 0.49-0.80, P = 0.0002) also decreased with the treatment of SFI. Conclusion: SFI combined with PBC for the treatment of advanced NSCLC improved the ORR, DCR, and quality of life, and reduced the incidence of myelosuppression and gastrointestinal adverse reactions. However, considering the limitations of existing evidence, further verification using high-quality RCTs is required. Systematic review registration: https://inplasy.com/inplasy-2022-7-0026, identifier INPLASY202270026.

Determination of the intermediates in glycolysis and tricarboxylic acid cycle with an improved derivatization strategy using gas chromatography-mass spectrometry in complex samples.

Traditional Chinese medicine (TCM) is recognized as a complex matrix, and improved analytical methods are crucial to extract the key indicators and depict the interaction and alteration of the complex matrix. Shenqi Fuzheng Injection (SQ), a water extract of Radix Codonopsis and Radix Astragali, has demonstrated preventative effects on myotube atrophy induced by chemotherapeutic agents. To achieve the improved analytical capability of complex biological samples, we established a highly reproducible, sensitive, specific, and robust gas chromatography-tandem mass spectrometry (GC-MS) method to detect glycolysis and tricarboxylic acid (TCA) cycle intermediates with optimized factors in the extraction and derivatization process. Our method detected fifteen metabolites and covered most intermediate metabolites in glycolysis and TCA cycles, including glucose, glucose-6-phosphate, fructose-6-phosphate, dihydroxyacetone phosphate, 3-diphosphoglycerate, phosphoenolpyruvate, pyruvate, lactate, citrate, cis-aconitate, isocitrate, α-ketoglutarate, succinate, fumarate, and malate. Through methodological verification of the method, it was found that the linear correlation coefficients of each compound in the method were greater than 0.98, all of which had lower limits of quantification, the recovery rate was 84.94-104.45%, and the accuracy was 77.72-104.92%. The intraday precision was 3.72-15.37%, the interday precision was 5.00-18.02%, and the stability was 7.85-15.51%. Therefore, the method has good linearity, accuracy, precision, and stability. The method was further applied to study the attenuating effects of the SQ in a chemotherapeutic agents-induced C2C12 myotube atrophy model to evaluate the changes in the tricarboxylic acid cycle and glycolytic products under the action by the complex systems of TCM and disease model. Our study provided an improved method to explore TCM's pharmacodynamic constituents and action mechanisms.

Efficacy and safety of EGFR­TKIs plus Shenqi Fuzheng injection for non-small cell lung cancer patients with EGFR-sensitive mutations.

PURPOSE: The aim of this retrospective study is to evaluate the impact on efficacy and safety between epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) alone and in combination with Shenqi Fuzheng injection (SFI) in patients with advanced NSCLC harboring epidermal growth factor receptor (EGFR) activating mutations. METHODS: Retrospectively, information of 88 patients receiving EGFR-TKIs as first-line targeted treatment or in combination with SFI in the Affiliated Drum Tower Hospital of Nanjing University Medical College and the Affiliated Cancer Hospital of Anhui University of Science and Technology was collected. The primary endpoint was to assess progression-free survival (PFS) and safety of EGFR-TKIs alone or in combination with SFI. RESULTS: Between January 2016 and December 2019, a total of 88 patients were enrolled in this research, including 50 cases in the EGFR-TKIs single agent therapy group and 38 cases in the SFI combined with EGFR-TKIs targeted-therapy group. The median PFS (mPFS) of monotherapy group was 10.50 months (95%CI 9.81-11.19), and 14.30 months (95%CI 10.22-18.38) in the combination therapy group. Compared to the single EGFR-TKIs administration, combinational regimen with SFI exhibited a lower incidence of rash and diarrhea in patients and was even better tolerated. CONCLUSIONS: SFI combined with the first-generation EGFR-TKIs are more efficient, can prominently prolong the PFS and attenuate the adverse reactions in patients with advanced NSCLC with EGFR-sensitive mutations.

Study on protective effect of Shenqi Fuzheng injection on immune myocarditis injury induced by anti-PD-1 antibody / 中国药理学通报

Aim To investigate the effeot of Shenqi Fuzheng injection on the prevention of immune myocarditis induced by anti-PD-1 antibody by reducing the production of inflammatory factors and the expression of myocardial injury markers. Methods Thirty-two maie PD-1 humanized mice with C57BL/6 genetic background were randomly divided into control group, myocarditis model group, anti-PD-1 antibody group and Shenqi Fuzheng injection group (n = 8). Except the control group, mice in other groups were intraperitoneally injected with myocardial myosin heavy chain peptide (5 mg • kg

Evaluation of the efficacy and safety of Camrelizumab combined with Shenqi Fuzheng injection in the treatment of advanced non-squamous non-small cell lung cancer patients / 中国药师

