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.Principles, technical specifications, and clinical application of lung watershed topography map 2.0: A thoracic surgery expert consensus (2024 version)
Wenzhao ZHONG ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Wei JIANG ; Deping ZHAO ; Hecheng LI ; Xiaolong YAN ; Lijie TAN ; Junqiang FAN ; Guibin QIAO ; Qiang NIE ; Mingqiang KANG ; Weibing WU ; Hao ZHANG ; Zhigang LI ; Zihao CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):141-152
With the widespread adoption of low-dose CT screening and the extensive application of high-resolution CT, the detection rate of sub-centimeter lung nodules has significantly increased. How to scientifically manage these nodules while avoiding overtreatment and diagnostic delays has become an important clinical issue. Among them, lung nodules with a consolidation tumor ratio less than 0.25, dominated by ground-glass shadows, are particularly worthy of attention. The therapeutic challenge for this group is how to achieve precise and complete resection of nodules during surgery while maximizing the preservation of the patient's lung function. The "watershed topography map" is a new technology based on big data and artificial intelligence algorithms. This method uses Dicom data from conventional dose CT scans, combined with microscopic (22-24 levels) capillary network anatomical watershed features, to generate high-precision simulated natural segmentation planes of lung sub-segments through specific textures and forms. This technology forms fluorescent watershed boundaries on the lung surface, which highly fit the actual lung anatomical structure. By analyzing the adjacent relationship between the nodule and the watershed boundary, real-time, visually accurate positioning of the nodule can be achieved. This innovative technology provides a new solution for the intraoperative positioning and resection of lung nodules. This consensus was led by four major domestic societies, jointly with expert teams in related fields, oriented to clinical practical needs, referring to domestic and foreign guidelines and consensus, and finally formed after multiple rounds of consultation, discussion, and voting. The main content covers the theoretical basis of the "watershed topography map" technology, indications, operation procedures, surgical planning details, and postoperative evaluation standards, aiming to provide scientific guidance and exploration directions for clinical peers who are currently or plan to carry out lung nodule resection using the fluorescent microscope watershed analysis method.
4.Epidemiological characteristics and influencing factors of the cluster outbreaks of influenza-like illness in Yangpu District, Shanghai, 2012‒2022
Qianru XIE ; Chenyan JIANG ; Fangfang TAO ; Peng QIAO
Shanghai Journal of Preventive Medicine 2025;37(4):319-323
ObjectiveTo analyze the epidemiological characteristics and influencing factors of clustered influenza-like illness (ILI) outbreaks in Yangpu District, Shanghai from 2012 to 2022, and to provide a scientific basis for formulating specific prevention and control measures of influenza in this district. MethodsData on clustered ILI outbreaks from 2012 to 2022 were collected, and the epidemiological pattern of the cluster outbreaks of influenza and its influencing factors of prevalence and duration were explored using statistical methods such as descriptive epidemiology, χ² test and logistic regression analysis. ResultsA total of 60 clustered ILI outbreaks were reported in Yangpu District, Shanghai from 2012 to 2022, with a cumulative number of 543 cases and an annual average incidence rate of 16.96%. The male-to-female ratio was1.06∶1. The largest number of ILI were reported in 2019, mainly from November to January of the next year, with December being the peak of outbreaks. The Streets of Changhai Rd. in Yangpu District had the largest number of reported outbreaks, accounting for 30.00% of the total outbreaks. Influenza cluster outbreaks occurred in schools, with the majority of outbreaks and cases reported in primary schools (accounting for 65.00% and 62.06% of the total, respectively). The outbreaks were mainly caused by influenza B virus, accounting for 50% of the total number of outbreaks. The prevalence rate of influenza cluster outbreaks varied among different schools in terms of their affiliated streets, school attributes and school types, with those in Kongjiang Rd. Subdistrict, private schools, and childcare institutions being relatively high. The duration of outbreaks reported for >2 days was longer than those reported for ≤2 days (OR=8.604, 95%CI: 1.509–49.067). ConclusionThe ILI outbreaks in Yangpu District present a seasonal pattern, with primary schools and Changhai Rd. Street as the targeted places for implementing prevention and control measures. Timely detection and reporting and active disposal can prevent a further spread of the outbreaks.
