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.

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.

Objective:To explore the correlations between the cerebral infarction area and cytokines and immune status in patients with acute ischemic stroke,and to provide the theoretical basis for immunotherapy of the patients with different degrees of cerebral infarction.Methods:Sixty-seven patients with acute ischemic stroke within 72 h of the onset were randomly selected according to the inclusion and exclusion criteria,and were divided into large-area cerebral infarction group(n=34)and non-large-area cerebral infarction group(n=33)on the basis of the biggest infarction area in the sequences of magnetic resonance diffusion-weighted imaging(CDWI).Clinical baseline characteristics such as gender,age,and medical history were collected from the patients in two groups,the serum levels of interleukin(IL)-2,IL-6,IL-10,and IL-17A,tumor necrosis factor-α(TNF-α),and interferon-γ(IFN-γ)were measured using flow cytometry;the absolute values of lymphocytes(LYM#),lymphocyte percentages(LYM％),and neutrophil/lymphocy ratios(NLR)in peripheral blood of the patients caiculated,and the ratios of IFN-γ/IL-4,TNF-α/IL-4,and TNF-α/IL-10 rations were also calculated.The values of National Institutes of Health Stroke Scale(NIHSS)scores of the patients were evaluatd on the basis of the assessment of clinical neurological signs.The correlations of the cerebral infarction area and NIHSS score,cytokines and immune status groups of the patients in two were tested by rank correlation analysis.Results:Compared with non-large-area cerebral infarction group,the serum levels of IL-2,IL-6,IL-10,IL-17A,TNF-α,and IFN-γ as well as the NLR in the peripheral blood of the patients in large-area cerebral infarction group were significantly increased(P＜0.01),while the LYM#,LYM％and TNF-α/IL-4 were significantly decreased(P＜0.01).There was a positive correlation between cerebral infarction area and NIHSS score in the patients in large-area cerebral infarction group(rs=0.521,P＜0.05),and there was a significantly positive correlation between cerebral infarct area and NIHSS score in the patients in non-large-area cerebral infarction group(rs=0.721,P＜0.001).The NIHSS scores were positively correlated with serum IL-6(rs=0.306,P=0.005),IL-4(rs=0.252,P＜0.001),IL-2(rs=0.109,P=0.025),IL-17A(rs=0.405,P＜0.001),and IFN-γ(rs=0.146,P＜0.001)levels in two groups;no correlations were found between NIHSS scores and TNF-α(rs=0.039,P=0.726)and IL-10(rs=0.121,P=0.192)levels.NIHSS scores of the patients in two groups had negative correlatious with the serum level of LYM#(rs=-0.026,P=0.036)and LYM％(rs=-0.008,P=0.002),and had positive correlated with NLR(rs=0.315,P=0.009).Conclusion:The infarction area of the patients with actue cerebral infarction is correlated with the NIHSS score,the inflammatory response,the degree of adaptive immune injury,and the immune status.The have positive correlation with cytokines and immune markers and the overall size of the infarction area.Compared with the patients with non-large-acea cerebral infarction,the immunosuppression of the patients with large-area infarcted areas is more likely to occure.

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.

In recent decades, the prevalence of hyperuricemia and gout has increased dramatically due to lifestyle changes. The drugs currently recommended for hyperuricemia are associated with adverse reactions that limit their clinical use. In this study, we report that berberine (BBR) is an effective drug candidate for the treatment of hyperuricemia, with its mechanism potentially involving the modulation of gut microbiota and its metabolite, succinic acid. BBR has demonstrated good therapeutic effects in both acute and chronic animal models of hyperuricemia. In a clinical trial, oral administration of BBR for 6 months reduced blood uric acid levels in 22 participants by modulating the gut microbiota, which led to an increase in the abundance of Bacteroides and a decrease in Clostridium sensu stricto_1. Furthermore, Bacteroides fragilis was transplanted into ICR mice, and the results showed that Bacteroides fragilis exerted a therapeutic effect on uric acid similar to that of BBR. Notably, succinic acid, a metabolite of Bacteroides, significantly reduced uric acid levels. Subsequent cell and animal experiments revealed that the intestinal metabolite, succinic acid, regulated the upstream uric acid synthesis pathway in the liver by inhibiting adenosine monophosphate deaminase 2 (AMPD2), an enzyme responsible for converting adenosine monophosphate (AMP) to inosine monophosphate (IMP). This inhibition resulted in a decrease in IMP levels and an increase in phosphate levels. The reduction in IMP led to a decreased downstream production of hypoxanthine, xanthine, and uric acid. BBR also demonstrated excellent renoprotective effects, improving nephropathy associated with hyperuricemia. In summary, BBR has the potential to be an effective treatment for hyperuricemia through the gut-liver axis.

