1.Association of atopic dermatitis with ankylosing spondylitis:A two-sample Mendelian randomized study
Mingjing WEI ; Zhengchao SHAO ; Haoyue WAN ; Yiheng WANG ; Wenqi CHEN
Chinese Journal of Immunology 2025;41(5):1055-1059
Objective:To investigate whether there is a causal relationship between atopic dermatitis(AD)and ankylosing spondylitis(AS).Methods:Genetic data of AD and AS were extracted from genome-wide association studies(GWAS)by Mendelian randomization(MR),and inverse variance-weighted(IVW)analysis was used as main analysis,supplemented by weighted median,MR-Egger,weighted mode,etc,and verified by a series of sensitivity analyses.Results:IVW analysis of AD by AS:OR=1.015,95%CI:1.005~1.025,P=0.004.IVW analysis of AD for AS:OR=1.001,95%CI:1.000~1.002,P=0.120.Conclusion:AS has a statisti-cally small causal relationship on AD,and AD has no causal effect on AS.
2.Analysis on Current Status of Clinical Trial Registration on TCM Prevention and Treatment of Irritable Bowel Syndrome
Shiwei QIAN ; Biao LIANG ; Shuo HUANG ; Yiheng YANG ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):62-66
Objective To explore the distribution characteristics and development trend of TCM prevention and treatment for irritable bowel syndrome(IBS)by analyzing the clinical trials of TCM prevention and treatment for IBS registered in China Clinical Trial Registry(ChiCTR).Methods The ChiCTR database was retrieved to collect and organize clinical trials related to the TCM prevention and treatment of IBS from the establishment of the database to May 1,2024.Characteristics of the included trials were analyzed and summarized using SPSS 25.0 and Excel 2021.Results A total of 73 clinical trials were included,of which 65 were pre-registered.The registered research projects involved 14 provincial-level administrative regions,including Beijing,Jiangsu,Guangdong,Shanghai,and Sichuan,and 46 clinical trial institutions,among which Beijing University of Chinese Medicine(6 items,7.89%)registered a higher number.The top three sources of research funding were,in order,local finance(26 items,35.62%),state finance(20 items,27.40%),and hospital funding(10 items,13.70%).The types of studies were predominantly interventional(68 items,93.15%),and the study designs were predominantly randomized parallel controlled studies(64 items,87.67%),but only 27 studies(36.99%)used a blinded approach.The main interventions included acupuncture and moxibustion,Chinese patent medicines,classic prescriptions/hospital-prepared remedies,etc.Conclusion The number of clinical research registrations in this field has been gradually increasing in recent years,but there are problems such as uneven regional distribution,low use of blinding,and lack of standardization of registration information.
3.Analysis of the Current Status of Clinical Trial Registration for TCM in the Treatment of Psoriasis
Yiheng YANG ; Zhan ZHANG ; Biao LIANG ; Shiwei QIAN ; Jiachun NI ; Shuo HUANG ; Changpeng HAN ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):67-72
Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.
4.Association of atopic dermatitis with ankylosing spondylitis:A two-sample Mendelian randomized study
Mingjing WEI ; Zhengchao SHAO ; Haoyue WAN ; Yiheng WANG ; Wenqi CHEN
Chinese Journal of Immunology 2025;41(5):1055-1059
Objective:To investigate whether there is a causal relationship between atopic dermatitis(AD)and ankylosing spondylitis(AS).Methods:Genetic data of AD and AS were extracted from genome-wide association studies(GWAS)by Mendelian randomization(MR),and inverse variance-weighted(IVW)analysis was used as main analysis,supplemented by weighted median,MR-Egger,weighted mode,etc,and verified by a series of sensitivity analyses.Results:IVW analysis of AD by AS:OR=1.015,95%CI:1.005~1.025,P=0.004.IVW analysis of AD for AS:OR=1.001,95%CI:1.000~1.002,P=0.120.Conclusion:AS has a statisti-cally small causal relationship on AD,and AD has no causal effect on AS.
