1.Exploring CRISPR/Cas9 Technology for The Modernization of Traditional Chinese Medicine
Shu-Xian WANG ; Fei-Fei GUO ; Guang-Qiang MA
Progress in Biochemistry and Biophysics 2026;53(4):1000-1014
The clustered regularly interspaced short palindromic repeats (CRISPR)/associated protein 9 (CRISPR /Cas9) immune system is an adaptive immune system widely distributed in bacteria and archaea. It precisely defends against invasion by exogenous phages, viruses, and plasmids through sequence-specific endogenous immune response mechanisms. As the most prominent member of this family, the CRISPR/Cas9 system has evolved into the most widely applied, flexible, and efficient technical platform in the field of genome engineering due to its exceptional genome modification capabilities. Within the CRISPR/Cas9 system, the Cas9 protein, precisely guided by a single-stranded guide RNA (gRNA), can specifically recognize target DNA sequences and induce double-strand breaks. This activates the cell’s DNA repair mechanisms, enabling gene knockout, knock-in, or modification. Demonstrating significant advantages in specificity, flexibility, and operability, CRISPR/Cas9 technology has shown immense potential in the medical field, opening new avenues for modernizing traditional Chinese medicine (TCM) research. On one hand, this technology can be used to construct precise disease models and tailor personalized treatment plans. It enables in-depth elucidation of the molecular mechanisms underlying the action targets and signaling pathways of TCM formulas and active components, thereby unraveling the scientific secrets of their complex mechanisms of action. On the other hand, it demonstrates powerful tool value in improving TCM germplasm resources, identifying and screening superior varieties, evaluating the controllability of TCM quality, and producing innovative drugs, providing technical support for the standardization and precision of TCM. Simultaneously, the high-throughput omics data generated by CRISPR technology is driving artificial intelligence (AI) to construct virtual disease models and drug prediction systems. This empowers the intelligent screening of effective TCM components, the precise prediction of potential targets, and the exploration of “reducing toxicity while enhancing efficacy” through formula combinations. This synergistic innovation between CRISPR and AI aligns perfectly with precision medicine’s urgent demand for personalized, efficient drug development, injecting new momentum into the modernization and transformation of TCM. This paper first systematically reviews and explains the developmental trajectory, structural basis, and action mechanisms of the CRISPR/Cas9 system, tracing its scientific evolution from a bacterial immune system to a gene-editing tool. It then comprehensively outlines the current state of convergence between precision medicine concepts and modernization research in TCM, analyzing the synergistic points and potential spaces for their integration. Against the backdrop of rapid precision medicine advancement, this paper emphasizes how CRISPR/Cas9 gene editing technology empowers in-depth analysis of TCM mechanisms—including specific applications in disease model construction, therapeutic target validation, and multi-target network regulation studies. It further elaborates on its multidimensional practical contributions to modernizing TCM, spanning key domains such as germplasm resource innovation, bioactive compound biosynthesis, quality standardization control, and novel TCM drug development. Finally, this paper envisions the future landscape of deep integration between CRISPR technology and AI: from data-driven intelligent drug screening to high-throughput precision discovery of effective TCM components, and further to intelligent model construction based on “reducing toxicity while enhancing efficacy” mechanisms. The synergistic convergence of these multidimensional technologies will pioneer new scientific paradigms and translational pathways for TCM modernization, propelling TCM toward leapfrogging development in the era of precision medicine.
2.Rapid On-site Analysis of Four Prohibited Sex Hormones in Cosmetics Using Online Derivatization Reaction and A Miniature Mass Spectrometer
Li-Li TONG ; Yan-Hong HU ; Ren-You YANG ; Yue-Guang LYU ; Yu-Han SHANG ; Qing LYU ; Qing ZHANG ; Qiang WANG ; Xiang-Yu GUO
Chinese Journal of Analytical Chemistry 2025;53(10):1623-1630
Due to the poor ionization efficiency and the weak mass spectrometry(MS)intensity of weakly polar substances,direct analysis using the traditional electrospray ionization mass spectrometry(ESI-MS)is a big challenge.In this study,a novel rapid on-site detection method of four prohibited sex hormones in cosmetics was proposed using online derivatization strategy coupled with a miniature mass spectrometer.The target substances in the samples were extracted by a custom-made polyaniline/multi-walled carbon nanotube solid-phase microextraction(SPME)probe.The stirring speed was 200 r/min,the extraction temperature was 40℃,and the extraction time was 2 min.A pulled dual-channel θ borosilicate glass capillary emitter was used as the nano-ESI ion source.The SPME probe was inserted into the channel containing methanol in theθborosilicate glass capillary.When the spray voltage was applied,the four sex hormones were desorbed and formed spray microdroplets,which then collided with the hydroxylamine microdroplets generated from the other channel.The microdroplets of reaction product entered into the miniature mass spectrometer for direct analysis.The limits of detection(LOD)and limits of quantification(LOQ)for the four sex hormones were 10-20 ng/mL and 20-50 ng/mL,respectively.The recoveries were from 84.6%to 107.8%with the relative standard deviations(RSD)from 4.1%to 11.6%.Compared to detection without derivatization,the MS signals of the four target substances were increased by 3 to 15 times.This method was simple,rapid,highly efficient and sensitive,and suitable for on-site rapid analysis of weakly polar sex hormones in cosmetics.
