1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Impact of palliative care on medication use and medical utilization in patients with advanced cancer.
Dingyi CHEN ; Haoxin DU ; Yichen ZHANG ; Yanfei WANG ; Wei LIU ; Yuanyuan JIAO ; Luwen SHI ; Xiaodong GUAN ; Xinpu LU
Journal of Peking University(Health Sciences) 2025;57(5):996-1001
OBJECTIVE:
To evaluate the effect of palliative care on drug use, medical service utilization and medical expenditure of patients with advanced cancer.
METHODS:
A cohort of patients including pal-liative care and standard care was constructed using the medical records of the patients in Peking University Cancer Hospital from 2018 to 2020, and coarsened exact matching was used to match the two groups of patients. The average monthly opioid consumption, hospitalization rate, intensive care unit (ICU) rate and operation rate, and the average monthly total cost were selected to evaluate drug use, medical service utilization and medical expenditure. Chi-square test and Wilcoxon signed rank test were used to compare the differences between the two groups before and after exposure and the change in the palliative care group. The net impact of palliative care on the patients was calculated using the difference-in-differences analysis.
RESULTS:
In this study, 180 patients in the palliative care group and 3 101 patients in the stan-dard care group were finally included in the matching, and the matching effect of the two groups was good (L1 < 0.1). Before and after exposure, the average monthly opioid consumption in the palliative care group was significantly higher than that in the standard care group (Before exposure: 0.3 DDD/person-month vs. 0.1 DDD/person-month, P < 0.01; After exposure: 0.7 DDD/person-month vs. 0.1 DDD/person-month, P < 0.01; DDD refers to defined daily dose), palliative care significantly increased the average monthly opioid consumption in the patients (0.3 DDD/person-month, P < 0.01). The hospitalization rate (48.9% vs. 74.3%, P < 0.01) and operation rate (3.9% vs. 8.8%, P < 0.01) of the patients in palliative care group were significantly lower than those in standard care group, and the ICU rate became similar between the two groups (1.1% vs. 1.6%, P=0.634). Palliative care significantly reduced the patients ' hospitalization rate (-25.6%, P < 0.01), ICU rate (-4.9%, P < 0.01) and operation rate (-14.5%, P < 0.01). Before and after exposure, the average monthly total costs of pal-liative care group were slightly higher than those of standard care group (Before exposure: 20 092.3 yuan vs. 19 132.8 yuan, P=0.725; After exposure: 9 719.8 yuan vs. 8 818.8 yuan, P=0.165). Palliative care increased the average monthly total cost by 2 208.8 yuan, but it was not statistically significant (P=0.316).
CONCLUSION
Palliative care can increase the opioid consumption in advanced cancer patients, reduce the rates of hospitalization, ICU and surgery, but has no significant effect on medical expenditure.
Humans
;
Palliative Care/economics*
;
Neoplasms/drug therapy*
;
Analgesics, Opioid/economics*
;
Male
;
Female
;
Middle Aged
;
Aged
;
Hospitalization/economics*
;
Intensive Care Units/statistics & numerical data*
;
Health Expenditures/statistics & numerical data*
;
Adult
;
Drug Utilization/statistics & numerical data*
;
Patient Acceptance of Health Care/statistics & numerical data*
3.Developing a polygenic risk score for pelvic organ prolapse: a combined risk assessment approach in Chinese women.
Xi CHENG ; Lei LI ; Xijuan LIN ; Na CHEN ; Xudong LIU ; Yaqian LI ; Zhaoai LI ; Jian GONG ; Qing LIU ; Yuling WANG ; Juntao WANG ; Zhijun XIA ; Yongxian LU ; Hangmei JIN ; Xiaowei ZHANG ; Luwen WANG ; Juan CHEN ; Guorong FAN ; Shan DENG ; Sen ZHAO ; Lan ZHU
Frontiers of Medicine 2025;19(4):665-674
Pelvic organ prolapse (POP), whose etiology is influenced by genetic and clinical risk factors, considerably impacts women's quality of life. However, the genetic underpinnings in non-European populations and comprehensive risk models integrating genetic and clinical factors remain underexplored. This study constructed the first polygenic risk score (PRS) for POP in the Chinese population by utilizing 20 disease-associated variants from the largest existing genome-wide association study. We analyzed a discovery cohort of 576 cases and 623 controls and a validation cohort of 264 cases and 200 controls. Results showed that the case group exhibited a significantly higher PRS than the control group. Moreover, the odds ratio of the top 10% risk group was 2.6 times higher than that of the bottom 10%. A high PRS was significantly correlated with POP occurrence in women older than 50 years old and in those with one or no childbirths. As far as we know, the integrated prediction model, which combined PRS and clinical risk factors, demonstrated better predictive accuracy than other existing PRS models. This combined risk assessment model serves as a robust tool for POP risk prediction and stratification, thereby offering insights into individualized preventive measures and treatment strategies in future clinical practice.
