1.Quantitative Molecular Detection of Angelicae Sinensis Radix and Its Processed Products Based on Herb-Q Method
Mingyu ZHANG ; Wenjun JIANG ; Baoyu JI ; Yue WANG ; Haitao ZHANG ; Haobo ZHANG ; Xue FENG ; Xiwen LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):192-200
ObjectiveAngelicae Sinensis Radix, a commonly used medicinal herb with both medicinal and edible properties, is frequently adulterated in the market, severely affecting the clinical efficacy of preparations. While qualitative identification techniques for adulterants and counterfeits are now relatively mature, quantitative detection methods for adulterated processed products remain unexplored. Quantitative detection research of Angelicae Sinensis Radix and its primary closely related adulterant, "Tu Danggui" (Angelica gigas), was conducted to establish a herbal quantitative molecular detection (Herb-Q) method for Angelicae Sinensis Radix and its processed products, providing a model for the establishment of quantitative detection technologies for Angelicae Sinensis Radix and related health products. MethodsThe specific single-nucleotide polymorphism (SNP) loci of Angelicae Sinensis Radix and Angelica gigas Nakai were screened based on the complete chloroplast genome sequence. The specific SNP loci of Angelicae Sinensis Radix were selected for quantitative methodological investigations (linearity, limit of quantification, limit of detection, and reproducibility) by mixing the powder of the herbs with different adulteration ratios. Huoxue Zhitong powder with three distinct adulteration ratios (15%, 25%, and 35%) was utilized to ascertain the precision of the Herb-Q method for the quantitative detection of Chinese patent medicines containing Angelicae Sinensis Radix. ResultsBy comparing the 123 chloroplast genome sequences of Angelicae Sinensis Radix, based on the principles of intraspecies conservation, interspecies specificity, and meeting the requirements of pyrophosphate high-throughput sequencing, it was determined that 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 and 38 592nd locus (T/C) in the chloroplast genome sequence NC_029393.1 could be the exclusive molecular identification loci of Angelicae Sinensis Radix and Angelica gigas Nakai, respectively. The linear relationship R2 of the Herb-Q method established by selecting the specific 9 674th locus (A/G) of Angelicae Sinensis Radix was 0.997 4 (R2>0.99), indicating an excellent linear relationship. The limits of quantification and detection were established at 2.0%, exhibiting excellent reproducibility [relative standard deviation(RSD)<2.0%]. The established quantitative system based on the Herb-Q method detected the adulteration amount of counterfeit A. gigas in the Huoxue Zhitong powder, with an average deviation of 1.3% for three molecular quantitative replicates. ConclusionThis research demonstrates that the Herb-Q quantitative detection method established based on the 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 of Angelicae Sinensis Radix has good applicability, objectivity, and accuracy for Angelicae Sinensis Radix and A. gigas, and its processed products. This method has the capacity to provide technical support for the quantitative detection of commercially available Angelicae Sinensis Radix derivatives, including traditional Chinese medicinal preparations, dietary supplements, and nutraceuticals.
