1.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
2.Study on quality standard of wine-processed Coptidis Rhizoma standard decoction
Huilin YANG ; Kaiwei HUANG ; Yanghua LI ; Suqin CAI ; Shuping XU ; Jiabao WEI ; Hui ZHANG ; Weizhi ZHAO ; Pei TAN
International Journal of Traditional Chinese Medicine 2025;47(9):1285-1292
Objective:To establish the quality standard of the standard decoction of wine-processed Coptidis Rhizoma by studying the extraction rate, fingerprint and component quantitative analysis.Methods:ccording to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules, 15 batches of the standard decoction of wine-processed Coptidis Rhizoma were prepared, and the paste rate was determined; HPLC fingerprints of 15 batches of standard decoction of wine-processed Coptidis Rhizoma were established, and evaluated by combining similarity evaluation, clustering analysis, principal component analysis and orthogonal partial least squares discriminant analysis; the contents of berberine, epiberberine, pamadine, and safranine in the samples of the 15 batches were determined and analyzed their transfer rates.Results:A total of 15 batches of standard decoction samples were calibrated with 11 common peaks, referring to the recognition of 8 components. The similarity between the samples and the control product was greater than 0.900; the clustering analysis could cluster the 15 batches of samples into 2 classes; the results of the principal component analysis showed that the cumulative variance contribution rate of the 3 principal component factors was 89.388%; the OPLS-DA screened out the 3 components of the quality difference; the 15 batches of samples out of the paste rate was 15.7% -20.8%, and the mass fractions of berberine, epiberberine, safranine, and palmatine were 18.47%-24.38%, 2.82%-3.49%, 5.08%-6.69%, and 4.84%-6.68%, respectively, with transfer rates of 41.7%-61.7%, 46.9%-68.7%, 39.8%-61.5%, and 43.8%-65.2%.Conclusion:The fingerprint and content determination method established in this study is accurate, stable, simple, and can be used for the quality control and evaluation of the standard decoction of wine-processed Coptidis Rhizoma.
3.Clinical Observation on Fire Needling in Treating Lumbar Disc Herniation of Cold-Damp Type Under the Guidance of Meridian Sinew Theory
Cuilian ZHU ; Shuping LUO ; Xingxing SHEN ; Xuemeng XU ; Bin NIE
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(1):147-152
Objective To observe the clinical efficacy of fire needling in treating lumbar disc herniation(LDH)of cold-damp type under the guidance of meridian sinew theory.Methods A total of 70 cases of patients with LDH of cold-damp type were randomly divided into observation group and control group,35 cases in each group,the control group was given conventional acupuncture treatment,and the observation group was treated with fire needling under the guidance of meridian sinew theory on the basis of the treatment of the control group,and the course of treatment covered three courses,one week as a course.After three courses of treatment,the clinical efficacy of the two groups was evaluated,and the changes in the Visual Analogue Scale(VAS)scores of pain,the Japanese Orthopedic Association(JOA)scores,and traditional Chinese medicine(TCM)syndrome scores of patients in the two groups before and after treatment were observed.Results(1)During the study,there were three cases in the observation group and five cases in the control group were failed to follow-up.Finally,32 cases in the observation group and 30 cases in the control group were included in the efficacy statistics.(2)The total effective rate was 93.75%(30/32)in the observation group and 86.67%(26/30)in the control group.The clinical efficacy of the observation group was superior to that of the control group,and the difference being statistically significant(P<0.05).(3)After treatment,the VAS and JOA scores of patients in the two groups improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.05).(4)After treatment,the TCM scores of the two groups of patients improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.05).Conclusion Under the guidance of the meridian sinew theory,fire needling in treating LDH of cold-damp type can significantly reduce the degree of pain,improve the lumbar function,alleviate LDH-related symptoms,so as to improve the patients'quality of life.