3.The Influence of COVID-19 Infection on the Mobilization and Collection of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma.
Guo-Rong WANG ; Guang-Zhong YANG ; Yun LENG ; Yin WU ; Ai-Jun LIU ; Wen-Ming CHEN
Journal of Experimental Hematology 2025;33(2):455-462
OBJECTIVE:
To analyze the effect of COVID-19 infection on the mobilization and collection of autologous peripheral blood stem cells in patients with multiple myeloma.
METHODS:
The general baseline data, treatment factors before mobilization collection, collection status, and treatment overview after collection of autologous peripheral blood stem cells at Beijing Chaoyang Hospital affiliated with Capital Medical University from January 1, 2020 to July 15, 2023 were analyzed.
RESULTS:
269 patients underwent mobilization and collection of autologous peripheral blood stem cells. Among them, 32 cases with COVID-19 infection history (COVID-19 group) and 237 cases without COVID-19 infection history (non-COVID-19 group). In the COVID-19 group, 17 cases were treated with chemotherapy (etoposide)+G-CSF, and 15 cases were treated with plerixafor +G-CSF. In the non-COVID-19 group, 214 cases were treated with chemotherapy +G-CSF, 17 cases were treated with plerixafor +G-CSF, and 6 cases were treated with chemotherapy + plerixafor +G-CSF. The number of CD34+ cells, collection success rate, and excellence rate in the COVID-19 group and the non-COVID-19 group were [5.52 (0.94-26.87) vs 4.80 (0.53-37.20)]×106/kg (P =0.610), (93.8% vs 85.2%) (P =0.275), (62.5% vs 49.4%) (P =0.190), respectively. Among 113 patients mobilized with etoposide +G-CSF, the number of CD34+ cells, success rate, and excellence rate collected from COVID-19 infection (17 cases) and non-COVID-19 infection (96 cases) were [7.54 (2.66-26.87) vs 7.78 (2.26-37.20)]×106/kg (P =0.847), (100.0% vs 100.0%) (no P value), (82.4% vs 86.5%) (P =0.655), respectively. Among 32 patients mobilized by plerixafor +G-CSF, the number of CD34+ cells, success rate and excellence rate of COVID-19 infection (15 cases) and non-COVID-19 infection (17 cases) were [3.82 (0.94-7.27) vs 4.11 (0.53-9.05)]×106/kg (P =0.821), (86.7% vs 88.2%) (P =0.893), (40.0% vs 35.3%) (P =0.784), respectively. In 32 patients with COVID-19 infection, the number of CD34+ cells collected by etoposide +G-CSF (17 cases) and plerixafor +G-CSF (15 cases), as well as the success rate and excellence rate were [7.54 (2.66-26.87) vs 3.82(0.94-7.27)]×106/kg (P =0.004), (100.0% vs 86.7%) (P =0.120), (82.4% vs 40.0%) (P =0.014), respectively. By 2023.7.31, 232 patients (86.2%, 232/269) had received transplantation, including 24 patients in the COVID-19 group and 208 patients in the non-COVID-19 group. The median number of CD34+ cells infused in the two groups was [3.67 (2.50-13.44) vs 3.11(1.12-19.89)]×106/kg (P =0.058), the median days of neutrophil engraftment [11(9-13) vs 11(9-17)] (P =0.674), the median days of platelet engraftment [11(0-23), 12(0-43)] (P =0.279), respectively.