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.

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.

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.

Objective:To explore the impact of treatment duration with human urinary kallidinogenase (HUK) on the efficacy and safety of acute ischemic stroke (AIS).Methods:In this subgroup analysis of RESK study, a total of 990 AIS patients recruited from 65 centers in China between August 2015 and June 2020 were included and divided into short medication group (HUK for 8 days, n=185) or long medication group (HUK for 15 days or 21 days, n=805). The proportions of patients with modified Rankin Scale (mRS) score of 0, 0-1, 0-2 at 90 days, National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 22 days, the proportions of patients with Barthel index (BI)≥95 at 90 days, and the incidences of adverse events were analyzed. Comparisons between groups were conducted using chi-square test, single factor and multivariate Logistic regression analysis, etc. Results:Multivariate regression analysis showed that the proportions of patients with 90-day mRS score of 0-2 [74.1% (137/185) vs 75.0% (604/805); OR=1.047, 95% CI 0.676-1.620, P=0.838] and 22-day NIHSS score change from baseline (4.60±2.00 vs 4.26±2.80; OR=-0.390, 95% CI -1.125-0.344, P=0.297) showed no statistically significant difference between the short medication and long medication groups; the proportions of patients with 90-day mRS score of 0-1 [48.1% (89/185) vs 59.1% (476/805); OR=0.674, 95%CI 0.463-0.983, P=0.041] and 90-day BI≥95 [43.6% (79/181) vs 55.1% (442/802); OR=0.614, 95%CI 0.420-0.897, P=0.012] were significantly lower in the short medication group than in the long medication group. There was no statistically significant difference in the incidences of adverse events between these 2 groups. Conclusions:In AIS patients, consecutive 8-day dosing of HUK improved immediate (22-day NIHSS score) and long-term outcome (90-day mRS score 0-2) and was safely tolerated. When applicable, extended duration of HUK could improve long-term disability-free rate (90-day mRS score 0-1) and quality of life (90-day BI) without increasing the risk of adverse events.

Objective To analyze the epidemiological characteristics of occupational hand-arm vibration disease (OHAVD) in Guangdong Province from 2006 to 2022. Methods The data of newly reported OHAVD cases and suspected occupational disease cases in Guangdong Province from 2006 to 2022 was collected from the Report Card of Occupational Diseases and Report Card of Suspected Occupational Diseases using Occupational Diseases and Health Hazard Factors Monitoring Information System under China Disease Prevention and Control Information System. Epidemiological characteristics of the newly reported OHAVD cases and related suspected occupational disease reports were analyzed. Results A total of 660 newly reported OHAVD cases were reported in Guangdong Province from 2006 to 2022. The number of cases showed a periodic fluctuating trend over the years. Males accounted for 98.64% of the newly reported OHAVD cases with a median age of 38 years and a median hand-transmitted vibration exposure period of 8.7 years. These cases were predominantly distributed in the Pearl River Delta region, including Zhongshan City, Dongguan City, Guangzhou City, Shenzhen City and Foshan City, accounting for 99.25%. The manufacturing enterprises had 98.79% of the cases, investment enterprises of Hong Kong, Macao and Taiwan merchants of China had 83.18% of the cases, and large- and medium-sized enterprises had 92.73% of the cases. The 660 cases were distributed in 440 enterprises, but there were some characteristics of group outbreaks. There were 20 enterprises (4.55% of the total number of enterprises) had more than three cases involving 219 cases (33.18%). There were five enterprises which had more than 10 cases and the cases number ranged from 12 to 56. Among 382 newly reported OHAVD cases from 2014 to 2022, 44.24% were identified as suspected occupational diseases before diagnosis, of which 59.76% (101/169) were determined by occupational health inspection institutions. Conclusion Newly reported OHAVD cases in Guangdong Province were aggregated in terms of regional distribution, industry, enterprise ownership, and enterprise scale, with a risk of group outbreaks. It is suggested to enhance the OHAVD prevention and control in male workers exposed to hand-transmitted vibrations in the Pearl River Delta's manufacturing enterprises.