2.Quantitative Molecular Detection of Angelicae Sinensis Radix and Its Processed Products Based on Herb-Q Method
Mingyu ZHANG ; Wenjun JIANG ; Baoyu JI ; Yue WANG ; Haitao ZHANG ; Haobo ZHANG ; Xue FENG ; Xiwen LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):192-200
ObjectiveAngelicae Sinensis Radix, a commonly used medicinal herb with both medicinal and edible properties, is frequently adulterated in the market, severely affecting the clinical efficacy of preparations. While qualitative identification techniques for adulterants and counterfeits are now relatively mature, quantitative detection methods for adulterated processed products remain unexplored. Quantitative detection research of Angelicae Sinensis Radix and its primary closely related adulterant, "Tu Danggui" (Angelica gigas), was conducted to establish a herbal quantitative molecular detection (Herb-Q) method for Angelicae Sinensis Radix and its processed products, providing a model for the establishment of quantitative detection technologies for Angelicae Sinensis Radix and related health products. MethodsThe specific single-nucleotide polymorphism (SNP) loci of Angelicae Sinensis Radix and Angelica gigas Nakai were screened based on the complete chloroplast genome sequence. The specific SNP loci of Angelicae Sinensis Radix were selected for quantitative methodological investigations (linearity, limit of quantification, limit of detection, and reproducibility) by mixing the powder of the herbs with different adulteration ratios. Huoxue Zhitong powder with three distinct adulteration ratios (15%, 25%, and 35%) was utilized to ascertain the precision of the Herb-Q method for the quantitative detection of Chinese patent medicines containing Angelicae Sinensis Radix. ResultsBy comparing the 123 chloroplast genome sequences of Angelicae Sinensis Radix, based on the principles of intraspecies conservation, interspecies specificity, and meeting the requirements of pyrophosphate high-throughput sequencing, it was determined that 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 and 38 592nd locus (T/C) in the chloroplast genome sequence NC_029393.1 could be the exclusive molecular identification loci of Angelicae Sinensis Radix and Angelica gigas Nakai, respectively. The linear relationship R2 of the Herb-Q method established by selecting the specific 9 674th locus (A/G) of Angelicae Sinensis Radix was 0.997 4 (R2>0.99), indicating an excellent linear relationship. The limits of quantification and detection were established at 2.0%, exhibiting excellent reproducibility [relative standard deviation(RSD)<2.0%]. The established quantitative system based on the Herb-Q method detected the adulteration amount of counterfeit A. gigas in the Huoxue Zhitong powder, with an average deviation of 1.3% for three molecular quantitative replicates. ConclusionThis research demonstrates that the Herb-Q quantitative detection method established based on the 9 674th locus (A/G) in the chloroplast genome sequence NC_042826.1 of Angelicae Sinensis Radix has good applicability, objectivity, and accuracy for Angelicae Sinensis Radix and A. gigas, and its processed products. This method has the capacity to provide technical support for the quantitative detection of commercially available Angelicae Sinensis Radix derivatives, including traditional Chinese medicinal preparations, dietary supplements, and nutraceuticals.
3.Investigation of Specific Antibody Levels of Autoimmune Gastritis and Analysis of Influencing Factors in A Community Population in Xinjiang
Huan LIU ; Xiaoling HUANG ; AI HEMAIJIANG KURBANJIANG ; Yan FENG ; Weidong LIU ; Shenglong XUE ; Zequan XIAO ; AINI ABDUREIM ; Xinwen GUO ; Maosen JIANG ; Feng GAO
Medical Journal of Peking Union Medical College Hospital 2026;17(4):1042-1050
To investigate the positivity rates of specific antibodies, including parietal cell antibody (PCA) and anti-inner factor antibody (IFA), in a community population in Xinjiang for autoimmune gastritis (AIG), determine the prevalence of AIG, and analyze the correlations of PCA and IFA with clinical characteristics, pepsinogen (PG), gastrin 17 (G17), and A cross-sectional survey was conducted using stratified random cluster sampling in community populations across 10 regions of Xinjiang from January 2022 to December 2023. General information was collected via a self-designed questionnaire, and fasting venous blood samples were obtained to measure laboratory parameters including PCA, IFA, PG Ⅰ, PG Ⅱ, PG Ⅰ/PG Ⅱ ratio, and G17. The positivity rates of PCA and IFA and the prevalence of AIG were calculated. Spearman correlation analysis was used to assess the relationships of PCA and IFA with PG Ⅰ, PG Ⅱ, PG Ⅰ/PG Ⅱ ratio, and G17. The diagnostic efficacy of PCA and IFA for atrophic gastritis was evaluated using receiver operating characteristic (ROC) curves, and multivariate logistic regression analysis was performed to identify factors influencing PCA and IFA positivity. A total of 2018 community participants were included, comprising 972 males (48.17%) and 1046 females (51.83%), with a mean age of 42±19 years. The predominant ethnic groups were Han (42.22%) and Kazakh (33.10%). Hp-Ab positivity was observed in 1244 cases (61.65%). Serological criteria for atrophic gastritis were met in 56 cases (2.78%). PCA positivity was found in 253 cases (12.54%), IFA positivity in 30 cases (1.49%), and dual positivity in 11 cases (0.55%). A total of 617 participants (30.57%) voluntarily underwent endoscopic examination, among whom 7 cases (1.13%) were histopathologically confirmed as AIG. Positivity rates for PCA and IFA varied among ethnic groups, with the highest rates observed in the Kirgiz population (23.53% and 5.88%, respectively). Spearman correlation analysis revealed that PCA was negatively correlated with the PG Ⅰ/PG Ⅱ ratio ( The positivity rate of PCA is relatively high in the community population in Xinjiang and varies across different ethnic groups, whereas the positivity rate of IFA is lower than that of PCA. Age, history of alcohol consumption, history of allergies, and history of thyroid disease are associated with PCA positivity, while no correlation was found between Hp-Ab and PCA or IFA. The prevalence of histopathologically confirmed AIG among participants undergoing endoscopic examination is 1.13%.