Objective To investigate the clinical efficacy and safety of the Camrelizumab combined with Shenqi Fuzheng injection of advanced non-squamous non-small cell lung cancer(NSCLC).Methods Patients with advanced squamous NSCLC diagnosed and treated in the department of medical oncology of The First Affiliated Hospital of Xi'an Jiaotong University from January 2018 to January 2023 were selected as the study subjects,and all patients were treated with pemetrexed combined with carboplatin chemotherapy.On the basis of the chemotherapy regimen,patients were divided into the Camrelizumab group(treated with Carelizumab)and the Camrelizumab+SFI group(treated with Camrelizumab+SFI).The short-term and long-term efficacy were evaluated using objective response rate(ORR),disease control rate(DCR),progression free survival(PFS),and overall survival(OS).Survival data were analyzed using Kaplan-Meier method.The occurrence of side effects the adverse drug reactions was evaluated according to the common terminology standard for adverse events(CTCAE 4.03).Results A total of 95 patients with advanced NSCLC were included in this study.Among them,48 patients were in the Camrelizumab group,and 47 patients were in the Camrelizumab+SFI group.The ORR of advanced non-squamous NSCLC patients in the Camrelizumab+SFI group and Carolizumab group were 59.57％and 45.83％,respectively(x2=1.799,P=0.180),with DCR of 78.72％and 58.33％,respectively(x2=4.569,P=0.033).The median PFS(8.87 months vs.6.30 months,P=0.001 7)and median OS(9.13 months vs.7.73 months,P=0.037)of patients in the Camrelizumab+SFI group were significantly higher than those in the Camrelizumab group.In addition,there was no significant difference in the incidence of adverse reactions between two groups(P＞0.05).Conclusion Camrelizumab combined with Shenqi Fuzheng injection can improve the disease control rate and prolong the PFS and OS of patients with advanced non-squamous NSCLC.

Efficacy and safety of Shenqi Fuzheng injection combined with docetaxel treatment regime in patients with metastatic castration-resistant prostate cancer / 中国药师

Objective To explore the efficacy and safety of Shenqi Fuzheng injection(SFI)combined with docetaxel treatment regime in patients with metastatic castration-resistant prostate cancer(mCRPC).Methods The present studyretrospectively selected mCRP patients diagnosed and treated in the department of urology of Weinan Central Hospital from January 2017 to January 2022 from the electronic medical record system.According to the treatment plan,mCRPC patients were divided into Docetaxel group and Docetaxel+SFI group,receiving docetaxel+prednisone acetate treatment and docetaxel+prednisone acetate+SFI treatment,respectively.The short-term efficacy[objective response rate(ORR)and disease control rate(DCR)]and long-term efficacy[progression free survival(PFS)and overall survival(OS)]of two groups of mCRPC patients were eveluated.The occurrence of adverse reactions during treatment in mCRPC patients was eveluated using were eveluated the common terminology standard for good events(CTCAE 4.03).Results A total of 305 mCRPC patients were included in this study,including 159 cases in Docetaxel+SFI group and 146 cases in Docetaxel group.The ORR and DCR of the Docetaxel+SFI group were significantly higher than those of the Docetaxel group(P＜0.05).The median PFS and median OS of mCRPC patients in the Docetaxel+SFI group were significantly higher than those in the camrelizumab group(P＜0.001).In addition,the incidence of adverse events such as hair loss,diarrhea,nausea and vomiting,anorexia,peripheral edema,and neutropenia in mCRPC patients in the Docetaxel+SFI group was significantly lower than that in the Docetaxel group(P＜0.05).Conclusion Shenqi Fuzheng injection combined with docetaxel has a significant therapeutic effect on mCRP patients,which can improve disease control rate,prolong PFS and OS,and reduce the incidence of adverse reactions.

Authentication of Shenqi Fuzheng Injection via UPLC-Coupled Ion Mobility-Mass Spectrometry and Chemometrics with Kendrick Mass Defect Filter Data Mining.

Nearly 5% of the Shenqi Fuzheng Injection's dry weight comes from the secondary metabolites of Radix codonopsis and Radix astragali. However, the chemical composition of these metabolites is still vague, which hinders the authentication of Shenqi Fuzheng Injection (SFI). Ultra-high performance liquid chromatography with a charged aerosol detector was used to achieve the profiling of these secondary metabolites in SFI in a single chromatogram. The chemical information in the chromatographic profile was characterized by ion mobility and high-resolution mass spectrometry. Polygonal mass defect filtering (PMDF) combined with Kendrick mass defect filtering (KMDF) was performed to screen potential secondary metabolites. A total of 223 secondary metabolites were characterized from the SFI fingerprints, including 58 flavonoids, 71 saponins, 50 alkaloids, 30 polyene and polycynes, and 14 other compounds. Among them, 106 components, mainly flavonoids and saponins, are contributed by Radix astragali, while 54 components, mainly alkaloids and polyene and polycynes, are contributed by Radix codonopsis, with 33 components coming from both herbs. There were 64 components characterized using the KMDF method, which increased the number of characterized components in SFI by 28.70%. This study provides a solid foundation for the authentification of SFIs and the analysis of its chemical composition.