5.Features of HBV RNA level in different stages of the natural history of chronic hepatitis B virus infection and its correlation with HBV DNA and HBsAg
Han GAO ; Juanli WU ; Yushuang ZHANG ; Yiheng ZHANG ; Lei WANG ; Tao LI ; Lixin ZHANG
Journal of Clinical Hepatology 2025;41(4):637-642
ObjectiveTo investigate the features of serum HBV RNA in different stages of the natural history of chronic hepatitis B virus (HBV) infection without antiviral treatment, as well as its correlation with serum HBV DNA and HBsAg. MethodsA total of 306 treatment-naïve patients with chronic HBV infection who attended Department of Infections Diseases and Hepatoloty, the Second Hospital of Shandong University from January 2023 to June 2024 were divided into six groups based on the different stages of natural history, i.e., HBeAg-positive chronic HBV infection group with 29 patients, HBeAg-positive chronic hepatitis B (CHB) group with 107 patients, HBeAg-negative chronic HBV infection group with 18 patients, HBeAg-negative CHB group with 60 patients, HBeAg-positive indeterminate-phase chronic HBV infection group with 7 patients, and HBeAg-negative indeterminate-phase chronic HBV infection group with 85 patients. Real-time isothermal RNA amplification was used to measure serum high-sensitivity HBV RNA. The Kruskal-Wallis H test was used for comparison between multiple groups of continuous data, while the Mann-Whitney U test was used for comparison between two groups. The Spearman method was used to investigate the correlation of HBV RNA with HBV DNA and HBsAg. ResultsThe HBeAg-positive chronic HBV infection group showed the highest level of serum HBV RNA [7.5 (7.4 — 7.9) log10 copies/mL], followed by the HBeAg-positive CHB group [7.4 (6.4 — 7.9) log10 copies/mL], the HBeAg-negative CHB group [4.5 (3.0 — 5.7) log10 copies/mL], and the HBeAg-negative chronic HBV infection group [1.0 (1.0 — 2.0) log10 copies/mL]; the HBeAg-positive indeterminate-phase chronic HBV infection group had a serum HBV RNA level of 3.9 (3.7 — 5.7) log10 copies/mL, and the HBeAg-negative indeterminate-phase chronic HBV infection group had a serum HBV RNA level of 2.0 (1.0 — 3.0) log10 copies/mL; there was a significant difference in serum HBV RNA level between the six groups (H=830.770, P<0.001). There was a significant difference in HBV RNA level between the HBeAg-positive chronic HBV infection group and all the other groups except the HBeAg-positive CHB group (all P<0.001). In the 306 patients with HBV infection, HBV RNA was strongly correlated with HBV DNA (r=0.92, P<0.001) and was moderately correlated with HBsAg (r=0.67, P<0.001). The correlation between serum HBV RNA and HBsAg in HBeAg-positive patients (r=0.61, P<0.001) was stronger than that in HBeAg-negative patients (r=0.31, P<0.001). For the patients with HBeAg-positive chronic HBV infection, the male patients with ALT>30 U/L and the female patients with ALT>19 U/L had a significantly lower serum HBV RNA level than the male patients with ALT≤30 U/L and the female patients with ALT≤19 U/L (P<0.001), and there was no significant difference in serum HBV RNA level between the latter group of patients and the HBeAg-positive CHB group (P>0.05). ConclusionIn patients with chronic HBV infection who do not receive antiviral therapy, there is a difference in serum HBV RNA level in different stages of natural history, and serum HBV RNA level has the strongest correlation with HBV DNA and a relatively weak correlation with HBsAg. In patients with HBeAg-positive chronic HBV infection, serum HBV RNA level in male patients with ALT>30 U/L and female patients with ALT>19 U/L are in the transition stage between HBeAg-positive chronic HBV infection and HBeAg-positive CHB.
6.Analysis of serum HBV markers in chronic HBV infected patients with HBV DNA below the detection limit and below the quantification limit after long-term nucleotide analogues treatment
Yan ZHAO ; Yiheng ZHANG ; Jing HE ; Lina WANG ; Tao LI ; Yundong QU ; Lei WANG ; Yan WANG
Chinese Journal of Experimental and Clinical Virology 2025;39(4):454-460
Objective:This study aims to investigate the differences between two groups of patients treated with nucleos(t)ide analogues(NAs):those with undetectable HBV DNA by ultrasensitive testing and those with HBV DNA below the quantification limit. The findings will provide a basis for the clinical interpretation and rational use of ultrasensitive HBV DNA results.Methods:This cross-sectional study included patients with chronic HBV infection who were treated with NAs between May 2023 and December 2023 at the outpatient clinic and inpatient department of the Hepatology Department,The Second Hospital of Shandong University. All patients had ultrasensitive HBV DNA results that were either undetectable or less than 20 IU/ml. The group with undetectable ultrasensitive HBV DNA was defined as the target not detected(TND)group,while the group with HBV DNA levels below 20 IU/ml was defined as the limit of quantitation(LOQ)group. Data on patients' sex,age,type of NAs used,routine blood tests,liver and kidney function,quantitative hepatitis B serology,ultrasensitive HBV DNA,HBV pregenomic RNA(pgRNA),abdominal ultrasound,CT or MRI imaging were collected. Differences between the two groups in terms of demographic data and HBV markers were analyzed.Results:A total of 827 patients were included in the study,with 536 patients in the TND group and 291 in the LOQ group. Compared with the TND group,the LOQ group had a younger age( P<0.001),and higher level of ALT,AST,HBeAg positive rate,HBsAg,and HBV pgRNA(all P<0.001). Subgroup analyses stratified by HBeAg status,cirrhosis status,and sex showed that the LOQ group had significantly higher levels of HBsAg and HBV pgRNA compared to the TND group in all subgroups(all P<0.05). Conclusion:The LOQ group had significantly higher levels of HBsAg and HBV pgRNA compared to the TND group.
