1.Development of a Core Outcome Set for Clinical Evaluation of Chronic Pulmonary Heart Disease Treated with Traditional Chinese Medicine Therapy
Baihan NIU ; Mingyan ZHANG ; Zhaochen JI ; Bo PANG ; Haiyin HU ; Junhua ZHANG
Journal of Traditional Chinese Medicine 2025;66(12):1227-1232
ObjectiveTo construct an outcome set for clinical evaluation of traditional Chinese medicine (TCM) for chronic pulmonary heart disease, and to provide consensus outcomes for the evaluation of the clinical effectiveness of TCM for chronic pulmonary heart disease. MethodsWe searched randomised controlled trials of TCM for chronic pulmonary heart disease on China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (WF), VIP Chinese Science Journals Database (VIP), Chinese Biomedical Literature Service Database (SinoMed), PubMed, Cochrane Library, and Embase. We also searched Chinese Clinical Trial Registry Platform and the U.S. Clinical Trial Registry database to obtain the outcome indicators reported in the clinical research protocols of TCM for chronic pulmonary heart disease. The outcome indicators were also collected through semi-structured interviews of clinicians and patients. Then integrated the outcome indicators collected by the above methods to construct the indicator pool. Through two rounds of Delphi surveys and a consensus conference, the core outcome set for clinical evaluation of TCM for chronic pulmonary heart disease was determined. ResultsAfter screening, there were 1313 literature meeting the criteria, and 595 outcome indicators were extracted, then combined with the outcomes from semi-structured interviews which clinicians and patients concerned, finally an indicator item pool containing 369 outcome indicators were formed. After the initial screening of indicators in the pool by the steering committee, 58 indicators were established into the initial list of indicator entries. In the first round of Delphi survey, the expert coordination coefficient for the results was 0.401, and the Cronbach coefficient was 0.989. A total of 35 indicators that did not meet the criteria [<70% of the participants rated the outcome as 7~9 (critical) and the mean of the expert ratings <7] were deleted, and 23 were retained, with 7 new indicators added that were open to supplementation by the experts, resulting in a total of 30 indicators that were included in the second round of Delphi survey. In the second round of Delphi survey, the expert coordination coefficient was 0.303, and the Cronbach coefficient was 0.974, with a total of 7 indicators that did not meet the criteria being deleted, and 21 indicators being retained for the consensus conference. After the consensus meeting, the core outcome set for clinical evaluation of chronic pulmonary heart disease in two major categories, acute exacerbation stage and stable stage, was finally determined, in which there were four indicators in acute exacerbation stage: N-terminal B-type natriuretic peptide precursor (NT-proBNP), blood qi analysis, all-cause mortality rate, and complication rate; and there were eight indicators in the stable stage: pulmonary function index, six-minute walk test distance, New York cardiac function classification, all-cause mortality rate, re-hospitalisation rate, Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score, Short Form 36 Health Survey (SF-36), and TCM syndrome score. ConclusionThe core outcome sets of TCM clinical evaluation in the acute exacerbation stage and stable stage are constructed, which is helpful to improve the practicability, comparability and transparency of TCM clinical research results in pulmonary heart disease.
2.Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Xiaolei WU ; Haiyin HU ; Yuetong WANG ; Fauci Alice Josephine ; Yazi ZHANG ; Wenting SONG ; Fengwen YANG ; Boli ZHANG ; Junhua ZHANG ; Zhaochen JI
Digital Chinese Medicine 2025;8(2):123-136
Objective:
Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.
Methods:
RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated.
Results:
A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized.