4.Banxia Xiexin Decoction reshapes tryptophan metabolism to inhibit progression of colon cancer.
Yi-Fang JIANG ; Yu-Qing HUANG ; Heng-Zhou LAI ; Xue-Ke LI ; Liu-Yi LONG ; Feng-Ming YOU ; Qi-Xuan KUANG
China Journal of Chinese Materia Medica 2025;50(5):1310-1320
This study explores the effect and mechanism of Banxia Xiexin Decoction(BXD) in inhibiting colon cancer progression by reshaping tryptophan metabolism. Balb/c mice were assigned into control, model, low-dose BXD(BXD-L), and high-dose BXD(BXD-H) groups. Except the control group, the other groups were subcutaneously injected with CT26-Luc cells for the modeling of colon cancer, which was followed by the intervention with BXD. Small animal live imaging was employed to monitor tumor growth, and the tumor volume and weight were measured. Hematoxylin-eosin(HE) staining was used to observe the pathological changes in mouse tumors. Immunohistochemistry was used to detect Ki67 expression in tumors. Immunofluorescence and flow cytometry were used to detect the infiltration and number changes of CD3~+/CD8~+ T cells in the tumor tissue. Enzyme-linked immunosorbent assay(ELISA) was employed to measure the levels of interferon-gamma(IFN-γ) and interleukin-2(IL-2) in tumors. Targeted metabolomics was employed to measure the level of tryptophan(Trp) in the serum, and the Trp content in the tumor tissue was measured. Western blot and RT-qPCR were employed to determine the protein and mRNA levels, respectively, of indoleamine 2,3-dioxygenase 1(IDO1), MYC proto-oncogene, and solute carrier family 7 member 5(SLC7A5) in the tumor tissue. Additionally, a co-culture model with CT26 cells and CD8~+ T cells was established in vitro and treated with the BXD-containing serum. The cell counting kit-8(CCK-8) assay was used to examine the viability of CT26 cells. The content of Trp in CT26 cells and CD8~+ T cells, as well as the secretion of IFN-γ and IL-2 by CD8~+ T cells, was measured. RT-qPCR was used to determine the mRNA levels of MYC and SLC7A5 in CT26 cells. The results showed that BXD significantly inhibited the tumor growth, reduced the tumor weight, and decreased the tumor volume in the model mice. In addition, the model mice showed sparse arrangement of tumor cells, varying degrees of patchy necrosis, and downregulated expression of Ki67 in the tumor tissue. BXD elevated the levels of IFN-γ and IL-2 in the tumor tissue, while upregulating the ratio of CD3~+/CD8~+ T cells and lowering the levels of Trp, IDO1, MYC, and SLC7A5. The co-culture experiment showed that BXD-containing serum reduced Trp uptake by CT26 cells, increased Trp content in CD8~+T cells, enhanced IL-2 and IFN-γ secretion of CD8~+T cells, and down-regulated the mRNA levels of MYC and SLC7A5 in CT26 cells. In summary, BXD can inhibit the MYC/SLC7A5 pathway to reshape Trp metabolism and adjust Trp uptake by CD8~+ T cells to enhance the cytotoxicity, thereby inhibiting the development of colon cancer.
