1.Allogeneic lung transplantation in miniature pigs and postoperative monitoring
Yaobo ZHAO ; Ullah SALMAN ; Kaiyan BAO ; Hua KUI ; Taiyun WEI ; Hongfang ZHAO ; Xiaoting TAO ; Xinzhong NING ; Yong LIU ; Guimei ZHANG ; He XIAO ; Jiaoxiang WANG ; Chang YANG ; Feiyan ZHU ; Kaixiang XU ; Kun QIAO ; Hongjiang WEI
Organ Transplantation 2026;17(1):95-105
Objective To explore the feasibility and reference value of allogeneic lung transplantation and postoperative monitoring in miniature pigs for lung transplantation research. Methods Two miniature pigs (R1 and R2) underwent left lung allogeneic transplantation. Complement-dependent cytotoxicity tests and blood cross-matching were performed before surgery. The main operative times and partial pressure of arterial oxygen (PaO2) after opening the pulmonary artery were recorded during surgery. Postoperatively, routine blood tests, biochemical blood indicators and inflammatory factors were detected, and pathological examinations of multiple organs were conducted. Results The complement-dependent cytotoxicity test showed that the survival rate of lymphocytes between donors and recipients was 42.5%-47.3%, and no agglutination reaction occurred in the cross-matching. The first warm ischemia times of D1 and D2 were 17 min and 10 min, respectively, and the cold ischemia times were 246 min and 216 min, respectively. Ultimately, R1 and R2 survived for 1.5 h and 104 h, respectively. Postoperatively, in R1, albumin (ALB) and globulin (GLB) decreased, and alanine aminotransferase increased; in R2, ALB, GLB and aspartate aminotransferase all increased. Urea nitrogen and serum creatinine increased in both recipients. Pathological results showed that in R1, the transplanted lung had partial consolidation with inflammatory cell infiltration, and multiple organs were congested and damaged. In R2, the transplanted lung had severe necrosis with fibrosis, and multiple organs had mild to moderate damage. The expression levels of interleukin-1β and interleukin-6 increased in the transplanted lungs. Conclusions The allogeneic lung transplantation model in miniature pigs may systematically evaluate immunological compatibility, intraoperative function and postoperative organ damage. The data obtained may provide technical references for subsequent lung transplantation research.
2.Related factors and prognostic impact of cardiac valve calcification in maintenance hemodialysis patients
Chengjun WANG ; Xiaorong BAO ; Zixuan QIAO ; Miao MIAO ; Wei YE ; Lizhen WANG ; Zhengjia HE ; Jiao WANG
Chinese Journal of Clinical Medicine 2025;32(4):568-577
Objective To explore risk factors for cardiac valve calcification (CVC) in maintenance hemodialysis (MHD) patients and evaluate its impact on cardiovascular events and mortality. Methods Retrospective selection of 223 patients with MHD admitted to the Department of Nephrology of Jinshan Hospital, Fudan University from June 30, 2019 to June 30, 2024, and enrollment completed within one week of June 30, 2019. Patients were divided into CVC and non-CVC groups. Baseline data and 5-year follow-up data were collected. The binary logistic regression analysis was performed to explore the risk factors for CVC. Kaplan-Meier survival curve was used to analyze the survival rate of patients. Cox proportional hazard regression model was applied to evaluate the impact of CVC on the survival rates of MHD patients. Results Totally, 223 MHD patients with an average age of (58.4±13.5) years and an average dialysis duration of (64.0±55.4) months were involved. Among them, 136(61.0%) were males, 117(52.5%) were complicated with CVC. Age, dialysis duration, diabetic kidney disease (DKD), the serum corrected total calcium and phosphate, intact parathyroid hormone (iPTH), high-sensitive C-reactive protein (hsCRP), and homocysteine (Hcy) were independent related factors for CVC (P<0.05). Both all-cause mortality (46.6% vs 28.7%) and cardiovascular mortality (33.3% vs 16.0%) were significantly higher in the CVC group than those in the non-CVC group (P<0.01). Conclusions Age, dialysis duration, the primary disease, calcium and phosphate, and inflammation- and nutrition-related serum indicators are associated with CVC in MHD patients. CVC significantly increases mortality risk of MHD patients.
