1.A preclinical and first-in-human study of superstable homogeneous radiolipiodol for revolutionizing interventional diagnosis and treatment of hepatocellular carcinoma.
Hu CHEN ; Yongfu XIONG ; Minglei TENG ; Yesen LI ; Deliang ZHANG ; Yongjun REN ; Zheng LI ; Hui LIU ; Xiaofei WEN ; Zhenjie LI ; Yang ZHANG ; Syed Faheem ASKARI RIZVI ; Rongqiang ZHUANG ; Jinxiong HUANG ; Suping LI ; Jingsong MAO ; Hongwei CHENG ; Gang LIU
Acta Pharmaceutica Sinica B 2025;15(10):5022-5035
Transarterial radioembolization (TARE) is a widely utilized therapeutic approach for hepatocellular carcinoma (HCC), however, the clinical implementation is constrained by the stringent preparation conditions of radioembolization agents. Herein, we incorporated the superstable homogeneous iodinated formulation technology (SHIFT), simultaneously utilizing an enhanced solvent form in a carbon dioxide supercritical fluid environment, to encapsulate radionuclides (such as 131I,177Lu, or 18F) with lipiodol for the preparation of radiolipiodol. The resulting radiolipiodol exhibited exceptional stability and ultra-high labeling efficiency (≥99%) and displayed notable intratumoral radionuclide retention and in vivo stability more than 2 weeks following locoregional injection in subcutaneous tumors in mice and orthotopic liver tumors in rats and rabbits. Given these encouraging findings, 18F was authorized as a radiotracer in radiolipiodol for clinical trials in HCC patients, and showed a favorable tumor accumulation, with a tumor-to-liver uptake ratio of ≥50 and minimal radionuclide leakage, confirming the feasibility of SHIFT for TARE applications. In the context of transforming from preclinical to clinical screening, the preparation of radiolipiodol by SHIFT represents an innovative physical strategy for radionuclide encapsulation. Hence, this work offers a reliable and efficient approach for TARE in HCC, showing considerable promise for clinical application (ChiCTR2400087731).
2.Expert consensus on imaging diagnosis and analysis of early correction of childhood malocclusion.
Zitong LIN ; Chenchen ZHOU ; Ziyang HU ; Zuyan ZHANG ; Yong CHENG ; Bing FANG ; Hong HE ; Hu WANG ; Gang LI ; Jun GUO ; Weihua GUO ; Xiaobing LI ; Guangning ZHENG ; Zhimin LI ; Donglin ZENG ; Yan LIU ; Yuehua LIU ; Min HU ; Lunguo XIA ; Jihong ZHAO ; Yaling SONG ; Huang LI ; Jun JI ; Jinlin SONG ; Lili CHEN ; Tiemei WANG
International Journal of Oral Science 2025;17(1):21-21
Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans
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Malocclusion/diagnostic imaging*
;
Child
;
Consensus
3.Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.
Juan XIA ; Xiaoan TAO ; Qinchao HU ; Wei LUO ; Xiuzhen TONG ; Gang ZHOU ; Hongmei ZHOU ; Hong HUA ; Guoyao TANG ; Tong WU ; Qianming CHEN ; Yuan FAN ; Xiaobing GUAN ; Hongwei LIU ; Chaosu HU ; Yongmei ZHOU ; Xuemin SHEN ; Lan WU ; Xin ZENG ; Qing LIU ; Renchuan TAO ; Yuan HE ; Yang CAI ; Wenmei WANG ; Ying ZHANG ; Yingfang WU ; Minhai NIE ; Xin JIN ; Xiufeng WEI ; Yongzhan NIE ; Changqing YUAN ; Bin CHENG
International Journal of Oral Science 2025;17(1):54-54
Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans
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Chemoradiotherapy/adverse effects*
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Consensus
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Risk Factors
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Stomatitis/etiology*
4.An improved reporter gene assay for evaluating the biological activity of recombinant human growth hormone.
Xiaoming ZHANG ; Heyang LI ; Ying HUANG ; Ping LV ; Lvyin WANG ; Kezheng XU ; Yi LI ; Xinyue HU ; Yue SUN ; Cheng-Gang LIANG ; Jing LI
Journal of Pharmaceutical Analysis 2025;15(5):101073-101073
Image 1.
