1.Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Xiaolei WU ; Haiyin HU ; Yuetong WANG ; Fauci Alice Josephine ; Yazi ZHANG ; Wenting SONG ; Fengwen YANG ; Boli ZHANG ; Junhua ZHANG ; Zhaochen JI
Digital Chinese Medicine 2025;8(2):123-136
Objective:
Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.
Methods:
RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated.
Results:
A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized.
Conclusion
Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
2.Endoscopic Transforaminal Lumbar Interbody Fusion Combined With Huge-large Cage Insertion for Lumbar Instability
Chinese Journal of Minimally Invasive Surgery 2025;25(5):282-288
Objective To investigate clinical efficacy of endoscopic transforaminal lumbar interbody fusion(Endo-TLIF)combined with huge-large cage insertion technique in the treatment of lumbar instability.Methods A retrospective analysis was made on 18 cases of lumbar instability from May 2022 to August 2022.Endo-TLIF was performed to complete neural decompression,Kambin's triangle exposure,and endplate preparation.A huge-large cage was inserted in the intervertebral space through the Kambin's triangle with full-visualization endoscopy.Results The operation time was(180.3±24.4)min,and the intraoperative blood loss was(72.2±25.6)ml.Symptoms of numbness and weakness in the front thigh were gradually relieved after symptomatic treatment in 1 case.The hospital stay was(7.9±1.8)d.The 18 cases were followed up for 19-22 months(mean,19.9±1.1 months).As compared to pre-operation,Visual Analogue Scale[(2.3±1.4)points vs.(7.7±1.0)points,P=0.000;(1.1±0.4)points vs.(7.7±1.0)points,P=0.000]and Oswestry Disability Index[(18.61±4.79)% vs.(52.78±8.08)%,P=0.000;(9.28±4.03)% vs.(52.78±8.08)%,P=0.000]were significantly improved at 3 months after surgery and at final follow-up.As compared to pre-operation,the intervertebral height[(12.56±1.62)mm vs.(8.28±1.27)mm,P=0.000;(12.11±1.45)mm vs.(8.28±1.27)mm,P=0.000]and intervertebral foramen heigh[(22.89±2.00)mm vs.(17.17±1.69)mm,P=0.000;(22.61±1.86)mm vs.(17.17±1.69)mm,P=0.000]were significantly improved at 3 months after surgery and at the final follow-up.All the patients had a good bone fusion,and the excellent and good rate of the modified Macnab criteria was 94.4%(17/18).Conclusion Endo-TLIF combined with huge-large cage insertion can acquire a significantly good clinical outcomes in patients with lumbar instability,with advantages of safe and simple performance,good recovery of intervertebral height,and minimal damage to paraspinal soft tissue.
3.Expression and characterization of the TsNas36 protein of Trichinella spiralis
Guangquan SI ; Junpeng SONG ; Qingbo LYU ; Xue BAI ; Yang WANG ; Xiaolei LIU ; Lixi-ao ZHANG
Chinese Journal of Veterinary Science 2025;45(6):1225-1232,1242
Trichinella spiralis zinc metalloproteinase NAS-36 gene(TsNas36)is a member of the zinc metalloproteinase family found in excretory secretory products(ESP)of T.spiralis.In this study,TsNas36 gene was cloned and expressed,and its biological characteristics and temporal and spatial characteristics were identified.These results provide a theoretical and material basis for ex-ploring the biological function of TsNas36 gene.Bioinformatics analysis showed that TsNas36 was 470 amino acids(AA)in length with a molecular weight of about 54.69 kDa,no transmembrane region,and contained a signal peptide(1-20 AA),an Astacins domain(116-320 AA)and a CUB domain(355-470 AA).There were five active site residues located at amino acids 216(His),217(Glu),220(His),226(His)and 275(Tyr).The expression plasmid pET-28a(+)/TsNas36 was constructed and induced to express in E.coli BL21(DE3)to obtain the recombinant protein rTs-Nas36.The recombinant protein was used to immunize rabbits to obtain anti-rTsNas36 polyclonal antibody serum.Indirect ELISA results showed that the antibody titer reached 1∶105.qRT-PCR and Western blot results showed that the transcription levels of TsNas36 were significantly higher in newborn larvae(NBL)than in adult worm(AW)and muscle larva(ML)stages.Immunofluo-rescence results showed that TsNas36 was only localized in the epidermis of NBL.In summary,this study characterized the biological characteristics of the TsNas36 gene and found that this gene is highly period-specific and may be involved in the unique developmental process of NBL.
