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.Research progress of dyspnea belief intervention in patients with chronic obstructive pulmonary disease
Shasha CAI ; Mingyue ZHANG ; Xinyue XIANG ; Yong FANG ; Lihua HUANG
Chinese Journal of Practical Nursing 2024;40(5):397-401
Patients with chronic obstructive pulmonary disease have the disease phenomenon of fear of exercise because of dyspnea, which can accelerate the body degradation rate, weaken muscle strength, reverse increase dyspnea, and delay the recovery of the disease. As a result, this article examines the theoretical underpinnings and specific measures of dyspnea belief intervention programs for chronic obstructive pulmonary disease patients at home and abroad, summarizes the limitations of previous studies, and makes pertinent recommendations in an effort to serve as a guide for early patient prevention and the development of scientific and feasible intervention programs.
4.Sequence analysis of whole genome of influenza A(H3N2) virus in Huai′an
Pengfei YANG ; Fang HE ; Wanli YIN ; Tong GAO ; Wang ZHANG ; Mingyue WEI ; Chenglong XIONG ; Wei HU
Chinese Journal of Experimental and Clinical Virology 2024;38(2):156-161
Objective:To study the biological traits and mutations of the influenza A (H3N2) virus in order to produce a vaccine and offer references for controlling and preventing influenza epidemics.Methods:Four strains of the influenza A(H3N2) virus were chosen from the Huai′an surveillance network laboratory. Nucleic acid extraction, library building, and sequencing (CridION x5 MKI Nanopore) were used to produce the whole-genome sequences. Using homologous alignments of whole-genome sequences, phylogenetic tree construction, and amino acid variant screening, bioinformatics analysis was carried out.Results:The nucleotide identity between 8 gene segments ranged from 97.1% to 100.0%. The gene that differed the most from the reference sequences was HA (97.1%-99.9%), and the gene that differed the least was MP (98.6%-99.9%). The HA gene (3.06%) and MP gene (1.43%) were the regions with the greatest and lowest frequencies of nucleotide site change, respectively. The rates of nucleotide change varied significantly between the genes ( χ2=14.293, P=0.046). Four influenza A(H3N2) virus strains′ whole-genome phylogenies from each of the eight gene segments maintained a roughly consistent topological structure. One strain was linked to the 3C.2a1b.1b clade, which was lost at the 142NWT, 149NGT(HA1), and 436NLS(NA). Three strains were linked to the 3C.2a1b.2a.1a clade lineage. Amantadine and NA inhibitors were effective against all Huai′an strains. Conclusions:The antigenicity of one strain of Huai'an strain changed and its matching with the vaccine strain of that year was low. It is suggested that the genetic surveillance of H3N2 influenza virus should be continuously strengthened to provide scientific basis for influenza prevention and control and influenza vaccine screening.
5.Regulatory Effects of Acupuncture on Gut Microbiota in Mice with Breast Cancer Related Fatigue
Zhuan LYU ; Ruidong LIU ; Kaiqi SU ; Xiaodi RUAN ; Shikui QI ; Mingyue YU ; Yiming GU ; Jing GAO ; Qi LIU ; Lu FANG ; Xiaodong FENG
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(7):2402-2411
Objective To investigate the effect of acupuncture on fatigue improvement and gut microbiota in mice with cancer-related fatigue(CRF),and explore its possible mechanism of action.Methods The mice model of CRF of breast cancer after chemotherapy was established by tumor bearing and chemotherapy.After acupuncture intervention,fatigue was evaluated by general condition,forced swimming and open field experiment.Then 16S rDNA sequencing was used to analyze the structural abundance of gut microbiota in mice.Results Acupuncture could significantly improve the fatigue degree and general condition of the mice model of CRF of breast cancer after chemotherapy.At the same time,acupuncture could adjust the abundance of gut microbiota structure,up-regulate the abundance levels of Lactobacillus,Bacteroides,firmicutes,actinobacteria,and down-regulate the abundance levels of Proteobacteria and Staphylococcus.There were also differences in the abundance of flora structure among the groups,but the abundance of beneficial bacteria was relatively high in the acupuncture group,and the abundance of pathogenic bacteria was relatively high in the other two groups.Conclusion Acupuncture may play a role in the treatment of CRF by regulating the abundance of gut microbiota structure,increasing intestinal beneficial bacteria,inhibiting pathogenic bacteria,improving body immunity,and alleviating adverse reactions caused by chemotherapy for breast cancer.
