1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Textual Research on Key Information of Classic Formula Shengma Gegentang
Yuli LI ; Ping JIANG ; Zhenyi YUAN ; Yuanyuan HE ; Ya'nan MAO ; Shasha WANG ; Wenyan ZHU ; Zhouan YIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):187-197
Shengma Gegentang is one of the classic formulas in the Catalogue of Ancient Classic Prescriptions (Second Batch). This study reviewed ancient and modern literature and used literature tracing and bibliometric methods to analyze the historical evolution, efficacy, indications, dosage decoctions, and modern clinical disease spectrum of Shengma Gegentang. The results indicated that the earliest record of Shengma Gegentang can be found in the Taiping Huimin Heji Jufang of the Song dynasty, but its origin can be traced back to the Shaoyao Siwu Jiejitang in the Beiji Qianjin Yaofang of the Tang dynasty. The composition dosage of Shengma Gegentang is 413 g of Cimicifugae Rhizoma, 619.5 g of Puerariae Lobatae Radix, 413 g of Paeoniae Radix Alba, and 413 g of Glycyrrhizae Radix et Rhizoma, which are ground into coarse powder. Each dose is 12.39 g, and the amount of water added is 300 mL. 100 mL of solution is decocted and taken at the right time. The four drugs in the formula play the role of relieving exterior syndrome, penetrating pathogenic factors, and detoxicating together. Its indications are widely involved in internal medicine, pediatrics, surgery, ophthalmology and otorhinolaryngology, obstetrics and gynecology, sexually transmitted diseases, and other diseases, such as measles, sores, acne, spots, surgical gangrene, red eyes, toothache, chancre, and fetal poison. The epidemic diseases treated by Shengma Gegentang are complicated, including rash, pox, macula, numbness, summer diarrhea, dysentery, sha disease, febrile symptoms, spring warmth, winter warmth, and cold pestilence. At the same time, it is a plague prevention formula. Although Shengma Gegentang has a wide range of indications, it cannot be separated from the pathogenic mechanism of evil Qi blocking the muscle surface and heat in the lungs and stomach. The modern clinical disease spectrum of Shengma Gegentang involves the ophthalmology and otorhinolaryngology system, nervous system, pediatric-related diseases and syndromes, skin system, hepatobiliary system, and digestive system. It plays a key role in the treatment of epidemic diseases such as measles, chronic hepatitis B, dysentery, and tetanus.
4.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
5.Iodine Nutrition,Thyroid-stimulating Hormone,and Related Factors of Postpartum Women from three Different Areas in China:A Cross-sectional Survey
Yun Xiao SHAN ; Yan ZOU ; Chun Li HUANG ; Shan JIANG ; Wen Wei ZHOU ; Lan Qiu QIN ; Qing Chang LIU ; Yan Xiao LUO ; Xi Jia LU ; Qian De MAO ; Min LI ; Yu Zhen YANG ; Chen Li YANG
Biomedical and Environmental Sciences 2024;37(3):254-265
Objective Studies on the relationship between iodine,vitamin A(VA),and vitamin D(VD)and thyroid function are limited.This study aimed to analyze iodine and thyroid-stimulating hormone(TSH)status and their possible relationships with VA,VD,and other factors in postpartum women. Methods A total of 1,311 mothers(896 lactating and 415 non-lactating)from Hebei,Zhejiang,and Guangxi provinces were included in this study.The urinary iodine concentration(UIC),TSH,VA,and VD were measured. Results The median UIC of total and lactating participants were 142.00 μg/L and 139.95 μg/L,respectively.The median TSH,VA,and VD levels in all the participants were 1.89 mIU/L,0.44 μg/mL,and 24.04 ng/mL,respectively.No differences in the UIC were found between lactating and non-lactating mothers.UIC and TSH levels were significantly different among the three provinces.The rural UIC was higher than the urban UIC.Obese mothers had a higher UIC and a higher prevalence of excessive TSH.Higher UICs and TSHs levels were observed in both the VD deficiency and insufficiency groups than in the VD-sufficient group.After adjustment,no linear correlation was observed between UIC and VA/VD.No interaction was found between vitamins A/D and UIC on TSH levels. Conclusion The mothers in the present study had no iodine deficiency.Region,area type,BMI,and VD may be related to the iodine status or TSH levels.
