Objective: To conduct screening for rare blood types within important blood group systems for the Chinese population, such as Rh, Duffy, Kidd, P1Pk, Diego, and MNS, in the Guangzhou region, and to establish a corresponding rare blood type database and physical repository. Methods: The saline medium microplate method was used to screen blood donors with the ccDEE phenotype combined with either Jk(a-) or Jk(b-). The polybrene microplate method was employed to screen for donors with Fy(a-), s(-), Lu(b-), Di(b-), k(-), and p phenotypes. The urea lysis microplate method was applied to screen for the Jk(a-b-) phenotype. A high-resolution melting (HRM) curve method was established for screening some donors with the Di(b-) phenotype. Subsequently, expanded phenotyping of antigens in the Rh, Kidd, MNS, Duffy, P1Pk, Lewis, Kell, and Lutheran blood group systems was performed on identified rare blood type donors using monoclonal antibodies. The test results are entered into the Rare Blood Type Bank Management System of the Guangzhou Blood Center, enabling functions such as confirmation reminders and cryopreservation storage when the donor donates again. Red blood cells of rare blood types are processed into frozen red blood cells for long-term storage. Results: Among voluntary blood donors, 16 cases of the ccDEE combined with Jk(a-) phenotype were identified (0.221 7%, 16/7 216); 10 cases of the ccDEE combined with Jk(b-) phenotype (0.138 6%, 10/7 216); 78 cases of the Fy(a-) phenotype (0.169 5%, 78/46 012); 39 cases of the Lu(b-) phenotype (0.138 2%, 39/28 214); 31 cases of the s(-) phenotype (0.081 8%, 31/37 913); 22 cases of the Di(b-) phenotype (0.029 9%, 22/73 691); 30 cases of the Jk(a-b-) phenotype (0.010 1%, 30/298 250); and 1 case of the k(-) phenotype (0.001 3%, 1/77 382), which was further identified as KELnull phenotype (K0). No p phenotype donors were identified (0/88 528). A total of 228 units of frozen red blood cells were prepared. The screening results were compared and analyzed with rare blood type data from other regions. Conclusion: This study, through a combination of different screening methods, significantly improved the efficiency of rare blood type screening while remaining cost-effective. By conducting large-scale screening and performing data informatization processing, a database and physical repository of rare blood types in the Guangzhou region were successfully established. This provides a strong guarantee for the timely supply of blood to patients with difficult-to-match and rare blood types in the region, effectively enhances the level of transfusion safety in the region, and offers a practical paradigm for constructing a comprehensive blood transfusion support system.

OBJECTIVE To analyze the development history， current status， and major challenges of central （cloud） pharmacies within China’s close-knit county-level medical communities， and to provide references for improving the overall effectiveness of the primary-level pharmaceutical supply and support system.METHODS Policy documents and practical case data related to central （cloud） pharmacies in county-level medical communities from 31 provinces （autonomous regions and municipalities） in China were collected. A qualitative approach combining policy text analysis and comparative case analysis was employed to longitudinally trace and cross-sectionally compare the development history and current status of central （cloud） pharmacies， identify existing problems， and propose targeted recommendations. RESULTS &CONCLUSIONS The development of central （cloud） pharmacies in China has undergone three stages： initial exploration， pilot expansion and mechanism deepening， and high-level promotion with local responses. While adhering to national policy directives， various regions have conducted diverse explorations in organizational and legal forms， management models， and institutional frameworks. However， several challenges remain， including insufficient policy guidance， an imperfect mechanism for drug coordination and supply security， weaknesses in hardware infrastructure and information technology development， and the need to strengthen statistical monitoring and outcome evaluation systems. It is recommended that the construction of central （cloud） pharmacies should be oriented toward achieving their fundamental functions， improve the institutional framework， adopt differentiated construction models tailored to local conditions， enhance the coordinated drug supply and support system， strengthen information technology infrastructure and professional capacity building， unify evaluation standards， and improve performance assessment mechanisms， so as to elevate the overall effectiveness of the primary-level pharmaceutical supply and support system.

The quality of clinical trials is critical to ensuring the safety and rights of participants, and ensuring the reliability of trial data. It directly affects the scientific validity of research conclusions and the effectiveness of regulatory decisions. This study aimed to establish an efficient quality management system to enhance the overall quality of clinical trials. Our hospital had established a dedicated quality control team, and developed a quality management module which was integrated to the clinical trial management system. Since February 2021, the hospital had fully digitized the electronic management of quality control processes, and achieved closed-loop management throughout the entire clinical trial by using this system. Key measures of the system included formulating tailored quality control plans, optimizing the design of quality control checklists, and refining quality control feedback mechanisms to improve management efficiency. In 2024, the annual quality control workload had reached 807 activities, with a completion rate of 93% and a timeliness rate of 91%. These outcomes demonstrate that the system could effectively improve the management quality and efficiency of pharmaceutical and medical devices clinical trials. The system could provide insights and practical references for the standardized implementation and quality assurance of clinical trials.

