1.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
2.Analysis of Risk Factors and Establishment of Prediction Model for Turbidity Toxicity Accumulation Syndrome in Patients with Chronic Atrophic Gastritis
Yican WANG ; Chenggong ZHAO ; Pengli DU ; Jie WANG ; Yuxi GUO ; Haiyan BAI ; Yongli HUO ; Xiaomeng LANG ; Zheng ZHI ; Bolin LI ; Jianping LIU ; Yanru CAI ; Jianming JIANG ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):288-295
ObjectiveThis paper aims to explore the risk factors for chronic atrophic gastritis (CAG) with turbidity toxin accumulation syndrome and establish a prediction model. MethodsClinical data of 180 patients with CAG who participated in the "clinical study of Xianglian Huazhuo Particles blocking CAG cancer transformation" of Hebei Sheng Zhong Yi Yuan from July 2021 to March 2022 were collected. After confounding factors were controlled by propensity score matching, patients were divided into a training set (namely dev) and a validation set (namely vad) in a seven to three ratio. The risk factors for CAG with turbidity toxin accumulation syndrome in the training set were investigated by using univariate Logistic regression analysis and least absolute shrinkage and selection operator (namely Lasso) regression algorithms. Subsequently, a model, named model 1se, was developed by using the training set data to predict the risk factors for CAG with turbidity toxin accumulation syndrome. The accuracy of the prediction model was assessed by using various methods, including the receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test (H-L), calibration plot, and decision curve analysis (DCA). ResultsAge, body mass index (BMI), family history of cancer, job and life satisfaction, yellow and greasy fur with slippery pulse, and heavy body sensation were independent risk factors of the model. The prediction model showed excellent predictive value for both the training and validation sets. ConclusionThe established prediction model for CAG with turbidity toxin accumulation syndrome has high discrimination and excellent calibration, which could provide an excellent clinical basis for disease diagnosis and individualized treatment of patients.
3.Effects of Different Microbial Fertilizers on Physiology and Rhizosphere Soil Environment of Codonopsis pilosula
Xia JIANG ; Junxi ZHAO ; Panpan SHI ; Xiaoxuan WANG ; Chenhui DU ; Shuosheng ZHANG ; Haixian ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):241-251
ObjectiveTo study the effects of applying different microbial fertilizers on the growth and rhizosphere soil environment of Codonopsis pilosula and provide a theoretical basis for ecological cultivation of this medicinal plant. MethodsSeven groups were designed, including CK (no application of microbial fertilizer), T1 (Trichoderma longibrachiatum fertilizer), T2 (Bacillus subtilis fertilizer), T3 (Trichoderma viride fertilizer), T4 (compound microbial fertilizer), T5 (C. pilosula stems and leaves fermented with compound microbial fertilizer), and T6 (Scutellaria baicalensis stems and leaves fermented with T. viride fertilizer). The physiological indicators, yield, and quality of C. pilosula and the physicochemical properties, enzyme activities, and microbial diversity in the rhizosphere soil of different fertilizer treatments were measured. ResultsGroup T1 showed slight decreases in soluble protein content (SPC) and superoxide dismutase (SOD). Groups T2-T6 showed increases in physiological indicators such as proline (Pro), soluble solids content (SSC), SPC, catalase (CAT), and peroxidase (POD) and a decrease in malondialdehyde (MDA) in C. pilosula leaves. All the fertilizer treatments increased the yield of C. pilosula and the total polysaccharide content in the roots. T1, T2, T3, T4, and T5 increased the total flavonoid content in the roots. Meanwhile, T4 increased the total saponin content in the roots. All the fertilizer treatments reduced the pH and increased the electric conductivity (EC), soil organic matter (SOM), and alkaline nitrogen (AN) in the soil. T2 and T5 increased the available phosphorus (AP), and T3, T4, T5, and T6 increased the available potassium (AK) in the soil. All the fertilizer treatments increased the activities of urease, sucrase, and CAT in the soil. Except that T1 decreased the bacterial diversity in the soil, other fertilizer treatments significantly increased bacterial and fungal diversity in the soil. Different fertilizer treatments significantly affected the composition of bacterial and fungal communities in the soil. At the phylum level, the dominant bacterial phyla included Proteobacteria, Acidobacteriota, and Bacteroideta, and the dominant fungal phyla were Ascomycota, Mortierellomycota, and unclassified_fungi in the rhizosphere soil of C. pilosula after bacterial fertilizer treatment. At the genus level, unclassified Gemmatimonadaceae, Sphingomonas, and unclassified Vicinamibacteraceae were the dominant bacterial genera, while unidentified, unclassified Fungi, and unclassified Sordariomycetes were the dominant fungal genera in the rhizosphere soil. The results of redundancy analysis indicated that the main physicochemical factors affecting changes of microbial communities in the rhizosphere soil of C. pilosula were pH, EC, AK, AN, AP, and soil organic matter (SOM) in the soil. The correlation heatmap showed that Bryobacter had significantly positive correlations with EC, AK, and AN. There was a significantly negative correlation between Fusarium and SOM. In summary, applying an appropriate amount of microbial fertilizer can promote the growth and improve the rhizosphere soil environment of C. pilosula. ConclusionThe compound microbial fertilizer and the C. pilosula stems and leaves fermented with compound microbial fertilizer can improve the soil nutrients, growth, development, yield, and quality of C. pilosula, and thus they can be applied to the artificial cultivation of C. pilosula.
