1.Signal mining of cardiotoxicity risk in arsenical for injection based on the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring in China and the US FDA Adverse Event Reporting System database
Qiaoyan YI ; Yanjun XIE ; Yutong SHU ; Qiuhong ZHANG ; Yingmei QI ; Min LI ; Xia ZHAO ; Fengqin LIU ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2024;26(3):133-137
Objective:To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical.Methods:The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval ( CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4. Results:There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1 294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high.Conclusions:Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions.
2.Signal mining of cardiotoxicity risk in arsenical for injection based on the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring in China and the US FDA Adverse Event Reporting System database
Qiaoyan YI ; Yanjun XIE ; Yutong SHU ; Qiuhong ZHANG ; Yingmei QI ; Min LI ; Xia ZHAO ; Fengqin LIU ; Xia LI ; Yi HAN
Adverse Drug Reactions Journal 2024;26(3):133-137
Objective:To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical.Methods:The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval ( CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4. Results:There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1 294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high.Conclusions:Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions.
3.Guidelines for Psychological Rehabilitation Intervention Combined Integrated Traditional Chinese and Western Medicine After Radical Surgery for Early and Middle Stage Colorectal Cancer
Yufei YANG ; Lili TANG ; Lingyun SUN ; Ying PANG ; Zixu WANG ; Qiuli YANG ; Yun XU ; Haibo ZHANG ; Peng SHU ; Yutong FEI ; Rongyan PENG ; Jiaxi LIU
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(21):10-23
In recent years, the incidence of colorectal cancer has been rising in China, and with the promotion of early screening and early diagnosis, most colorectal cancers are able to achieve long-term survival through timely diagnosis and treatment. Nevertheless, 30%-70% of patients with early to mid-stage colorectal cancer after radical surgery still have psychological problems such as anxiety, depression, and fear of recurrence and metastasis, and they hope to seek help from traditional Chinese medicine(TCM) treatment. In order to further standardize the integrated traditional Chinese and western medicine psychological rehabilitation interventions of stage Ⅰ-Ⅲ colorectal cancer after radical surgery, and to improve the diagnosis and treatment level, under the support of the pilot project of clinical collaboration between Chinese and western medicine for major and difficult diseases of National Administration of TCM, experts in oncology, integrated Chinese and western medicine, psychology, surgery, nursing, evidence-based medicine and other disciplines from 10 units nationwide participated in the work, led by Xiyuan Hospital,China Academy of Chinese Medical Sciences and Beijing Cancer Hospital. Based on the methodology and process of guideline development of the World Health Organization Handbook for Guideline Development and the Regulations for Group Standards of China Association of Chinese Medicine, the Guidelines for Psychological Rehabilitation Intervention Combined Integrated Traditional Chinese and Western Medicine After Radical Surgery for Early and Middle Stage Colorectal Cancer have been developed according to the current best evidence, extensive consultation with clinical experts and following the situation of current clinical practice. The guideline provides the psychological characteristics, the needs and willingness to accept psychological rehabilitation, the interventions for psychological rehabilitation, evaluation of efficacy, follow-up review, educational guidance and others of patients with stage Ⅰ-Ⅲ colorectal cancer after radical surgery. It can provide guidance for TCM(integrated Chinese and western medicine) clinicians and psychologists engaged in the psychological rehabilitation of integrated Chinese and western medicine oncology, especially for doctors in primary medical institutions.
4.Immunomodulatory effects and mechanisms of distraction osteogenesis.
Shude YANG ; Ning WANG ; Yutong MA ; Shuaichen GUO ; Shu GUO ; Hongchen SUN
International Journal of Oral Science 2022;14(1):4-4
Distraction osteogenesis (DO) is widely used for bone tissue engineering technology. Immune regulations play important roles in the process of DO like other bone regeneration mechanisms. Compared with others, the immune regulation processes of DO have their distinct features. In this review, we summarized the immune-related events including changes in and effects of immune cells, immune-related cytokines, and signaling pathways at different periods in the process of DO. We aim to elucidated our understanding and unknowns about the immunomodulatory role of DO. The goal of this is to use the known knowledge to further modify existing methods of DO, and to develop novel DO strategies in our unknown areas through more detailed studies of the work we have done.
Bone Regeneration/physiology*
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Bone and Bones
;
Osteogenesis/physiology*
;
Osteogenesis, Distraction/methods*
;
Tissue Engineering

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