4.Influence of long-term spaceflight on human speed perception characteristics
Duming WANG ; Xinqi ZHANG ; Yu TIAN ; Xiaolei SONG ; Xianliang GE ; Lidong WANG ; Rui ZHAO ; Zongxiao SUN ; Chunhui WANG
Space Medicine & Medical Engineering 2025;36(1):7-14
Objective Accurate speed perception is crucial for tasks such as man-controlled rendezvous and docking,and teleoperation of space manipulator.Therefore,it is necessary to conduct in-orbit experiments to explore the influence of long-term spaceflight on human speed perception characteristics.Methods The Time-to-Collision(TTC)paradigm was selected to develop experimental software,using a tablet computer for stimulus presentation.Human speed perception characteristics were evaluated based on the subjects'keystroke response data on the keyboard.Through ground-based experiments,the usability and reliability of the paradigm were explored,and the gravity internal model effect was quantitatively analyzed.Through in-orbit experiments on space station tasks,the influence of long-term spaceflight on human speed perception characteristics was further investigated.Results Under the 1G environment on the ground,the TTC paradigm has a high test-retest reliability(r>0.8),and indicators such as average deviation rate and absolute value of average deviation rate show no practice effect.In addition,ground experiments found that compared to vertical upward movement,vertical downward movement is estimated to be faster(i.e.,keystroke time is advanced),showing the existence of the gravity internal model effect.In the microgravity environment of spaceflight,there are no significant differences in average deviation rate and absolute value of average deviation rate among three stages(pre-flight,in-flight,post-flight)and seven tests,indicating that no obvious changes in astronauts'speed perception ability were found at the existing test time points and paradigms.However,the gravity internal model effect(difference between vertical downward and vertical upward)showed a trend of fading in the early stage of astronauts entering orbit.Conclusion Based on the computer screen TTC estimation paradigm,no significant changes in human speed perception ability were found during long-term spaceflight,but microgravity may weaken the human brain's gravity internal model.
5.Expression and characterization of the TsNas36 protein of Trichinella spiralis
Guangquan SI ; Junpeng SONG ; Qingbo LYU ; Xue BAI ; Yang WANG ; Xiaolei LIU ; Lixi-ao ZHANG
Chinese Journal of Veterinary Science 2025;45(6):1225-1232,1242
Trichinella spiralis zinc metalloproteinase NAS-36 gene(TsNas36)is a member of the zinc metalloproteinase family found in excretory secretory products(ESP)of T.spiralis.In this study,TsNas36 gene was cloned and expressed,and its biological characteristics and temporal and spatial characteristics were identified.These results provide a theoretical and material basis for ex-ploring the biological function of TsNas36 gene.Bioinformatics analysis showed that TsNas36 was 470 amino acids(AA)in length with a molecular weight of about 54.69 kDa,no transmembrane region,and contained a signal peptide(1-20 AA),an Astacins domain(116-320 AA)and a CUB domain(355-470 AA).There were five active site residues located at amino acids 216(His),217(Glu),220(His),226(His)and 275(Tyr).The expression plasmid pET-28a(+)/TsNas36 was constructed and induced to express in E.coli BL21(DE3)to obtain the recombinant protein rTs-Nas36.The recombinant protein was used to immunize rabbits to obtain anti-rTsNas36 polyclonal antibody serum.Indirect ELISA results showed that the antibody titer reached 1∶105.qRT-PCR and Western blot results showed that the transcription levels of TsNas36 were significantly higher in newborn larvae(NBL)than in adult worm(AW)and muscle larva(ML)stages.Immunofluo-rescence results showed that TsNas36 was only localized in the epidermis of NBL.In summary,this study characterized the biological characteristics of the TsNas36 gene and found that this gene is highly period-specific and may be involved in the unique developmental process of NBL.