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.Relationship between non-suicidal self-injury behavior and self-stigma in adolescents with mood disorder: the chained mediation role of self-esteem and social avoidance/distress
Tianmei TAO ; Qiao JIANG ; Jia LUO
Sichuan Mental Health 2025;38(4):333-339
BackgroundNon-suicidal self-injury (NSSI) in adolescents is a serious global public health issue. Self-stigma is identified as a key factor hindering adolescents from seeking professional psychological help, while only a few studies have dealt with the self-stigma in adolescents with mood disorder exhibiting NSSI behavior. ObjectiveTo investigate the influencing factors of self-stigma among adolescents with mood disorder who exhibit NSSI behavior, and to examine the chained mediation role of self-esteem and social avoidance/distress in the relationship between NSSI behavior and self-stigma, with the aim of providing references for the detection and intervention of self-stigma in such patients. MethodsA total of 220 consecutive adolescent patients with mood disorder who met "the International Classification of Diseases, Tenth Edition"(ICD-10) diagnostic criteria for depressive disorder or depressive episode of bipolar disorder and attended the Fourth People's Hospital of Wuhu from November 2022 to November 2023 were recruited. The Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ), Internalized Stigma of Mental Illness (ISMI) Scale, Self-Esteem Scale (SES), and Social Avoidance/Distress Scale (SADS) were employed to assess the participants. Correlation among variables was evaluated using Pearson's correlation coefficient. Multivariate linear regression analysis was utilized to identify the factors influencing self-stigma among adolescent patients with mood disorder exhibiting NSSI. The proposed mediating hypotheses were tested using Model 6 in the SPSS Process macro (version 3.0). ResultsValid responses were received from 204/220 (92.73%) participants, including 153 cases with NSSI and 51 cases without NSSI. The NSSI (vs. no NSSI) group reported significantly higher scores on ISMI and SADS (t=-5.187, -4.564, P<0.01), and lower scores on SES (t=4.478, P<0.01). In the NSSI group, the total score of ISMI demonstrated a positive correlation with the total score of SADS and the behavioral questionnaire score in ANSAQ (r=0.644, 0.316, P<0.01), and a negative correlation with the total score of SES (r=-0.724, P<0.01). Multivariate linear regression analysis revealed that NSSI severity (β=0.132, P<0.05) and social avoidance/distress (β=0.309, P<0.01) were found to be positive predictors of the self-stigma, whereas self-esteem (β=-0.493, P<0.01) was a significant negative predictor of the self-stigma. Additionally, self-esteem and social avoidance/distress partially mediated the relationship between NSSI and self-stigma, with a mediating effect of 0.237 (95% CI: 0.103~0.374), which constituted 55.89% of the total effect. The mediating effect included two paths: NSSI behavior→self-esteem→self-stigma (effect size was 0.163, 95% CI: 0.069~0.273) and NSSI behavior→self-esteem→social avoidance/distress→self-stigma (effect size was 0.063, 95% CI: 0.020~0.119). ConclusionThe severity of NSSI can affect self-stigma in adolescents with mood disorders either directly through mediating self-esteem or indirectly through the chained mediation path of self-esteem and social avoidance/distress.[Funded by Scientific Research Projects of Wuhu Fourth People's Hospital in 2000(number,kjxm202203)]
7.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.
