1.The value of total volume response and total mass response in the therapeutic evaluation of lung metastasis of hepatocarcinoma
Jun-cheng WAN ; Cai-hong YU ; Chang-yu LI ; Yong-jie ZHOU ; Wei ZHANG ; Jian-hua WANG ; Zhi-ping YAN ; Guo-wei YANG ; Zhuo-yang FAN ; Xu-dong QU
Fudan University Journal of Medical Sciences 2025;52(2):201-208,231
Objective To analyze the correlation between lesion volume,lesion mass,and maximum lesion diameter in the assessment of advanced hepatocarcinoma with lung metastasis,and to evaluate the application value of total volume response and total mass response of lung metastatic lesions in efficacy assessment.Methods A retrospective analysis was conducted on the CT imaging data of 20 patients clinically confirmed with hepatocarcinoma and lung metastases,followed by subsequent follow-up to monitor their survival outcomes.Volume measurement software was used to measure the volume of lesions before and after treatment.We recored lesion diameter,volume measurements and CT values,calculated the mass of the lesions.The correlation between lesion volume,mass and diameter was analyzed,as well as the correlation between the change rates of volume,mass and lesion diameter.Additionally,the total volume and total mass of all lesions were calculated.The correlation between the change rates of total volume/total mass and the change rate of pulmonary lesion diameter under the RECIST 1.1 criteria,as well as the correlation with changes in patients'tumor markers,were analyzed.Furthermore,the overall volume response and overall mass response of lesions were evaluated based on changes in total volume and total mass,and their consistencies with the RECIST 1.1 criteria for efficacy evaluation were analyzed.Finally,univariate Cox regression analysis was performed to explore the association between these variables and patient survival outcomes.Results There was strong correlation between lesion volume,mass and tumor diameter(r=0.771,0.775),between the rate of change in mass and the rate of change in lesion diameter(r=0.846),and between the rates of change in total volume/total mass and the rate of change in pulmonary lesion diameter under the RECIST 1.1 criteria(r=0.800,0.896).The correlation between the rates of change in total volume/total mass and patients'tumor markers was not statistically significant.There was moderate correlation between the rate of change in volume and the rate of change in lesion diameter(r=0.692).The evaluation results of total volume response and total mass response for pulmonary lesions in advanced hepatocarcinoma with lung metastasis were generally consistent with the RECIST 1.1 criteria(Kappa=0.486,0.426).Univariate Cox regression analysis revealed that total lesion volume(P=0.047)and total lesion mass(P=0.049)were independent prognostic factors for survival outcomes.Conclusion Lesion volume,mass,and diameter,as well as their respective change rates,were found to be interrelated.Furthermore,total lesion volume and total lesion mass were identified as independent prognostic factors for survival outcomes.The total volume response and total mass response are promising evaluation methods in evaluating the efficacy of lung metastasis of hepatocarcinoma,which are different from the RECIST 1.1 evaluation criteria.
2.Association between dietary behavior and type 2 diabetes in the older adults aged 65 years and over in 18 longevity areas of China
Xuehua HU ; Yue CHEN ; Zenghang ZHANG ; Chen CHEN ; Yingli QU ; Xi MENG ; Jun WANG ; Zinan XU ; Zheng LI ; Sixin LIU ; Wenhui SHI ; Zhanhong XUE ; Fanye LONG ; Xiaoming SHI ; Yuebin LYU
Chinese Journal of Preventive Medicine 2025;59(5):588-596
Objective:To explore the impact of plant and animal dietary behaviors on type 2 diabetes mellitus (T2DM) in older adults aged ≥65 in 18 longevity areas of China.Methods:The subjects were 5 223 older adults over 65 years old from the Healthy Ageing and Biomarkers Cohort Study (HABCS) in 18 longevity areas in China. Through a questionnaire survey and physical examination, information about their demographic characteristics, lifestyles, daily activities, self-health status, current diseases, and fasting venous blood were collected. Food Frequency and Questionnaire (FFQ) was used to collect data on food intake frequency. Based on the prior method, the plant-based diet index (PDI) and animal-based diet index (ADI) of 5 223 older adults were calculated. Subjects were divided into three groups (low-level group: PDI<39 or ADI<31, middle-level group: 39≤PDI≤42 or 31≤ADI≤34, high-level group: PDI>42 or ADI>34) by tertiles of PDI and ADI. Multivariate logistic regression was used to analyze the association between PDI and ADI and the risk of T2DM.Results:The average age of 5 223 subjects was (84.8±11.5) years, with the median ( Q1, Q3) of PDI about 41(38, 43) and the median ( Q1, Q3) of ADI about 33 (30, 35). The prevalence rate of T2DM was 16.41% (857/5 223). After adjusting for covariates, multivariate logistic regression showed that PDI was negatively associated with T2DM. Compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 0.83 (0.69-0.99). ADI was positively associated with T2DM, and compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 1.28 (1.06-1.55). For every one-point increase in PDI and ADI, the risk of T2DM decreased by 2% and increased by 3%, respectively, with the OR (95% CI) of 0.98 (0.96-1.00) and 1.03 (1.01-1.06), respectively. Conclusion:In Chinese older adults ≥65 years in 18 longevity areas, higher adherence to the plant-based behavior may be negatively associated with the risk of T2DM, while higher adherence to the animal-based behavior may be positively associated with the risk of T2DM.