Conclusion
Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
3.Literature Analysis Report of Clinical Randomized Controlled Trials of proprietary Chinese Medicines(2021)
Dehui PENG ; Yazi ZHANG ; Haiyin HU ; Junhua ZHANG ; Zhaochen JI ; Hui WANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):109-118
Objective This study aims to summarize and evaluate clinical evidence of randomized controlled trial(RCT)of Chinese patent medicine published in 2021 and providing reasonable suggestions.Methods The collection literatures of Evidence Database System of TCM(EVDS)was main source,and CNKI,Wan Fang Data,VIP,SinoMed,Cochrane Library,PubMed,and EMbase databases were supplement.Obtaining the RCT of Chinese patent medicine published in 2021,and to analyze and evaluate their characteristics and methodological quality.Results 2215 RCTs of Chinese patent medicine(2206 in Chinese/9 in English)were included,which involving 237,379 patients,26 types of diseases,and 750 types of proprietary Chinese medicines(619 types of oral Chinese patent medicine,91 types of Chinese injections,and 40 types of topical Chinese patent medicine).The circulatory system diseases,respiratory system diseases and neurological diseases was highlight research area.The most number of diseases were ischemic Stroke,coronary heart disease,and angina pectoris.The sample size between 30 and 8,000 cases,and the case sources were mainly single-center.Methodologically,the implementation of allocation concealment and blinding remained unappreciated.Conclusion The number of RCTs publication increased in 2021 compared with 2020,more studies pay attention to neurological disease research,and quality control and standardized management during study design and implementation still need to be improved.
4.Characterization of the prevalence of HIV-infected patients aged 50 years and above in Tiantai County, Zhejiang Province from 2006 to 2020
Junhua GE ; Haiyan HU ; Tianlan PANG ; Shanling WANG ; Guiwei ZHU
Shanghai Journal of Preventive Medicine 2024;36(10):939-943
ObjectiveTo analyze the epidemiological characteristics of the newly reported HIV-infected cases aged ≥50 years in Tiantai County from 2006 to 2020, and to provide a scientific basis for the formulation of intervention measures and control strategies for the elderly. MethodsData of the newly reported HIV-infected individuals aged ≥50 years in Tiantai County from 2006 to 2020 were analyzed. A trend χ2 test was used to analyze the changing trends of the composition ratio over the years. ResultsA total of 201 HIV-infected cases aged ≥50 years were newly reported from 2006 to 2020, accounting for 52.62% of the total reported cases, and the proportion of HIV- infected patients aged ≥50 years in the total number of reported cases increased from 12.50% in 2011 to 80.00% in 2020, showing a yearly increasing trend (χ2trend=36.898, P<0.001). The mean age of the elderly at diagnosis of HIV infection was (64.8±9.1) years old, and the average age of infection was (58.1±9.3) years old. Patients who were male (79.10%), married with a spouse (58.21%), with an educational level of primary school and below (68.16%), with a local registered residence (75.12%) and peasants (88.06%) were associated with increased risk of HIV infection. Heterosexual transmission (89.55%) was the major route of HIV transmission among the HIV-infected cases aged ≥50 years and 75.12% of them were detected while visited medical and healthcare facilities. Among heterosexual transmission, males were more likely to be infected through non-marital heterosexual contact(χ2=229.381, P<0.001), while females were more likely to be infected through contact with their positive spouse or fixed sexual partner(χ2=216.699, P<0.001). The AIDS epidemic had affected 15 townships (streets) in the county. Pingqiao Town and Chicheng Street were seriously affected, with the confirmed cases accounted for 45.27% of the total number of the cases in the county. ConclusionThe number of the newly reported HIV-infected cases aged ≥50 years in Tiantai County showed a rapid growth trend from 2006 to 2020. Males with low educational level predominated in the total number of the cases. Commercial heterosexual behavior is the main route of infection. Lack of timely detection and management on positive clandestine prostitutes, resulting in the existence of gathering trend in the key towns. Crackdown on clandestine prostitution should be strengthened, and interventions on high-risk sexual behaviors should be carried out, in order to promote the acquisition of HIV/AIDS prevention knowledge and behavioral change for the elderly, furthermore, to control the spread and epidemic of HIV/AIDS.
