1.Management Costs of Drugs for Clinical Trials in China
Xiaoqing NI ; Zhiwen REN ; Yujie SONG ; Qinan YIN ; Lin HE
Herald of Medicine 2025;44(6):1016-1020
According the Good Clinical Practice(GCP)and programmatic requirements,we analyze the management characteristics and the costs of drugs for clinical trials in different specialties from the drug management;The characteristics of the management of drugs for different specialties was summarize and the differential factors that may affect the management cost was explored,so as to provide theoretical support for the research institutions to utilize the resources in a rational and efficient way.This article provides a guarantee for the drug management with the aim of enhancing the quality and efficiency of clinical trials.
2.Exploration and Practice of the Drug Management Systerm for Clinical Trials
Xiaoqing NI ; Zhiwen REN ; Yujie SONG ; Qinan YIN ; Lin HE
Herald of Medicine 2025;44(2):336-341
Objective This study aims to discuss and summarize the management system for drugs used in clinical trials,with the objective of elevating the management standards.Methods Considering the situation of diverse departmental needs and the multi-campus structure,the study analyzed and explored the management of drugs for clinical trials to build a corresponding management system,including pharmacy construction,equipment,personnel qualifications,data management,drug reception,storage,distribution,and recycling protocols.The effecttivness of the system was evaluated through comparative analysis of data from 2022 to 2023 at our hospital.Result Improvements in the management of drugs for clinical trials were observed in 2023 across varous aspects.Conclusion Refining the management system of drugs for clinical trials can enhance Good Clinical Practice(GCP)supervision and service,providing an important reference for the management system.
3.Mechanistic study of combined poisoning of diazepam and ethanol based on metabolomics
Ni HU ; Lishuang LIU ; Yiwei GUO ; Tao WANG ; Zhimei BAI ; Jing ZHANG ; Jiajie ZHANG ; Bochao LI ; Pingrong ZHOU ; Hongwei LIU ; Zhiwen WEI ; Keming YUN ; Lele WANG
Chinese Journal of Forensic Medicine 2025;40(3):284-287
Objective To study the plasma metabolomics of mice poisoned by different dosage of the combination of diazepam and ethanol,and to reveal the toxicological mechanisms of combined poisoning of diazepam and ethanol.Methods Female Kunming mice were randomly divided into blank group,single and combined poisoning group(n=6),Based on the LD50 of diazepam co-administered with graded ethanol doses,mice in the single-drug and combined groups received oral gavage at 1/2,1,and 2 × LD50.Retro-orbital blood samples(~500 μL)were collected within 24 hours post-administration and analyzed by UPLC-QE-MS technology.Principal component analysis and orthogonal partial least squares discriminant analysis were used to identify differential metabolites and associated metabolic pathways.Results A total of 387 differential metabolites were identified in the combined poisoning group of diazepam and ethanol implicating the key pathways including tryptophan metabolism,phenylalanine metabolism,arginine and proline metabolism,Glycerophospholipid metabolism,phenylalanine,tyrosine and tryptophan biosynthesis.Conclusion Combined diazepam and ethanol poisoning exerts significant systemic effects by disrupting neurotransmitters conduction,exacerbating oxidative stress response and dysregulating energy metabolism.
4.Management Costs of Drugs for Clinical Trials in China
Xiaoqing NI ; Zhiwen REN ; Yujie SONG ; Qinan YIN ; Lin HE
Herald of Medicine 2025;44(6):1016-1020
According the Good Clinical Practice(GCP)and programmatic requirements,we analyze the management characteristics and the costs of drugs for clinical trials in different specialties from the drug management;The characteristics of the management of drugs for different specialties was summarize and the differential factors that may affect the management cost was explored,so as to provide theoretical support for the research institutions to utilize the resources in a rational and efficient way.This article provides a guarantee for the drug management with the aim of enhancing the quality and efficiency of clinical trials.
