1.Analysis on the current situation of clinical trials registration of Chinese materia medica in China
Jing HUANG ; Bin FENG ; Shuibing LIU ; Hongxu YANG ; Huan ZHANG ; Lifei CHENG ; Yihuan LIU ; Weigang WANG ; Jia JU
International Journal of Traditional Chinese Medicine 2025;47(10):1454-1460
Objective:To analyze the current status of clinical trials of Chinese materia medica for the purpose of registration in China; To provide reference for the research and development of new TCM drugs.Methods:Clinical trials of Chinese materia medica/natural medicine registered in Drug Clinical Trial Registration and Information Disclosure Platform were retrieved from inception to December 31, 2024. Excel 2019 software was used to input and analyze the data such as the number of registered clinical trials, date of first publication, study status, field of indication, trial phases, sponsors, group leader, and design types.Results:A total of 1 137 Chinese materia medica clinical trials had been registered, accounting for 4.12% of the total number registered on the platform. Phase Ⅱ clinical trials accounted for the highest proportion (58.8%), and 99.7% of clinical trials conducted domestically. The sponsors were predominantly domestically pharmaceutical enterprises. These 1 137 clinical trials of Chinese materia medica clinical trials involved 752 drug categories, 28 dosage forms, and 796 varieties (the same class of drugs had different drug dosage forms), with capsules being the most common. The indications primarily focused on respiratory, digestive, cardio-cerebrovascular, neuropsychiatric, gynecological diseases. The group leader of clinical trials was distributed in 28 provinces, among which the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine as the group leader, undertook the most clinical trials of TCM. 89.9% of the clinical trials adopted the randomized controlled trial design, and only 31.9% of the clinical trials purchased insurance for the subjects.Conclusion:The research and development of new TCM drugs has entered a phase of vigorous development. Further efforts are still needed in establishing systematic guidelines for Chinese materia medica clinical trials, accelerating the internationalization of TCM, exploring innovative dosage forms and indications, and strengthening the protection of participants' rights.
2.Reliability and Validity Evaluation of TCM Identification Scale of Five Human Qualities in Elderly People
Manman LU ; Rui YU ; Baozhao JU ; Feng GU ; Huan ZHANG ; Zengjin JIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):153-160
ObjectiveBased on the Huangdi Neijing,a traditional Chinese medicine(TCM)identification scale of five human qualities was constructed and applied in elderly people to evaluate its reliability and validity. MethodsBased on the original text of the Huangdi Neijing and a review of relevant ancient and modern literature, an identification scale of five human qualities was developed through Delphi expert interviews. Offline surveys were conducted to evaluate the feasibility,reliability,and validity of its application in elderly people,and the scale was evaluated and revised. ResultsThe scale of five human qualities is divided into five subscales:wood,fire,earth,metal,and water. Each subscale is divided into four dimensions:morphological structure,psychological characteristics,tolerance,and physiological characteristics,with a total of 75 items. The survey results in elderly people show that:(1) The recovery rate and completion rate are 100%,and the average filling time is 23.3 min. 85.5% of the samples are completed within the preset time. (2) Reliability analysis results:The homogeneity reliability of each subscale,Chronbach's α,ranges from 0.702 to 0.793. The scores of each subscale in the split-half reliability range from 0.758 to 0.841, indicating that the internal consistency of the scale is good. (3) Validity analysis results. Content validity:During the development stage of the scale,the item pool,dimensions,and structure of the scale are designed reasonably, and the content is complete. The evaluation of content validity shows that the item-level content validity index (I-CVI) ranges from 0.83 to 1.00, and the scale-level content validity index for universal agreement (S-CVI/UA) is 0.92,indicating good content validity of the scale. Construct validity extracts 22 common factors based on an eigenvalue of 1,with a contribution rate of 62.333% to the overall system. The number of common factors in the five subscales is 4,5,4,5,and 4,respectively,with contribution rates of 52.64%,53.376%,51.445%,51.359%,and 50.714%,respectively,indicating the required structure for physical fitness measurement in elderly people. ConclusionThe scale constructed in this study has high reliability and validity,and it is suitable for evaluating the physical condition of elderly people in TCM.
