1.Signals mining and analysis of inebilizumab adverse events
Jiayi ZHANG ; Chen LIU ; Xiaotong ZHANG
China Pharmacy 2026;37(2):215-219
OBJECTIVE To mine and analyze adverse event signals associated with inebilizumab, and to provide reference for safe and rational clinical use. METHODS Reports of adverse event related to inebilizumab were collected from the FDA adverse event reporting system (FAERS) database, from Q2 2020 to Q4 2024. Adverse events were standardized and categorized according to the preferred term (PT) and system organ class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA) version 26.0. Signals were mined using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method. RESULTS A total of 783 adverse event reports with inebilizumab as the primary suspected drug were identified, involving 297 patients. Most reports originated from the United States and Japan, with physicians being the primary reporters. Female patients outnumbered males, and the most common age group was 45-64 years. Using the ROR method and BCPNN method, a total of 29 valid adverse event signals were detected, involving 12 SOCs and comprising 225 adverse event reports. The five most frequently reported PTs were headache, nausea, fatigue, infectious pneumonia and arthralgia. The five PTs with the strongest signal intensity were: B-cell recovery, decreased blood immunoglobulin G, spinal compression fracture, COVID-19 and acute respiratory distress syndrome. Among the 29 valid signals for adverse event, 19 were not documented in the drug package inserts, involving 10 SOCs and comprising 107 adverse event reports. These encompassed nervous system disorders, general disorders and administration site conditions, eye disorders, among others. CONCLUSIONS Inebilizumab treatment not only causes adverse events documented in the product information, such as infections, immunoglobulin reduction and infusion-related reactions but also leads to potential signals, including B-cell recovery, spinal compression fracture. When using this drug in clinical practice, the patient’s risk of infection and baseline immune status should be assessed, relevant indicators should be closely monitored, and targeted preventive measures should be considered when necessary.
2.ICU-acquired muscle weakness in COVID-19 patients who underwent lung transplantation
World Journal of Emergency Medicine 2025;16(1):94-96
Lung transplantation (LT) has emerged as a crucial life-saving option for critically ill patients with severe coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) or irreversible lung injury.[1] Intensive care unit-acquired weakness (ICU-AW) is a prevalent complication in critically ill patients.[2] The recovery of recipients undergoing LT for COVID-19-related respiratory failure may face impediments due to ICU-AW, which negatively affects early mobilization and functional improvement. This study describes two cases of successful bilateral LT for severe COVID-19-related ARDS with the occurrence of ICU-AW and subsequent successful discharge.
3.Chinese expert consensus on the evaluation and postoperative management of lung transplant recipient in COVID-19 patients
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(01):1-7
Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic at the end of December 2019, more than 85% of the population in China has been infected. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mainly affects the respiratory system, especially the lungs. The mortality rate of patients with severe infection is high. A percentage of 6% to 10% of patients will eventually develop into COVID-related acute respiratory distress syndrome (CARDS), which requires mechanical ventilation and extracorporeal membrane oxygenation (ECMO) support. Some patients who survive acute lung injury will subsequently develop post COVID-19 pulmonary fibrosis (PCPF). Both fully treated CARDS and severe PCPF are suitable candidates for lung transplantation. Due to the special course, evaluation strategies are different from those used in patients with common end-stage lung disease. After lung transplantation in COVID-19 patients, special treatment is required, including standardized nucleic acid testing for the novel coronavirus, adjustment strategy of immunosuppressive drugs, and rational use of antiviral drugs, which is a big challenge for the postoperative management of lung transplantation. This consensus was evidence-based written and was reached by experts after multiple rounds of discussions, providing reference for assessment and postoperative management of patients with interstitial pneumonia after COVID-19 infection.
