1.Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
Yuan QIAO ; Fangyi MA ; Yubei HAN ; Mingyue ZHAO ; Minghuan JIANG ; Yu FANG
China Pharmacy 2025;36(2):146-153
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China, and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI, Wanfang Data, PubMed and Web of Science were systematically searched, and the retrieval time was from the inception to December 31st, 2023. The summary and analysis were performed from the aspects of theme selection, indicator system construction, evaluation methods, comprehensive decision-making, quality control, etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs, Chinese patent medicines, cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8, all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making, quality control, or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However, there are still issues and challenges such as incomplete evaluation methods and standards, few cases of evaluation results being converted into decision-making, and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored; when the evidence-based basis is insufficient, real-world research should be conducted as much as possible, so as to accelerate the policy transformation of evaluation results.
2.Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
Yuan QIAO ; Fangyi MA ; Yubei HAN ; Mingyue ZHAO ; Minghuan JIANG ; Yu FANG
China Pharmacy 2025;36(2):146-153
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China, and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI, Wanfang Data, PubMed and Web of Science were systematically searched, and the retrieval time was from the inception to December 31st, 2023. The summary and analysis were performed from the aspects of theme selection, indicator system construction, evaluation methods, comprehensive decision-making, quality control, etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs, Chinese patent medicines, cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8, all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making, quality control, or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However, there are still issues and challenges such as incomplete evaluation methods and standards, few cases of evaluation results being converted into decision-making, and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored; when the evidence-based basis is insufficient, real-world research should be conducted as much as possible, so as to accelerate the policy transformation of evaluation results.
3.Ethical considerations on the be-welling of offspring born from assisted reproductive technology
Hongping WU ; Caihong MA ; Rong LI ; Jie QIAO ; Ping LIU
Chinese Medical Ethics 2025;38(5):663-667
In recent years, the number of special clinical cases related to assisted reproductive technology (ART) for pregnancy has been on the rise annually. For example, gamete donation, assisted reproduction for couples of advanced maternal ages, and the ownership and disposition of embryos when one or both partners pass away, all involve the health of offspring and conflicts of interest in the implementation of ART. Although China’s ethical principles for ART include the protection of the offspring, the detailed rules are vague and urgently need to be supplemented and improved. In addition, the clinical application of ART lacks legislative collaborative governance. The corresponding administrative departments, practitioners, and infertile couples should work together. Starting from the perspective of focusing on the well-being of offspring born from the clinical application of ART, while conducting clinical research to address technical challenges, efforts should be made to overcome ethical dilemmas in the application of technology, comprehensively consider the well-being of offspring born from assisted reproductive treatments and help them seek the best care to promote their healthy growth.
4.Causal effects of different exercise intensities on the risk of osteoarthritis
Haoyu MA ; Hongchao QIAO ; Qianqian HAO ; Dongbo SHI
Chinese Journal of Tissue Engineering Research 2025;29(6):1305-1311
BACKGROUND:Increasing evidence supports the association between different exercise intensities and the risk of osteoarthritis,but this may be affected by confounding and reverse causality,and the conclusions have not been unified. OBJECTIVE:To explore the causal association between different exercise intensities and osteoarthritis using Mendelian randomization method. METHODS:Data from genome-wide association studies associated with different exercise intensities were selected,and instrumental variables were screened with a threshold of P<5×10-8.Causal associations between exposure and risk of outcome were assessed using five analysis methods of Mendelian randomization with inverse variance weighting as the primary analysis method.Selected instrumental variables were used to assess causal associations between different exercise intensities and osteoarthritis,and sensitivity analyses with inverse Mendelian randomization were performed. RESULTS AND CONCLUSION:In the analysis results of the inverse variance weighting method,low-intensity exercise showed a significant protective effect on knee osteoarthritis[odds ratio(OR)=0.14,95%confidence interval(CI):0.06-0.32,P<0.001],while sedentary behavior without exercise intensity,such as watching TV,was confirmed to be a risk factor for knee osteoarthritis and hip osteoarthritis(OR=2.24,95%CI:1.74-2.88,P<0.001;OR=1.34,95%CI:1.01-1.78,P=0.04).Through the reverse Mendelian randomization analysis of osteoarthritis to different exercise intensities,it was found that osteoarthritis was negatively correlated with low-intensity exercise and positively correlated with watching TV.The analysis results show that there is a two-way causal relationship between different exercise intensity and osteoarthritis risk.