OBJECTIVE To provide references and recommendations for improving the regulatory framework for cell and gene therapy products and treatments in China.METHODS This study systematically examined the"dual-track regulatory"frameworks for regenerative medicine products and treatments in Japan and the Republic of Korea,summarized their beneficial experiences,and explored optimization strategies for China's regulatory practices.RESULTS&CONCLUSIONS Both Japan and the Republic of Korea have established clear management processes for two distinct pathways"registered clinical trials for regenerative medicine products"and"clinical research on regenerative medicine treatments"guided by shared principles of"risk stratification"and"full lifecycle oversight".Based on these findings,it is recommended that China:strengthen top-tier legislative framework to explicitly delineate the regulatory scope governing cell and gene therapy products and treatments;clarify the jurisdictional responsibilities of relevant regulatory bodies to enhance oversight efficacy;appropriately calibrate the regulatory scope,and adopt a balanced regulatory approach that harmonizes standardization with innovation incentives,thereby accelerating the clinical translation of regenerative medicine products.

Objective:To explore the value of 18F-fluorodeoxyglucose ( 18F-FDG) PET-CT dual-modality habitat imaging technology in predicting the epidermal growth factor receptor (EGFR) mutation status in lung adenocarcinoma. Methods:This study was designed as a cross-sectional study. Clinical and imaging data of 403 patients with lung adenocarcinoma who underwent 18F-FDG PET-CT imaging with definitive EGFR results from January 2018 to April 2022 at the Third Affiliated Hospital of Soochow University were retrospectively analyzed.The patients were divided into a development set (282 cases) and a validation set (121 cases) using a stratified random sampling method at a 7∶3 ratio. An adaptive clustering algorithm was used to segment the regions of interest, forming different habitats and obtaining derived parameters. Independent samples t-test or Mann-Whitney U test were used to compare clinical, imaging indicators, and habitat-derived parameters between EGFR mutant and wild-type patient. The clinical, imaging indicators, and habitat-derived parameters that showed statistically significant differences in univariate analysis were included in multivariate logistic regression to construct clinical and clinical-habitat combined models, respectively. The receiver operating characteristic curve and area under the curve (AUC) were used to evaluate the model′s ability to predict EGFR mutations in lung adenocarcinoma. Additionally, the net reclassification index (NRI) was employed to assess the model′s classification improvement capability. Results:There were 249 cases of EGFR mutation and 154 cases of wild type. The optimal number of habitats was two, namely Habitat 1 and Habitat 2. The parameters included in the clinical model were smoking history, bronchial sign, pleural indentation sign, and tumor diameter. The parameters incorporated into the clinical-habitat combined model were smoking history, bronchial sign, pleural indentation sign, Habitat 2, and Habitat 1 voxel count. In the development set, the AUCs for predicting EGFR mutations in lung adenocarcinoma using the clinical model and the clinical-habitat combined model were 0.723 and 0.733, respectively, with no statistically significant difference ( Z=0.60, P=0.549); In the validation set, the AUCs were 0.684 and 0.715, respectively, with no statistically significant difference ( Z=1.32, P=0.186). The accuracy (0.694) and specificity (0.609) of the clinical-habitat combined model in the validation set were slightly higher than those of the clinical model (0.686 and 0.565, respectively). NRI analysis confirmed that the clinical-habitat combined model improved the correct classification of EGFR wild-type lung adenocarcinoma by 10.9% compared to the clinical model ( P=0.018). Conclusion:18F-FDG PET-CT dual-modality habitat imaging technology can be used to analyze the microenvironment of lung adenocarcinoma and has the potential in non-invasively predicting EGFR mutation status, providing an important basis for personalized and accurate treatment of patients with lung adenocarcinoma.

OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients'medicine instructions in China.METHODS Through searching the official website of the European Medicines Agency(EMA)and related literature,the definition,basic nature,and content of patients'medicine instructions in the European Union were introduced,and the characteristics of the management system of patients'medicine instructions in the European Union were analyzed in terms of the management department,approval and change procedures,readability requirements and information accessibility requirements.At the same time,the pilot situation of patients'medicine instructions in China,as well as problems in the paths of classification and management,readability of content,and information timeliness were analyzed to put forward suggestions.RESULTS & CONCLUSIONS European Union had a dedicated department for the management of medicine instructions;the approval and change procedures for patients'medicine instructions were clear,the readability requirements were detailed,the readability verification program with patient participation was established,and multi-channel and timely information disclosure was adopted.It is recommended that China establish a mechanism to categorize and manage professionals'and patients'medicine instructions,guide multiple parties to participate in the design of patients'medicine instructions and refine the readability requirements,and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.