5.Mechanistic study of combined poisoning of diazepam and ethanol based on metabolomics
Ni HU ; Lishuang LIU ; Yiwei GUO ; Tao WANG ; Zhimei BAI ; Jing ZHANG ; Jiajie ZHANG ; Bochao LI ; Pingrong ZHOU ; Hongwei LIU ; Zhiwen WEI ; Keming YUN ; Lele WANG
Chinese Journal of Forensic Medicine 2025;40(3):284-287
Objective To study the plasma metabolomics of mice poisoned by different dosage of the combination of diazepam and ethanol,and to reveal the toxicological mechanisms of combined poisoning of diazepam and ethanol.Methods Female Kunming mice were randomly divided into blank group,single and combined poisoning group(n=6),Based on the LD50 of diazepam co-administered with graded ethanol doses,mice in the single-drug and combined groups received oral gavage at 1/2,1,and 2 × LD50.Retro-orbital blood samples(~500 μL)were collected within 24 hours post-administration and analyzed by UPLC-QE-MS technology.Principal component analysis and orthogonal partial least squares discriminant analysis were used to identify differential metabolites and associated metabolic pathways.Results A total of 387 differential metabolites were identified in the combined poisoning group of diazepam and ethanol implicating the key pathways including tryptophan metabolism,phenylalanine metabolism,arginine and proline metabolism,Glycerophospholipid metabolism,phenylalanine,tyrosine and tryptophan biosynthesis.Conclusion Combined diazepam and ethanol poisoning exerts significant systemic effects by disrupting neurotransmitters conduction,exacerbating oxidative stress response and dysregulating energy metabolism.
6.Exploration and Practice of the Drug Management Systerm for Clinical Trials
Xiaoqing NI ; Zhiwen REN ; Yujie SONG ; Qinan YIN ; Lin HE
Herald of Medicine 2025;44(2):336-341
Objective This study aims to discuss and summarize the management system for drugs used in clinical trials,with the objective of elevating the management standards.Methods Considering the situation of diverse departmental needs and the multi-campus structure,the study analyzed and explored the management of drugs for clinical trials to build a corresponding management system,including pharmacy construction,equipment,personnel qualifications,data management,drug reception,storage,distribution,and recycling protocols.The effecttivness of the system was evaluated through comparative analysis of data from 2022 to 2023 at our hospital.Result Improvements in the management of drugs for clinical trials were observed in 2023 across varous aspects.Conclusion Refining the management system of drugs for clinical trials can enhance Good Clinical Practice(GCP)supervision and service,providing an important reference for the management system.
7.Summary of the best evidence for exercise scheme after bariatric and metabolic surgery in obese patients
Zhiwen LI ; Kun LAN ; Xiaowei ZHANG ; Xuerui LYU ; Xuejiao LEI ; Yuru XU ; Cuiping NI ; Yingli PAN
Chinese Journal of Modern Nursing 2021;27(19):2548-2555
Objective:To evaluate and summarize the best evidence for exercise scheme after bariatric and metabolic surgery in obese patients at home and abroad.Methods:We used "obesity" " bariatric and metabolic surgery" "sleeve gastrectomy" "gastric bypass surgery" "banding surgery" "exercise" "physical activity" "exercise therapy" "guideline" "expert consensus" "systematic review" "Meta-analysis" and "evidence summary" as keywords, and searched databases such as UpToDate, Cochrane Library, PubMed, China National Knowledge Infrastructure (CNKI) , Wanfang Data, and the guide network and professional association platforms by computer. Literature retrieved included guidelines, expert consensus, best clinical practice, clinical decision-making, systematic reviews, and the search time limit was from the database establishment to July 18, 2020. Two researchers evaluated the quality of literature and extracted evidence, and the evidence was revised and perfected through expert consultation.Results:A total of 4 systematic reviews and Meta-analysis articles, 2 clinical decision-making articles, 4 guidelines, and 1 expert consensus were included. The evidence was collected from 7 aspects, namely the importance of exercise, pre-exercise evaluation, exercise style, exercise intensity and duration, exercise safety, exercise follow-up, exercise effect evaluation, and finally 33 best evidences were summed up.Conclusions:Evidence of exercise scheme after bariatric and metabolic surgery in obese patients is comprehensive. Medical institutions and clinical medical and nursing staff can combine the institutional environment to transform and apply the evidence.