3.Predictive value of RAVI combined with Tp-Te for prognosis in CSHF patients
Ying LI ; Jun-xiao SONG ; Xue-ling QU
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(1):66-71
Objective:To investigate the association of right atrial volume index(RAVI),T-wave peak to end interval(Tp-Te)with prognosis of patients with chronic systolic heart failure(CSHF),and the predictive value of RAVI combined with Tp-Te for prognosis in these patients.Methods:The clinical data of 172 CSHF patients admitted in Department of Cardiovascular Medicine,Weihai Municipal Hospital,Cheeloo College of Medicine,Shandong University between January 2020 and July 2021 were retrospectively enrolled.RAVI and Tp-Te was measured by echocardiography and ECG respec-tively.According to prognosis within 1-year follow-up,they were divided into unfavorable outcome group(n=84)and favorable outcome group(n=88).Multivariate Logistic regression was employed to analyze influencing factors for unfa-vorable outcome within 1-year in CSHF patients,and receiver operating characteristic(ROC)curve was applied to ana-lyze predictive value of RAVI combined Tp-Te for unfavorable outcome in CSHF patients.Results:During the follow-up,84 cases suffered from unfavorable outcomes,including 23 cases of death,61 cases of rchospitalization due to acute heart failure.RAVI[(42.65±3.81)ml/m2 vs.(26.42±2.32)ml/m2]andTp-Te[(112.84±10.13)ms vs.(95.12±4.52)ms]in unfavorable outcome group were significantly higher than those of favorable outcome group(P<0.001 all).Pearson correlation analysis indicated that RAVI,Tp-Te were inversely correlated with left ventricular ejection fraction(LVEF)(r=-0.619,-0.537,P<0.001 all),and positively correlated with left ventricular end-systolic vol-ume(LVESV),left ventricular end-diastolic volume(LVEDV)and N-terminal pro brain natriuretic peptide(NT-proBNP)(r=0.512~0.564,P<0.001 all).Multivariate Logistic regression analysis indicated that NT-proBNP(OR=1.865,95%CI 1.127~3.086,P=0.002),RAVI(OR=1.697,95%CI 1.204~2.392,P<0.001)andTp-Te(OR=1.640,95%CI 1.208~2.227,P<0.001)were independent risk factors for unfavorable outcome within 1-year in CSHF patients.ROC analysis found that RAVI combined Tp-Te predicting unfavorable outcome within 1-year in CSHF pa-tients had significant better diagnostic performance(AUC=0.949,95%CI 0.905~0.977)comparing to RAVI(0.788,95%CI 0.719~0.846)and Tp-Te(0.840,95%CI 0.777~0.892)alone(Z=4.435,3.856,P<0.001 all).Conclu-sion:Increased RAVI and Tp-Te were risk factors for unfavorable outcome in CSHF patients,and the combination of RAVI and Tp-Te had good predictive value for prognosis in CSHF patients.