4.Clinical Observation on Filiform-Heated Needle Combined with Qingbu Huacuo Decoction in the Treatment of Acne of Damp-Heat due to Spleen Deficiency Syndrome
Linya NI ; Dejian DUAN ; Haifang GAN ; Shuping XU ; Dan HUANG ; Jiayao NIE ; Sichen LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(2):390-396
Objective To observe the clinical efficacy and safety of filiform-heated needle combined with Qingbu Huacuo Decoction in the treatment of acne of damp-heat due to spleen deficiency syndrome.Methods Seventy patients with acne of damp-heat due to spleen deficiency syndrome admitted to the seventh clinical Medical School of Guangzhou University of Chinese Medicine from May 2023 to March 2024 were randomly divided into the observation group and the control group according to random number table method,with 35 patients in each group.Health education was given to the patients in both groups.The control group was given oral administration of Doxycycline Hyclate Tablets combined with filiform-heated needle for treatment,and the observation group was treated with filiform-heated needle combined with Qingbu Huacuo Decoction orally,the course of treatment for the two groups covered six weeks.After six weeks of treatment,the clinical efficacy of the two groups was evaluated,and the changes in Global Acne Grading System(GAGS)score and Quality of Life-Acne(Qol-Acne)score,as well as the traditional Chinese medicine(TCM)syndrome scores before and after treatment were observed.The changes of skin barrier function indicators such as trans epidermal water loss(TEWL)content,skin moisture content,and sebum content before and after treatment were compared between the two groups of patients.Moreover,the safety of the two groups and the occurrence of adverse reactions were evaluated.Results(1)After treatment,the GAGS scores of patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,with a statistically significant difference(P<0.05).(2)After treatment,the Qol-Acne scores of the patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the three aspects of self-perception,emotional functioning,and self-assessment,with a statistically significant difference(P<0.05),and the observation group was slightly superior to the control group in improving social functioning,but the difference being not statistically significant(P>0.05).(3)After treatment,the content of TEWL,skin moisture,and sebum of patients in the two groups were significantly improved(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.05).(4)After treatment,the TCM syndrome scores of the two groups of patients were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,with a statistically significant difference(P<0.05).(5)The total effective rate was 94.29%(33/35)in the observation group and 74.29%(26/35)in the control group.The clinical efficacy of the observation group was superior to that of the control group,the difference being statistically significant(P<0.05).(6)Comparison of the incidence of adverse reactions between the two groups,the difference being not statistically significant(P>0.05).Conclusion Filiform-heated needle combined with Qingbu Huacuo Decoction in the treatment of acne of damp-heat due to spleen deficiency syndrome can significantly improve the clinical symptoms of patients,thus improving their quality of life,with good safety.
5.Clinical Observation on Modified Danggui Yinzi Combined with Thumb-Tack Needling for Subcutaneous Embedding in the Treatment of Chronic Spontaneous Urticaria of Wind Dryness Due to Blood Deficiency Type
Linya NI ; Shuping XU ; Dejian DUAN ; Liyan LAI ; Qiaomin LIN ; Haifang GAN
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(4):914-920
Objective To observe the clinical efficacy of modified Danggui Yinzi combined with thumb-tack needling for subcutaneous embedding in the treatment of chronic spontaneous urticaria(CSU)of wind dryness due to blood deficiency type.Methods A total of 68 cases of patients admitted to the dermatology wards and outpatient clinics of The Seventh Clinical School of Guangzhou University of Chinese Medicine with a definitive diagnosis of CSU of wind dryness due to blood deficiency type were selected as the study subjects from July 2023 to February 2024.The patients were randomly divided into the observation group and the control group according to the random number table method,with 34 cases in each group.The control group was treated with Cetirizine Dihydrochloride Tablets,and the observation group was treated with modified Danggui Yinzi combined with thumb-tack needling for subcutaneous embedding based on the treatment of the control group,the course of treatment covered four weeks.After one month of treatment,the clinical efficacy of the two groups was evaluated,and the changes in Urticaria Activity Score(UAS)and Dermatology Life Quality Index(DLQI)scores and traditional Chinese medicine(TCM)syndrome scores before and after treatment were observed in the two groups.The changes of serum total immunoglobulin E(total IgE)levels before and after treatment in the two groups were compared.The safety and recurrence cases of the two groups were evaluated.Results(1)The total effective rate was 91.18%(31/34)in the observation group and 70.59%(24/34)in the control group.The efficacy of the observation group was superior to that of the control group,the difference being statistically significant(P<0.05).(2)After two,three,and four weeks of treatment,the UAS scores of the patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.01).(3)After treatment,the DLQI scores and TCM syndrome scores of the patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.01).(4)After treatment,the total IgE levels of patients in the two groups were improved significantly(P<0.05),and the improvement in the observation group was significantly superior to that in the control group,the difference being statistically significant(P<0.01).(5)The comparison of the incidence of adverse reactions between the two groups showed that the difference being not statistically significant(P>0.05).(6)In the follow-up after the completion of treatment,the recurrence rate was 5.88%(2/34)in the observation group and 23.53%(8/34)in the control group,and the recurrence rate of the observation group was significantly lower than that of the control group,the difference being statistically significant(P<0.05).Conclusion Modified Danggui Yinzi combined with thumb-tack needling for subcutaneous embedding in the treatment of CSU of wind dryness due to blood deficiency type can significantly alleviate the clinical symptoms of the patients,improve their quality of life,and reduce the recurrence rate.