3.Impacts of preoperative regional arterial infusion chemotherapy com-bined with laparoscopic surgery on patients with colorectal cancer
Jin-feng WANG ; Lei PENG ; Bao FU ; Xiao-he CHEN
Chinese Journal of Current Advances in General Surgery 2025;28(7):517-521
Objective:To investigate the impacts of preoperative regional arterial infusion chemotherapy(PRAC)combined with laparoscopic surgery on the efficacy,safety,immune function,and serum levels of matrix metallopro-teinase-7(MMP-7)and human cartilage glycoprotein(YKL-40)in patients with colorectal cancer.Methods:This study retrospectively selected 164 patients with colorectal cancer(January 2014 to December 2016)as the research subjects.Patients who underwent conventional treatment and laparoscopic surgery were included into control group(81 cases);patients undergoing PRAC+laparoscopic surgery were included into observation group(83 cases).The clinical efficacy,stress response indicators,immune function related indicators,changes in serum MMP-7 and YKL-40 levels,and occurrence of adverse reactions in two groups were observed before treatment(T0)and after 4 cycles of chemotherapy(T1).Results:At T1,the total effective rate of observation group(85.54%)was greatly higher than that of control group(67.90%)(P<0.05).The levels of cortisol(Cor),neutrophile granulocyte(NE),white blood cell count(WBC),and interleukin(IL)-6 were prominently increased in both groups(P<0.05),but the levels of these indicators in observation group were greatly lower than those in control group(P<0.05).The levels of IgM and IgA in both groups were greatly reduced(P<0.05),but the levels of IgM and IgA in observation group were prominently higher than those in control group(P<0.05).The levels of MMP-7 and YKL-40 decreased in both groups(P<0.05),and the level in observation group was prominently lower than that in control group(P<0.05).There was no significant difference in the overall incidence of adverse reactions and 5-year survival rate between control group and observation group(P>0.05).Conclusion:The combination of PRAC and laparoscopic surgery has prominent healing effects and certain safety in patients with colorectal cancer.It can effectively improve immune function,reduce serum MMP-7 and YKL-40 levels.
4.Health economic evaluation of minimally invasive surgery in treatment of digestive tract cancers: a Meta-analysis
Xiaoyue YIN ; Ning ZHOU ; Xueli YANG ; Zhuoyu SUN ; Yinghui BAO ; Shengshu WANG ; Ke HAN ; Jing LONG ; Min ZHAO ; Haowei LI ; Rongrong LI ; Shimin CHEN ; Junhan YANG ; Huaihao LI ; Yueting SHI ; Guoning ZHU ; Jianhua WANG ; Shanshan YANG ; Boyan LI ; Wenchang WANG ; Shengyan DU ; Yao HE ; Enqiang LING-HU ; Huikai LI ; Miao LIU ; Juan XIE
Chinese Journal of Epidemiology 2025;46(1):154-165
Objective:To compare minimally invasive surgery with traditional open surgery, analyze the current application status of health economic evaluations in the treatment of digestive tract cancers, such as esophageal cancer, gastric cancer, and colorectal cancer by minimally invasive surgery and provide evidence for the rational selection of clinical treatment, alleviation of disease-related economic burdens, and rational allocation of healthcare resources.Methods:By using five databases, i.e. China National Knowledge Infrastructure, Wanfang data, Chinese Biomedical Literature Database, PubMed, and Embase, a database was established to retrieve all the papers about health economic studies of minimally invasive surgery for esophageal cancer, gastric cancer, and colorectal cancer published until December 31, 2023. Literature was analyzed by using software NoteExpress 3.8, and data were processed using Excel 2021. The quality of included papers was evaluated using the CHEERS 2022 checklist, and Meta-analysis was conducted by using software Stata 17.0.Results:A total of 10 919 relevant papers were retrieved, and 59 studies were included. Only 14 studies (23.7%) used standard health economic evaluation methods. Meta-analysis results revealed no significant differences in direct medical expenditure and total expenditure between minimally invasive surgery and open surgery. However, the expenditure for minimally invasive surgery exhibited a significant increase [mean difference ( MD)=5 973.12 