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.Association of NLRP3 genetic variant rs10754555 with early-onset coronary artery disease.
Lingfeng ZHA ; Chengqi XU ; Mengqi WANG ; Shaofang NIE ; Miao YU ; Jiangtao DONG ; Qianwen CHEN ; Tian XIE ; Meilin LIU ; Fen YANG ; Zhengfeng ZHU ; Xin TU ; Qing K WANG ; Zhilei SHAN ; Xiang CHENG
Chinese Medical Journal 2025;138(21):2844-2846
3.Multi-modal magnetic resonance imaging assessment and mechanism exploration of preterm white matter injury in neonatal rats.
Xiao-Tian GAO ; Hai-Mo ZHANG ; Xiao-Zu ZHANG ; Yi-Jing WANG ; Hui-Ning BI ; Miao YU ; Yan LI ; Xiao-Li WANG
Chinese Journal of Contemporary Pediatrics 2025;27(3):366-372
OBJECTIVES:
To evaluate preterm white matter injury (PWMI) in neonatal rats using multimodal magnetic resonance imaging (MRI) combined with histological assessments and to explore its underlying mechanisms.
METHODS:
Healthy 3-day-old Sprague-Dawley neonatal rats were randomly divided into a sham operation group and a PWMI group (n=12 in each group). A PWMI model was established in neonatal rats through hypoxia-ischemia. Laser speckle imaging was used to observe changes in cerebral oxygen saturation and blood flow at different time points post-modeling. Multimodal MRI was employed to assess the condition of white matter injury, while hematoxylin-eosin staining was utilized to observe morphological changes in the striatal area on the injured side. Immunofluorescence staining was performed to detect the proliferation and differentiation of oligodendrocyte precursor cells.
RESULTS:
At 0, 6, 12, 24, and 72 hours post-modeling, the relative blood flow and relative oxygen saturation on the injured side in the PWMI group were significantly lower than those in the sham operation group (P<0.05). At 24 hours post-modeling, T2-weighted imaging showed high signals in the white matter of the injured side in the PWMI group, with relative apparent diffusion coefficient values and Lorenz differential values being lower than those in the sham operation group (P<0.001); additionally, the arrangement of nerve cells in the PWMI group was disordered, and the number of EdU+PDGFR-α+ cells was higher than that in the sham operation group (P<0.001). At 28 days post-modeling, the relative fractional anisotropy values, the number of EdU+Olig2+ cells, and the fluorescence intensity of myelin basic protein and neurofilament protein 200 in the white matter region of the PWMI group were all lower than those in the sham operation group (P<0.001).
CONCLUSIONS
Multimodal MRI can evaluate early and long-term changes in PWMI in neonatal rat models in vivo, providing both imaging and pathological evidence for the diagnosis and treatment of PWMI in neonates. Hypoxia-ischemia inhibits the proliferation and differentiation of oligodendrocyte precursor cells in neonatal rats, leading to PWMI.
Animals
;
Rats, Sprague-Dawley
;
Magnetic Resonance Imaging/methods*
;
Rats
;
White Matter/injuries*
;
Animals, Newborn
;
Female
;
Multimodal Imaging
;
Male
;
Hypoxia-Ischemia, Brain/pathology*
4.Primary Non-Hodgkin Lymphoma in the Female Genital System: Report of Two Cases and Review of the Literature.
Tian-Yu ZHANG ; Li QIN ; Dong-Yan CAO ; Jia-Xin YANG ; Yi LIU ; Tao WANG
Acta Academiae Medicinae Sinicae 2025;47(2):314-318
Primary female genital system lymphoma(PFGSL)is a rare subtype of extranodal lymphoma and patients commonly present in the department of gynecology.At present,there is a lack of uniform standards for the treatment of PFGSL.Although the classification of lymphoid neoplasmas was updated by the World Health Organization classification of haematolymphoid tumors in 2016,PFGSL was still not elaborated in sufficient detail.Most cases of PFGSL are non-Hodgkin lymphoma,involving the ovary and cervix.In some cases,involvement of uterine corpus,vagina,and vulva is reported.In this article,we report two cases of non-Hodgkin lymphoma in the female genital system,one from the uterus and the other from the ovary.By presenting the diagnosis and treatment of the two cases and reviewing the literature,we aim to provide a reference for clinicians in recognizing and treating rare cases.