4.Heterologous Expression,Purification and Enzymatic Characterization of Xylitol Dehydrogenase from the Thermophilic Fungus Talaromyces emersonii
Er MENG ; Cong QU ; Ke YI ; Hui-Min LI ; Xin-Yi DUAN ; Zhe-Yuan ZHANG ; Shao-Long HE ; Yu-Tao LUO ; Lei WU ; Dong-Yi ZHANG ; Chang-Jun LIU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(7):1007-1018
The xylitol dehydrogenase(XDH)is a crucial enzyme involved in the xylose utilization in pentose-catabolizing yeasts and fungi.In addition to producing xylulose,XDH can also be employed to develop a biosensor for monitoring xylitol concentration.In this study,the gene encoding the thermophilic fungus Talaromyces emersonii XDH(TeXDH)was heterologously expressed in Escherichia coli BL21(DE3)at 16 ℃ in the soluble form.Recombinant TeXDH with high purity was purified by using a Ni-NTA affinity column.Size-exclusion chromatography and SDS-PAGE analysis demonstrated that the puri-fied recombinant TeXDH exists as a native trimer with a molecular mass of approximately 116 kD,and is composed of three identical subunits,each with a molecular weight of around 39 kD.The TeXDH strictly preferred NAD+as a coenzyme to NADP+.The optimal temperature and pH of the TeXDH were 40 ℃and 10.0,respectively.After EDTA treatment,the enzyme activity of TeXDH decreased to 43.26%of the initial enzyme activity,while the divalent metal ions Mg2+or Ca2+could recover the enzyme activity of TeXDH,reaching 103.32%and 110.69%of the initial enzyme activity,respectively,making them the optimal divalent metal ion cofactors for TeXDH enzyme.However,the divalent metal ions of Mn2+,Ni2+,Cu2+,Zn2+,Co2+,and Cd2+significantly inhibited the activity of TeXDH.ICP-MS and molecular doc-king studies revealed that 1 mol/L of TeXDH bound 2 mol/L Zn2+ions and 1 mol/L Mg2+ion.Further-more,TeXDH exhibited a high specificity for xylitol,laying the foundation for the development of future xylitol biosensors.
5.Heterologous Expression,Purification and Enzymatic Characterization of Xylitol Dehydrogenase from the Thermophilic Fungus Talaromyces emersonii
Er MENG ; Cong QU ; Ke YI ; Hui-Min LI ; Xin-Yi DUAN ; Zhe-Yuan ZHANG ; Shao-Long HE ; Yu-Tao LUO ; Lei WU ; Dong-Yi ZHANG ; Chang-Jun LIU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(7):1007-1018
The xylitol dehydrogenase(XDH)is a crucial enzyme involved in the xylose utilization in pentose-catabolizing yeasts and fungi.In addition to producing xylulose,XDH can also be employed to develop a biosensor for monitoring xylitol concentration.In this study,the gene encoding the thermophilic fungus Talaromyces emersonii XDH(TeXDH)was heterologously expressed in Escherichia coli BL21(DE3)at 16 ℃ in the soluble form.Recombinant TeXDH with high purity was purified by using a Ni-NTA affinity column.Size-exclusion chromatography and SDS-PAGE analysis demonstrated that the puri-fied recombinant TeXDH exists as a native trimer with a molecular mass of approximately 116 kD,and is composed of three identical subunits,each with a molecular weight of around 39 kD.The TeXDH strictly preferred NAD+as a coenzyme to NADP+.The optimal temperature and pH of the TeXDH were 40 ℃and 10.0,respectively.After EDTA treatment,the enzyme activity of TeXDH decreased to 43.26%of the initial enzyme activity,while the divalent metal ions Mg2+or Ca2+could recover the enzyme activity of TeXDH,reaching 103.32%and 110.69%of the initial enzyme activity,respectively,making them the optimal divalent metal ion cofactors for TeXDH enzyme.However,the divalent metal ions of Mn2+,Ni2+,Cu2+,Zn2+,Co2+,and Cd2+significantly inhibited the activity of TeXDH.ICP-MS and molecular doc-king studies revealed that 1 mol/L of TeXDH bound 2 mol/L Zn2+ions and 1 mol/L Mg2+ion.Further-more,TeXDH exhibited a high specificity for xylitol,laying the foundation for the development of future xylitol biosensors.
