1.Ethical issues and reflections on clinical research of radiopharmaceuticals
Yonglan HU ; Li WANG ; Feng JIANG ; Jiyin ZHOU ; Zhengjun CHEN ; Jie ZHANG ; Zengrui ZHANG
Chinese Medical Ethics 2025;38(2):254-260
Radiopharmaceuticals play an important role in the diagnosis and treatment of cardiovascular and cerebrovascular diseases, malignant tumors, central nervous system diseases, and other diseases. Under the urgent need for clinical diagnosis and treatment as well as medical development, the clinical research of radiopharmaceuticals has become a hotspot in international research. By analyzing the current situation of clinical research on radiopharmaceuticals in Europe, America, and China, the ethical issues of clinical research on radiopharmaceuticals were elaborated from four aspects, including lack of relevant laws and regulations, a higher risk of radiopharmaceuticals, dilemmas in ethical review, and insufficient radiation protection. Response principles and measures were proposed from four aspects, including improving regulations and policies, enhancing radiological protection for all parties involved in the research, strengthening ethical review, and reinforcing the training of relevant personnel, to enhance the quality and level of clinical research on radiopharmaceuticals.
2.Research advances in the effects of orexin and its receptor-related drugs on depression
Zhaoshu JIANG ; Ming CHENG ; Jie YANG ; Feng CAO ; Zhen ZHANG
China Pharmacy 2025;36(4):496-500
Depression is a psychiatric disorder whose main symptoms include low mood, loss of interest, anxiety, sleep disturbances, and changes in appetite. Orexin, a neuropeptide located in hypothalamic neurons, has a wide range of projections throughout the central nervous system and is involved in various behavioral modulations related to depression. This study systematically reviewed the effects of orexin and its receptor-related drugs on depression and found that orexin could exert complex regulatory effects on multiple brain regions by binding to related receptors, affecting emotions, sleep, anxiety, etc. The abnormal state of expression of plasma orexin in patients with depression was found. Exogenous orexin-A, selective orexin receptor 1 antagonists (SORA1s), selective orexin receptor 2 antagonists (SORA2s), and dual orexin receptor antagonists (DORAs) have demonstrated antidepressant-like effects in various animal models of depression. Among them, clinical trials involving exogenous orexin-A are relatively scarce. Drugs related to SORA1s and SORA2s, such as JNJ-61393215 and Setorexant, have made significant progress in the treatment of depression. DORAs, such as Suvorexant, Lemborexant, and Daridorexant, are primarily used to treat insomnia. Notably, Suvorexant has also shown potential in alleviating symptoms of anxiety and depression.
3.Working practices in eliminating the public health crisis caused by viral hepatitis in Hainan Province of China
Weihua LI ; Changfu XIONG ; Taifan CHEN ; Bin HE ; Dapeng YIN ; Xuexia ZENG ; Feng LIN ; Biyu CHEN ; Xiaomei ZENG ; Biao WU ; Juan JIANG ; Lu ZHONG ; Yuhui ZHANG
Journal of Clinical Hepatology 2025;41(2):228-233
In 2022, Hainan provincial government launched the project for the prevention and control of viral hepatitis with the goals of a hepatitis B screening rate of 90%, a diagnostic rate of 90%, and a treatment rate of 80% among people aged 18 years and above by the year 2025, and the main intervention measures include population-based prevention, case screening, antiviral therapy, and health management. As of December 31, 2024, a total of 6.875 million individuals in the general population had been screened for hepatitis B, with a screening rate of 95.6%. A total of 184 710 individuals with positive HBsAg were identified, among whom 156 772 were diagnosed through serological reexamination, resulting in a diagnostic rate of 84.9%. A total of 50 742 patients with chronic hepatitis B were identified, among whom 42 921 had hepatitis B-specific health records established for health management, with a file establishment rate of 84.6%. A total of 31 553 individuals received antiviral therapy, with a treatment rate of 62.2%. A total of 2.503 million individuals at a high risk of hepatitis C were screened, among whom 4 870 tested positive for HCV antibody and 3 858 underwent HCV RNA testing, resulting in a diagnostic rate of 79.2%, and 1 824 individuals with positive HCV RNA were identified, among whom 1 194 received antiviral therapy, with a treatment rate of 65.5%. In addition, 159 301 individuals with negative HBsAg and anti-HBs and an age of 20 — 40 years were inoculated with hepatitis B vaccine free of charge. Through the implementation of the project for the prevention and control of viral hepatitis, a large number of hepatitis patients have been identified, treated, and managed in the province within a short period of time, which significantly accelerates the efforts to eliminate the crisis of viral hepatitis.
