1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
4.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
5.Advances in role and mechanism of traditional Chinese medicine active ingredients in regulating balance of Th1/Th2 and Th17/Treg immune responses in asthma patients.
Ya-Sheng DENG ; Lan-Hua XI ; Yan-Ping FAN ; Wen-Yue LI ; Yong-Hui LIU ; Zhao-Bing NI ; Ming-Chan WEI ; Jiang LIN
China Journal of Chinese Materia Medica 2025;50(4):1000-1021
Asthma is a chronic inflammatory disease involving multiple inflammatory cells and cytokines. Its pathogenesis is complex, involving various cells and cytokines. Traditional Chinese medicine(TCM) theory suggests that the pathogenesis of asthma is closely related to the dysfunction of internal organs such as the lungs, spleen, and kidneys. In contrast, modern immunological studies have revealed the central role of T helper 1(Th1)/T helper 2(Th2) and T helper 17(Th17)/regulatory T(Treg) cellular immune imbalance in the pathogenesis of asthma. Th1/Th2 imbalance is manifested as hyperfunction of Th2 cells, which promotes the synthesis of immunoglobulin E(IgE) and the activation of eosinophil granulocytes, leading to airway hyperresponsiveness and inflammation.Meanwhile, Th17/Treg imbalance exacerbates the inflammatory response in the airways, further contributing to asthma pathology.Currently, therapeutic strategies for asthma are actively exploring potential targets for regulating the balance of Th1/Th2 and Th17/Treg immune responses. These targets include cytokines, transcription factors, key proteins, and non-coding RNAs. Precisely regulating the expression and function of these targets can effectively modulate the activation and differentiation of immune cells. In recent years,traditional Chinese medicine active ingredients have shown unique potential and prospects in the field of asthma treatment. Based on this, the present study systematically summarizes the efficacy and specific mechanisms of TCM active ingredients in treating asthma by regulating Th1/Th2 and Th17/Treg immune balance through literature review and analysis. These active ingredients, including flavonoids, terpenoids, polysaccharides, alkaloids, and phenolic acids, exert their effects through various mechanisms, such as inhibiting the activation of inflammatory cells, reducing the release of cytokines, and promoting the normal differentiation of immune cells. This study aims to provide a solid foundation for the widespread application and in-depth development of TCM in asthma treatment and to offer new ideas for clinical research and drug development of asthma.
Asthma/genetics*
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Humans
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Drugs, Chinese Herbal/chemistry*
;
Th2 Cells/drug effects*
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Th17 Cells/drug effects*
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T-Lymphocytes, Regulatory/drug effects*
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Th1 Cells/drug effects*
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Animals
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Cytokines/immunology*
;
Medicine, Chinese Traditional
6.Advances in pathogenesis of asthma airway remodeling and intervention mechanism of traditional Chinese medicine.
Ya-Sheng DENG ; Jiang LIN ; Yu-Jiang XI ; Yan-Ping FAN ; Wen-Yue LI ; Yong-Hui LIU ; Zhao-Bing NI ; Xi MING
China Journal of Chinese Materia Medica 2025;50(8):2050-2070
Asthma, a chronic inflammatory airway disease with a high global prevalence, has a complex pathogenesis, in which airway remodeling plays a key role in the chronicity of the disease. Airway remodeling involves a series of pathophysiological changes, including airway epithelial damage, proliferation of mucous glands and goblet cells, subepithelial fibrosis, proliferation and migration of airway smooth muscle cells, and epithelial-mesenchymal transition. These complex pathological changes significantly increase airway resistance and responsiveness, forming an important pathological basis for refractory asthma. Currently, the regulatory mechanisms of airway remodeling focus on signaling pathways and regulatory targets. The signaling pathways include phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt), nuclear factor-κB(NF-κB), transforming growth factor-β1(TGF-β1)/Smads, and mitogen-activated protein kinase(MAPK). The regulatory targets include microRNAs(miRNAs), competing endogenous RNAs(ceRNAs), long non-coding RNAs(lncRNAs), and circular RNAs(circRNAs). Key proteins involved in these processes include TGF-β1, silencing information regulator 2-related enzyme 1(SIRT1), chitinase 3-like protein 1(YKL-40), and adenosine deaminase-metalloproteinase 33(ADAM33). In recent years, the potential of traditional Chinese medicine in the treatment of asthma has become increasingly evident. Its active ingredients, extracts, and complexes can inhibit airway remodeling in asthma through multiple pathways, demonstrating a variety of effects, including anti-inflammatory actions, inhibition of smooth muscle cell proliferation and migration, regulation of epithelial-mesenchymal transition, attenuation of fibrosis and basement membrane thickening, reduction of mucus secretion, inhibition of vascular remodeling, modulation of immune imbalance, and antioxidative stress. This paper aims to provide an in-depth analysis of the pathogenesis and therapeutic targets of asthma, offering theoretical support and innovative strategies for clinical research and drug development in the treatment of asthma.