6.Value of CT perfusion imaging combined with serum EPA/AA in predicting hemorrhage transformation and short-term prognosis after thrombolysis in acute ischemic stroke with leukoaraiosis
Jian XIONG ; Zhan-li QU ; Yu REN ; Jun-ming YIN ; Yi-fei JI
Journal of Regional Anatomy and Operative Surgery 2025;34(1):32-37
Objective To investigate the value of CT perfusion imaging (CTP) combined with serum eicosapentaenoic acid (EPA)/arachidonic acid (AA) in predicting hemorrhage transformation and short-term prognosis after thrombolysis in acute ischemic stroke (AIS) patients with leukoaraiosis. Methods Ninety-eight AIS patients with leukoaraiosis admitted to the department of neurology of our hospital from January 2021 to December 2022 were selected and divided into the hemorrhage transformation group and non-hemorrhage transformation group according to whether hemorrhage transformation occurred after thrombolysis. The Fazekas scale was used to evaluate the leukoaraiosis of the patients. CTP parameters and EPA/AA were compared between patients in the two groups and patients with different degrees of leukoaraiosis in the hemorrhage transformation group. The predictive value of CTP parameters and EPA/AA on the occurrence of hemorrhage transformation was evaluated by receiver operating characteristic (ROC) curve. The prognosis was assessed according to the modified Rankin scale (mRS) score 1 month after thrombolysis;the linear and linear combinations are used to evaluate the linear relationship between variables;the ROC curve was used to evaluate the predictive value of CTP parameters and EPA/AA in the short-term prognosis of patients. Results The reactive cerebral blood flow (rCBF),reactive cerebral blood volume (rCBV),CTP integration index and EPA/AA in the hemorrhage transformation group were significantly lower than those in the non-hemorrhage transformation group (P<0.05),while the relative time to peak (rTTP) was significantly longer than that in the non-hemorrhage transformation group (P<0.05). The incidence of hemorrhage transformation increased with the increase of leukoaraiosis degree (P<0.05). In the hemorrhage transformation group,rCBF,rCBV,CTP integration index and EPA/AA of patients with mild leukoaraiosis were higher than those of patients with moderate-severe leukoaraiosis (P<0.05). In patients with mild leukoaraiosis,the area under the curve (AUC) of rCBF and EPA/AA in predicting hemorrhage transforma-tion were 0.712 and 0.720,respectively (P<0.05);in patients with moderate-severe leukoaraiosis,the AUC of rCBF,rCBV,rTTP,CTP integration index and EPA/AA in predicting hemorrhage transformation were 0.738,0.714,0.717,0.739 and 0.742,respectively (P<0.05). Among the 98 patients received thrombolysis,35 patients had a poor prognosis. The AUC of rCBF,rCBV,CTP integration index and EPA/AA in predicting short-term prognosis were 0.742,0.732,0.704 and 0.738,respectively,and the AUC of the four combined prediction was 0.968. Conclusion CTP parameters and EPA/AA have a certain predictive value for the occurrence of hemorrhage transformation after thrombolysis in AIS patients with leukoaraiosis,and rCBV,rCBF,CTP integration index and EPA/AA are important influencing factors of the short-term prognosis for these patients.
7.Differences in cytokines expression between mild and severe infant cases infected with respiratory syncytial virus
Guangyu XUE ; Yuting HU ; Kexin ZONG ; Qin LUO ; Shengnan YANG ; Miao FENG ; Xiaoyu YI ; Zhiqiang XIA ; Chen GAO ; Haijun DU ; Ying LI ; Ying CHEN ; Feng HE ; Yajuan WANG ; Yingli QU ; Jin CAO ; Wenyan TIAN ; Qinqin SONG ; Hailan YAO ; Jun HAN
Chinese Journal of Experimental and Clinical Virology 2025;39(3):370-377
Objective:To analyze the clinical characteristics and cytokines expression characteristics in infants with mild and severe respiratory syncytial virus (RSV) infection.Methods:From May 2023 to December 2023, plasma samples and clinical information were collected from 16 infants with RSV infection and 14 control infants. Cytek Aurora flow cytometry (Cytek, America) and Enzyme linked immunosorbent assay (ELISA) were used to detect the expression levels of 25 cytokines after mild and severe RSV infection.Results:Cough and nasal obstruction were the main clinical manifestations in infants with mild RSV infection, accompanied by polypnea, wheezing and other symptoms. The main symptoms of severe RSV infection were cough and rales, accompanied by fever and polypnea. In comparison with the control group, the expression levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-13, IL-22, TNF-α, IFN-α, IFN-β, MIP-1β, I-TAC, ENA-78, GROα, Eotaxin, and MCP-1 in the RSV infection group all exhibited an upregulation trend. Both IP-10 and MIP-3α demonstrated a downward trend in the RSV infection group; however, there was no statistically significant difference ( P>0.05). The levels of IL-10, IFN-γ, MIP-1α, and IL-8 in the RSV infection group were significantly higher than those in the control group, whereas the levels of MIG, TARC, and RANTES in the RSV infection group were significantly lower than those in the control group ( P<0.05). The levels of IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-22, IFN-β, IFN-γ, TNF-α, IL-8, I-TAC, MIP-1β, Eotaxin, and MCP-1 in the mild RSV infection group were significantly higher than those in the severe RSV infection group ( P>0.05). Among these, the levels of MIG, RANTES, TARC, MIP-3α, and ENA-78 in the mild infection group were all lower than those in the severe infection group. The expressions of ENA-78 and MIP-1α in the severe infection group were significantly higher than those in the mild infection group and also higher than those in the control group. There was no significant difference in IP-10 and GROα between the mild and severe RSV infection groups ( P>0.05). Conclusions:The differences in clinical features and cytokines between infants with mild and severe RSV infection provide important data support for the prevention and treatment of RSV infection in infants.
