1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
2.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
4.Study on the extraction, separation and purification process of Actinoside E
Fangliang QIAO ; Yiping JIANG ; Tianshuang XIA ; Aijun LIU ; Kai ZHAO ; Hailiang XIN
Journal of Pharmaceutical Practice and Service 2026;44(3):137-143
Objective To optimize the extraction, separation and purification process of Actinoside E. Methods Single factor experiment combined with orthogonal test was used to determine the optimal extraction process of Actinoside E using its content as an index. The extracts were separated and purified by optimizing the chromatographic conditions of macroporous resin, silica gel and ODS column. Results 25 times amount of 55% ethanol with heating reflux at 95℃ for one hour were used as the optimal extraction process of Actinoside E. The optimum separation and purification process was as follows: D101 macroporous resin column was eluted with 7 BV of 50% ethanol, silica gel column was eluted with 5 BV of ethyl acetate-ethanol(10∶1)and 50% methanol eluted fraction was purified repeatedly by ODS column to obtain Actinoside E. The transfer rate of Actinoside E in the whole process was 53.70%, the yield was 0.35%, and the purity was 99.9%. Conclusion The process is stable and viable, which can provide material foundation for the development and utilization of Actinoside E.
5.Analysis of undernutrition and associated factors among left behind and nonleftbehind primary and secondary school students in the Nutrition Improvement Program areas in central and western China
Chinese Journal of School Health 2026;47(3):327-331
Objective:
To investigate the prevalence of undernutrition and its associated factors among left behind and non left behind primary and secondary school students in the Nutrition Improvement Program for Rural Compulsory Education Students (NIPRCES) areas of central and western China, so as to provide evidence for improving the nutritional status of children and adolescents.
Methods:
A survey was conducted among 123 782 students selected by random cluster sampling method in grades 3-9 from NIPRCES in central (Hebei, Shanxi, Heilongjiang, Jilin, Anhui, Jiangxi, Henan, Hunan, Hubei, and Hainan) and western (Gansu, Guangxi, Inner Mongolia, Ningxia, Tibet, Shaanxi, Guizhou, Sichuan, Xinjiang, the Xinjiang Production and Construction Corps, Yunnan, Qinghai, and Chongqing) China in 2023. Anthropometric measurements and questionnaires were used to assess nutritional and dietary status. The prevalence of undernutrition was compared between left behind and non left behind students by Chi square test, and associated factors were analyzed by three level Logistic mixed effects model.
Results:
The prevalence of undernutrition was 8.5% (4 326) in left behind students and 8.1% (5 905) in non left behind students. Three level Logistic mixed effect model analysis showed that whether left behind or non left behind, the undernutrition rates of primary and secondary students in western regions were higher than those of students in central regions [ OR (95% CI )=1.72(1.57-1.87),2.25(2.07- 2.43 )]; the undernutrition risk was lower for those whose fathers had a cultural level of high school or above [ OR (95% CI )=0.69(0.62-0.77),0.90(0.82-0.98)] or junior high school [ OR (95% CI )=0.72(0.66-0.79),0.92(0.85-0.99)] compared to those with primary school or below; picky eating or selective eating increased the risk of undernutrition [ OR (95% CI )=2.36(2.07-2.68),2.28(2.04-2.55)], and primary and secondary school students without nutritional content in health education classes had higher rates of undernutrition [ OR (95% CI )=1.12(1.03-1.23),1.09(1.01-1.17)](all P <0.05).
Conclusion
The prevalence of undernutrition is slightly higher in left behind primary and secondary students than in non left behind primary and secondary students in central and western NIPRCES areas, with variations across different characteristics.
6.Analysis of characteristics of newly reported HIV positive male student cases in Jiangsu Province from 2023 to 2024
LIU Xiaoyan, CHEN Yuheng, SHI Hongjie, NING Xin, ZHANG Ying, YANG Dandan
Chinese Journal of School Health 2026;47(3):425-429
Objective:
To investigate the characteristics and potential risk factors associated with HIV infection among newly reported HIV positive male student cases in Jiangsu Province from 2023 to 2024, so as to provide evidence for targeted intervention strategies.
Methods:
Data were obtained from the China CDC Surveillance System on newly reported HIV positive male student cases from 2023 to 2024. A survey was conducted to collect information on demographic characteristics, knowledge of AIDS prevention, education and training history, HIV testing history, behavioral and substance use patterns, and other relevant factors prior to HIV diagnosis among 343 newly reported HIV positive male student cases in Jiangsu Province. Multivariate Logistic regression analysis was used to assess the risk factors of HIV infection among male students.
Results:
Among the HIV positive male student cases, homosexual behavior accounted for 93.88% of transmission routes, while 10.20% involved heterosexual contact, as well as 4.08% for two sexual hehaviors. Awareness of HIV prevention knowledge was 97.08%, and 66.76% had previously undergone HIV testing. Among the respondents, 10.50% had used rush poppers as enhancers, and 72.30% had received HIV prevention education within the past year. Among students cases with homosexual behavior, the median time from first homosexual contact to HIV diagnosis was ≤2 years, with 54.66% of cases falling into this category; the most common way of finding same sex partners was through social software, accounting for 88.20% of cases, while the proportion of those via "Blued" app reached 87.07% ; the proportion of using condoms every time during sexual activity in the past six months was 12.27%. Among the student cases with homosexual behavior, the results of multiple Logistic regression analysis showed that student cases aged 18 to 24 ( OR =4.52) and >24 ( OR = 19.23 ), without receiving education on HIV prevention in the past year ( OR =1.86), having consistent condom use ( OR =2.73) and not using condoms ( OR =2.12) during the last sexual activity were more likely to had the first same sex sexual activity for more than 3 years before being diagnosed as HIV positive cases (all P <0.05). Student cases who were uncertain about their partner s sexual identity ( OR =0.33), and who primarily identified same sex partners through "other" means ( OR = 0.23 ) were more likely to avoid HIV testing; in contrast, student cases with consistent condom use during the last homosexual encounter ( OR =7.20) was significantly associated with increased likelihood of HIV testing (all P <0.05).