Animals
;
Tryptophan/metabolism*
;
Colonic Neoplasms/pathology*
;
Mice
;
Drugs, Chinese Herbal/administration & dosage*
;
Mice, Inbred BALB C
;
Humans
;
Cell Line, Tumor
;
Indoleamine-Pyrrole 2,3,-Dioxygenase/metabolism*
;
Female
;
Disease Progression
;
Cell Proliferation/drug effects*
;
Proto-Oncogene Mas
;
Male
5.Orthopedic manipulation combined with percutaneous reduction and Kirschner wire internal fixation for Sanders typeⅡand Ⅲ calcaneal fractures.
Feng DAI ; Jin-Tao LIU ; Zhi-Gang ZHANG ; Xue-Qiang SHEN ; Li-Ming WU ; Peng-Fei YU ; Hong JIANG
China Journal of Orthopaedics and Traumatology 2025;38(3):306-310
OBJECTIVE:
To explore clinical effects of bone setting manipulation combined with pry reduction and Kirschner needle internal fixation in treating SandersⅡ-Ⅲ calcaneal fracture.
METHODS:
Clinical data of 52 patients with types Sanders Ⅱand Ⅲ calcaneal fracture (foot) treated with bone-setting manipulation combined with pry reduction and Kirscher needle internal fixation from July 2017 to July 2019 were retrospectively analyzed, including 43 males and 9 females, aged from 31 to 72 years old with an average of (50.83±10.48) years old; 15 patients with Sanders typeⅡ and 37 patients with Sanders type Ⅲ. The changes of Bühler angle, Gissane angle, calcaneus width and calcaneus height before operation and 24 months after operation were compared, and Maryland foot function score was performed to evaluate clinical effects.
RESULTS:
All patients were followed up from 24 to 60 months with an average of (41.50±9.86)months. The fracture healed normally and the healing time was (11.00±0.95) weeks. Bühler angle, Gissane angle, calcaneal bone width and calcaneal bone height were increased from (16.37±8.36)°, (96.27±9.62)°, (46.82±4.67) mm, (38.41±3.58) mm before operation to (31.48±8.24)°, (111.62±8.69)°, (42.06±4.83) mm, (44.21±3.82) mm at 24 months after operation, and the difference were statistically significant (P<0.01). Postoperative Maryland score at 24 months was (93.04±8.83), 40 patients got excellent result, 7 good and 5 fair.
CONCLUSION
Orthopedic manipulation combined with percutaneous reduction and Kirschner wire internal fixation could significantly improve Bühler angle, Gissane angle, width, and height of Sanders typeⅡ and Ⅲ calcaneal fractures, and the curative effect is satisfactory.
Humans
;
Male
;
Female
;
Calcaneus/surgery*
;
Middle Aged
;
Fracture Fixation, Internal/methods*
;
Adult
;
Aged
;
Fractures, Bone/therapy*
;
Retrospective Studies
;
Bone Wires
;
Manipulation, Orthopedic/methods*
6.Clinical observation of proximal femoral nail antirotation internal fixation in the treatment of Basicervical fracture in the elderly.
Xue-Kun HAN ; Ai-Chun WEI ; Jian-Feng JIANG
China Journal of Orthopaedics and Traumatology 2025;38(7):676-679
OBJECTIVE:
To investigate the clinical efficacy and key techniques of proximal femoral nail antirotation (PFNA) in the treatment of Basicervical fracture.
METHODS:
A retrospective analysis was performed on 23 patients with Basicervical fractures who underwent closed reduction and PFNA internal fixation under C-arm X-ray fluoroscopy between March 2019 and March 2023. The cohort included 9 males and 14 females. The age distributions was as follows:7 individuals aged from 60 to 69 years old, 5 individuals aged from 70 to 79 years old, 9 individuals aged from 80 to 89 years old, and 2 individuals aged from 90 to 99 years old. The operative time, intraoperative blood loss and fracture healing time were recorded. Hip function was evaluated according to the Harris score.