CONCLUSION
The history of COVID-19 infection did not affect the PBSC mobilization, collection and transplantation of patients with myeloma. In patients with COVID-19 infection, the results of chemotherapy mobilization with etoposide seems to be better than that of plerixafor mobilization, but further research is needed to clarify.
Humans
;
COVID-19/complications*
;
Multiple Myeloma/complications*
;
Hematopoietic Stem Cell Mobilization
;
Transplantation, Autologous
;
Granulocyte Colony-Stimulating Factor/therapeutic use*
;
Peripheral Blood Stem Cell Transplantation
;
SARS-CoV-2
;
Middle Aged
;
Peripheral Blood Stem Cells
;
Male
;
Female
;
Cyclams
;
Benzylamines
4.Effect of Cinnamaldehyde on Systemic Candida albicans Infection in Mice.
Xiao-Ru GUO ; Xiao-Guang ZHANG ; Gang-Sheng WANG ; Jia WANG ; Xiao-Jun LIU ; Jie-Hua DENG
Chinese journal of integrative medicine 2025;31(7):644-648
OBJECTIVE:
To investigate the therapeutic efficacy of cinnamaldehyde (CA) on systemic Candida albicans infection in mice and to provide supportive data for the development of novel antifungal drugs.
METHODS:
Ninety BALB/c mice were randomly divided into 3 groups according to a random number table: CA treatment group, fluconazole (positive control) group, and Tween saline (negative control) group, with 30 mice in each group. Initially, all groups of mice received consecutive intraperitoneal injections of cyclophosphamide at 200 mg/kg for 2 days, followed by intraperitoneal injection of 0.25 mL C. albicans fungal suspension (concentration of 1.0 × 107 CFU/mL) on the 4th day, to establish an immunosuppressed systemic Candida albicans infection animal model. Subsequently, the mice were orally administered CA, fluconazole and Tween saline, at 240, 240 mg/kg and 0.25 mL/kg respectively for 14 days. After a 48-h discontinuation of treatment, the liver, small intestine, and kidney tissues of mice were collected for fungal direct microscopic examination, culture, and histopathological examination. Additionally, renal tissues from each group of mice were collected for (1,3)- β -D-glucan detection. The survival status of mice in all groups was monitored for 14 days of drug administration.
RESULTS:
The CA group exhibited a fungal clearance rate of C. albicans above 86.7% (26/30), significantly higher than the fluconazole group (60.0%, 18/30, P<0.01) and the Tween saline group (30.0%, 9/30, P<0.01). Furthermore, histopathological examination in the CA group revealed the disappearance of inflammatory cells and near-normal restoration of tissue structure. The (1,3)-β-D-glucan detection value in the CA group (860.55 ± 126.73 pg/mL) was significantly lower than that in the fluconazole group (1985.13 ± 203.56 pg/mL, P<0.01) and the Tween saline group (5910.20 ± 320.56 pg/mL, P<0.01). The mouse survival rate reached 90.0% (27/30), higher than the fluconazole group (60.0%, 18/30) and the Tween saline group (30.0%, 9/30), with a significant difference between the two groups (both P<0.01).
CONCLUSIONS
CA treatment exhibited significant therapeutic efficacy in mice with systemic C. albicans infection. Therefore, CA holds potential as a novel antifungal agent for targeted treatment of C. albicans infection.
Animals
;
Acrolein/pharmacology*
;
Candida albicans/physiology*
;
Mice, Inbred BALB C
;
Candidiasis/pathology*
;
Antifungal Agents/therapeutic use*
;
Mice
;
Fluconazole/therapeutic use*
;
Kidney/drug effects*
;
Female
5.Astragaloside IV Alleviates Podocyte Injury in Diabetic Nephropathy through Regulating IRE-1α/NF-κ B/NLRP3 Pathway.
Da-Lin SUN ; Zi-Yi GUO ; Wen-Yuan LIU ; Lin ZHANG ; Zi-Yuan ZHANG ; Ya-Ling HU ; Su-Fen LI ; Ming-Yu ZHANG ; Guang ZHANG ; Jin-Jing WANG ; Jing-Ai FANG
Chinese journal of integrative medicine 2025;31(5):422-433
OBJECTIVE:
To investigate the effects of astragaloside IV (AS-IV) on podocyte injury of diabetic nephropathy (DN) and reveal its potential mechanism.