4.Trend in burden of rheumatoid arthritis in China from 1990 to 2021
WEN Jiaxin ; JIANG Junpeng ; FENG Min ; SHEN Xiaochen ; LI Xiaoyin
Journal of Preventive Medicine 2025;37(1):26-30
Objective:
To analyze the trend in burden of rheumatoid arthritis (RA) in China from 1990 to 2021, so as to provide insights into reducing the RA burden in China.
Methods:
Data of Global Burden of Disease Study 2021 were collected, and the incidence, mortality and disability-adjusted life years (DALY) of RA in China from 1990 to 2021 were analyzed and compared with global and different Socio-demographic Index (SDI) regions. The trend in burden of RA was analyzed using average annual percent change (AAPC).
Results:
The crude incidence rates of RA in China increased from 10.87/105 in 1990 to 17.38/105 in 2021, the crude mortality rates increased from 0.41/105 to 0.72/105, and the crude DALY rates increased from 34.26/105 to 58.61/105, with the increases of 59.98%, 77.95% and 71.06%, respectively. From 1990 to 2021, the standardized incidence rates of RA in China showed an increasing trend (AAPC=0.545%, P<0.05), the standardized mortality rates showed a decreasing trend (AAPC=-0.783%, P<0.05), and the standardized DALY rates showed no significant trend (AAPC=-0.017%, P>0.05). In 2021, the standardized incidence rate, standardized mortality rate and standardized DALY rate of RA were higher in females than in males; from 1990 to 2021, the standardized DALY rates of RA showed a decreasing trend in females (AAPC=-0.200%, P<0.05) and an increasing trend in males (AAPC=0.316%, P<0.05). The crude incidence rates of RA first increased and then decreased with age in 2021, reaching the highest in the age group of 75-<80 years at 34.36/105. Both the crude mortality rates and the crude DALY rates increased with age, reaching the highest in the age group of 95 years and older at 26.72/105 and 285.67/105, respectively. The standardized incidence rates and standardized DALY rates of RA in China in 2021 were lower than those in high SDI regions, while the standardized mortality rate was lower than that in medium-low SDI regions.
Conclusions
The burden of RA in China from 1990 to 2021 showed an upward trend, and was at a high level compared to different SDI regions. Higher disease burden of RA was seen in females and the elderly.
5.Construction of a predictive model for poorly differentiated adenocarcinoma in pulmonary nodules using CT combined with tumor markers
Jie JIANG ; Feng LIU ; Bo WANG ; Qin WANG ; Jian ZHONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(01):73-79
Objective To establish and internally validate a predictive model for poorly differentiated adenocarcinoma based on CT imaging and tumor marker results. Methods Patients with solid and partially solid lung nodules who underwent lung nodule surgery at the Department of Thoracic Surgery, the Affiliated Brain Hospital of Nanjing Medical University in 2023 were selected and randomly divided into a training set and a validation set at a ratio of 7:3. Patients' CT features, including average density value, maximum diameter, pleural indentation sign, and bronchial inflation sign, as well as patient tumor marker results, were collected. Based on postoperative pathological results, patients were divided into a poorly differentiated adenocarcinoma group and a non-poorly differentiated adenocarcinoma group. Univariate analysis and logistic regression analysis were performed on the training set to establish the predictive model. The receiver operating characteristic (ROC) curve was used to evaluate the model's discriminability, the calibration curve to assess the model's consistency, and the decision curve to evaluate the clinical value of the model, which was then validated in the validation set. Results A total of 299 patients were included, with 103 males and 196 females, with a median age of 57.00 (51.00, 67.25) years. There were 211 patients in the training set and 88 patients in the validation set. Multivariate analysis showed that carcinoembryonic antigen (CEA) value [OR=1.476, 95%CI (1.184, 1.983), P=0.002], cytokeratin 19 fragment antigen (CYFRA21-1) value [OR=1.388, 95%CI (1.084, 1.993), P=0.035], maximum tumor diameter [OR=6.233, 95%CI (1.069, 15.415), P=0.017], and average density [OR=1.083, 95%CI (1.020, 1.194), P=0.040] were independent risk factors for solid and partially solid lung nodules as poorly differentiated adenocarcinoma. Based on this, a predictive model was constructed with an area under the ROC curve of 0.896 [95%CI (0.810, 0.982)], a maximum Youden index corresponding cut-off value of 0.103, sensitivity of 0.750, and specificity of 0.936. Using the Bootstrap method for 1000 samplings, the calibration curve predicted probability was consistent with actual risk. Decision curve analysis indicated positive benefits across all prediction probabilities, demonstrating good clinical value. Conclusion For patients with solid and partially solid lung nodules, preoperative use of CT to measure tumor average density value and maximum diameter, combined with tumor markers CEA and CYFRA21-1 values, can effectively predict whether it is poorly differentiated adenocarcinoma, allowing for early intervention.
