1.Research Progress on the Risk of Excipients-Related Adverse Reactions in Pharmaceutical Preparations for IBD Treatment
Yanru ZHANG ; Qiuyue TU ; Ping WANG ; Zelin FENG ; Huizhen LI ; Yushan ZHU ; Haojia LIN ; Xinyue WEI ; Qinghua YI ; Hetong ZHANG ; Yueting LI ; Xiaoqin LI ; Yu WANG ; Dong XIE ; Xiaocang CAO
Medical Journal of Peking Union Medical College Hospital 2026;17(4):1135-1142
Patients with inflammatory bowel disease (IBD) require long-term pharmacotherapy. Due to the wide variety of clinically available drugs, medication safety has become increasingly concerning. As an indispensable component of pharmaceutical formulations, drug excipients may induce various adverse reactions, including rash, allergic responses, and gastrointestinal discomfort, and may even lead to severe organic injury. However, they are often overlooked in clinical practice. Therefore, identifying and managing excipient-related adverse reactions is crucial for ensuring medication safety. To address this issue, this article systematically reviews common excipients in IBD therapeutics, the underlying mechanisms of excipient-induced adverse reactions, and corresponding management strategies, aiming to enhance clinicians' awareness of excipient-related issues, improve their ability to recognize and manage such reactions, and ultimately ensure patient safety.
2.Pharmacovigilance Signal Mining and Analysis of Ustekinumab versus Upadacitinib for Inflammatory Bowel Disease Based on the FAERS Database
Dong XIE ; Yu WANG ; Haojia LIN ; Qiuyue TU ; Hetong ZHANG ; Huizhen LI ; Qinghua YI ; Zhengxiang LI ; Hengjie YUAN ; Xiaocang CAO
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1376-1383
To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety. Data were extracted from the Food and Drug Administration Adverse Event Reporting System(FAERS) database using OpenVigil 2.1. ADE reports were collected for ustekinumab(from Q3 2017 to Q1 2025) and upadacitinib(from Q3 2019 to Q1 2025), where each drug was identified as the primary suspected medication for IBD. Signal detection and statistical analysis were performed using the reporting odds ratio(ROR) and proportional reporting ratio(PRR) methods. A total of 3648 ADE reports for ustekinumab and 3812 for upadacitinib, with each as the primary suspected drug in IBD treatment, were retrieved. Using the ROR-PRR combined detection method, relevant ADE signals were identified. High-frequency ADEs associated with ustekinumab included hypersensitivity reactions, various infections, and brain fog, while those associated with upadacitinib included acne, flatulence, and herpes zoster. System organ class(SOC) analysis of positive signals indicated that both drugs commonly caused ADEs in categories such as Infections and infestations, Gastrointestinal disorders, Nervous system disorders, Skin and subcutaneous tissue disorders, and Respiratory, thoracic, and mediastinal disorders. Among these, Infections and infestations were the most frequent SOC, involving preferred terms such as Escherichia sepsis and Pneumococcal pneumonia. Ustekinumab and upadacitinib exhibit distinct safety profiles in the treatment of IBD. In addition to known ADEs described in the prescribing information, ustekinumab requires close monitoring for hypersensitivity reactions, opportunistic infections, and potential neurological risks. For upadacitinib, attention should be paid to risks of acne, herpes zoster, hypercholesterolemia, and thrombotic events. These findings provide important safety information to support individualized clinical decision-making in IBD management.
3.Analysis of Factors Affecting the Efficiency of Establishment of Mouse Parthenogenetic Embryonic Stem Cells
Zhisheng CHEN ; Haojia WU ; Lin LIU
Acta Laboratorium Animalis Scientia Sinica 2010;18(1):52-55,彩6
Objective To study the factor affecting the efficiency of establishment of parthenogenetic stem cells (PESCs)in mice. Methods PESC lines were derived from parthenogenetically activated blastocyst inner cell mass of different mice strains and cultured in different systems.Results The efficiency of establishing the pESC showed no significant difference in hybrid and inbred lines.But the efficiency was increased in culture systems added with ERK inhibitor or knockout serum replacement(KSR).Conclusion The efficiency of establishment of pESC was not directly related with the genetic background of mice but it was closely related to the culture systems.
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