5.Relationship between serum levels of miR-124,CD146 and Angptl2 and the stability of carotid atherosclerotic plaque in patients with acute cerebral infarction
Xia LI ; Jingmei WANG ; Junhua LI ; Yanyan HU ; Shanshan WANG ; Yajuan MAO ; Yiping WU
International Journal of Laboratory Medicine 2024;45(17):2121-2126,2131
Objective To explore the relationship between serum microRNA-124(miR-124),CD146,angio-poietin-like protein 2(Angptl2)and the stability of carotid atherosclerosis(CAS)plaque in patients with a-cute cerebral infarction(ACI),and to provide reference for early prevention and treatment of patients with ACI.Methods A total of 191 patients with ACI admitted in Handan Central Hospital from January 2020 to February 2023 were selected as ACI group,and another 61 healthy volunteers who were underwent physical examination during the same period were selected as control group.The patients with ACI were divided into unstable plaque group(56 cases),stable plaque group(71 cases),and non plaque group(64 cases)based on carotid color doppler ultrasound results.The serum miR-124 expression levels of all subjects were detected by real time fluorescence quantitative polymerase chain reaction(RT-qPCR),and the serum CD146 and Angptl2 levels were detected by enzyme-linked immunosorbent assay(ELISA).The influencing factors of the instabili-ty of CAS plaque in patients with ACI was analyzed by univariate and multivariate Logistic regression.The predictive value of serum miR-124,CD146 combined with Angptl2 for the instability of CAS plaque in patients with ACI was analyzed by the receiver operating characteristic(ROC)curve.Results The serum CD146 and Angptl2 levels in ACI group were higher than those in control group(P<0.05),and the miR-124 expression level was lower than that in control group(P<0.05).Univariate analysis showed that the stability of CAS plaques in ACI patients was correlated with age,hypertension,hyperlipidemia,fibrinogen(FIB),serum C-reac-tive protein(CRP),serum cystatin C(CyC),CD146,Angptl2 and miR-124(P<0.05).Multivariate Logistic regression analysis showed that the decrease of serum miR-124,the increase of CD146,the increase of Angptl2 and the combination of hyperlipidemia were risk factors for CAS plaque stability in ACI patients(P<0.05).The area under ROC curve(AUC)of serum miR-124,CD146,Angptl2 and the combination of the three indi-cators to predict CAS plaque instability in ACI patients were 0.741,0.719,0.781 and 0.834,respectively.Conclusion The serum miR-124 expression level,CD146 and Angptl2 levels are the influencing factors of CAS plaque instability in ACI patients,which may be involved in the formation and development of CAS plaque in ACI patients.The combined detection of the three factors has a good predictive effect on CAS plaque instability in ACI patients.
6.Association between body health score and the risk of hypertension among health examination population aged 40-65 years
Dashan WANG ; Li ZHENG ; Jing ZHOU ; Jin HU ; Yue MENG ; You LI ; Die WANG ; Junhua WANG ; Ziyun WANG
Chinese Journal of Health Management 2024;18(8):581-586
Objective:To analyze the association between body health score and the risk of hypertension among health examination population aged 40-65 years.Methods:This study was a cross-sectional study, and 1 104 people aged 40-65 years who underwent physical examination at the Physical Examination Centre of the First People′s Hospital of Fuquan City from March to November 2022 were selected. Clinical data, such as general information, physical examination, body composition and history of hypertension diseases, were collected. The body health score was reported by the Xiaomi Body Fat Scale′s accompanying exercise health software, and was calculated by combining body fat, water and other body composition data. The association between body health score and the risk of hypertension was analyzed using restricted cubic spline regression models, while a sensitivity analysis and sex-stratified analyses were performed. Multivariate logistic regression combined with stratified analysis was used to explore the association between dimensions of body composition and the risk of hypertension.Results:The body health score was significantly lower in hypertensive patients than in non-hypertensive patients among the 1 104 health examination population [52.0(30.0) vs 69.0(35.8) points] ( Z=-8.547, P<0.001). The lower the body health score, the higher the risk of hypertension ( χ2=18.48, PNonlinear<0.001). In the total population, high body mass index was associated with an increased risk of hypertension ( OR=1.744, 95% CI: 1.104-2.765), high protein content was associated with a reduced risk of hypertension ( OR=0.587, 95% CI: 0.344-0.982) (both P<0.05). Gender-stratified analyses showed that high protein content was associated with a reduced risk of hypertension only in men ( OR=0.233, 95% CI: 0.080-0.592) ( P=0.004). High body mass index was positively associated with the risk of hypertension when the body health score was ≥60 points ( OR=2.378, 95% CI: 1.255-4.542) ( P=0.008). High visceral adiposity index (VAI) was positively associated with the risk of hypertension when the body health score was <60 points ( OR=4.395, 95% CI: 1.466-13.620), and high protein content was negatively associated with the risk of hypertension ( OR=0.255, 95% CI: 0.091-0.638) (all P<0.05). Conclusions:Health examination population aged 40-65 years with lower scores of physical health are more likely to have a risk of hypertension. Men should pay attention to the impact of body protein in hypertension risk prevention and control. The effect of body mass index should be noted when body health scores are ≥60 points, and the effect of VAI and body protein should be considered when body health scores are <60 points.