3.Electroacupuncture combined with aerobic exercise can relieve hyperlipidemia
Huan WU ; Zhaoqing ZHANG ; Shiru JU ; Wei LIN ; Hongxing ZHANG
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(8):680-686
Objective:To observe any effect of combining electro-acupuncture with aerobic exercise on the expression of SR-BI receptor and caveolin-1 and ABCA1 proteins in the liver and on reverse cholesterol transport. Any relationship with inflammatory factors NF-κBp65, COX-2 and TNF-α in the aortic arch was also investigated.Methods:Thirty male SPF Sprague-Dawley rats were randomly divided into a normal group (NG), a model group (MG), and a group which received electro-acupuncture combined with aerobic exercise (the EAG group), each of 10. A hyperlipidemia model was induced in the rats of the MG and EAG groups by feeding a high-fat diet. For 4 weeks the EAG group received 30 minutes of electroacupuncture daily (frequencies of sparse/dense waves 2/100Hz, 1mA) at the ST40 and SP9 acupoints, followed by 60 minutes of no weight bearing swimming. No intervention was applied to the other groups. Before and after the intervention, serum was collected to observe lipid levels. Liver and aortic arch issue were resected to measure lipid deposition and inflammation using hematoxylin eosin staining. Caveolin-1, SR-BI and ABCA1 in the liver and NF-κBp65, COX-2 and TNF-α in the aortic arch were quantified using real-time PCRs and western blotting.Results:After successful modeling the levels of total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C), and the protein and mRNA expressions of NF-κBp65, TNF-α, COX-2 and COX-2 in the aortic arches of the MG had increased significantly. High density lipoprotein cholesterol (HDL-C) and the protein and mRNA expressions of caveolin-1, SR-BI and ABCA1 in the liver had decreased significantly. Compared with the MG, the levels of TC and LDL-C, as well as the protein and mRNA expressions of NF-κBp65, TNF-α, COX-2 and COX-2 in the aortic arches of the EAG had decreased significantly, while the average HDL-C l level, as well as the protein and mRNA of caveolin-1, SR-BI and ABCA1 in the liver were up-regulated significantly.Conclusions:Electroacupuncture combined with aerobic exercise can relieve hyperlipidemia through promoting cholesterol reverse transport and inhibiting inflammation in endothelial cells. Those effects may be related to up-regulating the expression of caveolin-1, SR-BI and ABCA1 in the liver and down-regulating inflammatory factors in the aortic arch.
4.Research Progress in TCM Regulating PD-1/PD-L1 Pathway in Malignant Tumors
Huan JU ; Dan ZHAO ; Dan LI ; Ruxi CHEN ; Bin HAN
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(8):187-192
Programmed death receptor programmed death ligand 1(PD-1/PD-L1)pathway is an important way to escape from immune surveillance and killing and producing immune escape and is widely expressed in various tumors.By regulating the expression of PD-1/PD-L1 signaling pathway,it can reactivate the anti-tumor immune response and prevent tumor cells from immune escape.PD-1/PD-L1 inhibitors play an important potential in the treatment of tumors,but it has certain limitations.TCM can regulate the body's immune system,improve the tumor microenvironment,and prolong survival.Based on the TCM regulation of PD-1/PD-L1 expression and the application of combining with PD-1/PD-L1 inhibitors in anti-tumor therapy,this study summarized the existing research content and provides reference for the combined application of TCM and immune checkpoint inhibitors in anti-tumor therapy.
5.Prospective multicenter cohort study on breast cancer screening using an automated breast ultrasound with remote reading
Xiaozhi DANG ; Yi GAO ; Xiang GU ; Yan JU ; Dongsheng YI ; Huan LIN ; Yi REN ; Xiaojie YUAN ; Hongping SONG
Chinese Journal of Oncology 2024;46(11):1067-1075
Objective:To construct a remote screening network for breast cancer based on automated breast ultrasound (ABUS) and explore the value of ABUS with remote reading for breast cancer screening.Methods:We constructed a remote breast cancer screening network including one remote reading center and 48 image-acquisition centers. We recruited women to participate in breast cancer screening at one of these image-acquisition centers from January 2021 to January 2023. The technicians collected the whole breast images using the ABUS. The images were then sent to the reading center through the PVBUS System and interpreted independently by two radiologists using the Breast Imaging Reporting and Data System (BI-RADS). BI-RADS categories 1 and 2 indicate negative screening results, and women diagnosed with these categories were recommended for annual breast ultrasound screening. BI-RADS categories 3, 4, and 5 indicate positive results. Women with BI-RADS category 3 lesions were recommended for follow-up examinations every 6 months using ABUS or handheld ultrasound, while those with BI-RADS 4 and 5 lesions were suggested to undergo pathological examinations.Results:In our study, we enrolled 10 344 women who completed the ABUS screening and were followed up for more than 12 months. After remote reading, 6 164 women were diagnosed with BI-RADS category 1 and 2 626 woman were within BI-RADS category 2. In contrast, 1 404 women were within BI-RADS category 3, a total of 135 women were within BI-RADS category 4, and 15 women were within BI-RADS category 5. The positive screening rate of ABUS was 15.0% (1 554/10 344). The ABUS with remote reading had a detection rate of 3.7/1 000 (38/10 344) for breast cancer screening, with a sensitivity of 97.4% (38/39) and a specificity of 85.3% (8 789/10 305). Among the 38 breast cancer cases detected, 92.1% (35/38) were invasive carcinomas, and 63.2% (24/38) were stage 0 or Ⅰ breast cancers.Conclusions:Breast cancer screening based on ABUS with remote reading provided an efficient and feasible solution to the problem of unevenly distributed medical resources and medical staff levels in various regions of China, enabling the decentralization of high-quality medical resources and improving the accessibility of high-quality screening services. It has provided an alternative for breast cancer screening in China.