RESULTS:
All 23 patients successfully underwent the operation, with the operation time ranging from 30 to 75 minutes and an average of (60.51±9.82) minutes. The intraoperative blood loss varied from 100 to 180 ml, averaging (145.36±25.21) ml, and the hidden blood loss ranged from 150 to 220 ml, with an average of (189.00±30.12) ml. All 23 patients were followed up, and the duration ranged from 6 to 28 months, with an average of (18.56±6.35) months. All incisions healed well, the fracture healing time ranged from 12 to 15 weeks, with an average of (14.30±1.82) weeks. During the follow-up period, one patient experienced a spiral blade cut-out, and no complications such as internal fixation rupture, avascular necrosis of the femoral head, fracture nonunion, hip varus deformity, or refracture occurred. At the latest follow-up, the results were evaluated by Harris hip function score:17 cases were excellent, 4 cases were good, 1 case was fair, and 1 case was poor.
CONCLUSION
PFNA internal fixation in the treatment of Basicervical fracture has the advantages of simple operation, less trauma, short operation time, rigid fixation, postoperative functional recovery and so on, which is an ideal fixation for elderly Basicervical fracture.
Humans
;
Female
;
Male
;
Aged, 80 and over
;
Aged
;
Retrospective Studies
;
Bone Nails
;
Middle Aged
;
Fracture Fixation, Internal/methods*
;
Fracture Healing
;
Fracture Fixation, Intramedullary
7.Multicenter randomized controlled trial of Yiqi Huoxue formula() for the treatment of ruptured lumbar disc herniation.
Yu ZHU ; Zhi-Qiang WANG ; Shun LIN ; Ying-Ying YAO ; Xue-Qiang SHEN ; Xiao-Chun LI ; Feng YU ; Xiao-Yang XIONG ; Yi SONG ; Meng-Fei CHEN ; Peng-Fei YU ; Hong JIANG ; Jin-Tao LIU
China Journal of Orthopaedics and Traumatology 2025;38(11):1112-1118
OBJECTIVE:
To observe the clinical symptoms and MRI outcomes of patients with ruptured lumbar disc herniation(LDH) through a multicenter randomized controlled study, and to evaluate the clinical efficacy and safety of Yiqi Huoxue formula() in the treatment of this disease.
METHODS:
A total of 160 outpatients and inpatients with ruptured LDH admitted to 4 medical centers from January 2023 to June 2023 were selected and randomly divided into the Yiqi Huoxue formula group and the control group, with 80 patients in each group. In the Yiqi Huoxue formula group, there were 43 males and 37 females, with an age of (41.03±9.56) years and a disease duration of (10.45±25.37) days, and the patients were treated with Yiqi Huoxue formula. In the control group, there were 34 males and 46 females, with an age of (42.14±8.73) years and a disease duration of (11.31±21.14) days;during the acute phase, patients in this group could take celecoxib capsules orally, and methylcobalamin orally at the same time. The Japanese Orthopaedic Association (JOA) score, Oswestry disability index (ODI), changes in the volume of herniated disc tissue on MRI, herniation rate, and absorption rate were recorded at the time of enrollment and during follow-ups at the 3rd, 6th, and 12th month after treatment.
RESULTS:
A total of 156 patients completed the clinical follow-up, and 4 patients withdrew midway. The clinical symptoms of all patients who completed the study were relieved to varying degrees, and reabsorption of herniated disc tissue was observed in all patients in the Yiqi Huoxue formula group after treatment. For the JOA score:in the Yiqi Huoxue formula group, it was (10.73±2.76) points before treatment and (24.65±2.19) points at the 12th month after treatment;in the control group, it was (11.01±1.20) points before treatment and (17.07±3.26) points at the 12th month after treatment. For the ODI score:in the Yiqi Huoxue formula group, it was (26.21±3.55) points before treatment and (5.65±2.19) points at the 12th month after treatment;in the control group, it was (27.92±2.51) points before treatment and (9.09±2.15) points at the 12th month after treatment. At the 12th month after treatment, the JOA and ODI scores of both groups were better than those before treatment, and the scores of the Yiqi Huoxue formula group were better than those of the control group, with statistically significant differences (P<0.05). In terms of the herniated disc volume and herniation rate on MRI, the Yiqi Huoxue formula group was superior to the control group, with statistically significant differences(P<0.05). Reabsorption occurred in 56.96%(45/79) of patients in the Yiqi Huoxue formula group, which was significantly higher than the 37.66%(29/77) in the control group.