4.Repair strategies for nonunion in old osteoporotic vertebral compression fractures:a case analysis
Xingcheng ZHAO ; Jun WANG ; Ming LU
Chinese Journal of Tissue Engineering Research 2025;29(3):538-546
BACKGROUND:Patients with osteoporotic compression fractures of the lumbar spine have varying degrees of changes in the sagittal parameters of the spine and pelvis,resulting in disequilibrium and rebalancing of the sagittal plane of the whole spine/lumbar spine.If the primary osteoporotic vertebral compression fracture is not treated promptly,it develops into an old osteoporotic vertebral compression fracture with nonunion over time. OBJECTIVE:To observe the effect of percutaneous vertebroplasty in nine patients with old osteoporotic lumbar compression fracture with nonunion. METHODS:A retrospective analysis was conducted on the clinical data of nine elderly patients with old osteoporotic lumbar compression fractures with nonunion treated in the Orthopedics Department of Shanghai Public Health Clinical Center from September 2018 to August 2022.All patients underwent revision treatment with percutaneous vertebroplasty and received regular anti-osteoporosis treatment and rehabilitation training.The lumbar spine X-ray plain film and three-dimensional CT test results were reviewed before discharge and during follow-up to evaluate the diffusion of bone cement.Visual analog scale score,lumbar Oswestry disability index score,and Roussouly classification were recorded before,after surgery and during follow-up. RESULTS AND CONCLUSION:(1)During postoperative follow-up,none of the 9 cases in this group experienced serious surgical complications such as nerve injury,infection,bone cement leakage,pulmonary embolism,and allergic shock,and no adverse reactions related to bone cement occurred.One patient died of respiratory failure due to COVID-19 infection 2 years after operation.(2)The visual analog scale score and Oswestry disability index score of postoperative pain in patients with recurrent vertebral fractures after percutaneous vertebroplasty were significantly lower than those before revision surgery.After the last follow-up percutaneous vertebroplasty revision surgery,the Roussouly classification of patients significantly improved.There was no statistically significant difference between the changes in vertebral body height during the last follow-up measurement and preoperative comparison.(3)These findings indicate that for patients with old osteoporotic lumbar compression fractures with nonunion,moderate injection of bone cement and effective dispersion of bone cement have a significant relieving effect on postoperative pain.Regular anti-osteoporosis and effective postoperative rehabilitation training can help patients improve their postoperative lumbar spine function.
5.Progress on mRNA tumor vaccine with non-viral delivery system
Jiao ZHOU ; Jianyu ZHENG ; Sizhen WANG ; Feng YANG
Journal of Pharmaceutical Practice and Service 2025;43(3):109-116
At the end of 2020, the FDA issued emergency use authorization for two mRNA vaccines(BNT162b2 and mRNA-
6.Thoughts of Syndrome Differentiation and Treatment and Effect Mechanism of Haoqin Qingdantang in Treating Viral Pneumonia Based on Theory of Treating Different Diseases with Same Therapy
Xin PENG ; Haotian XU ; Lei LIANG ; Zheyu LUAN ; Hanxiao WANG ; Yihao ZHANG ; Kun YANG ; Jihong FENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):209-217
The principle of treating different diseases with the same therapy is the essence of syndrome differentiation and treatment in traditional Chinese medicine (TCM). It means that when the same pathogenic changes or the same symptoms appear in the development of different diseases, the same principles or methods can be used for treatment. Due to the complexity and high variability of viral pathogenicity, the precise and effective treatment of different types of viral pneumonia (VP) has always been a research focus and difficulty in modern medicine. VP belongs to the category of external-contraction febrile disease, warm disease, and epidemic in TCM. Haoqin Qingdantang (HQQDD) is a representative formula for clearing heat and dispelling dampness in warm diseases, and its intervention in VP caused by various viral infections has significant effects. This study, guided by the theory of treating different diseases with the same therapy, links the related studies on using HQQDD to treat different types of VP and finds that influenza virus pneumonia (IVP), severe acute respiratory syndrome (SARS), and COVID-19 all have a common pathogenic mechanism of dampness-heat at different stages of respective diseases. When these diseases are dominated by damp-heat factors, the use of HQQDD yields remarkable therapeutic effects. Modern pharmacological studies have confirmed that HQQDD can inhibit virus replication, reduce fever reactions, inhibit the expression of inflammatory mediators, and regulate immune balance. Moreover, the sovereign medicine in this formula has excellent antiviral activity, and the formula reflects rich scientific connotations of treating VP. According to the theory of treating different diseases with the same therapy and based on the effective treatment practice and modern pharmacological research of HQQDD for different types of VP, this paper mines the underlying TCM theory of treatment with the same therapy, explores the syndrome differentiation and treatment strategy and effect mechanism of this formula for different types of VP, and analyzes the treatment mechanism and characteristics, with the aim of providing evidence and reference for the clinical application and modern research of HQQDD.
