1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
2.Synthetic MRI Combined With Clinicopathological Characteristics for Pretreatment Prediction of Chemoradiotherapy Response in Advanced Nasopharyngeal Carcinoma
Siyu CHEN ; Jiankun DAI ; Jing ZHAO ; Shuang HAN ; Xiaojun ZHANG ; Jun CHANG ; Donghui JIANG ; Heng ZHANG ; Peng WANG ; Shudong HU
Korean Journal of Radiology 2025;26(2):135-145
Objective:
To explore the feasibility of synthetic magnetic resonance imaging (syMRI) combined with clinicopathological characteristics for the pre-treatment prediction of chemoradiotherapy (CRT) response in advanced nasopharyngeal carcinoma (ANPC).
Materials and Methods:
Patients with ANPC treated with CRT between September 2020 and June 2022 were retrospectively enrolled and categorized into response group (RG, n = 95) and non RGs (NRG, n = 32) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The quantitative parameters from pre-treatment syMRI (longitudinal [T1] and transverse [T2] relaxation times and proton density [PD]), diffusion-weighted imaging (apparent diffusion coefficient [ADC]), and clinicopathological characteristics were compared between RG and NRG. Logistic regression analysis was applied to identify parameters independently associated with CRT response and to construct a multivariable model. The areas under the receiveroperating characteristic curve (AUC) for various diagnostic approaches were compared using the DeLong test.
Results:
The T1, T2, and PD values in the NRG were significantly lower than those in the RG (all P < 0.05), whereas no significant difference was observed in the ADC values between these two groups. Clinicopathological characteristics (Epstein–Barr virus [EBV]-DNA level, lymph node extranodal extension, clinical stage, and Ki-67 expression) exhibited significant differences between the two groups. Logistic regression analysis showed that T1, PD, EBV-DNA level, clinical stage, and Ki-67 expression had significant independent relationships with CRT response (all P < 0.05). The multivariable model incorporating these five variables yielded AUC, sensitivity, and specificity values of 0.974, 93.8% (30/32), and 91.6% (87/95), respectively.
Conclusion
SyMRI may be used for the pretreatment prediction of CRT response in ANPC. The multivariable model incorporating syMRI quantitative parameters and clinicopathological characteristics, which were independently associated with CRT response, may be a new tool for the pretreatment prediction of CRT response.
3.Synthetic MRI Combined With Clinicopathological Characteristics for Pretreatment Prediction of Chemoradiotherapy Response in Advanced Nasopharyngeal Carcinoma
Siyu CHEN ; Jiankun DAI ; Jing ZHAO ; Shuang HAN ; Xiaojun ZHANG ; Jun CHANG ; Donghui JIANG ; Heng ZHANG ; Peng WANG ; Shudong HU
Korean Journal of Radiology 2025;26(2):135-145
Objective:
To explore the feasibility of synthetic magnetic resonance imaging (syMRI) combined with clinicopathological characteristics for the pre-treatment prediction of chemoradiotherapy (CRT) response in advanced nasopharyngeal carcinoma (ANPC).
Materials and Methods:
Patients with ANPC treated with CRT between September 2020 and June 2022 were retrospectively enrolled and categorized into response group (RG, n = 95) and non RGs (NRG, n = 32) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The quantitative parameters from pre-treatment syMRI (longitudinal [T1] and transverse [T2] relaxation times and proton density [PD]), diffusion-weighted imaging (apparent diffusion coefficient [ADC]), and clinicopathological characteristics were compared between RG and NRG. Logistic regression analysis was applied to identify parameters independently associated with CRT response and to construct a multivariable model. The areas under the receiveroperating characteristic curve (AUC) for various diagnostic approaches were compared using the DeLong test.
Results:
The T1, T2, and PD values in the NRG were significantly lower than those in the RG (all P < 0.05), whereas no significant difference was observed in the ADC values between these two groups. Clinicopathological characteristics (Epstein–Barr virus [EBV]-DNA level, lymph node extranodal extension, clinical stage, and Ki-67 expression) exhibited significant differences between the two groups. Logistic regression analysis showed that T1, PD, EBV-DNA level, clinical stage, and Ki-67 expression had significant independent relationships with CRT response (all P < 0.05). The multivariable model incorporating these five variables yielded AUC, sensitivity, and specificity values of 0.974, 93.8% (30/32), and 91.6% (87/95), respectively.