6.Application value of metagenomic next-generation sequencing in diagnosis of spinal tuberculosis
Shangsheng XU ; Huanhua GU ; Yongchao HUO ; Chunwei WANG ; Shenglu BAI ; Shuping MA ; Yuxin SUN ; Wei XIE
Journal of Clinical Medicine in Practice 2025;29(19):79-82,88
Objective To explore the application value of metagenomic next-generation sequen-cing(mNGS)technology in the diagnosis of spinal tuberculosis.Methods A total of 129 patients with suspected spinal tuberculosis admitted from January 2021 to January 2023 were selected as study subjects.Lesion tissue samples were collected intraoperatively and subjected to conventional microbio-logical testing(CMT),Mycobacterium tuberculosis DNA(MTB-DNA)amplification testing,and mNGS testing.The diagnostic efficacy of different testing methods was compared using results of com-prehensive clinical diagnosis as the gold standard.Results Among 129 patients,101(78.29%)were confirmed to have spinal tuberculosis,and 28(21.71%)had other spinal infections.Using clinical results as the diagnostic gold standard,the sensitivity of mNGS was 94.06%(95/101),and specificity was 89.29%(25/28);the sensitivity of MTB-DNA amplification was 90.10%(91/101),and specificity was 89.29%(25/28);the sensitivity of CMT was 86.14%(87/101),and specifici-ty was 85.71%(24/28).Compared with MTB-DNA amplification and CMT,mNGS showed the highest consistency with clinical results,and its consistency in detecting different lesion sites was also optimal,with statistically significant differences(P<0.05).Conclusion mNGS testing has high diagnostic value for spinal tuberculosis and can provide a reference for clinical diagnosis,thereby guiding clinical decision-making.
7.Temporal regulatory functions of EGR4 in neural development of mice
Yawen LUO ; Murong XU ; Shuping ZHOU ; Hao LI ; Xiaochen BO ; Hebing CHEN
Military Medical Sciences 2025;49(6):437-442
Objective To study the dynamic regulatory role of early growth response 4(EGR4)in mouse neurodevelopment.Methods Data on single-cell chromatin accessibility(single-cell assay for transposase-accessible chromatin by sequencing,scATAC-seq)and transcriptome(single-cell RNA sequencing,scRNA-seq)from seven key stages spanning from the embryonic period to adulthood was collected and analyzed.The transcription factor binding site network was inferred,a quantitative analysis from a temporal perspective was conducted,its functional modules were parsed,and the results were visualized.Results egr4 was significantly highly expressed from the late embryonic stage to adulthood,and specifically activated during the maturation of inhibitory neurons[parvalbumin(PV)and somatostatin(SST)subtypes].Moreover,its transcription was not directly regulated by changes in chromatin accessibility.Temporal network analysis indicated that EGR4 became a regulatory hub in the late embryonic stage and drove neuron differentiation and subtype specification.Functional enrichment analysis showed that EGR4 regulated the"cell differentiation"pathway through dynamic interacting factors,and there were subtype-specific interaction modules in PV/SST neurons respectively.Conclusion EGR4 can participate in the late-stage maturation of cortical neurons through a stage-specific regulatory network.This study provides a new perspective on mechanisms underlying the temporal logic of neural development.
8.Clinical characteristics and pathogenic variant analysis of NOG-related symphangism spectrum disor-der
Xiaoqian YANG ; Xiaosai ZHANG ; Jinhui ZHANG ; Shuping SUN ; Hongen XU ; Bei CHEN
Journal of Audiology and Speech Pathology 2025;33(5):423-428
Objective To analyze the clinical phenotypes and genetic variants of three families with NOG-re-lated symphalangism spectrum disorder(NOG-SSD).Methods Clinical data of 11 family members from three NOG-SSD families were retrospectively analyzed,including medical history,physical examination,imaging studies,and audiological evaluations.Genomic DNA was extracted from peripheral blood samples of family members for whole-exome sequencing.Results Among the 11 family members,four exhibited mixed or conductive hearing loss.Probands from family 1 and 2 presented with mixed hearing loss,proximal symphalangism,flexion impairment of the fifth interphalangeal joint,and absence of skin creases.The proband and her mother in family 3 displayed con-ductive/mixed hearing loss,proximal symphalangism,and characteristic facial features(semicylindrical nose,hypo-plastic alae nasi,and thin upper lip with vermilion border).Whole-exome sequencing identified pathogenic variants in the NOG gene(NM_005450.6)in all three families.Family 1 and 2 harbored the novel missense variant c.236T>A(p.Met79Lys)and nonsense variant c.666C>G(p.Tyr222Ter),respectively,while family 3 carried the frameshift variant c.31del(p.Leu11SerfsTer51).All three variants were classified as pathogenic or likely pathogen-ic and have not been previously reported.Patients in family 1 and 2 were diagnosed with proximal symphalangism-1(SYM 1),whereas those in family 3 were diagnosed with multiple synostoses syndrome-1(SYNS1).Conclusion The NOG gene variants c.236T>A,c.666C>G,and c.31del are causative for NOG-SSD in these three families.