7.Retrospective analysis of prognostic factors in patients with advanced gastric cancer
Zhendong DUAN ; Junhua HU ; Zhongliang LIU ; Jing ZHOU
China Modern Doctor 2024;62(22):67-71
Objective To analyze the risk factors affecting the prognosis of patients with advanced gastric cancer,so as to provide evidence for identifying high-risk populations and guiding clinical treatment.Methods The clinical data of 282 patients with advanced gastric cancer who admitted to Zhoushan Hospital of Traditional Chinese Medicine from January 2017 to December 2021 were retrospectively analyzed.The survival outcome of patients was obtained by telephone follow-up and regular review.Kaplan-Meier method was used to analyze the overall survival(OS).Univariate and multivariate COX regression models were used to analyze the effects of clinical features on OS in patients with advanced gastric cancer.Results The median OS of 282 patients with advanced gastric cancer was 10.0 months.Univariate analysis showed that first-line chemotherapy,traditional Chinese medicine treatment,body mass index(BMI),Karnofsky performance status(KPS)score,hemoglobin(Hb)and albumin(Alb)were significantly correlated with the survival of patients with advanced gastric cancer(P<0.05).Multivariate COX regression models analysis showed that first-line chemotherapy,BMI,KPS score and Alb were independent risk factors affecting the survival of patients with advanced gastric cancer(P<0.05).Conclusion BMI,Alb,KPS score and first-line chemotherapy are independent risk factors for predicting the prognosis of patients with advanced gastric cancer,indicating nutrition management may be an important way to improve the outcome of patients with advanced gastric cancer.
8.Self-screening for arteriosclerosis in middle-aged and elderly residents and the construction of a primary care initial screening tool
Yue MENG ; Li ZHENG ; Jing ZHOU ; Dashan WANG ; Jin HU ; Die WANG ; You LI ; Junhua WANG ; Ziyun WANG
The Journal of Practical Medicine 2024;40(14):1947-1951
Objective To establish a simple model for arteriosclerosis(AS)screening to provide a viable tool for the timely identification of AS risk among residents aged 40~65 years.Methods Data were obtained from the Sleep and Chronic Diseases Program in Fuquan City.The original dataset was divided into a training subset and a validation subset(80%:20%).LASSO and logistic regression models were used to screen variables,perform multivariate regression analyses.Internal validation was performed using the Bootstrap method.Nomogram Plot was constructed,and risk score thresholds were determined based on ROC curves to classify high-risk populations.Results RS Model was established to include age,gender,napping,sleep efficiency,sleep disorders,hyperten-sion and diabetes,with AUC=74.80%and a model risk score threshold=84.20.PHC Model was established to include age,gender,napping,sleep efficiency,systolic blood pressure,fasting blood glucose,and pulse variables,with AUC=82.80%and a risk score threshold of 78.00.Decision curves showed that both models performed well in terms of calibration and actual benefits for health management.Conclusion The two AS screening models exhibit acceptable accuracy and differentiation.Therefore,it can be applied in residents'self-health management and in primary care organizations'screening work in a large scale.