4.Effects of Different Microbial Fertilizers on Physiology and Rhizosphere Soil Environment of Codonopsis pilosula
Xia JIANG ; Junxi ZHAO ; Panpan SHI ; Xiaoxuan WANG ; Chenhui DU ; Shuosheng ZHANG ; Haixian ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):241-251
ObjectiveTo study the effects of applying different microbial fertilizers on the growth and rhizosphere soil environment of Codonopsis pilosula and provide a theoretical basis for ecological cultivation of this medicinal plant. MethodsSeven groups were designed, including CK (no application of microbial fertilizer), T1 (Trichoderma longibrachiatum fertilizer), T2 (Bacillus subtilis fertilizer), T3 (Trichoderma viride fertilizer), T4 (compound microbial fertilizer), T5 (C. pilosula stems and leaves fermented with compound microbial fertilizer), and T6 (Scutellaria baicalensis stems and leaves fermented with T. viride fertilizer). The physiological indicators, yield, and quality of C. pilosula and the physicochemical properties, enzyme activities, and microbial diversity in the rhizosphere soil of different fertilizer treatments were measured. ResultsGroup T1 showed slight decreases in soluble protein content (SPC) and superoxide dismutase (SOD). Groups T2-T6 showed increases in physiological indicators such as proline (Pro), soluble solids content (SSC), SPC, catalase (CAT), and peroxidase (POD) and a decrease in malondialdehyde (MDA) in C. pilosula leaves. All the fertilizer treatments increased the yield of C. pilosula and the total polysaccharide content in the roots. T1, T2, T3, T4, and T5 increased the total flavonoid content in the roots. Meanwhile, T4 increased the total saponin content in the roots. All the fertilizer treatments reduced the pH and increased the electric conductivity (EC), soil organic matter (SOM), and alkaline nitrogen (AN) in the soil. T2 and T5 increased the available phosphorus (AP), and T3, T4, T5, and T6 increased the available potassium (AK) in the soil. All the fertilizer treatments increased the activities of urease, sucrase, and CAT in the soil. Except that T1 decreased the bacterial diversity in the soil, other fertilizer treatments significantly increased bacterial and fungal diversity in the soil. Different fertilizer treatments significantly affected the composition of bacterial and fungal communities in the soil. At the phylum level, the dominant bacterial phyla included Proteobacteria, Acidobacteriota, and Bacteroideta, and the dominant fungal phyla were Ascomycota, Mortierellomycota, and unclassified_fungi in the rhizosphere soil of C. pilosula after bacterial fertilizer treatment. At the genus level, unclassified Gemmatimonadaceae, Sphingomonas, and unclassified Vicinamibacteraceae were the dominant bacterial genera, while unidentified, unclassified Fungi, and unclassified Sordariomycetes were the dominant fungal genera in the rhizosphere soil. The results of redundancy analysis indicated that the main physicochemical factors affecting changes of microbial communities in the rhizosphere soil of C. pilosula were pH, EC, AK, AN, AP, and soil organic matter (SOM) in the soil. The correlation heatmap showed that Bryobacter had significantly positive correlations with EC, AK, and AN. There was a significantly negative correlation between Fusarium and SOM. In summary, applying an appropriate amount of microbial fertilizer can promote the growth and improve the rhizosphere soil environment of C. pilosula. ConclusionThe compound microbial fertilizer and the C. pilosula stems and leaves fermented with compound microbial fertilizer can improve the soil nutrients, growth, development, yield, and quality of C. pilosula, and thus they can be applied to the artificial cultivation of C. pilosula.
5.Genetic analysis of 74 fetuses terminated for skeletal dysplasia and evaluation of diagnostic performance of whole exome sequencing.