5.Construction and application of the "Huaxi Hongyi" large medical model
Rui SHI ; Bing ZHENG ; Xun YAO ; Hao YANG ; Xuchen YANG ; Siyuan ZHANG ; Zhenwu WANG ; Dongfeng LIU ; Jing DONG ; Jiaxi XIE ; Hu MA ; Zhiyang HE ; Cheng JIANG ; Feng QIAO ; Fengming LUO ; Jin HUANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):587-593
Objective To construct large medical model named by "Huaxi HongYi"and explore its application effectiveness in assisting medical record generation. Methods By the way of a full-chain medical large model construction paradigm of "data annotation - model training - scenario incubation", through strategies such as multimodal data fusion, domain adaptation training, and localization of hardware adaptation, "Huaxi HongYi" with 72 billion parameters was constructed. Combined with technologies such as speech recognition, knowledge graphs, and reinforcement learning, an application system for assisting in the generation of medical records was developed. Results Taking the assisted generation of discharge records as an example, in the pilot department, after using the application system, the average completion times of writing a medical records shortened (21 min vs. 5 min) with efficiency increased by 3.2 time, the accuracy rate of the model output reached 92.4%. Conclusion It is feasible for medical institutions to build independently controllable medical large models and incubate various applications based on these models, providing a reference pathway for artificial intelligence development in similar institutions.
6.Investigation and evaluation of annual effective doses to radiation workers caused by indoor radon concentrations in underground workplaces of medical institutions
Guozhen ZHU ; Meinan YAO ; Jiayi MA ; Yongzhong MA ; Qiao MA
Chinese Journal of Radiological Health 2025;34(4):489-493
Objective To investigate the annual effective doses to radiation workers caused by radon concentrations in the underground workplaces of medical institutions, and to provide a scientific basis for the prevention and control of indoor radon in underground places. Methods A typical sampling method was used to select 5-30 medical institutions in each of Hunan, Jiangxi, Guizhou, Hubei, and Sichuan provinces. A total of 66 monitoring points in 66 medical institutions were selected. The indoor radon concentrations in underground workplaces were measured cumulatively using CR-39 solid nuclear track detectors. The radiation dose to radiation workers was estimated according to the method outlined in the Requirements for control of indoor radon and its progeny (GB/T 16146—2015). The Kruskal-Wallis H test was used to compare the differences in indoor radon concentrations between different provinces. Results The average indoor radon concentration in the underground workplaces of 66 medical institutions was 69.8 Bq/m3, with the highest being 147.6 Bq/m3. The average indoor radon concentrations in the underground workplaces of medical institutions in Sichuan, Guizhou, Hubei, Jiangxi, and Hunan were 72.1, 83.2, 66.6, 88.4, and 61.5 Bq/m3, respectively. The annual effective doses to radiation workers caused by radon concentrations in underground workplaces were 0.57-0.83 mSv, with an average of 0.69 mSv. There was a significant difference in radon concentrations among provinces (P < 0.05). Conclusion The indoor radon concentrations and personnel exposure doses in the underground workplaces of monitored medical institutions comply with national control standards. However, continuous monitoring and necessary indoor radon prevention and control measures are still needed.
7.A Case of Hereditary Angioedema
Zusha QIAO ; Yan WANG ; Yanqing WANG ; Lu YANG ; Yan MA
JOURNAL OF RARE DISEASES 2025;4(3):331-333
A 43-year-old male patient presented with recurrent edema in different anatomical sites for over 10 years, with facial edema worsening 1 day prior to admission. He had been repeatedly admitted to dermatology, general surgery, and emergency departments of external hospitals due to " acute abdomen" and " laryngeal edema, " resistant to antihistamines and glucocorticoid therapy. Physical examination revealed non-pitting swelling of the right upper eyelid, bilateral cheeks, and lips asymmetrically. On the night of admission, he developed acute laryngeal edema with dyspnea, which was promptly treated, leading to clinical stabilization. Laboratory screening during the attack revealed decreased serum complement C4 levels, along with reduced functional activity and concentration of C1 esterase inhibitor, confirming a diagnosis of type 1 hereditary angioedema. The patient received lanadelumab for prophylaxis and achieved satisfactory clinical outcomes. He remains under long-term follow-up.