Female
;
Humans
;
Genital Neoplasms, Female/diagnosis*
;
Lymphoma, Non-Hodgkin/diagnosis*
;
Ovarian Neoplasms
5.Reasonable management and control practice of prophylactic use of antibiotics in urinary system lithotripsy
Yijun CHEN ; Zhuo WANG ; Miao HE ; Yu ZHANG ; Jing TIAN
Journal of Pharmaceutical Practice and Service 2025;43(12):614-618
Objective To analyze the effectiveness of reasonable control measures for prophylactic use of antibiotics in urinary system lithotripsy. Methods By antimicrobial stewardship, strengthening special comments on antibiotics and information notification on rational use of antibiotics, adding and improving the pre-review rules for antibiotics prescriptions, conducting in-depth clinical training and consultation by clinical pharmacists, strengthening innovation in rational use of drugs, and taking various measures to actively improve rational use of prophylactic antibiotics of lithotripsy in urology department, the changes of indexes related to antibiotics in urology department from 2019 to 2022 were analyzed. Results After active and reasonable control, Antibiotics Use Density in urology department decreased year by year. The utilization rate of antibiotics in inpatients decreased from 94.27% in 2019 to 77.47% in 2022. Various rate of microbial inspection reached the standard in 2022. The imipenem and cilastatin sodium for injection ranking of prophylactic use of antibiotics consumption DDDs for urinary system lithotripsy decreased from the 4th place in 2019 to the 8th place in 2022. The ranking of the urology department on carbapenem consumption DDDs in the whole hospital decreased from the 8th place in 2019 to the 12th place in 2022. At the same time, the incidence of urinary tract lithotripsy postoperative infection showed a decreasing trend year by year, from 0.84% in 2019 to 0.49% in 2022. Conclusion Positive control measures can promote the rational use of prophylactic antibiotics for urinary system lithotripsy.
6.Practice and evaluation of hospital antimicrobial stewardship empowered by digital intelligence technology
Li-Mian LIANG ; Yun-Ni YU ; Miao-Na LIU ; Ting HUANG ; Yi-Mei TIAN
Chinese Journal of Infection Control 2024;23(3):330-335
Objective To improve the efficiency of hospital antimicrobial management and ensure rational clinical use of antimicrobial agents with the aid of antimicrobial stewardship(AMS)empowered by digital intelligence tech-nology in hospital.Methods Information systems such as early warning of antimicrobial indexes,closed-loop ma-nagement of microbial detection information,and decision-making system of antimicrobial resistance monitoring data were applied to the traditional AMS system.Through hospital information systems(HIS)to collect data about thera-peutic antimicrobial use and healthcare-associated infection(HAI)quality control indexes of hospitalized patients in a tertiary first-class public hospital in Shenzhen City before and after digital technology improvement,indexes of 2021 and 2022 were as control group(before improvement)and observation group(after improvement)respective-ly,improvement trend of antimicrobial management was compared.Results After upgrading and renovating the hospital information system,hospital antimicrobial management indexes improved significantly compared to before the renovation.The use rate of antimicrobial agents and the preventive use rate of antimicrobial agents in class Ⅰincision surgery in patients in the observation group were both lower than those in the control group(27.0%vs 38.8%,20.9%vs 23.8%,respectively,both P<0.05).Antimicrobial use density in hospitalized patients in the observa-tion group was lower than that in the control group([33.27±3.03]DDDs vs[42.06±4.42]DDDs),difference was statistically significant(t=13.11,P<0.001).The observation group had a higher qualified rate for evaluating antimicrobial medical orders compared to the control group(98.5%vs 96.8%).The pathogenic detection rate of hospitalized patients before therapeutic antimicrobial use and pathogen detection rate related to HAI diagnosis were both higher than those in the control group(87.1%vs 84.5%,99.0%vs 95.4%,respectively),differences were both statistically significant(both P<0.05).Conclusion Empowering the hospital's AMS system with digital technology can promote more scientific,standardized,efficient,and rational antimicrobial management in hospitals.