Jiashan LI ; Siying LIANG ; Yan MIAO ; Xiaoyu DU ; Meiyan HAN ; Wei ZHAO ; Nan JIANG ; Yingchao ZHOU
Chinese Journal of Medical Genetics 2025;42(7):869-882
OBJECTIVE:
To explore the genetic etiology of fetal skeletal dysplasia using whole exome sequencing (WES) and copy number variation sequencing (CNV-seq) techniques, and the feasibility of using WES as the first-tier method for such fetuses.
METHODS:
Seventy four fetuses with skeletal dysplasia detected by prenatal ultrasound at the Genetic Testing Center of the Women and Children's Hospital Affiliated to Qingdao University from January 2020 to August 2024 were selected as the study subjects. Fetal muscle and peripheral blood samples of the pregnant women and their spouses were collected and subjected to WES analysis. CNV-seq was carried out on all fetal muscle tissue samples. And the results were compared with the CNVs indicated by WES. Genetic etiologies were analyzed across different subtypes of skeletal dysplasia. And the feasibility of using WES as the first-tier genetic test for similar fetuses was assessed, in addition with a systematic cost-effectiveness analysis. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No.: QFELL-YJ-2024-201).
RESULTS:
A total of 50 fetuses were diagnosed, which yielded a diagnostic rate of 67.57%. These included 6 chromosomal aneuploidies, 4 chromosomal CNVs and 40 monogenic disorders. The monogenic diseases had involved 46 variant sites in 23 pathogenic genes, among which 12 were unreported previously, including MYH3: c.735T>C, ALPL: c.1324C>T, NEK9: c.1973G>A, MAGEL2: c.2024_2025del, LMBR1: c.423+4914A>C, NEB: c.21273_21276del, COL1A1: c.2651G>C and c.2758G>C, ASPM: c.2473delinsGA, TBX5: c.704G>A, DYNC2H1: c.10893del, and DYNC2I2: c.1270C>T. Substantial concordance was reached between WES-derived CNV calls and CNV-seq findings. No clinically significant CNV was exclusively detected by CNV-seq. Cost-effectiveness modeling demonstrated that implementing WES as the first-tier genetic testing method could reduce the total expenditure when WES unit cost remained below 6.4 folds that of the CNV-seq.
CONCLUSION
Genetic variants including single nucleotide variations (SNV) of monogenic disorders, chromosomal aneuploidies and genomic CNVs are important causes for fetal skeletal dysplasia. WES is an accurate and efficient method for analyzing the etiology of fetal skeletal dysplasia, particularly in those with a family history of similar phenotype or maternal history of adverse pregnancies.
Humans
;
Exome Sequencing/methods*
;
Female
;
Pregnancy
;
DNA Copy Number Variations/genetics*
;
Genetic Testing/methods*
;
Prenatal Diagnosis/methods*
;
Adult
;
Male
;
Fetus
;
Bone Diseases, Developmental/diagnosis*
;
Ultrasonography, Prenatal
6.Application of chromosomal microarray analysis in the prenatal diagnosis of fetuses with isolated Congenital anomalies of the kidney and urinary tract.
Xiaoyu DU ; Yan MIAO ; Jiashan LI ; Siying LIANG ; Wei ZHAO ; Yingchao ZHOU ; Nan JIANG
Chinese Journal of Medical Genetics 2025;42(9):1033-1038
OBJECTIVE:
To explore the detection rate of copy number variations (CNVs) in fetuses with isolated Congenital anomalies of the kidney and urinary tract (CAKUT) and pregnancy outcomes in order to provide a basis for genetic counseling.
METHODS:
One hundred and eighty eight fetuses who underwent chromosomal microarray analysis (CMA) due to isolated CAKUT detected by prenatal ultrasonography at Qingdao Women and Children's Hospital from January 2021 to December 2024 were selected as the study subjects. According to the ultrasound findings, the fetuses were divided into 8 groups, including renal parenchymal dysplasia group, renal cystic dysplasia group, simple renal parenchymal echo enhancement group, abnormal development of renal collecting system group, duplicated kidney group, ectopic kidney group, horseshoe kidney group, and bladder/posterior urethral abnormalities group. The detection of CNVs was retrospectively analyzed, and the pregnant women were followed up to summarize their pregnancy outcomes. 2 test (or Fisher's exact probability method) was used to compare the CNV detection rates between the groups. This study was approved by the Medical Ethics Committee of the Qingdao Women and Children's Hospital (Ethics No.: QFELL-YJ-2025-85).