Asthma/pathology*
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Humans
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Airway Remodeling/drug effects*
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Drugs, Chinese Herbal/therapeutic use*
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Animals
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Signal Transduction/drug effects*
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Medicine, Chinese Traditional
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Transforming Growth Factor beta1/metabolism*
7.Scientific connotation of "blood stasis toxin" in hypoxic microenvironment: its "soil" function in tumor progression and micro-level treatment approaches.
Wei FAN ; Yuan-Lin LYU ; Xiao-Chen NI ; Kai-Yuan ZHANG ; Chu-Hang WANG ; Jia-Ning GUO ; Guang-Ji ZHANG ; Jian-Bo HUANG ; Tao JIANG
China Journal of Chinese Materia Medica 2025;50(12):3483-3488
The tumor microenvironment is a crucial factor in tumor occurrence and progression. The hypoxic microenvironment is widely present in tumor tissue and is a key endogenous factor accelerating tumor deterioration. The "blood stasis toxin" theory, as an emerging perspective in tumor research, is regarded as the unique "soil" in tumor progression from the perspective of traditional Chinese medicine(TCM) due to its dynamic evolution mechanism, which closely resembles the formation of the hypoxic microenvironment. Scientifically integrating TCM theories with the biological characteristics of tumors and exploring precise syndrome differentiation and treatment strategies are key to achieving comprehensive tumor prevention and control. This article focused on the hypoxic microenvironment of the tumor, elucidating its formation mechanisms and evolutionary processes and carefully analyzing the internal relationship between the "blood stasis toxin" theory and the hypoxic microenvironment. Additionally, it explored the interaction among blood stasis, toxic pathogens, and hypoxic environment and proposed micro-level prevention and treatment strategies targeting the hypoxic microenvironment based on the "blood stasis toxin" theory, aiming to provide TCM-based theoretical support and therapeutic approaches for precise regulation of the hypoxic microenvironment.
Humans
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Tumor Microenvironment/drug effects*
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Neoplasms/therapy*
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Animals
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Medicine, Chinese Traditional
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Disease Progression
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Drugs, Chinese Herbal
8.Application Analysis of Animal Models for Pelvic Inflammatory Disease Based on Data Mining
Yiqing ZHENG ; Yasheng DENG ; Yanping FAN ; Tianwei LIANG ; Hui HUANG ; Yonghui LIU ; Zhaobing NI ; Jiang LIN
Laboratory Animal and Comparative Medicine 2024;44(4):405-418
Objective To investigate the key elements for model establishment and determine the evaluation indicators of animal models for pelvic inflammatory disease(PID),providing a reference for improving modelling methods and optimizing the application of PID animal models.Methods The search query"Pelvic Inflammatory Disease"AND"Animal Model"OR"Rat"OR"Mouse"OR"Guinea Pig"OR"Rabbit"OR"Dog"OR"Pig"was used to retrieve relevant literature on PID animal models published from 2013 to 2023 in China Knowledge Network Infrastructure(CNKI),Wanfang,and PubMed databases.The studies were analyzed and categorized based on experimental animal types,modelling methods,modelling cycles,detection indicators,positive control drugs,and administration duration.A database was established for statistical analysis.Results A total of 214 research articles on PID animal models meeting the inclusion criteria were identified.The most commonly used model animals are Sprague Dawley(SD)rats,followed by Wistar rats.The most frequently employed modelling method is a combination of mechanical injury and bacterial infection,followed by the phenol mucilage method.The most common modelling cycles for acute pelvic inflammatory disease(APID)and chronic pelvic inflammatory disease(CPID)/sequelae of pelvic inflammatory disease(SPID)are 8 to 14 days,while for PID models without specific staging,the cycles are 7 days.High-frequency detection methods and indicators include histopathological observation using hematoxylin-eosin staining,enzyme-linked immunosorbent assay(ELISA)for serum-related indicators,morphological changes of tissues observed with the naked eye,and immunohistochemical detection of related protein expression in uterine tissues,and pathological scoring.The most frequently used positive control drugs are Fuke Qianjin Tablets,followed by Jingangteng Capsules.The most common administration duration for APID is 7 days,and for CPID/SPID models,it ranges from 15 to 21 days.Conclusion Currently,SD rats and Wistar rats are commonly used as experimental animals for PID models.The dual modelling method of mechanical injury combined with mixed bacterial infection aligns closely with clinical pathogenesis and can be used to establish a PID model that simulates postoperative uterine cavity infection.Depending on the research objectives,different positive drugs and detection indicators should be selected for comprehensive evaluation.Most existing PID animal model studies are based on western medical diagnosis,with fewer studies focusing on Traditional Chinese Medicine(TCM)syndromes.There is a need to integrate TCM theories of etiology and pathogenesis to construct PID animal models that are more in line with TCM clinical symptoms.