8.Establishment of a closed-loop management system for the whole-process traceability of outpatient drugs based on internet of things and blockchain technology
Yanjing MA ; Jun HANG ; Yanan WANG ; Wenting JIANG ; Aiming SHI ; Jie PAN ; Peng QIAO
China Pharmacy 2025;36(20):2502-2506
OBJECTIVE To establish a closed-loop management system for the whole-process traceability of outpatient drugs based on internet of things (IoT) and blockchain technology, and evaluate its implementation effects. METHODS A closed-loop management system for the whole-process traceability of outpatient drugs covering the entire drug lifecycle was designed using drug traceability codes integrated with IoT and blockchain technology. System effectiveness was evaluated from three dimensions: work efficiency, medication management quality and data safety by comparing indicators such as the acceptance time of incoming drugs and the number of collected drug traceability codes before the system implementation (October to December 2024) and after the system implementation (January to March 2025). RESULTS A closed-loop management system for the whole-process traceability of outpatient drugs, centered around the drug traceability code management system, was successfully established. The acceptance time for incoming drugs was shortened from (4.65±0.26) h before implementation to (0.34±0.08) h after implementation (P< 0.05). The number of collected drug traceability codes increased from 419 018 to 1 236 522, and the coverage rate of traceability codes rose from 28.36% to 89.88% (P<0.05). The time pharmacists spent on drug expiry management per week decreased from (128.40±19.20) min to (0.56±0.13) min (P<0.05), and the dispensing time for a single prescription (excluding a part of injections and repackaged drugs) was reduced from (143.25±17.67) s to (15.24±10.08) s (P<0.05). The time for drug return was reduced from 129.90 (122.32, 137.00) s to 104.36 (89.91, 117.33) s(P<0.05); the number of drug dispensing errors decreased from 2 cases to 0 cases. After the system was launched, there were no data security incidents in our outpatient pharmacy. CONCLUSIONS The constructed closed-loop management system for the whole-process traceability of outpatient drugs can significantly enhance drug traceability accuracy and drug management quality, improve pharmacist work efficiency, and reduce drug management risks, thus providing a feasible solution for the digital transformation of hospital pharmaceutical services.
9.Advances in molecular mechanisms and neuronal circuits underlying circadian rhythms in Drosophila.
Wu-Yan XU ; Chun-Xue QIAO ; Fei-Xiang LI ; Ding-Bang MA
Acta Physiologica Sinica 2025;77(4):627-640
Circadian rhythms are core regulatory mechanisms that evolved to align biological functions with the Earth's rotation. These rhythms are conserved across organisms from unicellular life to multicellular species and play essential roles in metabolism, immune responses, and sleep-wake cycle. Circadian disruptions are strongly associated with various diseases. Over the past decades, genetic studies in Drosophila and mice have identified key conserved clock genes and uncovered transcription-translation feedback loops governing circadian regulation. Additionally, rhythmic neurons in the brain integrate complex neural circuits to precisely regulate physiological and behavioral rhythms. This review highlights recent advances in understanding the neuronal circuit mechanisms of rhythmic neurons in the Drosophila brain and discusses future directions for translating circadian rhythm research into chronomedicine and precision therapies.
Animals
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Circadian Rhythm/genetics*
;
Neurons/physiology*
;
Drosophila/physiology*
;
Brain/physiology*
;
Nerve Net/physiology*
10.Evidence mapping of clinical research on 35 commonly used oral Chinese patent medicines in treatment of intracerebral hemorrhage.
Wen ZHANG ; Jun-Jie JIANG ; Yong-Qing MA ; Qiao-Feng LI ; Xing LIAO ; Cheng-Yu WU
China Journal of Chinese Materia Medica 2025;50(2):555-568
Evidence mapping was used to systematically analyze the clinical research evidence of oral Chinese patent medicines in the treatment of intracerebral hemorrhage(ICH), thus revealing the distribution and quality of evidence in this field. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science from inception to July 5, 2024. The distribution characteristics of evidence were presented numerically and graphically. A total of 35 Chinese patent medicines were identified, involving 261 articles. The basic information of the 35 Chinese patent medicines, publication trend, traditional Chinese medicine(TCM) syndromes, interventions, and outcome indicators were compared and analyzed, and the methodological quality of the articles was evaluated. The results indicated that the clinical scope of Chinese patent medicines in the treatment of ICH was broad. However, the available studies inadequately emphasized the advantages and characteristics of TCM, lacked the safety information and the standards for evaluating outcome indicators, and paid insufficient attention to cognitive ability and neuropsychology. In addition, these articles demonstrated low quality. It is recommended that follow-up clinical research should be standardized and highlight the characteristics of TCM. In the analysis of outcome indicators, TCM syndrome evaluation should be taken as an important outcome indicator, and the evaluation criteria should be unified. Moreover, more attention should be paid to patients' cognitive ability and neuropsychology. The holder of marketing license of Chinese patent medicines should standardize the clinical position and improve the safety information in the medicine instructions according to the relevant requirements of the National Medical Products Administration. Additionally, the proportion of Chinese patent medicines in the category A list of medical insurance should be increased, and the limited medical resources should be rationally allocated.
Cerebral Hemorrhage/drug therapy*
;
Humans
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Drugs, Chinese Herbal/therapeutic use*
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Medicine, Chinese Traditional
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Nonprescription Drugs/administration & dosage*
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Administration, Oral

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