1.Randomized Double-blind Placebo-controlled Study on Clinical Efficacy and Mechanism of Shexiang Baoxinwan in Treating Stable Angina Pectoris Complicated with Anxiety and Depression in Coronary Artery Disease
Jie WANG ; Linzi LONG ; Zhiru ZHAO ; Feifei LIAO ; Jieming LU ; Tianjiao LIU ; Yuxuan PENG ; Hua QU ; Changgeng FU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):159-169
ObjectiveTo evaluate the efficacy of Shexiang Baoxinwan in treating stable angina pectoris with Qi stagnation and blood stasis syndrome in patients with coronary artery disease (CAD) complicated with anxiety and depression and explore its underlying mechanisms. MethodsThis study employed a randomized, double-blind, and placebo-controlled clinical trial design. Patients admitted to the hospital were randomly assigned to the observation group and the control group, with 52 patients in each group. Patients in the observation and control groups received Shexiang Baoxinwan and placebo, respectively, both in combination with conventional Western medication. The dose was 45.0 mg, three times daily, for a total duration of eight weeks. The primary outcome was the Seattle Angina Questionnaire (SAQ) scores before and after treatment. Secondary outcomes included changes in traditional Chinese medicine (TCM) syndrome score, the patient health questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), inflammatory markers [interleukin-18 (IL-18), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), CD40, etc.], monoamine neurotransmitters [e.g., dopamine (DA)], vascular endothelial function markers [e.g., endothelin-1(ET-1)], adipokines, and ischemia-modified albumin (IMA). Adverse reactions were also recorded. ResultsA total of 92 patients completed the study, with 44 in the observation group and 48 in the control group. Compared with baseline, both groups showed significant decreases in PHQ-9, GAD-7, and TCM syndrome scores following treatment (P<0.05), along with a significant increase in SAQ scores (P<0.05). In the observation group, DA levels were significantly increased (P<0.05), while levels of IL-18, TNF-α, CD40, ET-1, and IMA were decreased (P<0.05). In contrast, the control group exhibited significantly increased CD40 levels (P<0.05). Compared with the control group after treatment, the observation group showed significant improvements in the SAQ dimensions of physical limitation, angina stability, treatment satisfaction, and disease perception, as well as in TCM syndrome score, PHQ-9 score, IL-18, CD40, ET-1, and IMA (P<0.05). No adverse reactions were observed in either group during treatment. ConclusionShexiang Baoxinwan can improve anxiety and depression, alleviate angina symptoms, and reduce TCM symptoms of Qi stagnation and blood stasis in CAD patients. The mechanism may involve anti-inflammation, improvement of vascular endothelial function, reduction of IMA, and increase of monoamine neurotransmitter levels.
2.Randomized Double-blind Placebo-controlled Study on Clinical Efficacy and Mechanism of Shexiang Baoxinwan in Treating Stable Angina Pectoris Complicated with Anxiety and Depression in Coronary Artery Disease
Jie WANG ; Linzi LONG ; Zhiru ZHAO ; Feifei LIAO ; Jieming LU ; Tianjiao LIU ; Yuxuan PENG ; Hua QU ; Changgeng FU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):159-169
ObjectiveTo evaluate the efficacy of Shexiang Baoxinwan in treating stable angina pectoris with Qi stagnation and blood stasis syndrome in patients with coronary artery disease (CAD) complicated with anxiety and depression and explore its underlying mechanisms. MethodsThis study employed a randomized, double-blind, and placebo-controlled clinical trial design. Patients admitted to the hospital were randomly assigned to the observation group and the control group, with 52 patients in each group. Patients in the observation and control groups received Shexiang Baoxinwan and placebo, respectively, both in combination with conventional Western medication. The dose was 45.0 mg, three times daily, for a total duration of eight weeks. The primary outcome was the Seattle Angina Questionnaire (SAQ) scores before and after treatment. Secondary outcomes included changes in traditional Chinese medicine (TCM) syndrome score, the patient health questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), inflammatory markers [interleukin-18 (IL-18), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), CD40, etc.], monoamine neurotransmitters [e.g., dopamine (DA)], vascular endothelial function markers [e.g., endothelin-1(ET-1)], adipokines, and ischemia-modified albumin (IMA). Adverse reactions were also recorded. ResultsA total of 92 patients completed the study, with 44 in the observation group and 48 in the control group. Compared with baseline, both groups showed significant decreases in PHQ-9, GAD-7, and TCM syndrome scores following treatment (P<0.05), along with a significant increase in SAQ scores (P<0.05). In the observation group, DA levels were significantly increased (P<0.05), while levels of IL-18, TNF-α, CD40, ET-1, and IMA were decreased (P<0.05). In contrast, the control group exhibited significantly increased CD40 levels (P<0.05). Compared with the control group after treatment, the observation group showed significant improvements in the SAQ dimensions of physical limitation, angina stability, treatment satisfaction, and disease perception, as well as in TCM syndrome score, PHQ-9 score, IL-18, CD40, ET-1, and IMA (P<0.05). No adverse reactions were observed in either group during treatment. ConclusionShexiang Baoxinwan can improve anxiety and depression, alleviate angina symptoms, and reduce TCM symptoms of Qi stagnation and blood stasis in CAD patients. The mechanism may involve anti-inflammation, improvement of vascular endothelial function, reduction of IMA, and increase of monoamine neurotransmitter levels.