5.Establishment and evaluation of a lipopolysaccharide-induced acute respiratory distress syndrome model in minipigs
Chuang-Ye WANG ; Ran WANG ; Jian ZHANG ; Ling-Xiao QIU ; Bin QING ; Heng YOU ; Jin-Cheng LIU ; Bin WANG ; Nan-Bo WANG ; Jia-Yu LI ; Xing LIU ; Shuang WANG ; Jin HU ; Jian WEN ; Quan LI ; Xiao-Ou HUANG ; Kun ZHAO ; Shuang-Lin LIU ; Gang LIU ; Mei-Ju WANG ; Qing XIANG ; Hong-Mei WU ; Xiao-Rong SUN ; Tao GU ; Dong ZHANG ; Qi LI ; Zhi XU
Medical Journal of Chinese People's Liberation Army 2025;50(9):1154-1161
Objective To establish a stable,reliable,and clinically relevant porcine model of endotoxin-induced acute respiratory distress syndrome(ARDS).Methods Ten 8-month-old male Bama minipigs were deeply sedated,followed by invasive mechanical ventilation and electrocardiographic monitoring.Lipopolysaccharide(LPS)was intravenously pumped at 600 μg/(kg·h)for 3 hours,then maintained at 15 μg/(kg·h)thereafter.Dynamic monitoring was performed at five time points after LPS injection(LPS 0,1,3,5,and 8 h),including arterial blood gas analysis and chest computed tomography(CT)scans.Pathological examination of lung tissues obtained via bronchoscopic biopsy(HE staining and transmission electron microscopy)was conducted.These indicators were comprehensively used to evaluate the success of the animal model.Results At 5 hours after LPS administration,8 minipigs developed symptoms such as skin cyanosis,elevated body temperature,and respiratory distress.The oxygenation index decreased to<300 mmHg.Chest CT scans showed diffuse pulmonary infiltrates.Histopathology revealed alveolar edema and hyaline membrane formation.Transmission electron microscopy demonstrated disruption of pulmonary blood-air barrier,depletion of lamellar bodies in type Ⅱ pneumocytes,inflammatory cell infiltration,and exudation of plasma proteins and fibrin.Compared with LPS 0 h,at LPS 8 h,the oxygenation index and arterial blood pH were significantly decreased(P<0.001),while blood lactic acid and serum potassium were significantly increased(P<0.05);serum calcium and base excess were significantly decreased(P<0.05),and the lung injury score based on HE-stained lung sections was significantly increased(P<0.01).Conclusion The porcine ARDS model established by continuous LPS injection can dynamically simulate the pathophysiological characteristics and typical pathological manifestations of clinical septic ARDS,making it an effective tool to study the pathogenesis,prevention,and treatment strategies of septic ARDS.
6.Construction of a personalized outpatient service platform based on patient profile in a hospital
Jing CHENG ; Gang LI ; Xiaohan HU ; Shuai GE ; Gang YAO
Chinese Journal of Hospital Administration 2025;41(8):599-603
Outpatient services reflect the overall management level of hospitals and is a key link affecting patients′ healthcare experiences. To address the challenges faced by traditional outpatient services and meet patients′ diverse medical needs, a tertiary hospital implemented personalized outpatient services in March 2024. By utilizing information technologies such as big data and artificial intelligence, patient profile and a personalized service knowledge base was constructed, and a personalized outpatient service platform was built (including various functional modules such as intelligent guidance, pre consultation, abnormal indicator management, and full course management, as well as intelligent recommendation engines). This platform could provide personalized health guidance, customer service, and diagnosis and treatment services for outpatient throughout the entire process from pre-diagnosis to post diagnosis.After the launch of the personalized outpatient service platform, patient satisfaction in the oncology and pediatric departments increased from 90% and 86% in May 2024 to 94% and 91% in May 2025, respectively. From May 2024 to May 2025, the intelligent customer service addressed 740 000 patient inquiries, with a resolution rate of 90%. The online conversion rate (the proportion of patients switching from offline visits to online follow-ups relative to the total number of offline visits during the same period) rose from 37% in May 2023 to 43% in May 2025. The platform had enhanced the quality and efficiency of outpatient services, effectively improved patients′ healthcare experiences, and could serve as a reference for other hospitals seeking to upgrade their outpatient services.