Humans
;
Female
;
Pelvic Organ Prolapse/epidemiology*
;
Middle Aged
;
Risk Assessment/methods*
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China/epidemiology*
;
Multifactorial Inheritance
;
Aged
;
Risk Factors
;
Genome-Wide Association Study
;
Genetic Predisposition to Disease
;
Case-Control Studies
;
Adult
;
Polymorphism, Single Nucleotide
;
Genetic Risk Score
;
East Asian People
4.Practice Exploration of a Clinical Rehabilitation Integrated Plan Based on Graded Management of Rehabili-tation Treatment Projects
Renhong HE ; Luwen ZHANG ; Zhiping CHENG ; Jungui ZHOU ; Gang LIU
Chinese Hospital Management 2024;44(3):45-48
Objective To explore the implementation effects and application value of the Clinical Rehabilitation Integration Plan based on the graded management of rehabilitation treatment programs in a 3A general hospital.Methods The details of the programme were firstly formulated according to the needs of clinical rehabilitation and the implementation plan was formed,and then the integrated clinical rehabilitation work was carried out for 1 year accordingly,and finally the effects before and after the implementation of the programme were compared and analysed by selecting the indicators of departmental operation and patient satisfaction.Results The rehabilitation programme was classified into 4 levels according to the degree of technical difficulty and medical risk,and its connotation and management requirements were defined in detail.The implementation of the programme included organisational structure,training and assessment,authorisation management and quality control.The programme was carried out in 8 clinical departments in the hospital,and the overall willingness of the clinical departments to develop early rehabilitation was improved since 2022.Conclusion This program can improve the operational efficiency of clinical departments and patient prognosis.
5.Multimorbidity and falls in middle-aged and elderly people in China:evidence from CHARLS
Qiao-Chu LU ; Kang WANG ; Luwen ZHANG
The Journal of Practical Medicine 2024;40(13):1851-1858
Objective To investigate the influencing factors of falls and serious falls among individuals aged 45 years and above in China,as well as explore the association between falls and multimorbidity,thereby pro-viding empirical evidence for the formulation of effective strategies to prevent falls.Methods The study utilized data from the CHARLS 2020 dataset and employed various statistical methods,including descriptive statistics,χ2 test,quadratic regression,and logistic regression.Additionally,subgroup analyses were conducted on key vari-ables.Results The prevalence of falls and serious falls among individuals aged 45 and above in China was found to be 17.42%and 6.86%,respectively.Multimorbidity emerged as a significant determinant influencing both falls and serious falls,with a higher number of diseases being associated with an increased prevalence of these events.Conclusion In order to effectively address the issue of falls in middle-aged and elderly individuals,particularly those with multimorbidity,it is imperative to integrate multimorbidity considerations into the comprehensive fall intervention process.
6.Development and Analysis of the Standard for Drug Use Monitoring and Evaluation
Jingjing ZHANG ; Liyan MIAO ; Jiancun ZHEN ; Jianguo ZHU ; Jun ZHANG ; Luwen SHI ; Ting XU ; Shiting LIU ; Bin WU
Herald of Medicine 2024;43(8):1212-1216
Drug use monitoring and evaluation play a key role in promoting drugs to return to clinical value,optimizing the basic medicine system,and improving the drug supply guarantee system.In order to promote the implementation of drug use monitoring and evaluation in medical institutions,the Pharmaceutical Affairs Committee of the Chinese Hospital Association led the efforts of organizing relevant domestic experts to follow the group standard development process.It successfully formulated the group standard of Drug Use Monitoring and Evaluation through the steps of problem sorting,framework construction,evidence collection,draft writing,opinion consultation,and standard formation.This article introduces the standard formulation process in detail,and explains and analyzes the content of the standard,aiming to help readers better understand the connotation of drug use monitoring and evaluation,and provide practical guidance.
7.Targeting TRMT5 suppresses hepatocellular carcinoma progression via inhibiting the HIF-1α pathways.
