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.Treacher Collins Syndrome 2 caused by a novel pathogenic variant in PLOR1D: clinical report and literature review
Shuping SUN ; Bin ZUO ; Wanli HE ; Hanjun WANG ; Hongen XU ; Wei LU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(9):934-940
Objective:To investigate the clinical features, molecular etiology, and treatment of a family with Treacher Collins Syndrome 2 (TCS2).Methods:Information of the proband (female, 8 years old) including medical history and family history was collected. Physical examination and examinations concerning laboratory, audiology, and radiology were performed on the proband. Physical examination was also performed on the family members. Genomic DNA of proband was extracted for whole exome sequencing, and then the genomic DNA of family members was extracted for Sanger sequencing. POLR1D and TCS2 related literatures published before August 31,2023 were searched and sifted in PubMed and CKNI databases. The clinical characteristics of TCS2 were summarized. Results:The proband had poor hearing since childhood, with pure tone audiometry indicating conductive hearing loss. She had a smaller jaw, bilateral preauricular fistulas and cup-shaped ear deformities. Temporal bone CT scan revealed deformities in the left external ear canal, bilateral middle ear and inner ear. A bone-conduction hearing aid device was surgically implanted, resulting in restoration of almost normal hearing levels. The proband′s mother also had a slightly smaller jaw. Genetic analysis revealed a novel heterozygous variant NM_015972.4:c.38_47del in the POLR1D gene in the proband, which was inherited from her mother. A review of the literature revealed no clear evidence of genotype-phenotype correlation in TCS2. Conclusions:Molecular diagnosis plays a vital role in the diagnosis of TCS2. Patients with normal facial phenotype may be carriers of pathogenic variants in the POLR1D gene and have the risk of passing it to the offsprings with complete penetrance. Proper bone conductive hearing devices can improve the quality of life of TCS2 patients.
9.Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR) Agonist LPM3480392 Active Pharmaceutical Ingredients
Congrui FENG ; Lixia LI ; Dan WANG ; Shuping WANG ; Lianqing ZHANG ; Zhihong XU ; Fengmei ZHOU ; Xin CHE
Chinese Journal of Modern Applied Pharmacy 2024;41(3):372-377
OBJECTIVE
To establish a determination method for the related substances of LPM3480392, a novel Gi protein-biased opioid receptor(MOR) agonist.
METHODS
The separation was carried out with Waters Symmetry Shield RP18 (150 mm×4.6 mm, 3.5 μm) by gradient elution method, using a mixture of 0.002 5 mol·L–1 sodium 1-octanesulfonate monohydrate in 0.01 mol·L–1 potassium dihydrogen phosphate-water solution(containing 0.1% triethylamine, adjusted pH to 2.50 with phosphate acid) and acetonitrile as the mobile phase at a flow rate of 1.0 mL·min–1 and the UV detection wavelength was set at 210 nm.
RESULTS
The chromatographic peaks of LPM3480392 and impurity A, impurity B, impurity C, impurity E and impurity F could be completely separated, the linear relationship of LPM3480392 was good in 0.064 9−5.191 2 μg·mL–1, while impurity A, impurity B, impurity C, impurity E and impurity F showed good linear relationship within 0.066 6−7.610 4 μg·mL–1, 0.166 0−3.794 0 μg·mL–1, 0.209 2−4.463 2 μg·mL–1, 0.167 9−7.672 6 μg·mL–1 and 0.016 4−7.505 7 μg·mL–1, respectively. The recovery rate was within 93.0%−103.2%.
CONCLUSION
The method is suitable for the determination of related substances in LPM3480392, and can provide valuable reference for the follow-up research and development of LPM3480392.
10.Application value of renal artery resistance index in the diagnosis of intra-abdominal hypertension in critically ill patients
Baoquan CHEN ; Ming CHEN ; Jinyang XU ; Guorong LYU ; Yanfen YANG ; Shuping YANG
Chinese Journal of Emergency Medicine 2024;33(3):360-364
Objective:To explore the application value of renal artery resistance index in the diagnosist of intra-abdominal hypertension (IAH) in critically ill patients.Methods:89 patients with risk factors of IAH in the intensive care unit of Zhangzhou Hospital Affiliated to Fujian Medical University from February 2022 to June 2022 were retrospective analyzed. The intra-abdominal pressure (IAP) were measured by bladder, and patients divided into IAH group (IAP≥12 mmHg) and non-IAH group (IAP <12 mmHg). The resistance index (RI) of the right renal aorta, segment artery and interlobar artery were measured by color Doppler ultrasound. The difference between the measurement indicators of patients in the IAH and non-IAH groups and the correlation with IAP were analyzed. As for different indicators to predict the diagnostic efficacy of IAH, ROC curve analysis was used to evaluate the effect. And further multivariate logistic regression analysis was to find independent risk predictor.Results:A total of 89 patients were included in the study, including 44 patients with normal IAP and 45 patients diagnosed IAH. There were significant differences in the right renal aorta, segmental artery and interlobar artery RI (all P<0.01). The interlobar artery RI≥0.698 was the highest diagnostic cut-off,area under the curve was 0.914, sensitivity was 82.2%, specificity was 97.7%, and Jordon index was 0.799. The Spearman correlation analysis of IAP and the ultrasonographic measurements revealed a strong correlation between right renal interlobar artery RI and IAP ( r=0.741, P<0.01). The multivariate logistic regression analysis showed that the right renal interlobar artery RI ( OR= 24.472, 95% CI:5.122~116.919, P<0.01) was an independent risk predictor of IAH ( P<0.01). Conclusion:Right renal interlobar artery RI had better diagnostic efficacy of IAH,renal ultrasound could be used as an alternative, non-invasive technique for the diagnosis and follow-up of IAH.


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