7.Construction of a personalized outpatient service platform based on patient profile in a hospital
Jing CHENG ; Gang LI ; Xiaohan HU ; Shuai GE ; Gang YAO
Chinese Journal of Hospital Administration 2025;41(8):599-603
Outpatient services reflect the overall management level of hospitals and is a key link affecting patients′ healthcare experiences. To address the challenges faced by traditional outpatient services and meet patients′ diverse medical needs, a tertiary hospital implemented personalized outpatient services in March 2024. By utilizing information technologies such as big data and artificial intelligence, patient profile and a personalized service knowledge base was constructed, and a personalized outpatient service platform was built (including various functional modules such as intelligent guidance, pre consultation, abnormal indicator management, and full course management, as well as intelligent recommendation engines). This platform could provide personalized health guidance, customer service, and diagnosis and treatment services for outpatient throughout the entire process from pre-diagnosis to post diagnosis.After the launch of the personalized outpatient service platform, patient satisfaction in the oncology and pediatric departments increased from 90% and 86% in May 2024 to 94% and 91% in May 2025, respectively. From May 2024 to May 2025, the intelligent customer service addressed 740 000 patient inquiries, with a resolution rate of 90%. The online conversion rate (the proportion of patients switching from offline visits to online follow-ups relative to the total number of offline visits during the same period) rose from 37% in May 2023 to 43% in May 2025. The platform had enhanced the quality and efficiency of outpatient services, effectively improved patients′ healthcare experiences, and could serve as a reference for other hospitals seeking to upgrade their outpatient services.
8.Comprehensive analysis of insulin products complex disulfide bonds structure by high resolution mass spectrum
Xin-yue HU ; Xiao-li DING ; Yue SUN ; Hui ZHANG ; Jing LI ; Cheng-gang LINAG
Acta Pharmaceutica Sinica 2024;59(1):188-197
The correct pairing of disulfide bonds maintains the correct folding mode and high-level structure formation of peptides and protein drugs, which is crucial for the quality control of products. In order to ensure that the disulfide bonds are correctly paired, disulfide bond analysis is an essential part of peptides and protein drug characterization. Mass spectrometry can be used to analyze disulfide bonds. However, insulin and its analogues have two pairs of disulfide bonds without restriction enzyme cutting site. Conventional collision-induced dissociation (CID) and high-energy induced cleavage (HCD) cannot accurately locate the complex disulfide bond. In our study, three methods were used to localize the complex disulfide, including enzyme digestion combined with key peptide fragment in source decay (ISD) fragmentation method, enzyme digestion combined with partial reduction alkylation method, intact protein source ISD and electron transfer dissociation (ETD) cleavage method, The applicability of insulin aspart, insulin lispro and insulin glargine were also investigated. This study provides a new way for the quality control of disulfide bonding mode of insulin and its analogues, and also provides a reference for the disulfide bond localization of peptides or proteins containing this complex disulfide bond.
9.Establishment of a method for determining the key parameters of hydrolysis kinetics of acid α -glucosidase for injection by ion chromatography
Xin-yue HU ; Jia-hao KONG ; Yue SUN ; Lü-yin WANG ; Xiao-ming ZHANG ; Ping LÜ ; Cheng-gang LIANG ; Jing LI
Acta Pharmaceutica Sinica 2024;59(12):3361-3366
The Dionex CaboPacTM PA10 BioLCTM Analyical 2 mm × 250 mm column was used with a protective column (Dionex CaboPacTM PA10 BioLCTM Guard 2 mm × 50 mm). 100 mmol·L-1 sodium hydroxide solution was used as eluent; the flow rate was 0.25 mL·min-1. Sample tray temperature: 35 ℃. The pulse amperometric detector was adopted, and the waveform was Gold CWE, Ag-AgCl RE, Carbo, Quad. The samples were cultured with 8 concentrations of glycogen substrates (0.31, 1.25, 2.5, 5, 10, 20, 30, and 40 mg·mL-1).
10.The research of a SEC-UV-RI method to determine the modifiction degree of PEG-rhGH
Yi LI ; Xiao-ming ZHANG ; Xin-yue HU ; Yue SUN ; Lü-yin WANG ; Du-yu CHEN ; Ping LÜ ; Cheng-gang LIANG ; Jing LI
Acta Pharmaceutica Sinica 2024;59(12):3367-3373
According to the requirements of the regulatory authorities, degree of modification (DP) should be included in the characterisation of the PEGylated protein drug substance, and is one of the critical quality attributes for quality control. In this study, based on the fundamental assumption that the refractive index (RI) signal and the ultraviolet (UV) signal of PEGylated protein are equal to the sum of the corresponding signal produced by the polyethylene glycol (PEG) and protein parts of the conjugates in their uncoupled state, we developed a method to determine the DP of PEGylated recombinant human growth hormone (inpegsomatropin). In this method, 20 μL of 1 mg·mL-1 human growth hormone (hGH) standard, 2 mg·mL-1 PEG reference substance and 1 mg·mL-1 drug substance solution were each injected to size exclusion chromatographic (SEC) column for separation, detected with ultraviolet and refractive index (UV-RI) detectors in series. Finally, the DP was calculated as the formula derived from the fundamental assumption. The developed SEC-UV-RI method showed good specificity, repeatability (RSD = 0.63%,

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