1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Frontier technologies and development trends of network pharmacology: a patent bibliometric analysis.
Li TAO ; Zhi-Peng KE ; Tuan-Jie WANG ; Zhen-Zhong WANG ; Liang CAO ; Wei XIAO
China Journal of Chinese Materia Medica 2025;50(11):3070-3078
This study systematically analyzed the global research landscape, technological composition, and core patents in the field of networks target and network pharmacology, and proposes further suggestions based on the IncoPat patent citation database and VOSviewer bibliometric network visualization tool. Using patent literature metrics and scientific knowledge mapping method, technological innovation pathways, research hotspots, and future directions in this field were further revealed. In particular, this field is moving towards data-driven, intelligent, and systematic approaches. Patent analysis indicated that most patent applications in this domain focused on traditional Chinese medicine(TCM), which have provided key engineering technical approaches to explore and solve complex problems of TCM. By integrating big data and artificial intelligence technologies, network targets and network pharmacology have conferred high-precision screening and quality control of key components and targets in herbal formulations and prescriptions, accelerating the clinical translation and industrialization of TCM-based new drugs and health products with medicine-food homology. Therefore, it is essential to optimize the patent protection system and establish integrated technology platforms in this field for ensuring the competitiveness of technological achievements in research and clinical application. These efforts will advance the widespread application and high-quality development of TCM modernization, precision medicine, and innovative drug discovery.
Bibliometrics
;
Patents as Topic
;
Humans
;
Medicine, Chinese Traditional
;
Network Pharmacology/trends*
;
Drugs, Chinese Herbal/pharmacology*
3.Development of intelligent equipment for rapid microbial detection of Atractylodis Macrocephalae Rhizoma decoction pieces based on measurement technology for traditional Chinese medicine manufacturing.
Yang LIU ; Wu-Zhen QI ; Yu-Tong WU ; Shan-Xi ZHU ; Xiao-Jun ZHAO ; Qia-Tong XIE ; Yu-Feng GUO ; Jing ZHAO ; Nan LI ; Shi-Jun WANG ; Qi-Hui SUN ; Zhi-Sheng WU
China Journal of Chinese Materia Medica 2025;50(16):4610-4618
Microbial detection and control of traditional Chinese medicine(TCM) decoction pieces are crucial for the quality control of TCM preparations. It is also a key area of research in the measurement technology and equipment development for TCM manufacturing. Guided by TCM manufacturing measurement methodologies, this study presented a design of a novel portable microbial detection device, using Atractylodis Macrocephalae Rhizoma decoction pieces as a demonstration. Immunomagnetic separation technology was employed for specific isolation and labeling of target microorganisms. Enzymatic signal amplification was utilized to convert weak biological signals into colorimetric signals, constructing an optical biosensor. A self-developed smartphone APP was further applied to analyze the colorimetric signals and quantify target concentrations. A portable and automated detection system based on Arduino microcontroller was developed to automatically perform target microbial separation/extraction, as well as mimetic enzyme labeling and catalytic reactions. The developed equipment specifically focuses on the rapid and quantitative microbial analysis of TCM active pharmaceutical ingredients, intermediates in TCM manufacturing, and final TCM products. Experimental results demonstrate that the equipment could detect Salmonella in samples within 2 h, with a detection limit as low as 5.1 × 10~3 CFU·mL~(-1). The equipment enables the rapid detection of microorganisms in TCM decoction pieces, providing a potential technical solution for on-site rapid screening of microbial contamination indicators in TCM. It has broad application prospects in measurement technology for TCM manufacturing and offers strong technical support for the modernization, industrialization, and intelligent development of TCM.
Drugs, Chinese Herbal/analysis*
;
Atractylodes/microbiology*
;
Rhizome/microbiology*
;
Biosensing Techniques/methods*
;
Medicine, Chinese Traditional
;
Colorimetry/instrumentation*
;
Quality Control
4.Susceptible Windows of Prenatal Ozone Exposure and Preterm Birth: A Hospital-Based Observational Study.
Rong Rong QU ; Dong Qin ZHANG ; Han Ying LI ; Jia Yin ZHI ; Yan Xi CHEN ; Ling CHAO ; Zhen Zhen LIANG ; Chen Guang ZHANG ; Wei Dong WU ; Jie SONG
Biomedical and Environmental Sciences 2025;38(2):255-260
5.Epidemic Evolution Trends and Spatiotemporal Clustering of Human Brucellosis in Xilingol League Inner Mongolia, from 2004 to 2023.