3.Arsenic trioxide preconditioning attenuates hepatic ischemia- reperfusion injury in mice: Role of ERK/AKT and autophagy.
Chaoqun WANG ; Hongjun YU ; Shounan LU ; Shanjia KE ; Yanan XU ; Zhigang FENG ; Baolin QIAN ; Miaoyu BAI ; Bing YIN ; Xinglong LI ; Yongliang HUA ; Zhongyu LI ; Dong CHEN ; Bangliang CHEN ; Yongzhi ZHOU ; Shangha PAN ; Yao FU ; Hongchi JIANG ; Dawei WANG ; Yong MA
Chinese Medical Journal 2025;138(22):2993-3003
BACKGROUND:
Arsenic trioxide (ATO) is indicated as a broad-spectrum medicine for a variety of diseases, including cancer and cardiac disease. While the role of ATO in hepatic ischemia/reperfusion injury (HIRI) has not been reported. Thus, the purpose of this study was to identify the effects of ATO on HIRI.
METHODS:
In the present study, we established a 70% hepatic warm I/R injury and partial hepatectomy (30% resection) animal models in vivo and hepatocytes anoxia/reoxygenation (A/R) models in vitro with ATO pretreatment and further assessed liver function by histopathologic changes, enzyme-linked immunosorbent assay, cell counting kit-8, and terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay. Small interfering RNA (siRNA) for extracellular signal-regulated kinase (ERK) 1/2 was transfected to evaluate the role of ERK1/2 pathway during HIRI, followed by ATO pretreatment. The dynamic process of autophagic flux and numbers of autophagosomes were detected by green fluorescent protein-monomeric red fluorescent protein-LC3 (GFP-mRFP-LC3) staining and transmission electron microscopy.
RESULTS:
A low dose of ATO (0.75 μmol/L in vitro and 1 mg/kg in vivo ) significantly reduced tissue necrosis, inflammatory infiltration, and hepatocyte apoptosis during the process of hepatic I/R. Meanwhile, ATO obviously promoted the ability of cell proliferation and liver regeneration. Mechanistically, in vitro studies have shown that nontoxic concentrations of ATO can activate both ERK and phosphoinositide 3-kinase-serine/threonine kinase (PI3K-AKT) pathways and further induce autophagy. The hepatoprotective mechanism of ATO, at least in part, relies on the effects of ATO on the activation of autophagy, which is ERK-dependent.
CONCLUSION
Low, non-toxic doses of ATO can activate ERK/PI3K-AKT pathways and induce ERK-dependent autophagy in hepatocytes, protecting liver against I/R injury and accelerating hepatocyte regeneration after partial hepatectomy.
Animals
;
Arsenic Trioxide
;
Autophagy/physiology*
;
Reperfusion Injury/prevention & control*
;
Mice
;
Male
;
Proto-Oncogene Proteins c-akt/physiology*
;
Arsenicals/therapeutic use*
;
Oxides/therapeutic use*
;
Liver/metabolism*
;
Extracellular Signal-Regulated MAP Kinases/metabolism*
;
Mice, Inbred C57BL
4.Clinical efficacy analysis of Shibao Decoction in the treatment of late-onset hypogonadism with kidney essence deficiency.