CONCLUSION
After treatment with Yiqi Huoxue formula, patients with ruptured LDH show significant improvement in clinical symptoms and a marked reduction in the volume of herniated discs. During the follow-up period, no obvious adverse drug reactions are observed in patients, and no recurrence of symptoms is found at the last follow-up, indicating that the formula has safe and reliable efficacy.
Humans
;
Male
;
Female
;
Intervertebral Disc Displacement/drug therapy*
;
Adult
;
Drugs, Chinese Herbal/adverse effects*
;
Middle Aged
;
Lumbar Vertebrae
8.Clinical characteristics of Behçet syndrome in 45 children.
Chen-Xi WEI ; Shu-Feng ZHI ; Li-Jun JIANG ; Xue ZHAO ; Qing-Xiao SU ; Xing-Jie QI ; Zan-Hua RONG
Chinese Journal of Contemporary Pediatrics 2025;27(10):1253-1258
OBJECTIVES:
To study the clinical characteristics of pediatric Behçet syndrome (BS).
METHODS:
A retrospective review was conducted on the medical records of children hospitalized in the Department of Pediatrics at the Second Hospital of Hebei Medical University between December 2014 and December 2024 who met diagnostic criteria for BS.
RESULTS:
Among 45 children with BS, 26 (58%) were male. Oral aphthous ulcers were the most common manifestation (43/45, 96%), followed by genital ulcers (23/45, 51%) and gastrointestinal involvement (18/45, 40%). Genital ulcers were more frequent in girls, whereas ocular involvement was more common in boys (P<0.05). The pathergy test was positive in 10 (22%), and HLA-B51 was positive in 13 (29%). Fecal calprotectin (FC) was elevated in 16 (36%); gastrointestinal involvement was more frequent in children with elevated FC than in those with normal FC (P<0.05). According to the respective criteria, 17 (38%) patients met the International Study Group criteria (1990), 33 (73%) met the International Criteria for Behçet Disease (2014), and 13 (29%) met the Pediatric Behçet Disease criteria (2015).
CONCLUSIONS
Pediatric BS shows marked clinical heterogeneity. HLA-B51 is associated with disease susceptibility.
Humans
;
Behcet Syndrome/genetics*
;
Male
;
Female
;
Child
;
Retrospective Studies
;
Adolescent
;
Child, Preschool
;
Leukocyte L1 Antigen Complex/analysis*
;
HLA-B51 Antigen
9.Research Progress of Neutrophil Extracellular Traps in Lung Cancer.
Xu HAO ; Yilin FENG ; Anqi LU ; Ying SUN ; Jinchan XIA ; Xue MEI ; Long FENG ; Min JIANG ; Baiyan WANG ; Huitong YANG
Chinese Journal of Lung Cancer 2025;28(3):201-212
Neutrophil extracellular traps (NETs), intricate reticular structures released by activated neutrophils, play a pivotal regulatory role in the pathogenesis of malignant tumors. Lung cancer is one of the most prevalent malignancies globally, with persistently high incidence and mortality rates. Recent studies have revealed that NETs dynamically modulate the tumor microenvironment through unique pathological mechanisms, exhibiting complex immunoregulatory characteristics during the progression of lung cancer, and this discovery has increasingly become a focal point in tumor immunology research. This paper provides a comprehensive review of the latest advancements in NETs research related to lung cancer, offering an in-depth analysis of their impact on lung cancer progression, their potential diagnostic value, and the current state of research on targeting NETs for lung cancer prevention and treatment. The aim is to propose novel strategies to enhance therapeutic outcomes and improve the prognosis for lung cancer patients.
.
Extracellular Traps/immunology*
;
Humans
;
Lung Neoplasms/metabolism*
;
Neutrophils/metabolism*
;
Animals
;
Tumor Microenvironment
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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