6.Clinical trial on vascular intervention anesthesia of intracranial aneurysms using different doses of remimazolam
De-Li ZHENG ; Ju-Zeng WANG ; Huan CHEN ; Hui-Li LI ; Ji SHI ; Li MENG
The Chinese Journal of Clinical Pharmacology 2024;40(13):1860-1864
Objective To explore the application effect and safety of general anesthesia with different doses of remimazolam during vascular intervention anesthesia of intracranial aneurysms.Methods Patients with intracranial aneurysms were divided into high,middle and low dose groups according to the random number table method.The venous access was opened after the patients entered the room,and the vital signs were closely monitored.The low,middle and high dose groups were intravenously injected with 0.25,0.30 and 0.35 mg·kg-1remazolam,respectively.After the loss of consciousness,alfentanil and mivacurium chloride were given for anesthesia induction.The anesthetic effect,recovery quality,hemodynamic indexes,cerebral hemodynamic indexes and neurological function indexes before anesthesia induction(T0),at the time of laryngeal mask insertion(T1),embolization(T2),5 min after operation(T3)and 30 min after operation(T4)were compared among the three groups.The incidence of postoperative cerebral vasospasm(CVS),delayed ischemic neurological dysfunction(DIND)and the incidence of adverse drug reactions related to anesthesia were counted.Results The onset times of anesthesia in the high,middle,and low dose groups were(5.03±1.28),(5.17±1.09),and(7.21±1.15)min,respectively;the number of anesthesia rescue interventions were(0.12±0.02),(0.21±0.06),and(1.51±0.23)times,respectively.There was statistically significant difference in the number of rescue interventions between the high and middle dose groups compared to the low dose group(all P<0.05).The therapeutic efficacy rates of flumazenil in the high,middle,and low dose groups were 18.18%,11.11%and 2.86%,respectively.the mean arterial pressure(MAP)at T2 were(87.06±6.02),(86.85±5.61)and(81.09±5.37)mmHg;the MAP at T4 were(92.05±5.13),(87.57±6.29)and(84.42±5.16)mmHg,respectively.There was statistically significant difference in MAP between the high and low dose groups(all P<0.05).There were no statistically significant differences in heart rate(HR),oxygen saturation(SpO2),left peak systolic velocity of middle cerebral artery(Vp-MCA),left mean systolic velocity of middle cerebral artery(Vm-MC)and pulsatility index(PI),S100β protein,and neuron-specific enolase(NSE)levels among the three groups at different time points(all P>0.05).There were no statistically significant differences in the incidence rates of cardiovascular system complications,delayed postoperative cognitive dysfunction,or anesthesia-related adverse reactions between the three groups(all P>0.05).Conclusion The safety of different doses of remimazolam general anesthesia in the vascular interventional therapy of intracranial aneurysms is high,and the effects on cerebral hemodynamics and neurological function are similar.However,high-dose remimazolam have shorter general anesthesia induction time and less intraoperative anesthesia remedy frequency while the high-dose remimazolam has higher postoperative flumazenil antagonist therapy.