Zhi Guo LIU ; Miao WANG ; Hao TANG ; Chui Zhao XUE ; Zhen Jun LI ; Can Jun ZHENG
Biomedical and Environmental Sciences 2025;38(7):848-855
OBJECTIVE:
Human brucellosis is a serious public health concern in the Xilingol League, Inner Mongolia; however, the epidemic trends are unclear.
METHOD:
In this study, Joinpoint regression analysis and spatiotemporal analysis were applied to investigate the epidemic evolution of human brucellosis.
RESULT:
From 2004 to 2023, a total of 35,747 cases were reported, with an annual average of 1787.35 cases and an annual average incidence rate of 176.04/100,000. The incidence increased from 173.96/100,000 in 2004 to 500.71/100,000 in 2009 and fluctuated to 61.43/100,000 in 2023. Three epidemic join points were observed in which the disease experienced an alternative rise and fall, peaking in 2009 (APC = 21.73, P > 0.001) and 2020 (APC = 21.51, P > 0.001). The disease showed a persistent decline trend in lentitude (AAPC = -5.30, P > 0.001), suggesting challenges in disease control and a higher risk of rebound. The most cases were reported in Xilinhot City ( n = 4,777), followed by 4,391 in Sonid Left Banner, and 4,324 in Abaga Banner. Spatiotemporal analysis revealed two high clusters (CI and CII) from 2005 to 2012, the high cluster encompassing eight counties and shifting from north to south.
CONCLUSION
The present analysis highlights that human brucellosis has decreased significantly in the Xilingol League, but the epidemic is still severe; further implementation of a strict control program is necessary.
China/epidemiology*
;
Humans
;
Brucellosis/epidemiology*
;
Epidemics
;
Spatio-Temporal Analysis
;
Incidence
;
Cluster Analysis
6.Molecular Characterization of New Recombinant Human Adenoviruses Detected in Children with Acute Respiratory Tract Infections in Beijing, China, 2022-2023.
Yi Nan GUO ; Ri DE ; Fang Ming WANG ; Zhen Zhi HAN ; Li Ying LIU ; Yu SUN ; Yao YAO ; Xiao Lin MA ; Shuang LIU ; Chunmei ZHU ; Dong QU ; Lin Qing ZHAO
Biomedical and Environmental Sciences 2025;38(9):1071-1081
OBJECTIVE:
Recombination events are common and serve as the primary driving force of diverse human adenovirus (HAdV), particularly in children with acute respiratory tract infections (ARIs). Therefore, continual monitoring of these events is essential for effective viral surveillance and control.
METHODS:
Respiratory specimens were collected from children with ARIs between January 2022 and December 2023. The penton base, hexon, and fiber genes were amplified from HAdV-positive specimens and sequenced to determine the virus type. In cases with inconsistent typing results, genes were cloned into the pGEM-T vector to detect recombination events. Metagenomic next-generation sequencing (mNGS) was performed to characterize the recombinant HAdV genomes.
RESULTS:
Among 6,771 specimens, 277 (4.09%, 277/6,771) were positvie for HAdV, of which 157 (56.68%, 157/277) were successfully typed, with HAdV-B3 being the dominant type (91.08%, 143/157), and 14 (5.05%, 14/277) exhibited inconsistent typing results, six of which belonged to species B. The penton base genes of these six specimens were classified as HAdV-B7, whereas their hexon and fiber genes were classified as HAdV-B3, resulting in a recombinant genotype designated P7H3F3, which closely resembled HAdV-B114. Additionally, a partial gene encoding L1 52/55 kD was identified, which originated from HAdV-B16.
CONCLUSION
A novel recombinant, P7H3F3, was identified, containing sequences derived from HAdV-B3 and HAdV-B7, which is similar to HAdV-B114, along with additional sequences from HAdV-B16.
Humans
;
Adenoviruses, Human/isolation & purification*
;
Respiratory Tract Infections/epidemiology*
;
Child, Preschool
;
Child
;
Recombination, Genetic
;
Male
;
Beijing/epidemiology*
;
Infant
;
Female
;
Phylogeny
;
Adenovirus Infections, Human/epidemiology*
;
Acute Disease
;
Genome, Viral
7.One-year recovery after lateral retinaculum release combined with chondroplasty in patients with lateral patellar compression syndrome.
Zhen-Long LIU ; Yi-Ting WANG ; Jin-Ming LIN ; Wu-Ji ZHANG ; Jiong-Yuan LI ; Zhi-Hui HE ; Yue-Yang HOU ; Jian-Li GAO ; Wei-Li SHI ; Yu-Ping YANG
Chinese Journal of Traumatology 2025;28(6):462-468
PURPOSE:
Lateral patellar compression syndrome (LPCS) is characterized by a persistent abnormally high stress exerted on the lateral articular surface of the patella due to lateral patellar tilt without dislocation and lateral retinaculum contracture, leading to anterior knee pain. The purpose of this study is to evaluate the efficacy and prognosis of lateral retinaculum release (LRR) combined with chondroplasty in the treatment of LPCS.