9.Study on the extensibility of platelet donor gene database in Shaanxi
Jun QI ; Xiaoli CAO ; Xin HU ; Fengqin LI ; Zhendong SUN ; Yuhui LI ; Manni WANG ; Tianju WANG ; Junhua WU ; Lixia SHANG ; Le CHEN ; Hua XU
Chinese Journal of Blood Transfusion 2023;36(7):637-641
【Objective】 To analyze the commonality and characteristics between voluntary blood donors and hematopoietic stem cell donors in this region, and explore the potential for integration and development between China Marrow Donors Program (CMDP) and voluntary blood donors, especially platelet donor databases, so as to improve recruitment success rate and inventory rate. 【Methods】 The database modeling and comparison methods were used to screen and stratify the matching and integration degree between the voluntary blood donors in recent 10 years and the marrow donors in the Shaanxi Branch of CMDP. The frequencies of HLA-A,-B alleles, HPA alleles and haplotypes were calculated with Arlequin 3. 5. 2. 2 software, and the matching probability of different platelet donor reserve pools was conducted according to the phenotypic frequencies. 【Results】 Among the voluntary donors with known HLA genotypes in this region, according to their blood donation behavior,the active blood donors excavated were divided into the first, second, third and fourth echelons of platelet donor reserve pools, with 696, 2 752, 9 092 and 12 028 donors, respectively. The first echelon had the highest proportion of 10-50 times of platelet donations and 10-20 times of whole blood donations, with 13.65% and 26.01%, respectively. The second echelon had 10-20 times of whole blood donations and 10-50 times of platelet donations, accounted for 15.04% and 1.38%, respectively, which were significantly different from other echelons' blood donation characteristics (P<0.05). With a database size of the existing platelet donor bank adding the first and second echelons (n=4 955), there was a 69.02% probability of matching at least one donor with matching HLA-A-B phenotype. When considering the matching ABO and HPA phenotypes, the probability of finding at least one donor with fully matching HLA, HPA and ABO isotype (type B as an example) was 48. 73%. 【Conclusion】 The three groups of whole blood donation, apheresis platelet donation and marrow donation in Xi'an area have a large cross-distribution. Compared with expanding the storage capacity from scratch, the active blood donors in CMDP database are the largest back-up force of platelet donors. While expanding the effective storage capacity, it can minimize the cost of building platelet donor bank and the demand for resources.
10.Clinical value of nucleic acid detection for hepatitis B virus screening in hospitalized patients
Chunhong DU ; Junhua HU ; Yuan ZHANG ; Jiwu GONG ; Jun ZHOU ; Qin MENG ; Juan LIU ; Jiangcun YANG ; Rong GUI ; Xianping LYU ; Rong XIA ; Fenghua LIU ; Li QIN ; Shu SU ; Jinqi MA ; Juan CAI ; Huifang JIN ; Qi ZHANG ; Jun ZHANG ; Rongyi CAO ; Xiying LI ; Peng WANG
Chinese Journal of Laboratory Medicine 2023;46(1):27-31
Objective:To explore clinical value of nucleic acid detection for hepatitis B virus (HBV) screening in hospitalized patients.Methods:This cross-sectional study collected and analyzed plasma samples from patients admitted to 10 domestic medical institutions from July 2021 to December 2021. Serological immunoassay and nucleic acid screening were used to simultaneously detect hepatitis B markers such as hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e Antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb),and HBV DNA. Statistical analysis was performed on the serology, nucleic acid test results and clinical information of the patients.Results:Of the 8 655 collected samples, HBsAg was positive in 216 (2.50%) samples,HBV DNA was positive in 238 (2.75%) samples ( P>0.05); 210 (2.43%) samples were positive for both HBsAg and HBV DNA, 28 (0.32%) were HBsAg negative and HBV DNA positive, 6 cases (0.07%) were HBsAg positive and HBV DNA negative. Conclusion:These results indicate that the HBV DNA testing is equally effective as hepatitis B virus serological detection for hepatitis B virus screening in hospitalized patients.

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