Shao-Kang CHEN ; Yi SHAN ; Zhen-Fu SHI ; Hai-Feng XU ; Yao-Hua ZHANG ; Yi LU
National Journal of Andrology 2025;31(7):630-636
OBJECTIVE:
To evaluate the clinical efficacy of "Shibao Decoction" in the management of late-onset hypogonadism (LOH) caused by deficiency of kidney essence.
METHODS:
Sixty male patients with late-onset hypogonadism of kidney essence deficiency type were randomly assigned to the treatment group and the control group, each with 30 cases. The patients in treatment group were treated with oral Shibao Decoction, while the control group was treated with oral Testosterone Undecanoate Capsules. The patients in both groups were treated for 12 weeks. The PADAM symptom score, TCM syndrome score, serum total testosterone (TT), serum free testosterone (FT), sex hormone binding globulin (SHBG), body mass index (BMI), total skeletal muscle mass index (SMI), appendicular skeletal muscle mass index (ASMI), FBG, FINS, and insulin resistance index (HOMA-IR) levels were compared between the two groups.
RESULTS:
After treatment, PADAM scores for each item and TCM symptoms score decreased, TT and FT increased in both groups, all with statistically significant differences from those of pre-treatment (P<0.05). The level of SHBG in the control group decreased (P<0.05), which had not changed significantly in the treatment group (P>0.05). After treatment, SMI and ASMI increased in both groups significantly (P<0.05). BMI decreased in the control group (P<0.05), which had not changed significantly in the treatment group (P>0.05). The level of FINS decreased in the control group (P<0.05), which had not changed significantly in the treatment group (P>0.05). FPG had not changed significantly in both groups (P>0.05), and the insulin resistance index (HOMA-IR) had significantly improved in both groups, all with statistically significant differences from those of pre-treatment (P<0.05). After treatment, the total effective rates of PADAM score and TCM syndrome score in the treatment group were 73.3% and 86.6% respectively, and the total effective rates in the control group were 66.7% and 76.6% respectively. The total effective rates of the two scores in the treatment group were slightly higher than those in the control group (P>0.05). There was no significant difference in the indicators between the two groups after treatment, and the treatment group is generally comparable with the control group in the therapeutic effects (P>0.05). And no adverse reactions occurred during treatment in both groups.
CONCLUSION
The "Shibao Decoction" has a remarkable therapeutic effect on late-onset hypogonadism caused by deficiency of kidney essence and has good safety. It can be used as an alternative to testosterone undecanoate and is worthy of clinical promotion and application.
Humans
;
Hypogonadism/etiology*
;
Drugs, Chinese Herbal/therapeutic use*
;
Male
;
Testosterone/therapeutic use*
;
Treatment Outcome
;
Sex Hormone-Binding Globulin
;
Medicine, Chinese Traditional
;
Middle Aged
;
Adult
;
Kidney
5.Analyzing brain structural network topology and connectivity in patients with refractory overactive bladder using diffusion tensor imaging and graph theory analysis
Yangkun FENG ; Feng LU ; Siyi FU ; Yuwei ZHANG ; Yun ZHANG ; Deshui YU ; Xiuhong HUA ; Xi LIU ; Jianfeng SHAO ; Yi FAN ; Ye HUA
Journal of Modern Urology 2025;30(12):1049-1055
Objective To investigate the regulatory mechanism of the central nervous system in patients with refractory overactive bladder (rOAB) using diffusion tensor imaging (DTI) and graph theory analysis. Methods A total of 43 rOAB patients (rOAB group) and 46 matched healthy controls (HC group) were recruited during May and Nov.2024. All participants were scanned with DTI, and surveyed with the overactive bladder symptom score (OABSS), and overactive bladder questionnaire (OAB-q). Their age, gender, height, weight, and educational years were collected.DTI plus graph theory analysis was employed to explore the alterations in global and local topological properties of the brain structural network in rOAB patients. Brain regions showing significant group differences in structural metrics [specifically, the right paracentral lobule (PCL.R) ]were further used as seed points for functional connectivity (FC) analysis. Correlations between the nodal clustering coefficient (NCp) of the identified region, FC strength, OABSS, and OAB-q score were investigated. Results The OABSS [8 (6,10) vs.0 (0,1) ]and OAB-q [71 (53,80) vs.20 (19,24) ]were higher in the rOAB group than the HC group (P<0.001). Graph theory analysis revealed no statistically significant differences in global network metrics between the two groups (P>0.05). However, the NCp was significantly higher in the PCL.R of rOAB group compared to HC group (P<0.05, FDR-corrected).FC analysis using the PCL.R as a seed region demonstrated significantly reduced FC value in the left cerebellar crus Ⅱ (Cerebelum_Crus2_L) of the rOAB group (P<0.05, FDR-corrected). Partial correlation analysis showed that the NCp of PCL.R was positively correlated with both OABSS (r=0.255, P=0.018) and OAB-q score (r=0.257, P=0.017). Conversely, the FC of Cerebelum_Crus2_L was significantly negatively correlated with OABSS (r=-0.545, P<0.001) and OAB-q score (r=-0.535, P<0.001). Conclusion Patients with rOAB exhibit distinct brain structural network alterations compared to healthy individuals, primarily manifestation in the NCp value of PCL.R increased, and the FC intensity of Cerebelum_Crus2_L is significantly weakened. These alterations in the topological properties of the structural network may be implicated in the pathogenesis of rOAB.