RESULTS:
Among the 188 fetuses with isolated CAKUT, 23 CNVs (12.23%) were detected, of which 13 cases (6.91%) were pathogenic and 10 cases were rated as variants of unknown significance (VOUS). Among the 8 groups, the three groups with the highest proportion were renal cystic dysplasia group, renal metaplasia group, and renal parenchymal dysplasia group. The detection rates of pathogenic CNVs in the three groups were 1.79% (1/56), 6.78% (4/59), and 16.67% (5/30), respectively, with statistically significant differences (P < 0.05). Parental verification was conducted on 12 fetuses detected with the CNVs, confirming that 2 cases were de novo and 10 were inherited from parents with a normal phenotype. After genetic counseling, the parents of 9 fetuses opted to terminate the pregnancy, while 11 chose to continue with the pregnancy, and 3 were lost to follow-up. At the time of last follow-up, the youngest offspring was 5 months old and the oldest was 3 years and 11 months old. One child had renal aplasia, and two were born with hydronephrosis, which have been cured through surgery. The remainders had no obvious abnormality with their growth and development.
CONCLUSION
CMA testing has important value for prenatal diagnosis of isolated CAKUT. In this study, the detection rate of pathogenic CNVs has increased sequentially in fetuses with renal cystic developmental abnormalities, renal collecting system developmental abnormalities, and renal parenchymal dysplasia, while there was no significant difference in the detection rate of CNVs. For fetuses with isolated CAKUT detected by prenatal ultrasound, CMA testing should be considered, and reasonable pregnancy decisions should be made based on the results of prenatal ultrasound and parental verification.
Humans
;
Female
;
Pregnancy
;
Prenatal Diagnosis/methods*
;
DNA Copy Number Variations/genetics*
;
Kidney/abnormalities*
;
Adult
;
Ultrasonography, Prenatal
;
Urogenital Abnormalities/diagnosis*
;
Microarray Analysis/methods*
;
Retrospective Studies
;
Urinary Tract/abnormalities*
;
Fetus
;
Pregnancy Outcome
;
Vesico-Ureteral Reflux
7.Empirical and modified hemostatic resuscitation for liver blast injury combined with seawater immersion: A preliminary study.
Haoyang YANG ; Chenglin DAI ; Dongzhaoyang ZHANG ; Can CHEN ; Zhao YE ; Xin ZHONG ; Yijun JIA ; Renqing JIANG ; Wenqiong DU ; Zhaowen ZONG
Chinese Journal of Traumatology 2025;28(3):220-225
PURPOSE:
To compare the effects of empirical and modified hemostatic resuscitation for liver blast injury combined with seawater immersion.
METHODS:
Thirty rabbits were subjected to liver blast injury combined with seawater immersion, and were then divided into 3 groups randomly (n = 10 each): group A (no treatment after immersion), group B (empirical resuscitation with 20 mL hydroxyethyl starch, 50 mg tranexamic acid, 25 IU prothrombin complex concentrate and 50 mg/kg body weight fibrinogen concentrate), and group C (modified resuscitation with additional 10 IU prothrombin complex concentrate and 20 mg/kg body weight fibrinogen concentrate based on group B). Blood samples were gathered at specified moments for assessment of thromboelastography, routine coagulation test, and biochemistry. Mean arterial pressure, heart rate, and survival rate were also documented at each time point. The Kolmogorov-Smirnov test was used to examine the normality of data distribution. Multigroup comparisons were conducted with one-way ANOVA.
RESULTS:
Liver blast injury combined with seawater immersion resulted in severe coagulo-fibrinolytic derangement as indicated by prolonged prothrombin time (s) (11.53 ± 0.98 vs. 7.61 ± 0.28, p<0.001), activated partial thromboplastin time (APTT) (s) (33.48 ± 6.66 vs. 18.23 ± 0.89, p<0.001), reaction time (R) (min) (5.85 ± 0.96 vs. 2.47 ± 0.53, p<0.001), decreased maximum amplitude (MA) (mm) (53.20 ± 5.99 vs. 74.92 ± 5.76, p<0.001) and fibrinogen concentration (g/L) (1.19 ± 0.29 vs. 1.89 ± 0.32, p = 0.003), and increased D-dimer concentration (mg/L) (0.38 ± 0.32 vs. 0.05 ± 0.03, p = 0.005). Both empirical and modified hemostatic resuscitation could improve the coagulo-fibrinolytic states and organ function, as indicated by shortened APTT and R values, decreased D-dimer concentration, increased fibrinogen concentration and MA values, lower concentration of blood urea nitrogen and creatine kinase-MB in group B and group C rabbits in comparison to that observed in group A. Further analysis found that the R values (min) (4.67 ± 0.84 vs. 3.66 ± 0.98, p = 0.038), APTT (s) (23.16 ± 2.75 vs. 18.94 ± 1.05, p = 0.001), MA (mm) (60.10 ± 4.74 vs. 70.21 ± 3.01, p < 0.001), and fibrinogen concentration (g/L) (1.68 ± 0.21 vs. 1.94 ± 0.16, p = 0.013) were remarkably improved in group C than in group B at 2 h and 4 h after injury. In addition, the concentration of blood urea nitrogen (mmol/L) (24.11 ± 1.96 vs. 21.00 ± 3.78, p = 0.047) and creatine kinase-MB (U/L) (85.50 ± 13.60 vs. 69.74 ± 8.56, p = 0.013) were lower in group C than in group B at 6 h after injury. The survival rates in group B and group C were significantly higher than those in group A at 4 h and 6 h after injury (p < 0.001), however, there were no statistical differences in survival rates between group B and group C at each time point.