6.Study on the clinical comprehensive evaluation of blood lipid-regulating drugs in five provinces and regions in Northwest China
Yuan QIAO ; Hang ZHAO ; Jiaxi DU ; Jingyi MAN ; Sen XU ; Fangyi MA ; Shuchen HU ; Jin PENG ; Minghuan JIANG ; Mingyue ZHAO ; Yu FANG
China Pharmacy 2023;34(10):1165-1171
OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid- regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions. METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs, the methods such as literature research, expert interviews, and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result. RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technicalevaluation section included 6 primary indicators, 13 secondary indicators, and 34 tertiary indicators, totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators, with a total score of 40 points (30 points for some drugs) and a total score of 150 points (or 140 points). The scoring results showed that the highest score was atorvastatin, followed by rosuvastatin and simvastatin. CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia; the rapid evaluation quantitative scoring table constructed in this study is comprehensive, systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.
7.Study on dental pulp vitality and success rate of dental pulp revascularization surgery in young permanent teeth with dental pulp necrosis
Linru CHANG ; Mingyue ZHU ; Ling FANG
Chinese Journal of Postgraduates of Medicine 2023;46(12):1116-1119
Objective:To study the efficacy and success rate of dental pulp revascularization surgery for young permanent teeth with dental pulp necrosis.Method:A total of 100 young patients with dental pulp necrosis of permanent teeth admitted to Xixi Hospital of Hangzhou from March 2019 to March 2023 were selected prospectively, they were divided into the control group and the study group according to the principles of balance and randomization, with 50 cases in each group. The control group and the research group received apical induction shaping surgery and pulp revascularization surgery, respectively. The treatment success rate, root canal wall thickness, crown root ratio, and dental pulp vitality and development of the affected teeth before and after 6 months of treatment were compared between the two groups.Results:The success rate in the study group was higher than that in the control group : 94.00%(47/50) vs. 80.00%(40/50), there was statistical difference ( χ2 = 4.33, P<0.05). After 6 months of treatment, the thickness of the root canal wall in the study group was greater than that in the control group, the affected tooth crown root ratio was lower than that in the control group: (2.43 ± 0.42) mm vs. (2.25 ± 0.39) mm, 0.71 ± 0.09 vs. 0.78 ± 0.11, there were statistical differences ( P<0.05). The proportion of active dental pulp and secondary dental pulp development in the study group during the last follow-up were higher than those in the control group: 92.00%(46/50) vs. 76.00%(38/50), 94.00%(47/50) vs. 80.00%(40/50), there were statistical differences ( P<0.05). Conclusions:The use of dental pulp revascularization surgery in young permanent teeth with dental pulp necrosis can prolong the root of the affected tooth, thicken the root canal ratio, and improve the success rate of treatment by increasing dental pulp vitality and promoting root development.