7.Expert consensus on surgical treatment of oropharyngeal cancer
China Anti-Cancer Association Head and Neck Oncology Committee ; China Anti-Cancer Association Holistic Integrative Oral Cancer on Preventing and Screen-ing Committee ; Min RUAN ; Nannan HAN ; Changming AN ; Chao CHEN ; Chuanjun CHEN ; Minjun DONG ; Wei HAN ; Jinsong HOU ; Jun HOU ; Zhiquan HUANG ; Chao LI ; Siyi LI ; Bing LIU ; Fayu LIU ; Xiaozhi LV ; Zheng-Hua LV ; Guoxin REN ; Xiaofeng SHAN ; Zhengjun SHANG ; Shuyang SUN ; Tong JI ; Chuanzheng SUN ; Guowen SUN ; Hao TIAN ; Yuanyin WANG ; Yueping WANG ; Shuxin WEN ; Wei WU ; Jinhai YE ; Di YU ; Chunye ZHANG ; Kai ZHANG ; Ming ZHANG ; Sheng ZHANG ; Jiawei ZHENG ; Xuan ZHOU ; Yu ZHOU ; Guopei ZHU ; Ling ZHU ; Susheng MIAO ; Yue HE ; Jugao FANG ; Chenping ZHANG ; Zhiyuan ZHANG
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(11):821-833
With the increasing proportion of human papilloma virus(HPV)infection in the pathogenic factors of oro-pharyngeal cancer,a series of changes have occurred in the surgical treatment.While the treatment mode has been im-proved,there are still many problems,including the inconsistency between diagnosis and treatment modes,the lack of popularization of reconstruction technology,the imperfect post-treatment rehabilitation system,and the lack of effective preventive measures.Especially in terms of treatment mode for early oropharyngeal cancer,there is no unified conclu-sion whether it is surgery alone or radiotherapy alone,and whether robotic minimally invasive surgery has better func-tional protection than radiotherapy.For advanced oropharyngeal cancer,there is greater controversy over the treatment mode.It is still unclear whether to adopt a non-surgical treatment mode of synchronous chemoradiotherapy or induction chemotherapy combined with synchronous chemoradiotherapy,or a treatment mode of surgery combined with postopera-tive chemoradiotherapy.In order to standardize the surgical treatment of oropharyngeal cancer in China and clarify the indications for surgical treatment of oropharyngeal cancer,this expert consensus,based on the characteristics and treat-ment status of oropharyngeal cancer in China and combined with the international latest theories and practices,forms consensus opinions in multiple aspects of preoperative evaluation,surgical indication determination,primary tumor re-section,neck lymph node dissection,postoperative defect repair,postoperative complication management prognosis and follow-up of oropharyngeal cancer patients.The key points include:① Before the treatment of oropharyngeal cancer,the expression of P16 protein should be detected to clarify HPV status;② Perform enhanced magnetic resonance imaging of the maxillofacial region before surgery to evaluate the invasion of oropharyngeal cancer and guide precise surgical resec-tion of oropharyngeal cancer.Evaluating mouth opening and airway status is crucial for surgical approach decisions and postoperative risk prediction;③ For oropharyngeal cancer patients who have to undergo major surgery and cannot eat for one to two months,it is recommended to undergo percutaneous endoscopic gastrostomy before surgery to effectively improve their nutritional intake during treatment;④ Early-stage oropharyngeal cancer patients may opt for either sur-gery alone or radiation therapy alone.For intermediate and advanced stages,HPV-related oropharyngeal cancer general-ly prioritizes radiation therapy,with concurrent chemotherapy considered based on tumor staging.Surgical treatment is recommended as the first choice for HPV unrelated oropharyngeal squamous cell carcinoma(including primary and re-current)and recurrent HPV related oropharyngeal squamous cell carcinoma after radiotherapy and chemotherapy;⑤ For primary exogenous T1-2 oropharyngeal cancer,direct surgery through the oral approach or da Vinci robotic sur-gery is preferred.For T3-4 patients with advanced oropharyngeal cancer,it is recommended to use temporary mandibu-lectomy approach and lateral pharyngotomy approach for surgery as appropriate;⑥ For cT1-2N0 oropharyngeal cancer patients with tumor invasion depth>3 mm and cT3-4N0 HPV unrelated oropharyngeal cancer patients,selective neck dissection of levels ⅠB to Ⅳ is recommended.For cN+HPV unrelated oropharyngeal cancer patients,therapeutic neck dissection in regions Ⅰ-Ⅴ is advised;⑦ If PET-CT scan at 12 or more weeks after completion of radiation shows intense FDG uptake in any node,or imaging suggests continuous enlargement of lymph nodes,the patient should undergo neck dissection;⑧ For patients with suspected extracapsular invasion preoperatively,lymph node dissection should include removal of surrounding muscle and adipose connective tissue;⑨ The reconstruction of oropharyngeal cancer defects should follow the principle of reconstruction steps,with priority given to adjacent flaps,followed by distal pedicled flaps,and finally free flaps.The anterolateral thigh flap with abundant tissue can be used as the preferred flap for large-scale postoperative defects.