yuan, P<0.001], while hospital stay and indirect expenditure significantly decreased ( MD: -4.85 days and -733.79 yuan, P<0.001). In China, for gastric cancer, the direct medical expenditure of endoscopic surgery was lower than that of open surgery ( MD=-33 000.00 yuan) with no significant difference ( P<0.001). In colorectal cancer cases, the direct medical and surgical expenditures for laparoscopic surgery were higher than those for open surgery ( MD: 4 277.94 yuan and 4 267.80 yuan, P<0.001), while the indirect and total medical expenditures decreased ( MD: -768.34 yuan and -159.10 yuan). Hospital stays in patients who had minimally invasive surgery for all three types of cancer were shorter than those who had open surgery ( P<0.001). Conclusions:In the treatment of gastrointestinal cancer, compared with open surgery, minimally invasive surgery shows higher expenditure, but has advantages, such as shorter hospital stay and lower indirect expenditure, and there were no significant differences in direct medical and total expenditures between the two approaches. When conducting health economic evaluation, factors such as postoperative complications, hospital stay, and patient's economic status should be considered for their impact on total medical expenditure. It is necessary to pay attention to the application of health economic evaluations in healthcare decision-making.
5.Association between hypertension subtypes and risk for all-cause mortality and cardio-cerebrovascular mortality in the elderly in communities of Beijing
Rongrong LI ; Shengshu WANG ; Haowei LI ; Shimin CHEN ; Junhan YANG ; Huaihao LI ; Yueting SHI ; Yinghui BAO ; Shengyan DU ; Wenchang WANG ; Jianhua WANG ; Xianghua FANG ; Hongbing YANG ; Ding MA ; Shanshan YANG ; Miao LIU ; Yao HE
Chinese Journal of Epidemiology 2025;46(3):366-375
Objective:To study the association between subtypes of hypertension and risk for all-cause mortality and cardio-cerebrovascular mortalities in the elderly in communities of Beijing.Methods:The data were collected from the Beijing Healthy Aging Cohort Study. The elderly in 5 urban areas (former Xicheng, former Xuanwu, Fangshan, Haidian and Tongzhou) and 4 rural areas (Yanqing, Miyun, Huairou and Daxing) in Beijing were selected as the study subjects by multi-stage stratified cluster random sampling. The baseline survey was conducted from July 2009 to September 2015. The follow-up was conducted until March 31, 2021, and a total of 6 326 participants were enrolled. Cox proportional hazard regression model was used to analyze the association of SBP, DBP, normal blood pressure, high normal blood pressure, simple systolic hypertension, simple diastolic hypertension and systolic diastolic hypertension with all-cause mortality and cardio-cerebrovascular mortality.Results:By March 31, 2021, the median follow-up time was 6.30 years, the all-cause mortality density was 201.67/10 000 person-years, and the cardio-cerebrovascular mortality density was 90.20/10 000 person-years. Multivariate Cox proportional hazard regression model analysis showed that the risk for all-cause mortality increased by 5.6% ( HR=1.056, 95% CI: 1.020-1.092), and the risk for cardio-cerebrovasculvar mortality increased by 12.5% ( HR=1.125, 95% CI: 1.071-1.182) for every 10 mmHg increase in SBP. The risk for all-cause mortality increased by 8.6% ( HR=1.086, 95% CI: 1.023-1.152), and the risk for cardio-cerebrovascular mortality increased by 19.9% ( HR=1.199, 95% CI: 1.101-1.306) for every 10 mmHg increase in DBP. Compared with the normal blood pressure group, the risk for all-cause mortality increased by 64.8% ( HR=1.648, 95% CI: 1.049-2.591) and the risk for cardio- cerebrovascular mortality increased by 112.8% ( HR=2.128, 95% CI: 1.069-4.233) in the simple diastolic hypertension group. The risk for all-cause mortality increased by 34.4% ( HR=1.344, 95% CI: 1.023-1.467) and the risk for cardio-cerebrovascular mortality increased by 111.3% ( HR=2.113, 95% CI: 1.384-3.225) in the systolic-diastolic hypertension group. Conclusions:In the elderly in communities of Beijing, beside systolic-diastolic hypertension. It is necessary to pay close attention to the simple diastolic hypertension, which has lower prevalence, and give targeted prevention and treatment.