8.Genetic characteristics of VP1 region of Coxsackievirus A10 in Yunnan Province
Yihui CAO ; Bingjun TIAN ; Zhichao WANG ; Jianping CUN ; Xiaofang ZHOU ; Lili JIANG ; Enfa QIAO
Journal of Public Health and Preventive Medicine 2025;36(6):25-29
Objective To investigate the genetic characteristics of the VP1 region of Coxsackievirus A10 (CVA10) in Yunnan Province. Methods Fecal samples of suspected hand, foot and mouth disease (HFMD) were subjected to real-time fluorescent quantitative PCR for detection of enterovirus CVA10. Positive samples were subjected to VP1 gene sequence amplification and Sanger sequencing. Sequence splicing was performed with DNAstar7.1 Seqman software, and nucleotide sequence and amino acid site analysis were performed using Mega 6.0 software. Results The sequencing of VP1 gene of CVA10 obtained a sequence of 894 nucleotides, encoding 298 amino acids. Compared with the original strain, there were mainly three active amino acid mutation regions, 13-33, 141-142, and 283-285. The nucleotide difference rate between the Yunnan isolates and the reference strain ranged from 16.92% to 30.90%, and the amino acid difference rate ranged from 2.58% to 4.00%. C1 and C2 group nucleotide difference was 10.58%, and the amino acid difference rate was 1.80%. The VP1 150-176 region exhibited highly conserved characteristics. Six CVA10 strains and Sichuan strain MW178898 belonged to the C1 group of the C genotype. The other 14 CVA10 strains belonged to the C2 group. Conclusion VP1 gene mutation is active and CVA10 is an important pathogen of HFMD in Yunnan. C2 genotype of CVA10 is dominant in this study, and C1 and C2 have co-circulated in Yunnan. It is necessary to strengthen monitoring and develop multivalent vaccines containing CVA10 epidemic genotype.
9.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
;
Drugs, Chinese Herbal/therapeutic use*
;
Medicine, Chinese Traditional
;
Nonprescription Drugs/administration & dosage*
;
Administration, Oral
10.Analysis of correlation between Barthel index score and preoperative occurrence of deep vein thrombosis in patients undergoing total hip arthroplasty revision surgery.
Ying SHEN ; Yao YAO ; Liang QIAO ; Dengxian WU ; Xinhua LI ; Qing JIANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(2):158-162
OBJECTIVE:
To explore the correlation between the Barthel index score and other factors with the preoperative occurrence of deep vein thrombosis (DVT) in patients undergoing total hip arthroplasty (THA) revision surgery.
METHODS:
A retrospective analysis was conducted on clinical data from 122 patients who met the inclusion criteria and underwent THA revision surgery between April 2017 and November 2020. Among them, 61 were male and 61 were female, with an age range of 32-85 years (mean, 65.3 years). The reasons for revision included prosthetic joint infection in 7 cases, periprosthetic fracture in 4 cases, prosthetic dislocation in 6 cases, and aseptic loosening in 105 cases. The Barthel index score was 76.4±17.7, with 10 cases classified as level 1, 57 as level 2, 37 as level 3, and 18 as level 4. Univariate analysis was performed on variables such as age, gender, body mass index, Barthel index score, preoperative D-dimer positivity, history of diabetes, hypertension, cancer, cerebral infarction, smoking, and thrombosis in patients with and without preoperative DVT. Furthermore, logistic regression was used to identify risk factors for preoperative DVT in THA revision surgery. The incidence of preoperative DVT was compared among different Barthel index score groups.
RESULTS:
Preoperative DVT was detected in 11 patients (9.02%), all of whom had intermuscular venous thrombosis. Among them, 1 had prosthetic joint infection, 1 had periprosthetic fracture, 1 had prosthetic dislocation, and 8 had aseptic loosening. Univariate analysis showed significant differences between the two groups in terms of age, gender, and Barthel index score ( P<0.05). logistic regression further revealed that female, age ≥70 years, and Barthel index score<60 were independent risk factors for preoperative DVT in patients undergoing THA revision surgery ( P<0.05). The incidence of preoperative DVT in patients with Barthel index scores of levels 1, 2, 3, and 4 were 0 case (0%), 2 cases (3.5%), 3 cases (8.1%), and 6 cases (33.3%), respectively. A significant correlation was found between Barthel index score classification and the incidence of preoperative DVT in patients undergoing THA revision surgery ( χ 2=10.843, P=0.001).
CONCLUSION
In patients undergoing THA revision surgery, older age, female, and lower Barthel index scores are associated with higher preoperative DVT incidence. For patients with low preoperative Barthel index scores, preoperative thrombosis screening should be emphasized.
Humans
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Arthroplasty, Replacement, Hip/adverse effects*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Retrospective Studies
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Reoperation
;
Aged, 80 and over
;
Venous Thrombosis/epidemiology*
;
Adult
;
Risk Factors
;
Postoperative Complications/etiology*
;
Preoperative Period


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