6.A clinical investigation of constructing a diagnostic model for sepsis-induced coagulopathy utilizing data-independent acquisition proteomics
Qi CHEN ; Jingchun SONG ; Xiaolei WAN ; Junjie ZENG ; Xiaomin SONG ; Lincui ZHONG ; Longping HE
Chinese Journal of Hematology 2025;46(1):45-52
Objective:This study used data-independent acquisition (DIA) proteomics to analyze plasma protein expression in sepsis-induced coagulopathy (SIC), identify key biomarkers, and develop a diagnostic model.Methods:This prospective study included 46 adult sepsis patients from the intensive care unit. Patients were categorized into a general sepsis group ( n=26) and an SIC group ( n=20) based on established SIC criteria. Plasma samples underwent proteomic and bioinformatics analyses to identify differentially expressed protein (DEP) using LASSO regression and Random Forest. A diagnostic model was constructed and assessed via receiver operating characteristic (ROC) curve analysis. Results:The baseline data revealed that SIC patients exhibited longer prothrombin times, lower platelet counts, and higher D-dimer, fibrin degradation products, blood lactate, SOFA scores, and APACHE Ⅱ scores compared with general sepsis patients ( P<0.05). DIA proteomics identified 2 637 proteins, with 240 DEP meeting the criteria (fold change >1.5, P<0.05), including 81 upregulated and 159 downregulated DEP. Subcellular localization analysis revealed that DEPs were predominantly extracellular and nuclear. Gene ontology (GO) annotation showed that DEP were mainly involved in cellular physiology, biological regulation, and stress response processes in biological processes. Domain annotation revealed a predominance of immunoglobulin V regions in DEP, which are crucial for antigen recognition and binding. KEGG enrichment analysis showed significant enrichment of DEP in pathways related to natural killer cell-mediated cytotoxicity, glycosylphosphatidylinositol anchor biosynthesis, tumor necrosis factor signaling, and NF-κB signaling. LASSO regression identified angiogenin and C-type lectin domain family 10 member A as key DEP. The SIC diagnostic nomogram showed an area under the curve of 0.896, with 0.731 specificity and 0.900 sensitivity. Conclusion:The nomogram incorporating angiogenin and C-type lectin domain family 10 member A provides an accurate tool for SIC diagnosis.
7.A clinical investigation of constructing a diagnostic model for sepsis-induced coagulopathy utilizing data-independent acquisition proteomics
Qi CHEN ; Jingchun SONG ; Xiaolei WAN ; Junjie ZENG ; Xiaomin SONG ; Lincui ZHONG ; Longping HE
Chinese Journal of Hematology 2025;46(1):45-52
Objective:This study used data-independent acquisition (DIA) proteomics to analyze plasma protein expression in sepsis-induced coagulopathy (SIC), identify key biomarkers, and develop a diagnostic model.Methods:This prospective study included 46 adult sepsis patients from the intensive care unit. Patients were categorized into a general sepsis group ( n=26) and an SIC group ( n=20) based on established SIC criteria. Plasma samples underwent proteomic and bioinformatics analyses to identify differentially expressed protein (DEP) using LASSO regression and Random Forest. A diagnostic model was constructed and assessed via receiver operating characteristic (ROC) curve analysis. Results:The baseline data revealed that SIC patients exhibited longer prothrombin times, lower platelet counts, and higher D-dimer, fibrin degradation products, blood lactate, SOFA scores, and APACHE Ⅱ scores compared with general sepsis patients ( P<0.05). DIA proteomics identified 2 637 proteins, with 240 DEP meeting the criteria (fold change >1.5, P<0.05), including 81 upregulated and 159 downregulated DEP. Subcellular localization analysis revealed that DEPs were predominantly extracellular and nuclear. Gene ontology (GO) annotation showed that DEP were mainly involved in cellular physiology, biological regulation, and stress response processes in biological processes. Domain annotation revealed a predominance of immunoglobulin V regions in DEP, which are crucial for antigen recognition and binding. KEGG enrichment analysis showed significant enrichment of DEP in pathways related to natural killer cell-mediated cytotoxicity, glycosylphosphatidylinositol anchor biosynthesis, tumor necrosis factor signaling, and NF-κB signaling. LASSO regression identified angiogenin and C-type lectin domain family 10 member A as key DEP. The SIC diagnostic nomogram showed an area under the curve of 0.896, with 0.731 specificity and 0.900 sensitivity. Conclusion:The nomogram incorporating angiogenin and C-type lectin domain family 10 member A provides an accurate tool for SIC diagnosis.