With the rapid development of generative adversarial networks (GAN), learning the mapping between CT and PET images enables cross-modality generation. This not only integrates anatomical and functional information to improve image quality, but also helps reduce the radiation exposure to some extent. Based on a review of representative GAN architectures such as conditional GAN and CycleGAN, this paper discusses their research progress and limitations in various application scenarios, including initial tumor diagnosis and staging, treatment evaluation and follow-up, as well as methods for reducing PET/CT radiation dose. Additionally, challenges related to small-sample learning, model interpretability, and cross-institutional standardization are highlighted, and the clinical application prospects of GAN-based cross-modality generation technology are explored.

Objective:To develop and assess a three-class machine learning model for predicting wild-type, 19 del, and 21 L858R mutations of the epidermal growth factor receptor (EGFR) in lung adenocarcinoma using 18F-FDG PET/CT radiomic features and clinical features. Methods:The retrospective data was collected from 703 patients (346 males, 357 females; age (64.3±9.0) years) with lung adenocarcinoma at the First People′s Hospital of Changzhou from January 2018 to June 2023. Patients were divided into the training set (563 cases) and test set (140 cases) at the ratio of 8∶2. Clinical features were selected using recursive feature elimination (RFE). Radiomic features were extracted from PET and CT images, and the optimal feature sets were selected using minimum redundancy maximum relevance (mRMR) and least absolute shrinkage and selection operator (LASSO) methods. Base models were constructed by using random forest (RF), logistic regression (LR), support vector machine (SVM), K-nearest neighbors (KNN), and multi-layer perceptron (MLP), and the stacking method was applied to establish the CT and PET ensemble models. Delong test was used to compare the AUC differences between the PET/CT combined model and the clinical + PET/CT integrated model.Results:Among 703 patients, 273 were with EGFR wild-type, 202 were with 19 del mutation, and 228 were with 21 L858R mutation. In the single-modal analysis, the AUCs of CT ensemble model in the training and test sets were 0.893 and 0.667, respectively, while the AUCs of PET ensemble model were 0.692 and 0.660. The AUC of PET/CT combined model were 0.897 in training set and 0.672 in test set. The AUC of clinical + PET/CT integrated model showed further improvement, with AUCs of 0.902 and 0.721 in training and test sets, respectively. Notably, the clinical + PET/CT integrated model outperformed PET/CT combined model in predicting wild-type EGFR (test set AUC: 0.784 vs 0.707; Z=3.28, P=0.001). Conclusion:The three-class model (clinical + PET/CT integrated model) based on 18F-FDG PET/CT radiomics and clinical features effectively predicts EGFR mutation subtypes in lung adenocarcinoma.

The quality of clinical trials is critical to ensuring the safety and rights of participants, and ensuring the reliability of trial data. It directly affects the scientific validity of research conclusions and the effectiveness of regulatory decisions. This study aimed to establish an efficient quality management system to enhance the overall quality of clinical trials. Our hospital had established a dedicated quality control team, and developed a quality management module which was integrated to the clinical trial management system. Since February 2021, the hospital had fully digitized the electronic management of quality control processes, and achieved closed-loop management throughout the entire clinical trial by using this system. Key measures of the system included formulating tailored quality control plans, optimizing the design of quality control checklists, and refining quality control feedback mechanisms to improve management efficiency. In 2024, the annual quality control workload had reached 807 activities, with a completion rate of 93% and a timeliness rate of 91%. These outcomes demonstrate that the system could effectively improve the management quality and efficiency of pharmaceutical and medical devices clinical trials. The system could provide insights and practical references for the standardized implementation and quality assurance of clinical trials.

Objective:To observe the clinical effect of aripiprazole combined with non-convulsive electroshock(MECT)for children and adolescents with first episode schizophrenia.Methods:94 children and adolescents with first episode schizophrenia who were admitted to Yiling Kangning Mental Hospital of Yichang from August 2022 to August 2024 were divided into control group(received aripiprazole,n=47)and study group(received aripiprazole combined with MECT,n=47)by using random number table method.The clinical efficacy,dysfunction scale[Positive and Negative Symptom Scale(PANSS),Montreal Cognitive Assessment Scale(MoCA),Wechsler Memory Scale(WMS)],glucose and lipid metabolism indexes[low density lipoprotein cholesterol(LDL-C),glycated hemoglobin(HbAlc),total cholesterol(TC),fasting blood glucose(FBG),High density lipoprotein cholesterol(HDL-C),inflammatory factor indexes[interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)],neurocytokine levels[serum brain-derived neurotrophic factor(BDNF),s100βprotein(s100β),homocysteine(Hcy)]and the occurrence of adverse reactions were compared between the two groups.Results:Compared with the control group after treatment,the clinical total effective rate,MoCA,WMS score,HDL-C,BDNF were higher,PANSS score,HbAlc,FBG,TC,LDL-C,TNF-α,IL-1β,IL-6,s100β and Hcy were lower in the study group(P＜0.05).There was no difference in the incidence of adverse reactions between the two groups(P＞0.05).Conclusion:Aripiprazole combined with MECT in the treatment of in children and adolescents with first episode schizophrenia can reduce the degree of inflammation,regulate glucose and lipid metabolism,improve clinical symptoms and neurological function of children,with good safety.