METHODS:
In in vitro experiment, podocytes were divided into 4 groups, normal, high glucose (HG), inositol-requiring enzyme 1 (IRE-1) α activator (HG+thapsigargin 1 µmol/L), and IRE-1α inhibitor (HG+STF-083010, 20 µmol/L) groups. Additionally, podocytes were divided into 4 groups, including normal, HG, AS-IV (HG+AS-IV 20 µmol/L), and IRE-1α inhibitor (HG+STF-083010, 20 µmol/L) groups, respectively. After 24 h treatment, the morphology of podocytes and endoplasmic reticulum (ER) was observed by electron microscopy. The expressions of glucose-regulated protein 78 (GRP78) and IRE-1α were detected by cellular immunofluorescence. In in vivo experiment, DN rat model was established via a consecutive 3-day intraperitoneal streptozotocin (STZ) injections. A total of 40 rats were assigned into the normal, DN, AS-IV [AS-IV 40 mg/(kg·d)], and IRE-1α inhibitor [STF-083010, 10 mg/(kg·d)] groups (n=10), respectively. The general condition, 24-h urine volume, random blood glucose, urinary protein excretion rate (UAER), urea nitrogen (BUN), and serum creatinine (SCr) levels of rats were measured after 8 weeks of intervention. Pathological changes in the renal tissue were observed by hematoxylin and eosin (HE) staining. Quantitative reverse transcription-polymerase chain reaction (RT-PCR) and Western blot were used to detect the expressions of GRP78, IRE-1α, nuclear factor kappa Bp65 (NF-κBp65), interleukin (IL)-1β, NLR family pyrin domain containing 3 (NLRP3), caspase-1, gasdermin D-N (GSDMD-N), and nephrin at the mRNA and protein levels in vivo and in vitro, respectively.
RESULTS:
Cytoplasmic vacuolation and ER swelling were observed in the HG and IRE-1α activator groups. Podocyte morphology and ER expansion were improved in AS-IV and IRE-1α inhibitor groups compared with HG group. Cellular immunofluorescence showed that compared with the normal group, the fluorescence intensity of GRP78 and IRE-1α in the HG and IRE-1α activator groups were significantly increased whereas decreased in AS-IV and IRE-1α inhibitor groups (P<0.05). Compared with the normal group, the mRNA and protein expressions of GRP78, IRE-1α, NF-κ Bp65, IL-1β, NLRP3, caspase-1 and GSDMD-N in the HG group was increased (P<0.05). Compared with HG group, the expression of above indices was decreased in the AS-IV and IRE-1α inhibitor groups, and the expression in the IRE-1α activator group was increased (P<0.05). The expression of nephrin was decreased in the HG group, and increased in AS-IV and IRE-1α inhibitor groups (P<0.05). The in vivo experiment results revealed that compared to the normal group, the levels of blood glucose, triglyceride, total cholesterol, BUN, blood creatinine and urinary protein in the DN group were higher (P<0.05). Compared with DN group, the above indices in AS-IV and IRE-1α inhibitor groups were decreased (P<0.05). HE staining revealed glomerular hypertrophy, mesangial widening and mesangial cell proliferation in the renal tissue of the DN group. Compared with the DN group, the above pathological changes in renal tissue of AS-IV and IRE-1α inhibitor groups were alleviated. Quantitative RT-PCR and Western blot results of GRP78, IRE-1α, NF-κ Bp65, IL-1β, NLRP3, caspase-1 and GSDMD-N were consistent with immunofluorescence analysis.
CONCLUSION
AS-IV could reduce ERS and inflammation, improve podocyte pyroptosis, thus exerting a podocyte-protective effect in DN, through regulating IRE-1α/NF-κ B/NLRP3 signaling pathway.
Podocytes/metabolism*
;
Animals
;
Diabetic Nephropathies/metabolism*
;
Saponins/therapeutic use*
;
Triterpenes/therapeutic use*
;
Signal Transduction/drug effects*
;
NF-kappa B/metabolism*
;
Protein Serine-Threonine Kinases/metabolism*
;
Male
;
Rats, Sprague-Dawley
;
NLR Family, Pyrin Domain-Containing 3 Protein/metabolism*
;
Endoribonucleases/metabolism*
;
Endoplasmic Reticulum Chaperone BiP
;
Rats
;
Diabetes Mellitus, Experimental/complications*
;
Endoplasmic Reticulum/metabolism*
;
Multienzyme Complexes
6.USP51/GRP78/ABCB1 axis confers chemoresistance through decreasing doxorubicin accumulation in triple-negative breast cancer cells.