8.Clinical pathway for integrated traditional Chinese and Western medicine in the diagnosis and treatment of acute pancreatitis
Yuan ZHANG ; Hao WANG ; Haiyan YIN ; Shengwei JIN ; Bangjiang FANG ; Guiwei LI ; Xijing ZHANG ; Hongmei GAO ; Donghao WANG ; Changsong WANG ; Keliang XIE ; Lai JIANG ; Yan QU ; Zhaocai ZHANG ; Jianying KAN ; Daihua YU ; Junling LIU ; Jun LI ; Weiwei AN ; Yong CHEN ; Jianbo YU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2025;32(3):257-261
Acute pancreatitis(AP)is a frequently encountered acute abdominal syndrome in clinical settings,and the integrated model of traditional Chinese and Western medicine(TCM-WM)has demonstrated notable advantages in the diagnosis and treatment of AP.To systematize and standardize clinical practices related to develop clinical pathway for integrated TCM-WM diagnosis and treatment of AP,which enhances the efficiency and quality of patient care.This pathway focuses on AP,a common acute and life-threatening disease within the digestive system,and outlines that the central pathological mechanism involves pancreatic injury and localized inflammation resulting from the abnormal activation of pancreatic enzymes.It has the characteristics of rapid onset,multiple causes,and complex manifestations.Severe cases can be life-threatening.At present,conventional treatments encompass a diverse range of modalities.Moreover,traditional Chinese medicine(TCM)holds distinct advantages in alleviating relevant symptoms,and TCM-WM is gaining increasing prevalence.To enhance the standardization and consistency of diagnostic and therapeutic practices,this clinical pathway clearly delineates the target patient population,which includes individuals diagnosed with abdominal pain disorder according to TCM and with AP in accordance with WM criteria,as well as the corresponding inclusion standards.The diagnostic framework integrates both TCM and WM guidelines,and further incorporates disease staging,severity grading,and syndrome differentiation to support a comprehensive and integrated diagnostic strategy.The treatment integrates approaches from both TCM and WM.Within the WM framework,interventions consist of basic supportive care,infection control,nutritional support,and the management of complications.In the context of TCM,the protocol includes syndrome differentiation and corresponding therapeutic strategies(Distinct syndrome patterns are identified and managed during the acute and convalescent phases),such as acupuncture and retention enema.This clinical pathway addresses multiple key components,including preventive strategies,post-treatment follow-up,criteria for evaluating therapeutic efficacy,admission and discharge,admission examination protocols,discharge criteria,and the rationale for deviations or withdrawal from the pathway.It is designed to provide a systematic and standardized reference framework for relevant clinical practices.