8.Expert consensus on nursing care of adults with status epilepticus
Fang LIU ; Xiaoying WANG ; Weibi CHEN ; Xiaomei ZHANG ; Fengru MIAO ; Weichi ZHANG ; Lan GAO ; Mingyue HAN ; Hong SUN
Chinese Journal of Modern Nursing 2023;29(6):701-709
Objective:To form the expert consensus on nursing care of adults with status epilepticus (SE), promote nurses to provide standardized and safe first aid, monitoring and support to SE patients, and effectively prevent and control complications, with a view to controlling seizures as soon as possible.Methods:The medical and nursing evidence on SE was retrieved, evaluated and summarized, and the retrieval time limit was from the establishment of the database to March 31, 2022. Recommendations and studies were extracted to form a first draft of consensus. A total of 31 experts were selected to conduct two rounds of Delphi expert consultation and expert demonstration meetings to analyze, revise and improve the experts' suggestions and form a consensus final draft.Results:The expert positive coefficient was 100.00% (31/31), the expert judgment coefficient was 0.93, the familiarity degree was 0.87, and the authority coefficient was 0.90. Kendall's harmony coefficient was 0.25 to 0.27 ( P<0.05). The final consensus included adult SE identification, first aid, monitoring and support, complication prevention and control, and effect evaluation of terminating SE. Conclusions:This consensus is practical and provides guidance for clinical nursing practice and quality control of SE patients.
9.The Chinese version of the Physical Function Intensive Care Test Score and its reliability and validity
Mingyue LIU ; Fang FANG ; Lili ZHAO
Chinese Journal of Modern Nursing 2022;28(26):3530-3534
Objective:To translate the Physical Function Intensive Care Test Score (PFIT-s) into Chinese, and to test its reliability and validity.Methods:Following the translation and back-translation principles of the Brislin model, the Chinese version of PFIT-s was formed by cultural adjustment through the expert consultation. From October to December 2021, convenience sampling was used to select 104 Intensive Care Unit (ICU) patients admitted to Shanghai General Hospital as the research object for investigation to test the reliability and validity of the Chinese version of PFIT-s.Results:The Chinese version of PFIT-s included a total of 4 items, namely assistance (sit to stand) , cadence (steps/min) , shoulder (flexion strength) and knee (extension strength) . A total of one common factor was extracted from exploratory factor analysis, and the cumulative variance contribution rate was 75.97%. The Cronbach's alpha coefficient of the Chinese version of PFIT-s was 0.879, and the scale-level content validity index was 0.958, and the item-level content validity index was 0.833 to 1.000. Using the Chinese version of Intensive Care Units Mobility Scale (IMS) as the criterion, the correlation coefficient between the Chinese version of PFIT-s and IMS was 0.884 ( P<0.01) . Conclusions:The Chinese version of PFIT-s has good reliability and validity and can be used to assess the physical function of ICU patients in China.
10.The Chinese version of the Physical Function Intensive Care Test Score and its reliability and validity
Mingyue LIU ; Fang FANG ; Lili ZHAO
Chinese Journal of Modern Nursing 2022;28(26):3530-3534
Objective:To translate the Physical Function Intensive Care Test Score (PFIT-s) into Chinese, and to test its reliability and validity.Methods:Following the translation and back-translation principles of the Brislin model, the Chinese version of PFIT-s was formed by cultural adjustment through the expert consultation. From October to December 2021, convenience sampling was used to select 104 Intensive Care Unit (ICU) patients admitted to Shanghai General Hospital as the research object for investigation to test the reliability and validity of the Chinese version of PFIT-s.Results:The Chinese version of PFIT-s included a total of 4 items, namely assistance (sit to stand) , cadence (steps/min) , shoulder (flexion strength) and knee (extension strength) . A total of one common factor was extracted from exploratory factor analysis, and the cumulative variance contribution rate was 75.97%. The Cronbach's alpha coefficient of the Chinese version of PFIT-s was 0.879, and the scale-level content validity index was 0.958, and the item-level content validity index was 0.833 to 1.000. Using the Chinese version of Intensive Care Units Mobility Scale (IMS) as the criterion, the correlation coefficient between the Chinese version of PFIT-s and IMS was 0.884 ( P<0.01) . Conclusions:The Chinese version of PFIT-s has good reliability and validity and can be used to assess the physical function of ICU patients in China.

Result Analysis
Print
Save
E-mail