Conclusion
SyMRI may be used for the pretreatment prediction of CRT response in ANPC. The multivariable model incorporating syMRI quantitative parameters and clinicopathological characteristics, which were independently associated with CRT response, may be a new tool for the pretreatment prediction of CRT response.
4.Synthetic MRI Combined With Clinicopathological Characteristics for Pretreatment Prediction of Chemoradiotherapy Response in Advanced Nasopharyngeal Carcinoma
Siyu CHEN ; Jiankun DAI ; Jing ZHAO ; Shuang HAN ; Xiaojun ZHANG ; Jun CHANG ; Donghui JIANG ; Heng ZHANG ; Peng WANG ; Shudong HU
Korean Journal of Radiology 2025;26(2):135-145
Objective:
To explore the feasibility of synthetic magnetic resonance imaging (syMRI) combined with clinicopathological characteristics for the pre-treatment prediction of chemoradiotherapy (CRT) response in advanced nasopharyngeal carcinoma (ANPC).
Materials and Methods:
Patients with ANPC treated with CRT between September 2020 and June 2022 were retrospectively enrolled and categorized into response group (RG, n = 95) and non RGs (NRG, n = 32) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The quantitative parameters from pre-treatment syMRI (longitudinal [T1] and transverse [T2] relaxation times and proton density [PD]), diffusion-weighted imaging (apparent diffusion coefficient [ADC]), and clinicopathological characteristics were compared between RG and NRG. Logistic regression analysis was applied to identify parameters independently associated with CRT response and to construct a multivariable model. The areas under the receiveroperating characteristic curve (AUC) for various diagnostic approaches were compared using the DeLong test.
Results:
The T1, T2, and PD values in the NRG were significantly lower than those in the RG (all P < 0.05), whereas no significant difference was observed in the ADC values between these two groups. Clinicopathological characteristics (Epstein–Barr virus [EBV]-DNA level, lymph node extranodal extension, clinical stage, and Ki-67 expression) exhibited significant differences between the two groups. Logistic regression analysis showed that T1, PD, EBV-DNA level, clinical stage, and Ki-67 expression had significant independent relationships with CRT response (all P < 0.05). The multivariable model incorporating these five variables yielded AUC, sensitivity, and specificity values of 0.974, 93.8% (30/32), and 91.6% (87/95), respectively.
Conclusion
SyMRI may be used for the pretreatment prediction of CRT response in ANPC. The multivariable model incorporating syMRI quantitative parameters and clinicopathological characteristics, which were independently associated with CRT response, may be a new tool for the pretreatment prediction of CRT response.
5.Synthetic MRI Combined With Clinicopathological Characteristics for Pretreatment Prediction of Chemoradiotherapy Response in Advanced Nasopharyngeal Carcinoma
Siyu CHEN ; Jiankun DAI ; Jing ZHAO ; Shuang HAN ; Xiaojun ZHANG ; Jun CHANG ; Donghui JIANG ; Heng ZHANG ; Peng WANG ; Shudong HU
Korean Journal of Radiology 2025;26(2):135-145
Objective:
To explore the feasibility of synthetic magnetic resonance imaging (syMRI) combined with clinicopathological characteristics for the pre-treatment prediction of chemoradiotherapy (CRT) response in advanced nasopharyngeal carcinoma (ANPC).
Materials and Methods:
Patients with ANPC treated with CRT between September 2020 and June 2022 were retrospectively enrolled and categorized into response group (RG, n = 95) and non RGs (NRG, n = 32) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The quantitative parameters from pre-treatment syMRI (longitudinal [T1] and transverse [T2] relaxation times and proton density [PD]), diffusion-weighted imaging (apparent diffusion coefficient [ADC]), and clinicopathological characteristics were compared between RG and NRG. Logistic regression analysis was applied to identify parameters independently associated with CRT response and to construct a multivariable model. The areas under the receiveroperating characteristic curve (AUC) for various diagnostic approaches were compared using the DeLong test.