Yang OU ; Kun ZHANG ; Qiuying SHUAI ; Chenyang WANG ; Huayu HU ; Lixia CAO ; Chunchun QI ; Min GUO ; Zhaoxian LI ; Jie SHI ; Yuxin LIU ; Siyu ZUO ; Xiao CHEN ; Yanjing WANG ; Mengdan FENG ; Hang WANG ; Peiqing SUN ; Yi SHI ; Guang YANG ; Shuang YANG
Acta Pharmaceutica Sinica B 2025;15(5):2593-2611
Recent studies have indicated that the expression of ubiquitin-specific protease 51 (USP51), a novel deubiquitinating enzyme (DUB) that mediates protein degradation as part of the ubiquitin‒proteasome system (UPS), is associated with tumor progression and therapeutic resistance in multiple malignancies. However, the underlying mechanisms and signaling networks involved in USP51-mediated regulation of malignant phenotypes remain largely unknown. The present study provides evidence of USP51's functions as the prominent DUB in chemoresistant triple-negative breast cancer (TNBC) cells. At the molecular level, ectopic expression of USP51 stabilized the 78 kDa Glucose-Regulated Protein (GRP78) protein through deubiquitination, thereby increasing its expression and localization on the cell surface. Furthermore, the upregulation of cell surface GRP78 increased the activity of ATP binding cassette subfamily B member 1 (ABCB1), the main efflux pump of doxorubicin (DOX), ultimately decreasing its accumulation in TNBC cells and promoting the development of drug resistance both in vitro and in vivo. Clinically, we found significant correlations among USP51, GRP78, and ABCB1 expression in TNBC patients with chemoresistance. Elevated USP51, GRP78, and ABCB1 levels were also strongly associated with a poor patient prognosis. Importantly, we revealed an alternative intervention for specific pharmacological targeting of USP51 for TNBC cell chemosensitization. In conclusion, these findings collectively indicate that the USP51/GRP78/ABCB1 network is a key contributor to the malignant progression and chemotherapeutic resistance of TNBC cells, underscoring the pivotal role of USP51 as a novel therapeutic target for cancer management.
7.CDK5-Induced HCN2 Channel Dysfunction in the Prelimbic Cortex Drives Allodynia and Anxiety-Like Behaviors in Neuropathic Pain.
Lu CHEN ; Shuai CAO ; Yun-Ze LIU ; Qi-Fan YANG ; Jin-Yu YANG ; Dan-Yang ZHANG ; Guo-Guang XIE ; Xiang-Sha YIN ; Ying ZHANG ; Yun WANG
Neuroscience Bulletin 2025;41(12):2254-2271
The prelimbic cortex (PL) plays a critical role in processing both the sensory and affective components of pain. However, the underlying molecular mechanisms remain poorly understood. In this study, we observed a reduction in hyperpolarization-activated cation current (Ih) in layer V pyramidal neurons of the contralateral PL in a mouse model of spared nerve injury (SNI). The expression of hyperpolarization-activated cyclic nucleotide-gated 2 (HCN2) channels was also decreased in the contralateral PL. Conversely, microinjection of fisetin, a partial agonist of HCN2, produced both analgesic and anxiolytic effects. Additionally, we found that cyclin-dependent kinase 5 (CDK5) was activated in the contralateral PL, where it formed a complex with HCN2 and phosphorylated its C-terminus. Knockdown of CDK5 restored HCN2 expression and alleviated both pain hypersensitivity and anxiety-like behaviors. Collectively, these results indicate that CDK5-mediated dysfunction of HCN2 in the PL underlies nerve injury-induced mechanical hypersensitivity and anxiety.
Animals
;
Hyperpolarization-Activated Cyclic Nucleotide-Gated Channels/metabolism*
;
Hyperalgesia/metabolism*
;
Cyclin-Dependent Kinase 5/metabolism*
;
Neuralgia/metabolism*
;
Male
;
Anxiety/metabolism*
;
Mice
;
Potassium Channels/metabolism*
;
Mice, Inbred C57BL
;
Disease Models, Animal
;
Pyramidal Cells/metabolism*
8.Re-Exploration for Dietary Iodine Intake in Chinese Adults using the Obligatory Iodine Loss Hypothesis.