6.Optimization of drug management model for investigator-initiated trial with benchmarking analysis
Yufei XI ; Tianxiao WANG ; Xue ZHANG ; Yingzhuo DING ; Li YAN ; Feng JIANG ; Xiangui HE ; Jiannan HUANG ; Qin LI
China Pharmacy 2025;36(3):280-284
OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial (IIT). METHODS With benchmarking analysis, based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai, a thorough review was conducted, involving relevant laws, regulations, and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects, a detailed comparative analysis of key processes was carried out, such as the receipt, storage, distribution, use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing, the training before project implementation was insufficient, and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems, improvement measures were put forward, including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs, etc. The related systems were improved, and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established, which helps to improve the institutional X2023076) framework of medical institutions in this field.
7.Therapeutic Effect and Mechanism of Shentong Zhuyutang Combined with Dilongtang in Treatment of Lumbar Disc Herniation with Qi Stagnation and Blood Stasis Syndrome
Huangsheng TAN ; Yinbo WANG ; Yong HUANG ; Juyi LAI ; Hualong FENG ; Zhiming LAN ; Yuanfei FU ; Yong JIANG ; Shenghua HE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):47-54
ObjectiveTo observe the clinical efficacy of Shentong Zhuyutang combined with Dilongtang in the treatment of lumbar disc herniation (LDH) with Qi stagnation and blood stasis syndrome, and its effect on nucleus pulposus reabsorption and immune-inflammatory factors, exploring its therapeutic mechanism from the perspective of reabsorption. MethodsA total of 120 patients with LDH from the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, treated between June 2020 and January 2023, were randomly divided into the control group (52 cases, with 8 dropouts) and the observation group (49 cases, with 11 dropouts) according to a random number table. The control group received routine treatment, while the observation group was treated with Shentong Zhuyutang combined with Dilongtang in addition to routine treatment. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA) score, and traditional Chinese medicine (TCM) syndrome score were measured before treatment and after 3 courses of treatment. Venous blood samples were collected for the determination of serological indexes. MR examination was performed during the 6-month follow-up to calculate the absorption rate. ResultsAfter treatment, both groups showed significant reductions in VAS, ODI, TCM syndrome score, serum tumor necrosis factor (TNF)-α, matrix metalloproteinase (MMP)-9, and vascular endothelial growth factor (VEGF) levels, and a significant increase in JOA score compared with pre-treatment values (P<0.05). Compared with the control group, the observation group showed significantly lower VAS, ODI, TCM syndrome score, serum TNF-α, MMP-9, and VEGF levels, and a significantly higher JOA score (P<0.05). The proportion of nucleus pulposus reabsorption in the observation group was 57.14% (28/49), significantly higher than 21.15% (11/52) in the control group (χ2=6.161, P<0.05). ConclusionShentong Zhuyutang combined with Dilongtang can effectively relieve pain, improve lumbar function, and alleviate TCM clinical symptoms in LDH patients with Qi stagnation and blood stasis syndrome. Imaging findings suggest that the treatment promotes the reabsorption of nucleus pulposus protrusion, while laboratory testing shows reduced serum levels of TNF-α, MMP-9, and VEGF, which contribute to the rehabilitation of patients.
