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.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.
8.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.
9.Research Progress on the Mechanism of Non-coding RNA Regulation of Bone Reconstruction in Osteoporosis and the Therapeutic Mechanism of Traditional Chinese Medicine for Tonifying Kidney and Strengthening Bone
WANG Xiaxia ; AN Fangyu ; YAN Chunlu ; SUN Bai ; WANG Chunmei ; LIU Ying ; SHI Yao ; YUAN Lingqing ; LYU Donghui ; ZHAO Yanzhen
Chinese Journal of Modern Applied Pharmacy 2023;40(17):2462-2472
Non-coding RNAs(ncRNAs) are special RNAs that they don't have protein coding function, but they can affect chromosome structure, gene transcription and participate in the processes of epigenetic modifications. ncRNAs include long non-coding RNAs, microRNA, etc. In recent years, it has been found that these ncRNAs can maintain bone remodeling by adjusting bone resorption and formation in osteoporosis(OP). In the future, it may be a key target of the drug action screening which is clarifying the regulatory mechanism of ncRNAs in the occurrence and development of OP. OP belongs to bone rheumatism category in traditional Chinese medicine, according to the theory of “the kidney generating marrow and dominating bone” in traditional Chinese medicine, kidney tonifying and bone strengthening formulas are used to treat the OP in clinic, and the curative effect is remarkable. It has been found that kidney tonifying and bone strengthening prescriptions can enhance the proliferation of osteoblasts or inhibit the differentiation of osteoclasts by up-regulating or down-regulating the expression of ncRNA, and finally maintain OP bone homeostasis, thus exerting therapeutic effect. However, the specific molecular mechanism is still in its exploratory stage. Therefore, this paper summarized the molecular mechanism of kidney tonifying and bone strengthening prescriptions regulating ncRNAs in the treatment of OP in recent years, in order to provide the new ideas for the screening of the key therapeutic targets of OP drugs and the prevention and treatment of OP with traditional Chinese medicine.
10.Clinical application of PET automatic drug infusion system combined with power peripherally inserted central catheter in 18F-FDG PET/CT imaging
Qinli QI ; Lingzhou ZHAO ; Donghui CHEN ; Xingmei ZHOU ; Changcun LIU ; Shan WU ; Ying ZHANG ; Jinhua ZHAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2023;43(11):684-688
Objective:To evaluate the feasibility of PET automatic drug infusion system combined with power peripherally inserted central catheter (PICC) for 18F-FDG injection and PET/CT imaging. Methods:Fifty patients with malignant neoplasms who underwent 18F-FDG PET/CT imaging in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine between December 2021 to July 2022 were prospectively enrolled. They were equally divided into power PICC group and peripheral venipuncture group. PET automatic drug infusion system was respectively connected with the pre-established channels of power PICC and peripheral venipuncture for 18F-FDG injection. Each patient underwent a routine PET/CT imaging at 1 h post-injection. The blood glucose, body weight, prescription dose and injection dose were recorded, and SUV max in the liver and cavoatrial junction were measured in both groups. The independent-sample t test was performed to compare the differences between 2 groups. The power PICC tip positions after 18F-FDG injection in power PICC group were observed. Results:The liver SUV max in the power PICC group and peripheral group were 2.54±0.50 and 2.57±0.31 ( t=0.37, P=0.716), and the SUV max of cavoatrial junction in the 2 groups were 1.68±0.25 and 1.63±0.22 ( t=-0.78, P=0.441), respectively. No significant differences were found in blood glucose, body weight, prescription dose and injection dose between the 2 groups ( t values: 0.00-0.13, all P>0.05). The ratios of injection dose to prescription dose in the 2 groups were 0.998 3±0.007 3 and 0.997 6±0.016 5, respectively, indicating high injection accuracy of the injection methods. No obvious drug residue was displayed at the end of catheter, resulting in good imaging quality. All the tip positions after injection were between T5 and T8, in line with the standardization management of power PICC. Conclusion:PET automatic drug infusion system combined with power PICC can be safely used for 18F-FDG injection and PET/CT imaging with less injection puncture.


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