6.Association of urinary albumin-to-creatinine ratio and cardiovascular health score with cardio-cerebrovascular mortality and all-cause mortality in urban elderly residents in Beijing
Junhan YANG ; Haowei LI ; Shimin CHEN ; Rongrong LI ; Huaihao LI ; Yueting SHI ; Yinghui BAO ; Shengyan DU ; Wenchang WANG ; Shanshan YANG ; Jianhua WANG ; Xianghua FANG ; Hongbing YANG ; Ding MA ; Shengshu WANG ; Miao LIU ; Yao HE
Chinese Journal of Epidemiology 2025;46(3):385-392
Objective:To investigate the association of urinary albumin-to-creatinine ratio (UACR) in normal range and cardiovascular health (CVH) score with cardio-cerebroascular and all-cause mortality in urban elderly residents in Beijing.Methods:Based on Beijing Healthy Aging Cohort Study, data from 1 817 elderly participants with normal UACR were analyzed, and UACR was used as both continuous and categorical variable. "Life's Essential 8" was used to develop a CVH score. Statistical analysis was performed by using software SPSS 26.0 and R 4.2.1, including two independent samples t-test, χ2 test and non-parametric test. Multivariable Cox proportional hazard regression models stratified by CVH score and the restricted cubic spline were used to analyse the association of UACR with the risk for cardio-cerebrovascular and all-cause mortality. Results:By March 31, 2021, the median follow-up time M ( Q1, Q3) was 11.28 (10.84, 11.36) years, a total of 308 deaths were recorded during follow-up, and the mortality density was 163.87/10 000 person-years. The age of the participants was (71.4±6.6) years, and 1 070 participants were women. The results showed that the risk for both cardio-cerebrovascular disease and all-cause mortality decreased with the decrease of UACR in the low CVH score group ( HR=0.500, 95% CI: 0.341-0.734; HR=0.793, 95% CI: 0.647-0.971), and in the high CVH score group, there was a decreasing trend in the risk for cardio-cerebrovascular mortality with the decrease of UACR ( HR=0.665, 95% CI: 0.447-0.990). Compared with the participants with low CVH score and higher UACR, the risk for cardio-cerebrovascular and all-cause mortality decreased by 68.9% and 45.6%, respectively, in the participants with high CVH score and lower UACR ( HR=0.311, 95% CI: 0.131-0.739; HR=0.544, 95% CI: 0.360-0.822), and the risk for all-cause mortality decreased by 26.7% in the participants with high CVH score and higher UACR ( HR=0.733, 95% CI: 0.542-0.993). Conclusions:In urban elderly residents in Beijing, higher UACR were associated with a significantly increased risk for cardio-cerebrovascular and all-cause mortality, and in the low-CVH score group, decreased UACR was protective factor against cardio-cerebrovascular and all-cause mortality. The combined effect of cardiovascular health status and normal UACR had a greater protection against the risk for cardio-cerebrovascular and all-cause mortality.