7.Prospective multicenter cohort study on breast cancer screening using an automated breast ultrasound with remote reading
Xiaozhi DANG ; Yi GAO ; Xiang GU ; Yan JU ; Dongsheng YI ; Huan LIN ; Yi REN ; Xiaojie YUAN ; Hongping SONG
Chinese Journal of Oncology 2024;46(11):1067-1075
Objective:To construct a remote screening network for breast cancer based on automated breast ultrasound (ABUS) and explore the value of ABUS with remote reading for breast cancer screening.Methods:We constructed a remote breast cancer screening network including one remote reading center and 48 image-acquisition centers. We recruited women to participate in breast cancer screening at one of these image-acquisition centers from January 2021 to January 2023. The technicians collected the whole breast images using the ABUS. The images were then sent to the reading center through the PVBUS System and interpreted independently by two radiologists using the Breast Imaging Reporting and Data System (BI-RADS). BI-RADS categories 1 and 2 indicate negative screening results, and women diagnosed with these categories were recommended for annual breast ultrasound screening. BI-RADS categories 3, 4, and 5 indicate positive results. Women with BI-RADS category 3 lesions were recommended for follow-up examinations every 6 months using ABUS or handheld ultrasound, while those with BI-RADS 4 and 5 lesions were suggested to undergo pathological examinations.Results:In our study, we enrolled 10 344 women who completed the ABUS screening and were followed up for more than 12 months. After remote reading, 6 164 women were diagnosed with BI-RADS category 1 and 2 626 woman were within BI-RADS category 2. In contrast, 1 404 women were within BI-RADS category 3, a total of 135 women were within BI-RADS category 4, and 15 women were within BI-RADS category 5. The positive screening rate of ABUS was 15.0% (1 554/10 344). The ABUS with remote reading had a detection rate of 3.7/1 000 (38/10 344) for breast cancer screening, with a sensitivity of 97.4% (38/39) and a specificity of 85.3% (8 789/10 305). Among the 38 breast cancer cases detected, 92.1% (35/38) were invasive carcinomas, and 63.2% (24/38) were stage 0 or Ⅰ breast cancers.Conclusions:Breast cancer screening based on ABUS with remote reading provided an efficient and feasible solution to the problem of unevenly distributed medical resources and medical staff levels in various regions of China, enabling the decentralization of high-quality medical resources and improving the accessibility of high-quality screening services. It has provided an alternative for breast cancer screening in China.
8.Factors Associated With Coronary Heart Disease Among Adult Residents in Jinjiang District,Chengdu City.
Qin-Xin LIU ; Chang SUN ; Lin-Hua LI ; Yu-Ju WU ; Yi-Shan ZHOU ; Jia-Hui MA ; Yan DU ; Lu LIU ; Huan ZHOU
Acta Academiae Medicinae Sinicae 2023;45(4):556-562
Objective To analyze the prevalence of coronary heart disease among community residents over 18 years old in Jinjiang district of Chengdu city,Sichuan province,and explore its associated factors,so as to provide a reference for the prevention and control of coronary heart disease in communities.Methods From October 15 to November 10 in 2021,a total of 5220 adult residents from 33 communities in Jinjiang were selected by multi-stage stratified random sampling for face-to-face questionnaire survey,physical examination,and laboratory blood test.Binary Logistic regression was employed to predict the factors associated with coronary heart disease among adult residents in Jinjiang.Results The crude and standard prevalence rates of coronary heart disease among 5220 adult residents were 3.39% and 2.11%,respectively.Logistic regression analysis showed that age (OR=1.068,95%CI=1.051-1.086,P<0.001),depressive symptoms (OR=1.639,95%CI=1.037-2.591,P=0.034),regular exercise (OR=0.584,95%CI=0.378-0.902,P=0.015),elevated blood pressure (OR=3.529,95%CI=2.344-5.312,P<0.001),dyslipidemia (OR=2.152,95%CI=1.291-3.587,P=0.003),and core knowledge score of chronic diseases (OR=1.144,95%CI=1.066-1.228,P<0.001) were associated with coronary heart disease among adult residents in Jinjiang.Conclusions The prevalence of coronary heart disease is high among adult residents in Jinjiang district of Chengdu.The urban residents who are older,have depressive symptoms,lack of exercise,elevated blood pressure,dyslipidemia,and score higher on core knowledge of chronic diseases are prone to coronary heart disease.
Adult
;
Humans
;
Adolescent
;
Risk Factors
;
Coronary Disease/epidemiology*
;
Hypertension
;
Surveys and Questionnaires
;
Dyslipidemias
;
China/epidemiology*
;
Prevalence
9.Relationship Between Maternal Negative Emotions and Feeding Patterns of Infants Aged 0-6 Months in Remote Rural Areas of Sichuan Province.