CONCLUSIONS
Modified hemostatic resuscitation could improve the coagulation parameters and organ function better than empirical hemostatic resuscitation.
Animals
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Rabbits
;
Resuscitation/methods*
;
Liver/injuries*
;
Seawater
;
Blast Injuries/therapy*
;
Fibrinogen/administration & dosage*
;
Male
;
Tranexamic Acid/administration & dosage*
;
Immersion
;
Hydroxyethyl Starch Derivatives/administration & dosage*
8.Construction and preliminary trial test of a decision-making app for pre-hospital damage control resuscitation.
Haoyang YANG ; Wenqiong DU ; Zhaowen ZONG ; Xin ZHONG ; Yijun JIA ; Renqing JIANG ; Chenglin DAI ; Zhao YE
Chinese Journal of Traumatology 2025;28(5):313-318
PURPOSE:
To construct a decision-making app for pre-hospital damage control resuscitation (PHDCR) for severely injured patients, and to make a preliminary trial test on the effectiveness and usability aspects of the constructed app.
METHODS:
Decision-making algorithms were first established by a thorough literature review, and were then used to be learned by computer with 3 kinds of text segmentation algorithms, i.e., dictionary-based segmentation, machine learning algorithms based on labeling, and deep learning algorithms based on understanding. B/S architecture mode and Spring Boot were used as a framework to construct the app. A total of 16 Grade-5 medical students were recruited to test the effectiveness and usability aspects of the app by using an animal model-based test on simulated PHDCR. Twelve adult Bama miniature pigs were subjected to penetrating abdominal injuries and were randomly assigned to the 16 students, who were randomly divided into 2 groups (n = 8 each): group A (decided on PHDCR by themselves) and group B (decided on PHDCR with the aid of the app). The students were asked to complete the PHDCR within 1 h, and then blood samples were taken and thromboelastography, routine coagulation test, blood cell count, and blood gas analysis were examined. The lab examination results along with the value of mean arterial pressure were used to compare the resuscitation effects between the 2 groups. Furthermore, a 4-statement-based post-test survey on a 5-point Likert scale was performed in group B students to test the usability aspects of the constructed app.
RESULTS:
With the above 3 kinds of text segmentation algorithm, B/S architecture mode, and Spring Boot as the development framework, the decision-making app for PHDCR was successfully constructed. The time to decide PHDCR was (28.8 ± 3.41) sec in group B, much shorter than that in group A (87.5 ± 8.53) sec (p < 0.001). The outcomes of animals treated by group B students were much better than that by group A students as indicated by higher mean arterial pressure, oxygen saturation and fibrinogen concentration and maximum amplitude, and lower R values in group B than those in group A. The post-test survey revealed that group B students gave a mean score of no less than 4 for all 4 statements.
CONCLUSION
A decision-making app for PHDCR was constructed in the present study and the preliminary trial test revealed that it could help to improve the resuscitation effect in animal models of penetrating abdominal injury.
Animals
;
Swine
;
Resuscitation/methods*
;
Mobile Applications
;
Humans
;
Algorithms
;
Emergency Medical Services/methods*
;
Male
;
Decision Making
;
Female
9.Erratum: Author Correction: Targeting of AUF1 to vascular endothelial cells as a novel anti-aging therapy.
Jian HE ; Ya-Feng JIANG ; Liu LIANG ; Du-Jin WANG ; Wen-Xin WEI ; Pan-Pan JI ; Yao-Chan HUANG ; Hui SONG ; Xiao-Ling LU ; Yong-Xiang ZHAO
Journal of Geriatric Cardiology 2025;22(9):834-834
[This corrects the article DOI: 10.11909/j.issn.1671-5411.2017.08.005.].
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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