6.Serological evaluation and antibody prediction model for inactivated COVID-19 vaccination in school children
Li ZHANG ; Yingfeng CHEN ; Chuanwu MAO ; Yuyang XIE ; Pinkai YE ; Xiaolian DONG ; Lufang JIANG ; Qingwu JIANG
Shanghai Journal of Preventive Medicine 2024;36(4):368-374
ObjectiveTo determine the serum antibody level and risk factors in the adolescent population in a county in Zhejiang Province, following the immunization with inactivated COVID-19 vaccine, and to construct a prediction model for antibody concentration. MethodsWe conducted the study in a county in Zhejiang Province, employing a stratified cluster random sampling strategy in school children who had received the inactivated COVID-19 vaccine. Data on gender, age, type of vaccine, and time of vaccination was collected. Serum samples were also collected to test for anti-S and N IgG antibody against the SARS-CoV-2 by using chemiluminescent immunoassay (CLIA). Risk factors were determined to construct a prediction model for antibody concentration. ResultsThe IgG antibody concentration was significantly higher in girls, those who received two doses, and those who had simply received the KX vaccine . It decreased with age and time interval between the sampling and last vaccination. The prediction model constructed by random forest regression in the study had a better model fit and predictive ability than that by the multivariable linear stepwise regression. ConclusionGender, age, vaccination dose, type of vaccine, and time of vaccination are associated with vaccination effectiveness of inactivated COVID-19 vaccines in adolescents. Prediction model could predict the antibody level in the vaccinated population, which can provide a new tool for better evaluation of vaccination effectiveness against emerging infectious diseases in future.
7.Developing Syllabus for Rare Breast Diseases Using the Integrated Multimodality of Case-/Problem-/Resource-Based Learning
Ru YAO ; Jiahui ZHANG ; Jie LIAN ; Yang QU ; Xinyue ZHANG ; Xin HUANG ; Lu GAO ; Jun ZHAO ; Li HUANG ; Yingzi JIANG ; Linzhi LUO ; Songjie SHEN ; Feng MAO ; Qiang SUN ; Bo PAN ; Yidong ZHOU
JOURNAL OF RARE DISEASES 2024;3(3):391-399
Objective This study aims at establishing a teaching catalog and content for breast rare dis-eases and developing the syllabus for the breast rare disease using integrated multimodality of case-/problem-/resource-based learning(CBL+PBL+RBL).Methods By conducting bibliometrics co-occurrence analysis,we collected 6291 articles on breast rare disease published from January,1975 to June,2024.Additionally,we re-trieved the Textbook on Rare Diseases,the Catalog of Chinese Rare Disease,and Second Batch of Rare Dis-ease Catalog and then decided the teaching content.Results From 16,387 keywords,1000(6.1%)keywords were identified through co-occurrence analysis,including 50(0.3%)candidate diseases.These were classified into three categories:rare primary breast diseases,rare genetic mutation-related diseases associated with breast cancer,and rare systemic multi-system diseases involving the breast.From the candidate list,20(0.1%)rare primary breast diseases were further selected for their notable clinical teaching significance,and significant multi-systemic diseases affecting the breast,whether related to gene mutations or not.Teaching plans were draf-ted using a diversified parallel teaching approaches,taking into account the characteristics of different diseases and the focus of different teaching methods.Conclusions This study initiated the development of the teaching content for breast rare diseases and developed the teaching syllabus using the CBL+PBL+RBL integrated multi teaching model and targeting each rare breast disease for the critical point for teaching.
8.Analysis of iodine nutritional status of children aged 8-10 years in Zhejiang Province from 2016 to 2021
Guangming MAO ; Zhe MO ; Simeng GU ; Yuanyang WANG ; Yujie JIANG ; Yahui LI ; Xueqing LI ; Zhijian CHEN ; Xiaofeng WANG ; Xiaoming LOU ; Chenyang LIU
Chinese Journal of Preventive Medicine 2024;58(1):11-17
Objective:To analyze the iodine nutrition status of children aged 8 to 10 years in Zhejiang Province from 2016 to 2021.Methods:A multi-stage stratified sampling method was used to select non-residential children aged 8 to 10 years from 90 counties in Zhejiang Province. A total of 114 103 children were included in the study from 2016 to 2021. Direct titration method and arsenic-cerium catalytic spectrophotometry were used to detect salt iodine content and urinary iodine level, respectively, to evaluate the iodine nutritional status of children. Ultrasound was used to detect thyroid volume and analyze the current prevalence of goiter in school-age children.Results:The age of 114 103 children was (9.04 ± 0.81) years old, with 50.0% of (57 083) boys. The median of iodine content M ( Q1, Q3) in children's household salt was 23.00 (19.80, 25.20) mg/kg, including 17 242 non-iodized salt, 6 173 unqualified iodized salt, and 90 688 qualified iodized salt. The coverage rate of iodized salt was 84.89%, and the coverage rate of qualified iodized salt was 79.48%. The proportion of non-iodized salt increased from 11.85% in 2016 to 16.04% in 2021 ( χ 2trend=111.427, P<0.001). The median of urinary iodine concentration M ( Q1, Q3) in children was 182.50 (121.00, 261.00) μg/L, among which the proportions of iodine deficiency, iodine suitability, iodine over suitability, and iodine excess were 17.25% (19 686 cases), 39.21% (44 745 cases), 26.85% (30 638 cases), and 16.68% (19 034 cases), respectively. The median of urinary iodine concentration in children in inland areas [ M ( Q1, Q3): 190.90 (128.80, 269.00) μg/L] was significantly higher than that in children in coastal areas [ M ( Q1, Q3): 173.00 (113.00, 250.30) μg/L] ( P<0.001). From 2016 to 2021, a total of 39 134 ultrasound examinations were conducted, and 1 229 cases of thyroid enlargement were detected. The goiter rate was 3.14% (95% CI: 2.97%-3.32%). The incidence of goiter in children in coastal areas [3.45% (95% CI: 3.19%-3.72%), 641/18 604] was higher than that in children in inland areas [2.86% (95% CI: 2.64%-3.10%), 588/20 530] ( P=0.001). Conclusion:From 2016 to 2021, the iodine nutrition level of children aged 8-10 years in Zhejiang Province is generally suitable, and the rate of goiter in children meets the limit of iodine deficiency disease elimination standards.