METHODS:
This retrospective study evaluated 40 patients who underwent LRR combined with chondroplasty for LPCS between 2020 and 2021. The assessment included improvement in postoperative tenderness and knee joint function. Patients were evaluated using the Lysholm, Tegner, and International Knee Documentation Committee 2000 scoring systems, as well as the visual analog scale, both preoperatively and postoperatively, with the paired comparisons analyzed using a t-test. Additionally, intraoperative observations were made regarding knee joint lesions, including cartilage damage and osteophyte formation, with analysis by the Chi-square test.
RESULTS:
The visual analog scale score for tenderness showed a significant decrease after surgery (p < 0.001). Evaluation of knee joint function also indicated significant improvements, as demonstrated by increased Lysholm, Tegner, and International Knee Documentation Committee 2000 scores postoperatively (p < 0.001, p = 0.011, p < 0.001, respectively). Furthermore, all LPCS patients included in the study presented with cartilage injuries and osteophyte formation. Significant differences were noted in the incidence of cartilage damage and osteophyte formation at different locations within the knee among patients with LPCS.
CONCLUSION
LRR combined with chondroplasty is an effective surgical approach for treating patients with LPCS, with satisfactory recovery observed at the 1-year follow-up. Additionally, the incidence of cartilage damage and osteophyte formation in LPCS patients varies significantly depending on the specific location within the knee joint.
Humans
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Male
;
Female
;
Retrospective Studies
;
Adult
;
Middle Aged
;
Patella/surgery*
;
Knee Joint/physiopathology*
;
Recovery of Function
;
Young Adult
;
Treatment Outcome
;
Cartilage, Articular/surgery*
;
Adolescent
8.The SPARC-related modular calcium binding 1 ( Smoc1 ) regulated by androgen is required for mouse gubernaculum development and testicular descent.
Zhi-Yi ZHAO ; Yong SIOW ; Ling-Yun LIU ; Xian LI ; Hong-Liang WANG ; Zhen-Min LEI
Asian Journal of Andrology 2025;27(1):44-51
Testicular descent occurs in two consecutive stages: the transabdominal stage and the inguinoscrotal stage. Androgens play a crucial role in the second stage by influencing the development of the gubernaculum, a structure that pulls the testis into the scrotum. However, the mechanisms of androgen actions underlying many of the processes associated with gubernaculum development have not been fully elucidated. To identify the androgen-regulated genes, we conducted large-scale gene expression analyses on the gubernaculum harvested from luteinizing hormone/choriogonadotropin receptor knockout ( Lhcgr KO) mice, an animal model of inguinoscrotal testis maldescent resulting from androgen deficiency. We found that the expression of secreted protein acidic and rich in cysteine (SPARC)-related modular calcium binding 1 ( Smoc1 ) was the most severely suppressed at both the transcript and protein levels, while its expression was the most dramatically induced by testosterone administration in the gubernacula of Lhcgr KO mice. The upregulation of Smoc1 expression by testosterone was curtailed by the addition of an androgen receptor antagonist, flutamide. In addition, in vitro studies demonstrated that SMOC1 modestly but significantly promoted the proliferation of gubernacular cells. In the cultures of myogenic differentiation medium, both testosterone and SMOC1 enhanced the expression of myogenic regulatory factors such as paired box 7 ( Pax7 ) and myogenic factor 5 ( Myf5 ). After short-interfering RNA-mediated knocking down of Smoc1 , the expression of Pax7 and Myf5 diminished, and testosterone alone did not recover, but additional SMOC1 did. These observations indicate that SMOC1 is pivotal in mediating androgen action to regulate gubernaculum development during inguinoscrotal testicular descent.
Animals
;
Male
;
Mice
;
Testis/growth & development*
;
Mice, Knockout
;
Androgens/pharmacology*
;
Testosterone/pharmacology*
;
Receptors, LH/metabolism*
;
Calcium-Binding Proteins/metabolism*
9.Prediction of testicular histology in azoospermia patients through deep learning-enabled two-dimensional grayscale ultrasound.