7.Analysis on Current Status of Clinical Trial Registration on TCM Prevention and Treatment of Constipation in China
Shuo HUANG ; Biao LIANG ; Yiheng YANG ; Jiachun NI ; Shiwei QIAN ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(5):62-67
Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.
8.Analysis on Registration Status of Clinical Trials of Common Anorectal Diseases in China Based on ChiCTR
Biao LIANG ; Yiheng YANG ; Jiachun NI ; Shiwei QIAN ; Shuo HUANG ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):55-59
Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35%of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.
9.Original species identification of Epimedii Folium (Epimedium) and their distributional responses to climate change
Yiheng WANG ; Kangjia LIU ; Meng LI ; Yuran BAI ; Chengcai ZHANG ; Binbin YAN ; Wenpan DONG ; Yan ZHANG ; Jiahui SUN
Science of Traditional Chinese Medicine 2025;3(2):178-185
Background: Epimedii Folium is well known for its medicinal value. Four Epimedium species—Euphorbia brevicornu, E. sagittatum, E. pubescens, and E. koreanum—are the designated original plants of Epimedii Folium. Objective: The objective of this study is to facilitate the identification of the four Epimedium species and clarify their distributional responses to climate change. Methods: In this study, we assessed the genetic divergence of the four species and identified the molecular markers for species identification by using chloroplast genome sequences. Furthermore, we forecasted the distribution of potentially suitable regions of the four species Folium under climate change. Results: The authors obtained 26 chloroplast genome sequences of the four species and identified 1393 variable sites and 273 indel events. Genetic divergence analyses revealed that E. koreanum had long genetic distance from the other three species. Compared with the complete chloroplast genome, six hypervariable markers were discovered, and both rps4-trnL and ndhF were chosen as Epimedii Folium-specific DNA barcodes. Climate change is expected to influence the geographical distribution of the four Epimedium species, which were primarily found in China, South Korea, and Japan, leading to both expansion and contraction of their distribution ranges. Conclusion: Two identification markers were selected as the specific DNA barcodes for all four original plant species of Epimedii Folium. In addition, the shift of potential suitable area in various climate scenarios has been predicted. With the support of identification markers and the dynamics of suitable distribution areas, we are able to establish a foundation for the sustainable utilization of medicinal Epimedium resources in the future.
10.Analysis of serum HBV markers in chronic HBV infected patients with HBV DNA below the detection limit and below the quantification limit after long-term nucleotide analogues treatment
Yan ZHAO ; Yiheng ZHANG ; Jing HE ; Lina WANG ; Tao LI ; Yundong QU ; Lei WANG ; Yan WANG
Chinese Journal of Experimental and Clinical Virology 2025;39(4):454-460
Objective:This study aims to investigate the differences between two groups of patients treated with nucleos(t)ide analogues(NAs):those with undetectable HBV DNA by ultrasensitive testing and those with HBV DNA below the quantification limit. The findings will provide a basis for the clinical interpretation and rational use of ultrasensitive HBV DNA results.Methods:This cross-sectional study included patients with chronic HBV infection who were treated with NAs between May 2023 and December 2023 at the outpatient clinic and inpatient department of the Hepatology Department,The Second Hospital of Shandong University. All patients had ultrasensitive HBV DNA results that were either undetectable or less than 20 IU/ml. The group with undetectable ultrasensitive HBV DNA was defined as the target not detected(TND)group,while the group with HBV DNA levels below 20 IU/ml was defined as the limit of quantitation(LOQ)group. Data on patients' sex,age,type of NAs used,routine blood tests,liver and kidney function,quantitative hepatitis B serology,ultrasensitive HBV DNA,HBV pregenomic RNA(pgRNA),abdominal ultrasound,CT or MRI imaging were collected. Differences between the two groups in terms of demographic data and HBV markers were analyzed.Results:A total of 827 patients were included in the study,with 536 patients in the TND group and 291 in the LOQ group. Compared with the TND group,the LOQ group had a younger age( P<0.001),and higher level of ALT,AST,HBeAg positive rate,HBsAg,and HBV pgRNA(all P<0.001). Subgroup analyses stratified by HBeAg status,cirrhosis status,and sex showed that the LOQ group had significantly higher levels of HBsAg and HBV pgRNA compared to the TND group in all subgroups(all P<0.05). Conclusion:The LOQ group had significantly higher levels of HBsAg and HBV pgRNA compared to the TND group.

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