Results:
The T1, T2, and PD values in the NRG were significantly lower than those in the RG (all P < 0.05), whereas no significant difference was observed in the ADC values between these two groups. Clinicopathological characteristics (Epstein–Barr virus [EBV]-DNA level, lymph node extranodal extension, clinical stage, and Ki-67 expression) exhibited significant differences between the two groups. Logistic regression analysis showed that T1, PD, EBV-DNA level, clinical stage, and Ki-67 expression had significant independent relationships with CRT response (all P < 0.05). The multivariable model incorporating these five variables yielded AUC, sensitivity, and specificity values of 0.974, 93.8% (30/32), and 91.6% (87/95), respectively.
Conclusion
SyMRI may be used for the pretreatment prediction of CRT response in ANPC. The multivariable model incorporating syMRI quantitative parameters and clinicopathological characteristics, which were independently associated with CRT response, may be a new tool for the pretreatment prediction of CRT response.
6.Synthetic MRI Combined With Clinicopathological Characteristics for Pretreatment Prediction of Chemoradiotherapy Response in Advanced Nasopharyngeal Carcinoma
Siyu CHEN ; Jiankun DAI ; Jing ZHAO ; Shuang HAN ; Xiaojun ZHANG ; Jun CHANG ; Donghui JIANG ; Heng ZHANG ; Peng WANG ; Shudong HU
Korean Journal of Radiology 2025;26(2):135-145
Objective:
To explore the feasibility of synthetic magnetic resonance imaging (syMRI) combined with clinicopathological characteristics for the pre-treatment prediction of chemoradiotherapy (CRT) response in advanced nasopharyngeal carcinoma (ANPC).
Materials and Methods:
Patients with ANPC treated with CRT between September 2020 and June 2022 were retrospectively enrolled and categorized into response group (RG, n = 95) and non RGs (NRG, n = 32) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The quantitative parameters from pre-treatment syMRI (longitudinal [T1] and transverse [T2] relaxation times and proton density [PD]), diffusion-weighted imaging (apparent diffusion coefficient [ADC]), and clinicopathological characteristics were compared between RG and NRG. Logistic regression analysis was applied to identify parameters independently associated with CRT response and to construct a multivariable model. The areas under the receiveroperating characteristic curve (AUC) for various diagnostic approaches were compared using the DeLong test.
Results:
The T1, T2, and PD values in the NRG were significantly lower than those in the RG (all P < 0.05), whereas no significant difference was observed in the ADC values between these two groups. Clinicopathological characteristics (Epstein–Barr virus [EBV]-DNA level, lymph node extranodal extension, clinical stage, and Ki-67 expression) exhibited significant differences between the two groups. Logistic regression analysis showed that T1, PD, EBV-DNA level, clinical stage, and Ki-67 expression had significant independent relationships with CRT response (all P < 0.05). The multivariable model incorporating these five variables yielded AUC, sensitivity, and specificity values of 0.974, 93.8% (30/32), and 91.6% (87/95), respectively.
Conclusion
SyMRI may be used for the pretreatment prediction of CRT response in ANPC. The multivariable model incorporating syMRI quantitative parameters and clinicopathological characteristics, which were independently associated with CRT response, may be a new tool for the pretreatment prediction of CRT response.
7.Investigation and analysis of plague epidemic Yersinia infection in Marmota himalayana, Yugur Autonomous County of Sunan, Gansu Province
Aiwei HE ; Daqin XU ; Ran DUAN ; Huaiqi JING ; Hua CHUN ; Binguo RONG ; Donghui ZHAN ; Zizhou LIU ; Wenhe BAI ; Jinxiao XI
Chinese Journal of Endemiology 2023;42(7):554-557
Objective:To study the epidemic situation of Marmota himalayana plague and Yersinias infection in Yugur Autonomous County of Sunan (Sunan County) of Gansu Province, and to provide new ideas for prevention and control of plague. Methods:From 2014 to 2018, liver and spleen, cecum, throat swabs and blood samples of Marmota himalayana were collected on the spot in Sunan County, where Yersinia strains were isolated and identified, and plague F1 antigen and antibody were detected. Results:A total of 634 liver and spleen samples, 427 cecum samples and 426 throat swabs samples were collected from Marmota himalayana, and 23 strains of Yersinia pestis, 2 strains of Yersinia marcescens, and 1 strain of Yersinia flexneri were detected, with the detection rates of 3.63% (23/634), 0.47% (2/427) and 0.23% (1/426), respectively. The detection rate of Yersinia pestis in different years was statistically significantly different (χ 2 = 13.19, P = 0.010). A total of 1 822 serum samples of Marmota himalayana were detected, and 5 F1 antibody positive samples were detected, with a positive rate of 0.27%, the difference of positive rate between different years was statistically significant (χ 2 = 25.22, P < 0.001); 282 liver and spleen tissue homogenates of Marmota himalayana were detected, 22 F1 antigen positive samples were detected, the positive rate was 7.80%, and there was no statistically significant difference between different years (χ 2 = 7.85, P = 0.097). The 23 strains of Yersinia pestis detected were distributed in Mati Tibetan Township (12 strains), Dahe Township (6 strains) and Qifeng Tibetan Township (5 strains); 1 strain of Yersinia flexneri and 2 strains of Yersinia marcescens were both located in Dahe Township. Conclusion:There is an epidemic of plague among animals in Sunan County from 2014 to 2018, and the areas where Yersinia pestis and non pathogenic Yersinia are detected overlapped.