Jia-Ying HU ; Zhen-Zhe LIN ; Li DING ; Zhi-Xing ZHANG ; Wan-Ling HUANG ; Sha-Sha HUANG ; Bin LI ; Xiao-Yan XIE ; Ming-De LU ; Chun-Hua DENG ; Hao-Tian LIN ; Yong GAO ; Zhu WANG
Asian Journal of Andrology 2025;27(2):254-260
Testicular histology based on testicular biopsy is an important factor for determining appropriate testicular sperm extraction surgery and predicting sperm retrieval outcomes in patients with azoospermia. Therefore, we developed a deep learning (DL) model to establish the associations between testicular grayscale ultrasound images and testicular histology. We retrospectively included two-dimensional testicular grayscale ultrasound from patients with azoospermia (353 men with 4357 images between July 2017 and December 2021 in The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China) to develop a DL model. We obtained testicular histology during conventional testicular sperm extraction. Our DL model was trained based on ultrasound images or fusion data (ultrasound images fused with the corresponding testicular volume) to distinguish spermatozoa presence in pathology (SPP) and spermatozoa absence in pathology (SAP) and to classify maturation arrest (MA) and Sertoli cell-only syndrome (SCOS) in patients with SAP. Areas under the receiver operating characteristic curve (AUCs), accuracy, sensitivity, and specificity were used to analyze model performance. DL based on images achieved an AUC of 0.922 (95% confidence interval [CI]: 0.908-0.935), a sensitivity of 80.9%, a specificity of 84.6%, and an accuracy of 83.5% in predicting SPP (including normal spermatogenesis and hypospermatogenesis) and SAP (including MA and SCOS). In the identification of SCOS and MA, DL on fusion data yielded better diagnostic performance with an AUC of 0.979 (95% CI: 0.969-0.989), a sensitivity of 89.7%, a specificity of 97.1%, and an accuracy of 92.1%. Our study provides a noninvasive method to predict testicular histology for patients with azoospermia, which would avoid unnecessary testicular biopsy.
Humans
;
Male
;
Azoospermia/diagnostic imaging*
;
Deep Learning
;
Testis/pathology*
;
Retrospective Studies
;
Adult
;
Ultrasonography/methods*
;
Sperm Retrieval
;
Sertoli Cell-Only Syndrome/diagnostic imaging*
10.Clinical Features, Prognostic Analysis and Predictive Model Construction of Central Nervous System Invasion in Peripheral T-Cell Lymphoma.
Ya-Ting MA ; Yan-Fang CHEN ; Zhi-Yuan ZHOU ; Lei ZHANG ; Xin LI ; Xin-Hua WANG ; Xiao-Rui FU ; Zhen-Chang SUN ; Yu CHANG ; Fei-Fei NAN ; Ling LI ; Ming-Zhi ZHANG
Journal of Experimental Hematology 2025;33(3):760-768
OBJECTIVE:
To investigate the clinical features and prognosis of central nervous system (CNS) invasion in peripheral T-cell lymphoma (PTCL) and construct a risk prediction model for CNS invasion.
METHODS:
Clinical data of 395 patients with PTCL diagnosed and treated in the First Affiliated Hospital of Zhengzhou University from 1st January 2013 to 31st December 2022 were analyzed retrospectively.
RESULTS:
The median follow-up time of 395 PTCL patients was 24(1-143) months. There were 13 patients diagnosed CNS invasion, and the incidence was 3.3%. The risk of CNS invasion varied according to pathological subtype. The incidence of CNS invasion in patients with anaplastic large cell lymphoma (ALCL) was significantly higher than in patients with angioimmunoblastic T-cell lymphoma (AITL) (P <0.05). The median overall survival was significantly shorter in patients with CNS invasion than in those without CNS involvement, with a median survival time of 2.4(0.6-127) months after diagnosis of CNS invasion. The results of univariate and multivariate analysis showed that more than 1 extranodal involvement (HR=4.486, 95%CI : 1.166-17.264, P =0.029), ALCL subtype (HR=9.022, 95%CI : 2.289-35.557, P =0.002) and ECOG PS >1 (HR=15.890, 95%CI : 4.409-57.262, P <0.001) were independent risk factors for CNS invasion in PTCL patients. Each of these risk factors was assigned a value of 1 point and a new prediction model was constructed. It could stratify the patients into three distinct groups: low-risk group (0-1 point), intermediate-risk group (2 points) and high-risk group (3 points). The 1-year cumulative incidence of CNS invasion in the high-risk group was as high as 50.0%. Further evaluation of the model showed good discrimination and accuracy, and the consistency index was 0.913 (95%CI : 0.843-0.984).
CONCLUSION
The new model shows a precise risk assessment for CNS invasion prediction, while its specificity and sensitivity need further data validation.
Humans
;
Lymphoma, T-Cell, Peripheral/pathology*
;
Prognosis
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Retrospective Studies
;
Central Nervous System Neoplasms/pathology*
;
Neoplasm Invasiveness
;
Male
;
Female
;
Central Nervous System/pathology*
;
Middle Aged
;
Adult

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