A Single-Arm Phase II Study to Evaluate Efficacy and Safety of First-Line Treatment With DCVAC/LuCa, Standard of Care Chemotherapy and Shenqi Fuzheng Injection in Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer Patients.

OBJECTIVES: To evaluate the efficacy and safety of first-line treatment with a dendritic cell vaccination for lung cancer (DCVAC/LuCa), standard of care chemotherapy and Shenqi Fuzheng injection in patients with advanced (stage IIIB/IV) non-small cell lung cancer. PATIENTS AND METHODS: Patients with histologically or cytologically confirmed recurrent metastatic or advanced NSCLC (stage IIIB/IV) with wild-type epidermal growth factor receptor (EGFR) or EGFR mutation which does not confer increased tumor susceptibility to EGFR-interacting drugs were recruited. For the treatment period, the first cycle of standard of care therapy (SoC) started 2 to 14 days after the leukapheresis procedure. SoC continued 4 to 6 cycles. DCVAC/LuCa was administered from the second cycle of SoC. DCVAC/LuCa was administered in a 3-week cycle schedule (5 doses) and then in a 6-week cycle schedule. Shenqi Fuzheng injection was administered 3 days before each DCVAC/LuCa administration for a total of 14 daily doses. Patients would undergo disease evaluation by computed tomography (CT) scan every 3 months. The primary and secondary endpoint was efficacy with regard to objective response rate (ORR) and progression free survival (PFS). The safety profile was measured by: incidence, type, and severity of all adverse events (AEs), laboratory abnormalities (blood routine test, urine test, and chemical test), physical status, and vital signs. Qi insufficiency was evaluated by tongue diagnosis and questionnaire survey with "Classification and Determination of constitution in TCM." RESULTS: Twenty-three patients from 3 hospitals who received combination therapy were included. ORR was 34.8% (95% CI:16.4%-57.3%). Median duration of response was 5.51 m (95% CI:2.70-8.32). Median PFS was 10.72 m (95% CI:4.52-16.93), 1-year survival was 77.8%. mOS was 21.97 m (95% CI:13.68-30.25). There was 1 severe AE related to a history of heart disease and there were no adverse events related to DCVAC/LuCa treatment. Qi insufficiency was improved significantly (P < .0001) from 41.19 ± 14.58 before treatment to 10.52 ± 16.58 after treatment. CONCLUSION: DCVAC/LuCa, combined with standard of care chemotherapy and Shenqi Fuzheng injection exhibited good benefit in Chinese patients with recurrent metastatic or advanced (stage IIIB/IV) NSCLC, and also significantly improved Qi insufficiency constitution. There were no related adverse events with DCVAC/LuCa treatment.

Shenqi Fuzheng Injection () Combined with Chemotherapy for Acute Leukemia: A Meta-Analysis.

OBJECTIVE: To evaluate to the efficacy and safety of Shenqi Fuzheng Injection (, SFI) combined with chemotherapy in the treatment of acute leukemia (AL) by meta-analysis. METHODS: PubMed, Cochrane library, Embase, SinoMed, China National Knowledge Infrastructure (CNKI), VIP Journal Integration Platform, Wanfang Database were searched from establishment to November 1, 2018. The randomized controlled trials (RCTs) of SFI combined with chemotherapy in the treatment of AL were included. The Cochrane risk assessment form (RevMan 5.1) was used to evaluate the quality of included studies. RESULTS: A total of 14 RCTs and 1,088 patients was included. The quality evaluation were mostly low risk or unclear. Meta-analysis showed that compared with chemotherapy alone, SFI combined with chemotherapy can improve the total clinical effective rate in patients with AL (RR=1.15, 95% CI: 1.056-1.177; P=0.0001), and relieve adverse reactions caused by chemotherapy drugs, including infection (RR=0.561, 95% CI: 0.397-0.792; P=0.001), nausea and vomiting (RR=0.662, 95% CI: 0.524-0.835; P=0.001), bleeding (RR=0.548, 95% CI: 0.39-0.768; P=0.0001), cardiotoxicity (RR=0.230, 95% CI: 0.080-0.660; P=0.006) and hyperhidrosis (RR=0.348, 95% CI: 0.208-0.581; P=0.0001). The incidence rates of adverse reactions in SFI combined with chemotherapy group were significantly lower than that of the chemotherapy alone group (P<0.01). CONCLUSIONS: Shenqi Fuzheng Injection combined with chemotherapy has good efficacy and safety for AL, and it can alleviate the adverse reactions caused by chemotherapy. However, subject to the limitations of the methodological quality of the literature, the conclusions of this study need to be further verified by large-scale and multi-center RCTs.