9.Imaging study on thoracic and lumbar physiological curvature in adolescent idiopathic scoliosis
Hao-Yang ZHANG ; Ni-Sang CHEN ; Guo-Qing SHI ; Xin YE ; Shuai-Lin LI ; Xiao-Ming LI ; Bing-Hua FAN ; Ying-Sen PAN ; Xiao-Ming YING
China Journal of Orthopaedics and Traumatology 2024;37(1):26-32
Objective To observe the alteration of thoracic and lumbar physiological curvature in adolescent idiopathic scoliosis(AIS)and the difference of physiological curvature between different types of scoliosis.Methods A retrospective analysis was conducted on 305 adolescent patients taken full spine X-ray in our hospital from January 2017 to December 2021.The patients were divided into normal group and scoliosis group.The normal group was composed of 179 patients,79 males and 100 females,aged 10 to 18 years old with an average of(12.84±2.10)years old,with cobb agle less than 10 degrees.The scol-iosis group was composed of 126 patients,33 males and 93 females,aged 10 to 18 years old with an average of(13.92±2.20)years old.The gender,age,Risser sign,thoracic kyphosis(TK)and lumbar lordosis(LL)in 2 groups were compared,and the TK and LL were also compared between different genders,different degrees of scoliosis and different segments of scoliosis.Re-sults The female ratio(P=0.001)and age(P<0.001)in scoliosis group were higher than them in normal group;the ratio of low-grade ossification was higher in normal group than in scoliosis group(P=0.038).TK was significantly smaller in scoliosis group than in normal group(P<0.001),but there was no significant difference in LL between the 2 groups(P=0.147).There were no significant difference in TK and LL between male and female.The TK was significantly bigger in mild AIS patients than in moderate AIS patients(P<0.05),but there was no significant difference in LL between mild and moderate patients(P>0.05).The TK and LL in different segments scoliosis were not found significant difference.Conclusion The physiological curvature of thoracic and lumbar spine is independent of gender.The thoracic physiological curvature becomes smaller in AIS patients,but lumbar curvature remains unchanged.The thoracic physiological curvature in mild AIS patients is greater than that in moderate AIS patients,but the lumbar curvature is almost unchanged between mild and moderate scoliosis and is similar with that in normal adolescent.The alteration of thoracic and lumbar physiological curvature in AIS patients may be related to relative an-terior spinal overgrowth,and the specific detailed mechanism needs to be further studied.
10.Synergistic effects of gentiopicroside combined with pabolizumab on photodynamic treatment of breast cancer mice
Jie-Ni FENG ; Chao-Fan GUO ; Hua-Long LIN ; Shao-Fei YUAN
The Chinese Journal of Clinical Pharmacology 2024;40(2):239-243
Objective To study the synergistic effects of gentiopicroside combined with pabolizumab on photodynamic therapy in mice with breast cancer.Methods MCF-7 cells were injected subcutaneously to establish a tumor bearing mouse model of breast cancer and were randomly divided into model group,control group,positive control group,experimental group and combination group,with 10 mice in each group.The control group was intraperitoneally injected with 50 mg·kg-1 of 5-aminolevulinic acid and irradiated with 200 J·cm-2 laser for 20 min,once a week.The positive control group was intraperitoneally injected with 100μg·kg-1 pabolizumab,twice a week,and photodynamic therapy once a week,the experimental group was intragastric given 100 mg·kg-1 gentiopicroside,once a day,and photodynamic therapy once a week,the combined group was intraperitoneally injected with pabolizumab(100 μg·kg-1),twice a week,and gavage of gentiopicroside(100 mg·kg-1)once a day and photodynamic therapy once a week.Five groups of mice were given the drug for 3 weeks.The tumor inhibition rate of each group was compared,and the levels of interleukin(IL)-12,interferon(INF)-γand tumor necrosis factor(TNF)-α were measured by enzyme-linked immunosorbent assay.The levels of B-cell lymphoma-2 associated gene(Bax),B-lymphoblastoma-2 gene(Bcl-2)and vascular endothelial growth factor(VEGF)protein in tumor tissues were determined by Western blot.Results The tumor inhibition rates of control,positive control,experimental and combined groups were(22.38±2.26)%,(42.27±3.21)%,(38.16±2.17)%and(60.24±2.84)%,respectively.The serum IL-12 levels of model,control,positive control,experimental and combined groups were(127.13±1.25),(132.29±2.31),(155.27±1.48),(163.31±2.67)and(185.24±1.71)pg·mL-1;INF-γ levels were(724.16±3.63),(891.12±4.45),(1 043.19±3.85),(1 082.34±4.51)and(1 492.13±6.57)pg·mL-1;TNF-α levels were(83.81±4.52),(65.26±3.77),(41.07±3.85),(43.59±3.94)and(27.12±3.93)pg·mL-1;the relative protein expression levels of Bax were 0.30±0.08,0.47±0.05,0.67±0.11,0.89±0.06 and 1.03±0.10;the relative protein expression levels of Bcl-2 were 0.99±0.04,0.86±0.06,0.71±0.05,0.46±0.06 and 0.31±0.08;the relative protein expression levels of VEGF were 1.06±0.04,0.92±0.03,0.76±0.04,0.49±0.04 and 0.29±0.08.The differences of above indexes between the combined group and the control,positive control group and experimental groups were statistically significant(all P<0.05).Conclusion Gentiopicroside combined with pembrolizumab can significantly enhance the tumor inhibition effect of photodynamic therapy on breast cancer mice,promote the apoptosis of breast cancer cells,and then inhibit the tumor progression of breast cancer mice.

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