Xiao Bing LIU ; Jun WANG ; Ya Jie LI ; Hong Xing TAN ; De Qian MAO ; Yan Yan LIU ; Wei Dong LI ; Wei YU ; Jun An YAN ; Jian Hua PIAO ; Chong Zheng GUO ; Xiao Li LIU ; Xiao Guang YANG
Biomedical and Environmental Sciences 2025;38(8):952-960
OBJECTIVE:
This study aimed to reexplore minimum iodine excretion and to build a dietary iodine recommendation for Chinese adults using the obligatory iodine loss hypothesis.
METHODS:
Data from 171 Chinese adults (19-21 years old) were collected and analyzed based on three balance studies in Shenzhen, Yinchuan, and Changzhi. The single exponential equation was accordingly used to simulate the trajectory of 24 h urinary iodine excretion as the low iodine experimental diets offered (iodine intake: 11-26 μg/day) and to further deduce the dietary reference intakes (DRIs) for iodine, including estimated average requirement (EAR) and recommended nutrient intake (RNI).
RESULTS:
The minimum iodine excretion was estimated as 57, 58, and 51 μg/day in three balance studies, respectively. Moreover, it was further suggested as 57, 58, and 51 μg/day for iodine EAR, and 80, 81, and 71 μg/day for iodine RNI or expressed as 1.42, 1.41, and 1.20 μg/(day·kg) of body weight.
CONCLUSION
The iodine DRIs for Chinese adults were established based on the obligatory iodine loss hypothesis, which provides scientific support for the amendment of nutrient requirements.
Humans
;
Iodine/administration & dosage*
;
Male
;
Female
;
China
;
Young Adult
;
Diet
;
Adult
;
Nutritional Requirements
;
East Asian People
9.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
10.Efficacy and safety of a facilitated percutaneous coronary intervention with half-dose recombinant staphylokinase in ST-segment elevation myocardial infarction
Tian-yu WU ; Wen-hao ZHANG ; Peng-sheng CHEN ; Chen LI ; Tian WU ; Zhan LÜ ; Tong WANG ; Kun LIU ; Zhi-wen TAO ; Xiao-xuan GONG ; Liang YUAN ; Yong LI ; Bo CHEN ; Xin CHEN ; Zeng-guang CHEN ; Nai-quan YANG ; Yuan-yuan SANG ; Xiao-yan WANG ; Bai-hong LI ; Li ZHU ; Guo-yu WANG ; Xin ZHAO ; Chuan LU ; Jun JIANG ; Rui-na HAO ; Chun-jian LI
Chinese Journal of Interventional Cardiology 2025;33(8):431-438
Objective To investigate the clinical efficacy and safety of facilitated percutaneous coronary intervention(PCI)with half-dose recombinant staphylokinase(r-SAK)in patients with ST-segment elevation myocardial infarction(STEMI)who are expected to undergo PCI within 120 minutes.Methods From October 2021 to August 2022,a total of 200 STEMI patients in eight centers were included and randomly assigned in a 1﹕1 ratio to either r-SAK group or control group.Patients received loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive an intravenous bolus of either 5 mg r-SAK or normal saline prior to PCI.The outcomes were set as ST-segment resolution(STR)at 60-90 minutes after PCI,the proportion and transition of pathological Q waves on the 5th day after PCI,and the proportion of high-sensitivity cardiac troponin T(hs-cTnT)peaking within 12 hours of onset.The safety outcome was major bleeding events defined as Bleeding Academic Research Consortium(BARC)≥type 3 bleeding during hospitalization.Results Compared with the control group,the r-SAK group had a higher proportion of STR≥70%within 60-90 minutes after PCI(58.3%vs.40.3%,P=0.009);a lower proportion of pathological Q waves(59.1%vs.74.1%,P=0.040);a lower rate of Q wave progression(14.8%vs.43.2%,P<0.001);a higher rate of Q wave disappearance(12.5%vs.3.7%,P=0.027);and a higher proportion of hs-cTnT peaking within 12 hours of symptom onset[31/40(77.5%)vs.17/33(51.5%),P=0.027].Regarding the safety outcome,no significant difference in BARC≥type 3 bleeding was found between the two groups during hospitalization(P>0.05).Conclusions For STEMI patients who were expected to undergo primary PCI within 120 minutes of symptom onset,the facilitated PCI with half-dose r-SAK significantly increased the proportion of STR≥70%at 60-90 minutes after PCI,reduced the formation of pathological Q waves,and shortened the time to peak hs-cTnT,without increasing the risk of bleeding,which should be an alternative reperfusion strategy worthy of further study.

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