8.Investigation on the relationship between chronic disease prevention literacy and health anxiety among chronic disease residents an urban-rural comparison
Yulian WEI ; Xin′e MAO ; Miao TIAN ; Jiahui ZHANG ; Shangping YU ; Yichen LU ; Yan WANG
Chinese Journal of Practical Nursing 2024;40(24):1879-1884
Objective:To understand the current status of the level of chronic disease prevention and treatment literacy and health anxiety among chronic disease residents, as well as the urban-rural differences, in order to provide a basis for improving the level of chronic disease prevention and treatment literacy among chronic disease residents.Methods:This was a cross-sectional study. From July to August 2022, a multi-stage random sampling method was adopted to select 201 rural residents with chronic diseases in one rural health center and 242 urban residents with chronic diseases in two community health service centers. General demographic characteristics questionnaire, Chronic Disease Prevention and Control Literacy Questionnaire and Short version of Health Anxiety Scale were used for questionnaire survey.Results:There were 93 males and 108 females with chronic diseases in 201 rural chronic disease residents, and the age range was 19-69 years. There were 116 males and 126 females with chronic diseases in 242 urban chronic disease residents, and the age range was 18-69 years old. The score of chronic disease prevention and control literacy of rural chronic disease residents (7.86 ± 2.25) was lower than that of urban chronic disease residents (8.55 ± 2.03). The score of health anxiety of rural chronic disease residents (13.69 ± 5.26) was higher than that of urban chronic disease residents (11.67 ± 5.95). Both differences were statistically significant ( t=-3.43, 3.79, both P<0.05). After controlling the general demographic data, the layered linear regression analysis of rural chronic disease residents and urban chronic disease residents showed that health anxiety can negatively affect rural chronic disease residents and urban chronic disease residents of chronic disease prevention and treatment literacy level ( β=-0.185, -0.129, both P<0.05). Conclusions:There are urban-rural differences in chronic disease prevention and treatment literacy and health anxiety of chronic disease residents in community. It is necessary to strengthen psychological construction among rural chronic disease residents in order to improve their chronic disease prevention and treatment literacy.
9.Study on the Correlation Between Traditional Chinese Medicine Syndrome Elements and Risk Factors in Children with IgA Vasculitis
Xue-Jiao LI ; Xiao-Jie LIN ; Miao-Zhen LIANG ; Li-Fang CHEN ; Huai-Min XU ; Wen-Tian LIU ; Yu-Ling LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(11):2856-2862
Objective To investigate the correlation between traditional Chinese medicine(TCM)syndrome elements and risk factors in children with IgA vasculitis(IgAV,also known as Henoch-Sch?nlein purpura).Methods The medical records of 131 children with IgAV were retrospectively analyzed.And then the distribution of their TCM syndrome elements was investigated,and the correlation of TCM syndrome elements with the gender,age,clinical symptoms,as well as risk factors such as mosquito bite,pathogen infection,and allergic rhinitis was analyzed.Results(1)Among the 131 children with IgAV,the diseases-location syndrome elements of IgAV involved lung in 97 cases(74.05%),spleen in 61 cases(46.56%),kidney in 54 cases(41.22%),liver in 17 cases(12.98%),and heart in 11 cases(8.40%);the disease-nature syndrome elements of IgAV involved blood stasis in 131 cases(100.00%),wind-damp in 125 cases(95.42%),wind-heat in 90 cases(68.70%),damp-heat in 72 cases(54.96%),blood heat in 49 cases(37.40%),qi deficiency in 19 cases(14.50%),and yin deficiency in three cases(2.29%).