Conclusions
Newly reported HIV positive male student cases in Jiangsu Province exhibit serious discrepancies between knowledge and practice regarding HIV prevention. Measures are needed to accelerate the optimization of campus based HIV prevention education content and delivery methods. Simultaneously, enhanced management of extracurricular male populations is essential to effectively control the spread of HIV.
7.Staged Efficacy of Qijia Rougan Prescription Combined with Entecavir for Chronic Hepatitis B-related Hepatic Fibrosis with Qi Deficiency and Collateral Stasis Syndrome Based on "Zhu Ke Jiao" Theory
Baixue LI ; Xin WANG ; Jibin LIU ; Li WEN ; Cen JIANG ; Wenjun WU ; Dong WANG ; Shuwan LIU ; Huabao LIU ; Yongli ZHENG ; Liang HUANG ; Yue SU ; Song ZHANG ; Yanan SHANG ; Hang ZHOU ; Quansheng FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):180-188
ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory, Qijia Rougan prescription, combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted, and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis (CHB-HF) who met the diagnosis and inclusion criteria were randomly assigned to an observation group (Qijia Rougan prescription + entecavir) and a control group (entecavir). The treatment duration was 24 weeks. Liver stiffness measurement (LSM), fibrosis-4 index (FIB-4), portal vein diameter, hepatitis B serology, biochemical indicators, hepatic fibrosis markers in serum [hyaluronic acid (HA), laminin (LN), procollagen Ⅲ peptide (PⅢP), and type Ⅳ collagen (Ⅳ-C)], and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis, with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment, the observation group showed a significant reduction in LSM and FIB-4 (P<0.01), as well as notable improvements in LN, Ⅳ-C, and various TCM syndrome scores (P<0.05, P<0.01). When compared to the control group after treatment, the observation group demonstrated significant improvements in LSM, FIB-4, and various TCM syndrome score indicators (P<0.05, P<0.01), indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment, the observation group had better improvement in regression of stages F2 and F3 (P<0.05). When compared to the control group after treatment, the observation group exhibited superior improvement in regression of stage F3 (P<0.05). No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone, the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3, which is a potential “interception” point of the “Zhu Ke Jiao” theory.
8.A Case of Autologous Reconstruction with TRAM Flap Combined with Contralateral Reduction in Lactational Patient with Breast Cancer and Macromastia
Weifang ZHANG ; Yueyao SUN ; Yanjun LIU ; Yifang WANG ; Xin CHEN ; Jie ZHANG ; Mengyang AN ; Bo LIU ; Fangjian SHANG
Cancer Research on Prevention and Treatment 2026;53(3):233-236
9.OBE-CDIO model of teaching for curriculum of exercise rehabilitation training
Hua LIU ; Liyuan WANG ; Xin MA ; Jing LI ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(3):270-275
ObjectiveTo investigate the effectiveness of teaching pedagogy based on outcome-based education (OBE) and conceive-design-implement-operate (CDIO) model in the teaching of exercise rehabilitation training. MethodsTwenty-seven postgraduate students majoring in exercise rehabilitation training of grade 2024 at Capital University of Physical Education and Sports were randomly divided into control group (n = 13) and experimental group (n = 14). The control group received routine teaching methods, while the experimental group received teaching of OBE-CDIO. After the course, theoretical scores, objective structured clinical examination (OSCE) scores and teaching satisfaction via questionnaire were compared between two groups. ResultsAfter the course, there was no significant difference in theoretical scores between two groups (t = 1.103, P > 0.05). Scores in all stations of OSCE were higher in the experimental group than in the control group (t > 2.181, P < 0.05), as well as the satisfaction scores of learning, enthusiasm, organization, group interaction, individual affinity, workload and examination (|t| > 3.781, P < 0.001). ConclusionThe teaching pedagogy based on the OBE-CDIO model can improve practical competence and teaching satisfaction among postgraduate students majoring in exercise rehabilitation training.
10.OBE-CDIO model of teaching for curriculum of exercise rehabilitation training
Hua LIU ; Liyuan WANG ; Xin MA ; Jing LI ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(3):270-275
ObjectiveTo investigate the effectiveness of teaching pedagogy based on outcome-based education (OBE) and conceive-design-implement-operate (CDIO) model in the teaching of exercise rehabilitation training. MethodsTwenty-seven postgraduate students majoring in exercise rehabilitation training of grade 2024 at Capital University of Physical Education and Sports were randomly divided into control group (n = 13) and experimental group (n = 14). The control group received routine teaching methods, while the experimental group received teaching of OBE-CDIO. After the course, theoretical scores, objective structured clinical examination (OSCE) scores and teaching satisfaction via questionnaire were compared between two groups. ResultsAfter the course, there was no significant difference in theoretical scores between two groups (t = 1.103, P > 0.05). Scores in all stations of OSCE were higher in the experimental group than in the control group (t > 2.181, P < 0.05), as well as the satisfaction scores of learning, enthusiasm, organization, group interaction, individual affinity, workload and examination (|t| > 3.781, P < 0.001). ConclusionThe teaching pedagogy based on the OBE-CDIO model can improve practical competence and teaching satisfaction among postgraduate students majoring in exercise rehabilitation training.


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