8.The effect of bedside chest radiograph in the diagnosis and follow-up of severe and critical COVID-19
Huai CHEN ; Yujian ZOU ; Bowen LAN ; Zhengguang WU ; Zhiwen NI ; Suidan HUANG ; Xiaoqing LIU ; Yuquan SONG ; Qingsi ZENG
Chinese Journal of Radiology 2020;54(6):539-543
Objective:To explore the value of bedside chest radiograph in the diagnosis and follow-up of severe and critical COVID-19.Methods:Twenty-nine patients with severe or critical COVID-19 were collected from January 23 to February 23, 2020,from four COVID-19 designated hospitals in Guangdong Province. Bedside radiography was taken in all the 29 patients, ranged from 1 to 16 times for each patient. Twenty-seven patients underwent follow-up, and the number of re-examination ranged 1 to 15 times, and the interval of review is 1 to 8 days.The imaging findings of bedside chest radiography and the imaging changes on follow-up chest radiography were analyzed retrospectively.Results:Twenty-nine patients were collected. The radiography showed the lesions involved all more than 3 lung fields. The films showed consolidation shadow in 19 cases, multiple patches of shadow in 23 cases, reticular pattern in 12 cases, strips shadow in 14 cases, interlobar fissure thickening in 18 cases, and "white lung" in 4 cases.The complications included pleural effusion in 4 cases, pneumothorax in 2 cases, mediastinal and subcutaneous emphysema in 1 case. The radiography showed the lesions progressed in 15 cases, with expanded involvement of the lung.The increase of lesion density was found in 6 cases, new lesions were noted in 5 cases, while both of them were found in 4 cases. Nine cases showed improvement, with reduced range and decreased density. Patchy or consolidation shadow turned to strips shadow or articular pattern shadow in 8 cases.There was no significant change in 3 cases with large consolidation shadow.Conclusions:Bedside chest radiography has a good value in the follow-up of severely and critically ill patients with COVID-19, and can provide great help for clinicians to evaluate their condition.
9.Comparative analysis of intervention in patients with chronic kidney disease at home and abroad
Yunxia NI ; Yongshu DIAO ; Zhiwen CHEN ; Dengyan MA
Chinese Journal of Practical Nursing 2017;33(31):2473-2476
This paper summarizes the intervention of chronic kidney disease at home and abroad from the intervention places, objects, contents, methods, executants and evaluation. Some intervention problems have been found in this paper: intervention places do not extend to the basic medical institutions; we draw less attention to those patients with special health needs; the theoretical basis of intervention strategies is inadequate; the content and evaluation of intervention are not comprehensive. The intervention research of chronic kidney disease in China is still a long way to go.
10.Standard in the clinical management of the lymph metastasis in pancreatic cancer
Guopei LUO ; Zhiwen XIAO ; Zuqiang LIU ; Meng GUO ; Jiang LONG ; Chen LIU ; Liang LIU ; Jin XU ; Quanxing NI ; Xianjun YU
China Oncology 2014;(2):81-86
Lymph metastasis has great impact on the prognosis of pancreatic cancer patients, which can relfect the biological and invasive potential of pancreatic cancer. However, currently, there is no standard in the clinical management of the lymph metastasis in pancreatic cancer. In this report, we will discuss and summarize the followings:lymph metastatic rate and its impact on prognosis, the rule of lymph metastasis, sentinel lymph node, intra-operative lymph nodes mapping, TNM staging, regional lymph nodes resection, number of lymph nodes examined, lymph node ratio, guiding adjuvant treatments, lymphatic targeted therapy.

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