7.Association between a body shape index and all-cause mortality in the elderly in communities of Beijing
Huaihao LI ; Shengshu WANG ; Haowei LI ; Rongrong LI ; Shimin CHEN ; Junhan YANG ; Yueting SHI ; Yinghui BAO ; Shengyan DU ; Wenchang WANG ; Jianhua WANG ; Xianghua FANG ; Hongbing YANG ; Ding MA ; Miao LIU ; Shanshan YANG ; Yao HE
Chinese Journal of Epidemiology 2025;46(3):393-401
Objective:To describe and analyze the distribution characteristics of a body shape index (ABSI) and its association with all-cause mortality in the elderly in communities of Beijing.Methods:The baseline and follow-up data of 10 423 subjects in Beijing Healthy Aging Cohort Study were used. The endpoint outcome was all-cause mortality in follow-up. The associations of ABSI, BMI and waist circumference with all-cause mortality were analyzed with a Cox proportional hazard regression model.Results:The mean follow-up time in this cohort was 6.36 years and the all-cause mortality was 15.27%. The restricted cubic spline results showed that ABSI showed a "U" association with all-cause mortality in the total population. After adjustment for confounding factors, compared with the normal ABSI group, the risk for all-cause mortality was higher in the low ABSI group ( HR=1.69, 95% CI: 1.32-2.17) and high ABSI group ( HR=1.75, 95% CI: 1.40-2.18). Compared with the normal BMI group, low BMI was associated with an increased risk for all-cause mortality ( HR=1.70, 95% CI: 1.40-2.08). Compared with the normal waist circumference group, central obesity was associated with a decreased risk for all-cause mortality ( HR=0.89, 95% CI: 0.80-0.99). The results of gender specific analysis on ABSI association with all-cause mortality were similar to that in total population, but the strength of association varied among different age groups. Cross-grouping results showed that older people with normal BMI and waist circumference and abnormal ABSI had an increased risk of all-cause mortality ( HR=1.91, 95% CI: 1.22-2.99). Conclusions:In Beijing, ABSI is correlated with the risk for all-cause mortality in the elderly population, which is more sensitive and specific than the traditional indicators (BMI and waist circumference). They can be used as one of the physical measurement indicators for all-cause mortality risk prediction in the health risk assessment and management in the elderly.
8.Association between physical activity and all-cause mortality in the elderly with different obesity status in Beijing: a prospective cohort study
Yueting SHI ; Junhan YANG ; Huaihao LI ; Shengshu WANG ; Haowei LI ; Shimin CHEN ; Rongrong LI ; Yinghui BAO ; Wenchang WANG ; Shengyan DU ; Jianhua WANG ; Xianghua FANG ; Hongbing YANG ; Ding MA ; Shanshan YANG ; Miao LIU ; Yao HE
Chinese Journal of Epidemiology 2025;46(3):402-409
Objective:To explore the association between physical activity (PA) level and all-cause mortality in the elderly with different obesity status in Beijing.Methods:The study subjects were from the Cardiovascular and Cognitive Healthy Study in Middle-Aged and Elderly Residents of Beijing, a total of 3 746 individuals aged ≥60 years in the baseline survey between 2013 and 2015 were included in the study. Questionnaire survey and physical examination were conducted to collect the basic information of the individuals. The metabolic equivalent of the elderly was used to calculate the PA level, and an international PA questionnaire was used to determine the PA intensity. BMI, waist-to-height ratio (WHtR) and a body shape index (ABSI) were used to evaluate individuals' obesity status. The distribution of different PA levels under different obesity states was described by using bar chart and cumulative percentage bar chart. Cox proportional hazard regression model was used to analyze the correlation between the level of PA and all-cause mortality risk in different types of obesity status.Results:By December 31, 2019, the median follow-up time was 5.46 years, and the mortality density was 244.55/10 000 person-years. Compared with the individuals in high-PA intensity group, the all-cause mortality risk increased by 41% ( HR=1.41, 95% CI: 1.14-1.76) and 122% ( HR=2.22, 95% CI: 1.76-2.81), respectively, in moderate and low PA intensity groups. Compared with the individuals in high-PA intensity-high-obesity group, based on the BMI, the all-cause mortality risk increased by 85% ( HR=1.85, 95% CI: 1.08-3.16) and 250% ( HR=3.50, 95% CI: 2.01-6.10) in those in moderate-PA intensity-high-obesity group and in low-intensity-high-obesity group. Based on the WHtR, the all-cause mortality risk increased by 53% ( HR=1.53, 95% CI: 1.02-2.29) and 218% ( HR=3.18, 95% CI: 2.09-4.86), respectively, in those with moderate-PA intensity-high-obesity and those with low-PA intensity-high-obesity. According to the ABSI, the all-cause mortality risk increased by 120% in those in low-PA intensity-high-obesity group ( HR=2.20, 95% CI: 1.53-3.18). Based on any one of the indicators BMI, WHtR, or ABSI, there was no significant difference in all-cause mortality risk between high-intensity-moderate-obesity group and high-intensity-low-obesity group (all P>0.05). Conclusions:PA level is closely associated with the all-cause mortality risk in the elderly in communities of Beijing. Increasing PA level can not only reduce the all-cause mortality risk but also reduce even eliminate the excess all-cause mortality risk associated with obesity.