8.Endoscopic Transforaminal Lumbar Interbody Fusion Combined With Huge-large Cage Insertion for Lumbar Instability
Chinese Journal of Minimally Invasive Surgery 2025;25(5):282-288
Objective To investigate clinical efficacy of endoscopic transforaminal lumbar interbody fusion(Endo-TLIF)combined with huge-large cage insertion technique in the treatment of lumbar instability.Methods A retrospective analysis was made on 18 cases of lumbar instability from May 2022 to August 2022.Endo-TLIF was performed to complete neural decompression,Kambin's triangle exposure,and endplate preparation.A huge-large cage was inserted in the intervertebral space through the Kambin's triangle with full-visualization endoscopy.Results The operation time was(180.3±24.4)min,and the intraoperative blood loss was(72.2±25.6)ml.Symptoms of numbness and weakness in the front thigh were gradually relieved after symptomatic treatment in 1 case.The hospital stay was(7.9±1.8)d.The 18 cases were followed up for 19-22 months(mean,19.9±1.1 months).As compared to pre-operation,Visual Analogue Scale[(2.3±1.4)points vs.(7.7±1.0)points,P=0.000;(1.1±0.4)points vs.(7.7±1.0)points,P=0.000]and Oswestry Disability Index[(18.61±4.79)% vs.(52.78±8.08)%,P=0.000;(9.28±4.03)% vs.(52.78±8.08)%,P=0.000]were significantly improved at 3 months after surgery and at final follow-up.As compared to pre-operation,the intervertebral height[(12.56±1.62)mm vs.(8.28±1.27)mm,P=0.000;(12.11±1.45)mm vs.(8.28±1.27)mm,P=0.000]and intervertebral foramen heigh[(22.89±2.00)mm vs.(17.17±1.69)mm,P=0.000;(22.61±1.86)mm vs.(17.17±1.69)mm,P=0.000]were significantly improved at 3 months after surgery and at the final follow-up.All the patients had a good bone fusion,and the excellent and good rate of the modified Macnab criteria was 94.4%(17/18).Conclusion Endo-TLIF combined with huge-large cage insertion can acquire a significantly good clinical outcomes in patients with lumbar instability,with advantages of safe and simple performance,good recovery of intervertebral height,and minimal damage to paraspinal soft tissue.
9.Prognostic analysis of male patients with breast cancer after mastectomy based on SEER database
Wenjie NI ; Linan SONG ; Hui YANG ; Xiaolei LIU ; Xiaofeng MU
Chinese Journal of Radiation Oncology 2024;33(10):922-927
Objective:To analyze the survival and prognostic factors of male patients with breast cancer after mastectomy.Methods:Male patients with invasive breast ductal cancer who underwent mastectomy from January 1, 2000 to December 31, 2018 were selected from the Surveillance, Epidemiology, and End Results (SEER) database. Survival analysis was performed by Kaplan-Meier method, and compared by log-rank test. Prognostic factors were identified by Cox proportional hazards regression analysis.Results:A total of 1231 cases were included, with an onset age of (67 ± 12) years. The proportion of stage I-II was 81.1%. The 10-year cancer-specific survival (CSS) rates for stage IA, IIA, IIB, IIIA, IIIB, and IIIC patients were 85.4%, 84.9%, 69.0%, 68.1%, 51.9%, and 48.3%, respectively (all P<0.001). For stage IA-IIB patients, the 10-year CSS rate was 79.2% in the postoperative radiotherapy group, compared to 83.0% in the non-radiotherapy group ( P=0.019). For stage IIIA-IIIC patients, the 10-year CSS rate was 61.7% in the postoperative radiotherapy group, compared to 52.9% in the non-radiotherapy group ( P=0.021). For stage IA-IIB patients, the 10-year CSS rate was 83.8% in the postoperative chemotherapy group, compared to 79.8% in the non-chemotherapy group ( P=0.342). For stage IIIA-IIIC patients, the 10-year CSS rate was 59.7% in the postoperative chemotherapy group, compared to 54.1% in the non-chemotherapy group ( P=0.052). Multivariate analysis showed that younger age, married and grade I-II differentiation were favorable prognostic factors. The earlier the tumor staging, the better the prognosis. Conclusions:Postoperative radiotherapy can improve the CSS of stage III male patients with breast cancer. Younger age, married, grade I-II differentiation are favorable prognostic factors. The earlier the tumor staging, the better the prognosis.