8.Risk factors in blood for attacks of angina in patients with coronavirus disease 2019 and stable angina.
Song GENG ; Donghui ZHOU ; Qi WANG ; Guofeng WANG ; Wei WEI ; Tao YU ; Zhiying DUAN ; Jing LIU ; Fei YU ; Yuanzhe JIN
Chinese Medical Journal 2023;136(11):1373-1375
Humans
;
Angina, Stable
;
COVID-19
;
Risk Factors
;
Patients
9.Quality regulatory issues and suggestions for the Lonicerae Japonicae Flos with property of drug and food homologous substance
Xin ZHAO ; Ruiqing WEN ; Donghui LI ; Jing ZHANG ; Xin WANG
International Journal of Traditional Chinese Medicine 2023;45(4):385-390
In the context of the national strategy of promoting the research and development of food and drug homologous substances, it is necessary to study the regulatory model of food and drug homologous substances as food. Medicinal and food homologous substances are regulated as "Chinese medicinal materials" or "Chinese decoction pieces" in the drug category, and as "food and drug homologous substances", "agricultural products" or "traditional Chinese medicine healthy food" in the food category. Drug supervision focuses on quality, while food supervision focuses on safety, and it is worth exploring whether there is a blind spot in the supervision of food and drug substances completely based on the food concept. In this paper, Lonicerae Japonicae Flos, as drug and food homologous substance, is selected as the research object, and its quality regulation status is investigated by reviewing the relevant laws and regulations and standards on food, analyzing the quality information and test results of the samples, and analyzing the necessity of quality regulation when serving as food, in order to provide a basis and reference for the way food substances are regulated.
10.Design and practice of general population cohort study in northeastern China
Hehua ZHANG ; Qing CHANG ; Qijun WU ; Yang XIA ; Shanyan GAO ; Yixiao ZHANG ; Yuan YUAN ; Jing JIANG ; Hongbin QIU ; Jing LI ; Chunming LU ; Chao JI ; Xin XU ; Donghui HUANG ; Huixu DAI ; Zhiying ZHAO ; Xing LI ; Xiaoying LI ; Xiaosong QIN ; Caigang LIU ; Xiaoyu MA ; Xinrui XU ; Da YAO ; Huixin YU ; Yuhong ZHAO
Chinese Journal of Epidemiology 2023;44(1):21-27
In 2016, a national one million general population cohort project was set up in China for the first time in "Precision Medicine Research" Key Project, National Key Research and Development Program of China, which consists of general population cohorts in seven areas in China. As one of the seven major areas in China, northeastern China has unique climate and specific dietary patterns, and population aging is serious in this area. And the burden of chronic and non-communicable diseases ranks tops in China. Therefore, it is of great significance to establish a large general population cohort in northeastern China to explore the area specific exposure factors related to pathogenesis and prognosis of chronic and non-communicable diseases, develop new prevention strategies to reduce the burden of the diseases and improve the population health in northeastern China. In July 2018, the general population cohort study in northeastern China was launched, the study includes questionnaire survey, health examination and blood, urine and stool sample collection and detection in recruited participants. By now, the cohort has covered all age groups, and the baseline data of 115 414 persons have been collected. This paper summarizes the design and practice of the general population cohort study in northeastern China to provide reference for related research in China.

Result Analysis
Print
Save
E-mail