9.Clinical phenotype and genetic analysis of MODY3 caused by the HNF1A-c.47T>A variant
Zhenjing WANG ; Caihui QI ; Mingzhong TIAN ; Xin LIU ; Xin LI ; Chao XU ; Shuping WANG
Chinese Journal of Endocrinology and Metabolism 2025;41(8):643-648
Objective:To investigate the clinical characteristics of a family with maturity-onset diabetes of the young type 3(MODY3) and assess its association with the novel HNF1A-c.47T>A variant.Methods:A genetic pedigree of the MODY3 family was constructed, and clinical data were collected. Whole-exome sequencing combined with Sanger sequencing was used, followed for familial co-segregation analysis. Bioinformatics tools, including multiple sequence alignment–based conservation analysis and protein structural prediction, were conducted to validate the association between the novel HNF1A-c.47T>A variant and MODY3.Results:Seven MODY3 patients were diagnosed in this family, all harboring the HNF1A-c.47T>A heterozygous variant. AlphaFold2 protein structure prediction indicated that the HNF1A-c.47T>A variant altered the conformation of the first pair of α-helices within the protein dimerization domain.Conclusion:Based on co-segregation analysis, sequence conservation assessment, protein structure prediction, and classification based on American College of Medical Genetics and Genomics(ACMG) Guidelines, the HNF1A-c.47T>A variant was determined to be pathogenic for MODY3. This study reports this novel pathogenic variant, expanding the mutational spectrum of MODY3. By revealing its disruptive effect on the protein dimerization domain, the findings provide a potential molecular basis for the diagnosis and management of patients carrying similar variants.
10.Mechanism of cordycepin improving myocardial tissue and oxidative stress in diabetic cardiomyopathy rats
Dan LI ; Shuping ZUO ; Shoujun ZHANG ; Baoqing XU ; Haigang WU ; Chunmiao LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(4):504-509
Objective To investigate the intervention effect of cordycepin on DCM rats and its reg-ulative effect on of AKT/GSK3β signaling pathway.Methods A total of 80 male SD rats were randomly divided into model group,cordycepin group,AKT inhibitor group and cordycepin+AKT inhibitor group,with 20 rats in each group.After the establishment of DCM model,corre-sponding intervention was given to each group.Another 20 healthy rats served as control group.Cardiac function indicators(LVEF,LVFS,LVESD,LVEDD),levels of IL-6,IL-1β,TNF-α,SOD,GSH-Px and MAD,and expression of AKT/GSK3β signaling pathway related proteins were de-termined and compared among the groups blotting.Results The model group had significantly lower LVEF and LVFS,decreased myocardial SOD and GSH-Px contents,and declined p-AKT/AKT and p-GSK3β/GSK3β,but increased LVESD and LVEDD and myocardial IL-6,IL-1β,TNF-αand MAD expression levels when compared with the control group(P<0.05).Cordycepin treat-ment obtained increased LVEF and LVFS and myocardial tissue SOD,GSH-Px,Bcl-2,p-AKT/AKT and p-GSK3β/GSK3β protein expressions,and decreased LVESD and LVEDD and myocar-dial expression of IL-6,IL-1β,TNF-α,MAD and Bax than the model group(P<0.05),while AKT inhibitor reversed all the changes induced by modelling(P<0.05).Combination of cordycepin+AKT inhibitor resulted in lower LVEF,LVFS and myocardial SOD,GSH-Px,Bcl-2,p-AKT/AKT,p-GSK3β/GSK3β protein levels,and increased LVESD,LVEDD and expressions of IL-6,IL-1β,TNF-α,MAD and Bax protein in myocardial tissue when compared with cordycepin group(P<0.05).And the combination also resulted in increases in LVEF and LVFS[(61.29±5.61)%vs(39.28±4.12)%,(39.05±3.43)%vs(24.47±2.73)%,P<0.05]and decreases in LVESD and LVEDD(4.36±0.48 mm vs 6.97±0.69 mm,6.07±0.61 mm vs 9.02±0.85mm,P<0.05)when compared with AKT inhibitor group.Conclusion Cordycepin improves cardiac function,myocar-dial injury,inflammation and oxidative stress in DCM rats probably by activating AKT/GSK3βsignaling pathway,and inhibits the apoptosis of cardiomyocyte.

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