9.The ninth edition of TNM staging for lung cancer: precise staging for precise diagnosis and treatment
Hanyue LI ; Yiyang WANG ; Hui LIU ; Hongxu LIU ; Liyan JIANG ; Yuchen HAN ; Wenyong ZHOU ; Teng MAO ; Wentao FANG
Chinese Journal of Surgery 2024;62(6):537-542
The ninth edition of TNM staging for lung cancer has been announced at the 2023 World Lung Cancer Congress and implemented from January 1, 2024. The focus of the ninth TNM staging change is dividing N2 into N2a and N2b, as well as M1c into M1c1 and M1c2. Although the T staging has not changed, it has played an important role in verifying the eighth edition of the T staging. The subdivision of stage N2 has led some patients with ⅢA of the eighth edition to experience ascending or descending stages, which will more accurately help to assess the condition and prognosis of patients with mediastinal lymph node metastasis, as well as the design of related clinical studies. Modifying the M1c staging will help define oligometastasis and explore new treatment models in the future. The ninth edition of the TNM staging system provides a more detailed division of different tumor loads, but there is no clear explanation for the staging of lung cancer after neoadjuvant therapy. Further data analysis is needed, and it is expected to be answered in the tenth edition of TNM staging.
10.Carrier screening for 223 monogenic diseases in Chinese population:a multi-center study in 33 104 individuals
Wei HOU ; Xiaolin FU ; Xiaoxiao XIE ; Chunyan ZHANG ; Jiaxin BIAN ; Xiao MAO ; Juan WEN ; Chunyu LUO ; Hua JIN ; Qian ZHU ; Qingwei QI ; Yeqing QIAN ; Jing YUAN ; Yanyan ZHAO ; Ailan YIN ; Shutie LI ; Yulin JIANG ; Manli ZHANG ; Rui XIAO ; Yanping LU
Journal of Southern Medical University 2024;44(6):1015-1023
Objective To investigate the epidemiological characteristics and mutation spectrum of monogenic diseases in Chinese population through a large-scale,multicenter carrier screening.Methods This study was conducted among a total of 33 104 participants(16 610 females)from 12 clinical centers across China.Carrier status for 223 genes was analyzed using high-throughput sequencing and different PCR methods.Results The overall combined carrier frequency was 55.58%for 197 autosomal genes and 1.84%for 26 X-linked genes in these participants.Among the 16 669 families,874 at-risk couples(5.24%)were identified.Specifically,584 couples(3.50%)were at risk for autosomal genes,306(1.84%)for X-linked genes,and 16 for both autosomal and X-linked genes.The most frequently detected autosomal at-risk genes included GJB2(autosomal recessive deafness type 1A,393 couples),HBA1/HBA2(α-thalassemia,36 couples),PAH(phenylketonuria,14 couples),and SMN1(spinal muscular atrophy,14 couples).The most frequently detected X-linked at-risk genes were G6PD(G6PD deficiency,236 couples),DMD(Duchenne muscular dystrophy,23 couples),and FMR1(fragile X syndrome,17 couples).After excluding GJB2 c.109G>A,the detection rate of at-risk couples was 3.91%(651/16 669),which was lowered to 1.72%(287/16 669)after further excluding G6PD.The theoretical incidence rate of severe monogenic birth defects was approximately 4.35‰(72.5/16 669).Screening for a battery of the top 22 most frequent genes in the at-risk couples could detect over 95%of at-risk couples,while screening for the top 54 genes further increased the detection rate to over 99%.Conclusion This study reveals the carrier frequencies of 223 monogenic genetic disorders in the Chinese population and provides evidence for carrier screening strategy development and panel design tailored to the Chinese population.In carrier testing,genetic counseling for specific genes or gene variants can be challenging,and the couples need to be informed of these difficulties before testing and provided with options for not screening these genes or gene variants.

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