Shenqi Fuzheng Injection () Combined with Chemotherapy for Acute Leukemia: A Meta-Analysis / 中国结合医学杂志

OBJECTIVE@#To evaluate to the efficacy and safety of Shenqi Fuzheng Injection (, SFI) combined with chemotherapy in the treatment of acute leukemia (AL) by meta-analysis.@*METHODS@#PubMed, Cochrane library, Embase, SinoMed, China National Knowledge Infrastructure (CNKI), VIP Journal Integration Platform, Wanfang Database were searched from establishment to November 1, 2018. The randomized controlled trials (RCTs) of SFI combined with chemotherapy in the treatment of AL were included. The Cochrane risk assessment form (RevMan 5.1) was used to evaluate the quality of included studies.@*RESULTS@#A total of 14 RCTs and 1,088 patients was included. The quality evaluation were mostly low risk or unclear. Meta-analysis showed that compared with chemotherapy alone, SFI combined with chemotherapy can improve the total clinical effective rate in patients with AL (RR=1.15, 95% CI: 1.056-1.177; P=0.0001), and relieve adverse reactions caused by chemotherapy drugs, including infection (RR=0.561, 95% CI: 0.397-0.792; P=0.001), nausea and vomiting (RR=0.662, 95% CI: 0.524-0.835; P=0.001), bleeding (RR=0.548, 95% CI: 0.39-0.768; P=0.0001), cardiotoxicity (RR=0.230, 95% CI: 0.080-0.660; P=0.006) and hyperhidrosis (RR=0.348, 95% CI: 0.208-0.581; P=0.0001). The incidence rates of adverse reactions in SFI combined with chemotherapy group were significantly lower than that of the chemotherapy alone group (P<0.01).@*CONCLUSIONS@#Shenqi Fuzheng Injection combined with chemotherapy has good efficacy and safety for AL, and it can alleviate the adverse reactions caused by chemotherapy. However, subject to the limitations of the methodological quality of the literature, the conclusions of this study need to be further verified by large-scale and multi-center RCTs.

Effects of Shenqi fuzheng injection on low-glucose-mediated immunosuppressive microenvironment and its mechanism of action / 中国临床药理学与治疗学

AIM: To investigate the effect of Shenqi fuzheng injection (SFI) on tumor immunity and its preliminary molecular mechanism. METHODS: The animal model of low glucose tumor microenvironment was established by B16-PKM2-OE; the level of interleukin-2(IL-2) and interferon-γ(IFN-γ), CD40L and transforming growth factor-β1(TGF-β1) were detected by ELISA kit; the expressions of glucose transporter-1 (Glut-1) and key enzymes of glycolysis ( HK, PFK and PK ) in CD4

Neuroprotective Effects of Shenqi Fuzheng Injection in a Transgenic SOD1-G93A Mouse Model of Amyotrophic Lateral Sclerosis.

Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease, in the pathogenesis of which oxidative stress (OS) was believed to play a key role. Shenqi Fuzheng Injection (SFI) concocted from two kinds of Chinese medicinal herbs, Radix Codonopsis and Radix Astragali, was proven to be eligible to reduce the OS injury and increase the activity of the nuclear factor-erythroid-2-related factor 2 (Nrf2) pathway, an antioxidant enzymes inducer. Objective: We aim to investigate the effects and potential mechanisms underlying the action of SFI on a well-established transgenic mouse model of ALS. Methods: Transgenic SOD1-G93A mice were intraperitoneally injected with SFI (40 ml/kg) three times a week from 87 days of age. Motor function, survival, pathological manifestations in the brain, and Nrf2 pathway-related assessments of the mice were performed. Results: SFI treatment efficiently postponed the disease onset (p = 0.022) and extended the overall survival (p = 0.038) of the SOD1-G93A mice. Moreover, SFI significantly reduced motor neuron loss (p < 0.001) and astrocytic activation (p < 0.05) in the motor cortex of the brain of SOD1-G93A mice at 130 days of age. The protective effects of SFI in the SOD1-G93A mice were associated with decreasing the level of malondialdehyde (p < 0.05) and increasing the levels of superoxide dismutase (p < 0.05), Nrf2 (p < 0.05), heme oxygenase-1 (p < 0.05), and glutathione S-transferase (p < 0.05) in the SOD1-G93A mice. Conclusion: The SFI treatment efficiently extended the overall survival and improved the pathological manifestations of the brain via alleviating the OS injury and activating the Nrf2 pathway in the animal model of ALS, which made SFI a potentially promising candidate for ALS treatment.