9.Research hotspots and trends of emergency response to public health emergencies in China
Meiru GUO ; Cuiping LEI ; Ximing FU ; Huifang CHEN ; Jianbiao CAO ; Long YUAN
Chinese Journal of Radiological Health 2025;34(1):61-66
Objective Emergency response to public health emergencies constitutes a vital component of the modernization of national governance systems and capacities, directly impacting national security, social stability, and public health. This study aims to analyze the key issues and research hotspots in the field of emergency response to public health emergencies, providing theoretical foundations and practical guidance for formulating scientific and effective emergency strategies and policies. Ultimately, it seeks to enhance the nation’s capability to respond to public health emergencies and safeguard public health. Methods Using core journals indexed in the China National Knowledge Infrastructure (CNKI) database as the data source,
10.Analysis of vaccine-associated immune thrombocytopenia reports based on the US Vaccine Adverse Event Reporting System
Chinese Journal of Biologicals 2025;38(02):161-166+171
Objective To investigate the clinical characteristics of vaccine-associated immune thrombocytopenia(VA-ITP)based on the US Vaccine Adverse Event Reporting System(VAERS), and to provide a reference for vaccine safety monitoring, vaccination prevention, and clinical diagnosis and treatment.Methods Data from VAERS on all reported cases of immune thrombocytopenia(ITP) after vaccination since the establishment of the database in 1990 to the data lock point of 7th November 2023 were analyzed retrospectively for information on such as sex, age, vaccine type, vaccine dose, and occurrence time of ITP.Results Among the 877 cases of VA-ITP, there were 868 cases of effective statistical vaccine types, involving 43 vaccine types. The top 10 vaccine types were COVID-19 vaccine(434 cases, 50%), MMR vaccine(82 cases, 9. 4%),HEPA vaccine(48 cases, 5. 5%), FLU3 vaccine(41 cases, 4. 7%), FLU4 vaccine(32 cases, 3. 7%), HPV4 vaccine(30 cases,3. 5%), DTAP vaccine(29 cases, 3. 3%), MMRV vaccine(32 cases, 3. 7%), VARZOS vaccine(17 cases, 2. 0%) and HPV9vaccine(13 cases, 1. 5%). Among the 877 reported cases, 843 cases with definite sex were counted, including 374 males and469 females, with a male-to-female ratio of 1∶1. 25. The 377 cases of patients were under 18 years of age, accounting for about 44. 7% of the total, and there was significant difference in the composition ratio of sexes among patients with VA-ITP at different ages(χ~2= 10. 029, P < 0. 05). The incidence of ITP within 8 days after vaccination, with a total of 336 cases, was39.9%, and there was no significant difference in the occurrence time composition ratio of ITP between different sexes(χ~2=3. 296, P > 0. 05). The 54. 9% of ITP occurred after the first dose of vaccine, and there was no significant difference in the composition ratio of different vaccination doses between male and female recipients(χ~2= 5. 323, P > 0. 05), but there was significant difference in the composition ratio of vaccination doses among different age groups(χ~2= 30. 591, P < 0. 01).Conclusion By analyzing the summary data from VAERS database, the adverse reaction of VA-ITP was fully recognized.After clinical vaccination, attention should be focused on the platelet status of minors and the elderly, as well as those who were vaccinated within 8 days, and the continuous vaccine safety monitoring should be carried out, which is helpful to reduce the missed diagnosis of vaccine adverse events(AE) and improve the efficiency of clinical diagnosis and treatment.


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