Chen-Fan LIAO ; Zheng-Jie CAI ; Fang-Qun LENG ; Rui-Qian WANG ; Ying LIAO ; Yu-Ju WU ; Huan ZHOU
Acta Academiae Medicinae Sinicae 2023;45(4):541-548
Objective To investigate the status of exclusive breastfeeding and bottle feeding in remote rural areas of Sichuan province and explore the relationship between negative emotions of mothers and feeding patterns of infants.Methods Multistage cluster sampling was employed to select the infants aged 0-6 months and their mothers in remote rural areas of Sichuan province.A self-designed questionnaire was used to collect the demographic characteristics of mothers and infants and the basic family information.The Chinese version of Depression Anxiety Stress scale was used to evaluate mothers' negative emotions,and the Breastfeeding Self-efficacy scale to assess the confidence level of mothers' behavior of adhering to exclusive breastfeeding.Results Totally 723 pairs of infants and their mothers were included.The exclusive breastfeeding and bottle feeding rates were 34.16% (247/723) and 57.54% (416/723),respectively.Mothers with depression tendency were less likely to adopt exclusive breastfeeding (OR=0.532,95%CI=0.291-0.974,P=0.041) and more likely to adopt bottle feeding (OR=1.877,95%CI=1.054-3.344,P=0.033).Further subgroup analysis of breastfeeding self-efficacy showed that in the group of low self-efficacy,the mothers with depression tendency were less likely to adopt exclusive breastfeeding (OR=0.461,95%CI=0.236-0.902,P=0.024) and more likely to adopt bottle feeding (OR=1.968,95%CI=1.047-3.701,P=0.036) than the mothers without depression tendency.In the group of high self-efficacy,mothers' depression,anxiety,and stress tendency had no significant correlation with infant feeding patterns (all P>0.05).Conclusions The mothers in the remote rural areas of Sichuan province are more likely to employ bottle feeding than exclusive breastfeeding.The mothers with stronger depression tendency demonstrate lower possibility of exclusive breastfeeding and higher possibility of bottle feeding.Breastfeeding self-efficacy may affect the association between maternal depression and infant feeding patterns.
Humans
;
Infant
;
Anxiety
;
China
;
Feeding Behavior
;
Self Efficacy
;
East Asian People
;
Mothers/psychology*
;
Depression/epidemiology*
10.Current Situation and Influencing Factors of Delay in Seeking Medical Treatment Among Residents in Rural Areas of Sichuan Province.
Fang-Qun LENG ; Yi-Shan ZHOU ; Chen-Fan LIAO ; Yan DU ; Yu-Ju WU ; Rui-Qian WANG ; Zhengjie CAI ; Huan ZHOU
Acta Academiae Medicinae Sinicae 2023;45(2):193-199
Objective To understand the current situation and explore the influencing factors of delay in seeking medical treatment for common symptoms of residents in the rural areas of Sichuan province. Methods In July 2019,multi-stage random sampling was carried out in Zigong city,Sichuan province,and the data were collected by face-to-face questionnaire interview.The residents who had lived at hometown for more than half a year in the past year and had seen a doctor in the most recent month were surveyed.Logistic regression was adopted to predict the influencing factors of delay in seeking medical treatment. Results A total of 342 subjects were enrolled,and the incidence of delay in seeking medical treatment was 13.45%(46/342).Compared with the young and middle-aged(<65 years)people,the elderly(≥65 years)people were more likely to have delay in seeking medical treatment (OR=2.187,95%CI=1.074-4.457,P=0.031).The rural residents who gave higher score of the overall quality of township health centers were less likely to have delay in seeking medical treatment (OR=0.854,95%CI=0.735-0.992,P=0.039). Conclusions The occurrence of delay in seeking medical treatment for common symptoms of rural residents in Sichuan province is low.Age and the overall quality evaluation of township health centers affect the occurrence of delay in medical treatment among the rural residents in Sichuan province.Efforts should be made to improve the awareness of disease prevention among the elderly in rural areas.The investment in health resources in township health centers should be increased to strengthen the introduction and training of talents.These measures can improve the health services in township health centers,guide residents to make timely use of health resources,and reduce the occurrence of delay in seeking medical treatment.
Middle Aged
;
Aged
;
Humans
;
Surveys and Questionnaires
;
Logistic Models
;
Rural Population
;
China/epidemiology*

Result Analysis
Print
Save
E-mail