9.Analysis of completion rate of tumor evaluation at initial assessment and after neoadjuvant therapy for mid and low rectal cancer : a national multicenter real-world study
Kexuan LI ; Tixian XIAO ; Xiaodong WANG ; Bin WU ; Guole LIN ; Yuchen GUO ; Ming QU ; Si WU ; Xiaodong YANG ; Yinshengbo′er BAO ; Baohua WANG ; Fan ZHANG ; Xiangwang YU ; Beizhan NIU ; Junyang LU ; Lai XU ; Guannan ZHANG ; Zhen SUN ; Guoyou ZHANG ; Yan SHI ; Hong JIANG ; Yongjing TIAN ; Yongxiang LI ; Hongwei YAO ; Jun XUE ; Quan WANG ; Lie YANG ; Qian LIU ; Yi XIAO
Chinese Journal of Digestive Surgery 2025;24(1):113-119
Objective:To investigate the completion rate of tumor evaluation at initial assessment and after neoadjuvant therapy for mid and low rectal cancer patients in the national multicenter real-world database.Methods:The prospective real-world study was conducted. The clinicopathological data of 1 074 patients who underwent surgical treatment for mid and low rectal cancer in 47 national medical institutions, including Peking Union Medical College Hospital et al, from May 12,2023 to May 11,2024 were collected. Observation indicators: (1) clinical characteristics of patients with mid and low rectal cancer; (2) initial colonoscopy and pathologic evaluation of tumors in patients with mid and low rectal cancer; (3) initial imaging evaluation of patients with mid and low rectal cancer; (4) imaging evaluation after neoadjuvant therapy for patients with mid and low rectal cancer. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M( Q1, Q3). Count data were described as absoluter numbers and/or percentages. Results:(1) Clinical characteristics of patients with mid and low rectal cancer. Of the 1 074 patients, there were 713 males and 361 females, aged 63(56,70)years. The body mass index of 1 074 patients was 24(21,26)kg/m 2.For American Society of Anesthesiologists classification, there were 147 cases of stage Ⅰ, 641 cases of stage Ⅱ, 157 cases of stage Ⅲ, 2 cases of stage Ⅳ, and there were 127 cases missing data. (2) Initial colonoscopy and pathologic evaluation of tumors in patients with mid and low rectal cancer. Of the 1 074 patients, there were 787 cases (73.28%) undergoing complete colonoscopy, and there were only 197 cases (18.34%) undergoing immunohistochemical evaluation of all four mismatch repair proteins. (3) Initial imaging evaluation of patients with mid and low rectal cancer. Of the 1 074 patients, there were 842(78.40%) patients completing magnetic resonance imaging (MRI) or ultrasound evaluation, and there were 914(85.10%) patients completing chest, abdomen, and pelvis enhanced computed tomography (CT) evaluation. In the 149 patients completing rectal ultrasound evaluation, there were 122 cases (81.88%) comple-ting T staging evaluation, and there were 81 cases (54.36%) completing N staging evaluation. In the 808 patients completing rectal MRI evaluation, there were 708 cases (87.62%) completing T staging evaluation, and there were 590 cases (73.02%) completing N staging evaluation. (4) Imaging evalua-tion after neoadjuvant therapy for patients with mid and low rectal cancer. Of the 388 patients with neoadjuvant therapy, there were 332 patients (85.57%) completing MRI or ultrasound evaluation, and there were 327 patients (84.28%) completing chest, abdomen, and pelvis enhanced CT evalua-tion. In the 70 patients completing rectal ultrasound evaluation, there were 65 cases (92.86%) com-pleting T staging evaluation, and there were 49 cases (70.00%) completing N staging evaluation. In the 327 patients completing rectal MRI evaluation, there were 246 cases (75.23%) completing T staging, and there were 228 cases (69.72%) completing N staging evaluation. Conclusion:The com-pletion rate of tumor imaging evaluation at initial assessment and after neoadjuvant therapy for mid and low rectal cancer patients on a national scale is relatively good.
10.Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Ying-Qiang ZHAO ; Yong-Fa XING ; Ke-Yong ZOU ; Wei-Dong JIANG ; Ting-Hai DU ; Bo CHEN ; Bao-Ping YANG ; Bai-Ming QU ; Li-Yue WANG ; Gui-Hong GONG ; Yan-Ling SUN ; Li-Qi WANG ; Gao-Feng ZHOU ; Yu-Gang DONG ; Min CHEN ; Xue-Juan ZHANG ; Tian-Lun YANG ; Min-Zhou ZHANG ; Ming-Jun ZHAO ; Yue DENG ; Chang-Jiang XIAO ; Lin WANG ; Bao-He WANG
Chinese journal of integrative medicine 2025;31(8):685-693
OBJECTIVE:
To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS:
This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS:
This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION
STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans
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Double-Blind Method
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Drugs, Chinese Herbal/adverse effects*
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Male
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Female
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Middle Aged
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Angina, Stable/physiopathology*
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Aged
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Syndrome
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Treatment Outcome
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Placebos
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Tablets

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