9.Efficacy and Safety of Erzhu Jiedu Decoction Granules in Treating Mid-advanced Hepatitis B Virus-Associated Primary Liver Cancer Patients with Pi (Spleen)-Deficiency and Dampness-Heat Syndrome.
Yang CHENG ; Hao-Yi WANG ; Cheng-Yi WAN ; Jie-Wen SHI ; Yuan-Yuan JIN ; Sheng-Li HE ; Bao-Bing YIN ; Jian-Jie CHEN
Chinese journal of integrative medicine 2025;31(5):394-401
OBJECTIVE:
To assess the efficacy and safety of Erzhu Jiedu Decoction (EZJDD) Granules in treating mid-advanced hepatitis B virus-associated primary liver cancer (HBV-PLC) patients with Pi (Spleen)-deficiency and dampness-heat syndrome.
METHODS:
From January 2021 to June 2023, a cohort of 132 patients were enrolled and randomly assigned to a control group or a EZJDD group according to the random numbers, with 66 patients in each group. The patients in the control group received conventional treatment for 3 months, followed by a 3-month follow-up. In addition to the conventional treatment, patients in the EZJDD group were administered EZJDD Granules (10.9 g/pack, 2 packs twice per day) orally for same duration. Progression-free survival (PFS) as primary outcome was evaluated by Kaplan Meier method. Karnofsky performance status (KPS) scores were used to assess the quality of life in two groups before and after treatment, and survival rates were determined as well. The efficacy of Chinese medicine syndrome was calculated with Nimodipine method. Liver function, tumor indicators and T lymphocyte subsets were measured, respectively. Safety indicators were recorded and assessed.
RESULTS:
Of the 116 patients who completed the study, 57 were in the control group and 59 in the EZJDD group. The median PFS was 3.53 months (106 days) in the EZJDD group compared to 2.33 months (70 days) in the control group (P=0.005). Six-month survival rate was 52.63% (30/57) in the control group and 69.49% (41/59) in the EZJDD group (P=0.039). The median KPS score in the EZJDD group [70(63, 90)] was higher than that in the control group [70(60, 80)] (P=0.013). The total effective rate of CM syndrome was 52.63% (30/57) in the control group and 77.97% (46/59) in the EZJDD group (P=0.005). The levels of alpha fetoprotein, alpha fetoprotein-L3, alpha-L-fucosidase and protein induced by Vitamin K absence or antagonist- II in the EZJDD group increased less than the control group (P>0.05). CD8+ levels were decreased, while CD3+ and CD4+ levels, as well as CD4+/CD8+ ratio were significantly increased in the EZZJD group (P<0.05). No treatment-related adverse reactions were observed during the study.
CONCLUSION
EZJDD Granules significantly prolonged the median PFS and improved 6-month survival rate in patients with mid-advanced HBV-PLC (Registration No. ChiCTR2200056922).
Humans
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Liver Neoplasms/complications*
;
Hepatitis B virus/physiology*
;
Hepatitis B/complications*
;
Treatment Outcome
;
Adult
;
Spleen/drug effects*
;
Quality of Life
;
Medicine, Chinese Traditional
;
Aged
;
Syndrome
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
;
Double-Blind Method
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Angina, Stable/physiopathology*
;
Aged
;
Syndrome
;
Treatment Outcome
;
Placebos
;
Tablets

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