10.Clinical characteristics and influencing factors of adverse outcomes in pregnancy complicated by primary Sj?gren's syndrome
Shiqi YANG ; Fei CHEN ; Weizhang LIANG ; Ruirui LI ; Xiaolei SONG ; Fang HE
Chinese Journal of Perinatal Medicine 2024;27(8):643-648
Objective:To explore the clinical characteristics of pregnancy complicated by primary Sj?gren's syndrome (pSS) and the related factors of adverse outcomes in pregnant women with pSS.Methods:A retrospective analysis was conducted on the clinical data of 32 pregnancies complicated by pSS treated in the Department of Obstetrics at the Third Affiliated Hospital of Guangzhou Medical University from February 2017 to August 2022. The patients were divided into two groups according to whether they had perinatal adverse outcomes: an adverse outcome group ( n=20) and a favorable outcome group ( n=12). The clinical characteristics of the two groups were compared with two independant sample t-test, Mann-Whitney U test, and Fisher's exact test, and multivariate logistic regression analysis was used to analyze the related factors of adverse outcomes in pregnant women with pSS. Results:(1) The average maternal age of the 32 pSS pregnancies was (32.9±4.6) years, the pre-pregnancy body mass index was (21.1±3.8) kg/m 2, and the median gestational age at delivery was 37.8 (35.4-38.5) weeks. There were 18 women (56.3%, 18/32) were diagnosed before pregnancy and 14 women (43.7%, 14/32) during pregnancy. Out of the 32 pregnancies, 25 (79.1%, 25/32) received therapy with glucocorticoids and/or hydroxychloroquine during pregnancy, whereas seven (21.9%, 7/32) had no medication during pregnancy. (2) The main adverse maternal outcomes included oligohydramnios (25%, 8/32), hypertensive disorder of pregnancy (18.8%, 6/32), preterm birth (18.8%, 6/32), fetal growth restriction (15.6%, 5/32), miscarriage (12.5%, 4/32), gestational diabetes mellitus (9.4%, 3/32), and postpartum hemorrhage (3.1%, 1/32). (3) Adverse neonatal outcomes included low birth weight infants in seven cases (25.0%, 7/28), neonatal asphyxia in seven cases (25.0%, 7/28), and two cases of congenital heart block (7.1%, 2/28). (4) The rate of diagnosis before pregnancy in the favorable outcome group was higher than the adverse outcome group [10/12 vs. 40.0%(8/20), Fisher's exact test, P=0.028]. There were no significant differences between the two groups concerning maternal age, pre-pregnancy BMI, weight gain during pregnancy, parity, rates of positivity for autoantibodies (antinuclear antibody, Sj?gren-specific antibody A, Sj?gren-specific antibody B, anti-Ro-52), and proportion of drug treatment (glucocorticoids, hydroxychloroquine) (all P>0.05). (5) Multivariate logistic regression analysis showed that diagnosis before pregnancy ( OR=0.02, 95% CI: 0.00-0.62, P=0.024) and positive Sj?gren-specific antibody B ( OR=0.01,95% CI: 0.00-0.75, P=0.038) were the protective factors. Conclusions:The clinical manifestations of pSS among pregnant women are varied and atypical,often with insidious onset. For pregnant women with pSS, being diagnosed before pregnancy, positive Sj?gren-specific antibody B may reduce adverse outcomes. It is important to address pre-pregnancy examination, early diagnosis and timely intervention to reduce the occurrence of adverse outcomes in pregnant women with pSS.

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