Qiong ZHAO ; Luwen ZHANG ; Qiufen HE ; Hui CHANG ; Zhiqiang WANG ; Hongcui CAO ; Ying ZHOU ; Ruolang PAN ; Ye CHEN
Journal of Zhejiang University. Science. B 2023;24(1):50-63
Accumulating evidence has confirmed the links between transfer RNA (tRNA) modifications and tumor progression. The present study is the first to explore the role of tRNA methyltransferase 5 (TRMT5), which catalyzes the m1G37 modification of mitochondrial tRNAs in hepatocellular carcinoma (HCC) progression. Here, based on bioinformatics and clinical analyses, we identified that TRMT5 expression was upregulated in HCC, which correlated with poor prognosis. Silencing TRMT5 attenuated HCC proliferation and metastasis both in vivo and in vitro, which may be partially explained by declined extracellular acidification rate (ECAR) and oxygen consumption rate (OCR). Mechanistically, we discovered that knockdown of TRMT5 inactivated the hypoxia-inducible factor-1 (HIF-1) signaling pathway by preventing HIF-1α stability through the enhancement of cellular oxygen content. Moreover, our data indicated that inhibition of TRMT5 sensitized HCC to doxorubicin by adjusting HIF-1α. In conclusion, our study revealed that targeting TRMT5 could inhibit HCC progression and increase the susceptibility of tumor cells to chemotherapy drugs. Thus, TRMT5 might be a carcinogenesis candidate gene that could serve as a potential target for HCC therapy.
Humans
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Carcinoma, Hepatocellular/pathology*
;
Cell Hypoxia
;
Cell Line, Tumor
;
Gene Expression Regulation, Neoplastic
;
Hypoxia-Inducible Factor 1, alpha Subunit/metabolism*
;
Liver Neoplasms/pathology*
;
Signal Transduction/genetics*
;
tRNA Methyltransferases/metabolism*
8.Exploring the practice of traditional Chinese medicine human resource cultivation mechanism of inno-vative TCM hospital's"three projects and one plan"
Mei ZHANG ; Yanming ZHENG ; Feng JIANG ; Lishan LUO ; Luwen ZHANG
Modern Hospital 2023;23(12):1923-1925,1928
Traditional Chinese medicine hospitals are the main battlefield for the inheritance,innovation,and develop-ment of traditional Chinese medicine.Human resource is the primary resource for the development of traditional Chinese medi-cine.The inheritance,innovation,and development of traditional Chinese medicine hospitals cannotwithout the cultivation and creation of high-quality teams.A traditional Chinese medicine hospital in Guangzhou has developed the"Three Projects and One Plan"human resource cultivation plan based on the idea of multi-level training that improve the overall quality of the workforce and focus on potential person.It has constructed a traditional Chinese medicine human resource cultivation system that covers the entire cycle of person.The hospital has carried out in new mechanism of traditional Chinese medicine human resource cultivation,and various measures have been implemented and achieved some success.And then,it will consider the next step of human re-source cultivation.
9.Research overview of chemical constituents, pharmacological activity, and clinical application of Swertia patens Burk.
Sicheng HUANG ; Zhenlian ZHANG ; Haifeng CAO ; Qiong ZHAO ; Luwen WANG ; Anguo HOU
International Journal of Traditional Chinese Medicine 2023;45(12):1604-1608
Swertia patens Burk. is a commonly used herbal medicine of the Yi nationality in Yunnan, China. It is widely used in the treatment of children with spastic abdominal pain, cholecystitis, and other diseases, mainly containing iridoid glycosides and ketone compounds. The highest and most significant pharmacological activity, with antispasmodic, analgesic, sedative, anti-inflammatory, liver-protecting, stomach-protecting, and other effects, is closely related to its effects of soothing the liver, clearing heat, and relieving stomach pain. As a very distinctive pediatric folk medicine, the related quality standards of Swertia patens Burk. have not been perfected, and the development of preparations is relatively lagging.
10.Analysis of the results of an international proficiency testing program for veterinary drug residue determination in food
Guangzhi GU ; Luwen ZHANG ; Yan CHEN ; Zhukang CHEN ; Jiwei LU ; Meicheng YANG
Shanghai Journal of Preventive Medicine 2023;35(9):910-914
ObjectiveTo evaluate the proficiency and consistency of domestic and foreign testing institutions in the field of veterinary drug residue detection in food, and to promote international cooperation and mutual recognition of testing results among these institutions. MethodsA robust statistical analysis was conducted on the testing results of 20 laboratories in eight countries and regions across North America, Europe, and Asia. The laboratories’ testing capabilities were evaluated using Z-score comparison. ResultsAmong the 20 participating laboratories, 18 achieved satisfactory results, resulting in a satisfaction rate of 90%, while 2 laboratories (10%) failed to meet the requirements. The satisfaction rate of domestic laboratories (100%) was higher than that of foreign laboratories (81.8%). ConclusionDomestic laboratories perform better than overseas laboratories in determining veterinary drug residues in food. To enhance testing capabilities, these overseas laboratories with unsatisfactory evaluation results should strengthen their daily quality control and ensure traceability of original records.

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