6.Gestational trophoblastic neoplasia with uterine arteriovenous malformation:vascular characteristics and clinical follow-up results
Qing ZHOU ; Yuan-Tao LIU ; Feng-Hua MA ; Xin LU ; He ZHANG ; Guo-Fu ZHANG
Fudan University Journal of Medical Sciences 2024;51(3):315-322
Objective To investigated vascular characteristics and clinical follow-up results of gestational trophoblastic neoplasia(GTN)with uterine arteriovenous malformation(UAVM)using contrast-enhanced magnetic resonance angiography(CE-MRA).Methods Patients clinically suspected of GTN at Obstetrics and Gynecology Hospital,Fudan University from Dec 2015 to Dec 2020 were selected.Imaging characteristics of conventional magnetic resonance imaging and CE-MRA before treatment.The International Federation of Gynecology and Obstetrics(FIGO)2000 clinical staging and prognosis scoring system was used to evaluate the severity of the condition and related risk factors,the treatment methods(chemotherapy,surgical treatment,and arterial embolization)and prognosis determined during follow-up were recorded.Results A total of 44 cases were included,including 5 cases of placental site trophoblastic tumor(PSTT)and 39 cases of the other GTN.There were 3 cases of PSTT combined with UAVM and 23 cases of the other GTN combined with UAVM.Thirty-nine cases of the other GTN were divided into two groups according to the presence or absence of UAVM.Data regarding the β-human chorionic gonadotropin(β-hCG)value(<10 000 mIU/mL and≥10 000 mIU/mL)were evaluated using Chi-square test,and the difference was statistically significant(P=0.001).The average FIGO scores of the two groups were 4.19±3.69 and 6.70±3.39,and the difference was statistically significant(P=0.035).Conclusion When β-hCG value≥10 000 mIU/mL,the probability of UAVM occurrence increases.The higher the prognosis score is,the more possibility of formation of UAVM.The use of CE-MRA technology helps to better diagnose UAVM.
7.Challenges and opportunities of occupational health and occupational medicine in the context of population aging
Guodong LU ; Hua FU ; Wuzhong LIU ; Zhijun ZHOU ; Yan YIN
Journal of Environmental and Occupational Medicine 2024;41(9):961-966
In the context of facing the dual challenges of aging population and declining birth rates, the absolute number of working-age population in China is decreasing, while the proportion of middle-aged and elderly workers is significantly increasing. However, China possesses a vast labor force, and the advantages of talent dividend are gradually emerging, both of which can offset the negative impact of the shrinking demographic dividend on social productivity. Labor is the most active factor among various production factors and is an important component for developing new quality productive forces. With the development of new quality productive forces, occupational health and occupational medicine are presented with new development opportunities. In the process of aging of the labor force, occupational health and occupational medicine can investigate how to utilize next-generation information technology, artificial intelligence, biotechnology, and other growth engines to safeguard the occupational health of workers, extend their working lives, actively unleash their creativity and initiative, and compensate for the labor shortage caused by an aging population and the potential decrease in labor productivity. This transformation in occupational health and occupational medicine is not only crucial for the health and career development of workers in an aging society, but will also have a positive impact on the creation of an age-friendly society and the sustainable development of productivity.
8.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
9.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
10.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+

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