8.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
Background:
s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer.
Methods:
We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R.
Results:
Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices.
Conclusions
SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation.
9.Influence evaluation of pharmaceutical quality control on medication therapy management services by the ECHO model
Kun LIU ; Huanhuan JIANG ; Yushuang LI ; Yan HUANG ; Qianying ZHANG ; Dong CHEN ; Xiulin GU ; Jinhui FENG ; Zijian WANG ; Yunfei CHEN ; Yajuan QI ; Yanlei GE ; Aishuang FU
China Pharmacy 2025;36(9):1123-1128
OBJECTIVE To evaluate the influence of pharmaceutical quality control on the efficiency and outcomes of standardized medication therapy management (MTM) services for patients with coronary heart disease by using Economic, Clinical and Humanistic Outcomes (ECHO) model. METHODS This study collected case data of coronary heart disease patients who received MTM services during January-March 2023 (pre-quality control implementation group, n=96) and June-August 2023 (post-quality control implementation group, n=164). Using propensity score matching analysis, 80 patients were selected from each group. The study subsequently compared the economic, clinical, and humanistic outcome indicators of pharmaceutical services between the two matched groups. RESULTS There were no statistically significant differences in baseline data between the two groups after matching (P>0.05). Compared with pre-quality control implementation group, the daily treatment cost (16.26 yuan vs. 24.40 yuan, P<0.001), cost-effectiveness ratio [23.12 yuan/quality-adjusted life year (QALY) vs. 32.32 yuan/QALY, P<0.001], and the incidence of general adverse drug reactions (2.50% vs. 10.00%, P=0.049) of post-quality control implementation group were decreased significantly; the utility value of the EuroQol Five-Dimensional Questionnaire (0.74± 0.06 vs. 0.71±0.07, P=0.003), the reduction in the number of medication related problems (1.0 vs. 0.5, P<0.001), the medication adherence score ([ 6.32±0.48) points vs. (6.10±0.37) points, P=0.001], and the satisfaction score ([ 92.56±1.52) points vs. (91.95±1.56) points, P=0.013] all showed significant improvements. Neither group experienced serious adverse drug reactions. There was no statistically significant difference in the incidence of new adverse reactions between the two groups (1.25% vs. 3.75%, P=0.310). CONCLUSIONS Pharmaceutical quality control can improve the quality of pharmaceutical care, and the ECHO model can quantitatively evaluate the effect of MTM services, making pharmaceutical care better priced and more adaptable to social needs, thus being worthy of promotion.
10.Annual review of global liver transplantation research in 2024: technological breakthroughs, precision management and future challenges
Yong JIANG ; Xiao FENG ; Wei LIU ; Yang YANG
Organ Transplantation 2025;16(3):350-358
In recent years, significant progress has been made in the field of liver transplantation in terms of donor expansion, technological innovation and perioperative management. Machine perfusion technology, through dynamic repair and assessment of donor liver quality, can effectively reduce postoperative complications and increase the utilization rate of marginal donor livers. The optimization of split liver transplantation technology combined with normothermic perfusion further alleviates the shortage of donors, but its promotion is still limited by technical barriers. Xenotransplantation has achieved preclinical breakthroughs in the field of genetically modified pig livers, but ethical and immune barrier issues need to be urgently resolved. In the field of liver cancer liver transplantation, the focus is on neoadjuvant treatment with immune checkpoint inhibitors and the development of recurrence prediction models, which promotes precise treatment. For perioperative management, the optimization of individualized immunosuppressive regimens, artificial liver support, and strategies for the prevention and control of vascular complications has significantly improved patients’ survival rates. Personalized treatment for children, elderly recipients, and recipients with multiple comorbidities provides new ideas for liver transplantation in special populations. In the future, liver transplantation research may focus on the integration of multidisciplinary approaches, individualized treatment and emerging technologies to advance the global liver transplantation cause to new heights.


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