(2)There were 69 cases(52.67%)of females and 62 cases(47.33%)of males among the IgAV children,with females outnumbering males.The age group of IgAV children was predominated by five to six years old,and 10 cases(7.63%)were younger than four years old,18 cases(13.74%)were four years old,39 cases(29.77%)were five years old,34 cases(25.95%)were six years old,17 cases(12.98%)were seven years old,and 13 cases(9.92%)were older than seven years old.The disease-nature syndrome elements such as blood stasis,wind-damp,wind-heat,and damp-heat were frequently seen in the age group of five to seven years old,yin deficiency was frequently seen in the age group older than seven years,and blood stasis was seen in all age groups.(3)The results of logistic regression analysis of the correlation between TCM syndrome elements and risk factors in IgAV patients showed that allergic rhinitis was positively correlated with blood stasis[OR=2.236,95%CI(1.049-4.007)],damp-heat[OR=2.183,95%CI(1.554-3.671)]and wind-damp[OR=1.202,95%CI(1.050-2.409)];pathogen infection was positively correlated with blood stasis[OR=3.199,95%CI(1.457-4.101)]and damp-heat[OR=1.119,95%CI(1.072-2.009)];mosquito bite was positively correlated with blood stasis[OR=4.533,95%CI(1.029-9.022)]and damp-heat[OR=2.257,95%CI(1.081-13.207)];the gender was positively correlated with blood stasis[OR=1.352,95%CI(1.271-3.018)]and wind-damp[OR=1.149,95%CI(1.071-3.102)].The differences were all statistically significant(P<0.05 or P<0.01).Conclusion IgAV usually involves the lungs and is also related to the five zang organs.Its pathogenesis is characterized by excess in superficiality such as blood stasis and wind-damp-heat in the early stage,and is predominated by deficiency in origin such as qi deficiency and yin deficiency in the later stage.For the children with IgAV,mosquito bite,pathogen infection and allergic rhinitis are more likely to induce blood stasis and wind-damp-heat;TCM syndrome elements such as wind-heat,damp-heat,blood heat,and qi deficiency are frequently seen in the males,while TCM syndrome elements such as blood stasis,wind-damp,and yin deficiency are frequently seen in the females.
10.Association between TyG-WC and risk of coronary heart disease in middle-aged and elderly population:a prospective cohort study with 10-year follow-up
Yu WANG ; Ying MIAO ; Qiang LIN ; Mao TIAN ; Zhuang CHEN ; Qin WAN
The Journal of Practical Medicine 2024;40(12):1731-1736
Objective To investigate the association between triglyceride glucose index(TyG)combined with waist circumference(WC)and the risk of new-onset coronary heart disease(CHD)in the middle-aged and elderly people in 10 years of non-interventional follow-up in Luzhou area.Methods A total of 8 647 eligible individu-als participated in epidemiological survey in Luzhou area were selected.The subjects were divided into different groups according to the quartiles of the TyG-WC and followed for ten years.The correlation between different TyG-WC quartile group and 10-year new CHD in middle-aged and elderly population was analyzed by using univariate analy-sis and Cox regression analysis.Results Of the 8 647 participants in the study,484 had new CHD,accounting for 5.5%.The comparison of the number of newly diagnosed CHD subjects grouped by TyG-WC quartiles indicated the 4th quartile group>the 3rd quartile group>the 2nd quartile group>the 1st quartile group,showing statistical significance(P<0.001).Cox regression analysis showed that without adjusting for any variables,the risk of new CHD in 10 years increased with the increase of TyG-WC quartile group,and the differences between the second,third and fourth quartile array and the first quartile array were statistically significant(P<0.05).After adjusting for age and sex and further adjusting for the influence of various influencing factors,the risk of new CHD in 10 years increased with the increase of TyG-WC quartile group.The difference between the third and fourth quartile array and the first quartile array was statistically significant(P<0.05).Conclusion TyG-WC is a risk factor for new-onset CHD in the middle-aged and elderly population in Luzhou area in 10 years of non-interventional follow-up,and TyG-WC may be a predictor of the risk of CHD in the middle-aged and elderly population.


Result Analysis
Print
Save
E-mail