1.Impact of prophylactic intra-aortic balloon pump in elderly high-risk coronary heart disease patients on postoperative newly developed atrial fibrillation after off-pump coronary artery bypass grafting
Wenbo WU ; Ziqiang ZHOU ; Yanjun WANG ; Hongwei QI ; Jiangang ZHAO ; Biao YUAN ; Mingying WU
Chinese Journal of Geriatrics 2025;44(12):1660-1666
Objective:To investigate the impact and clinical value of preoperative intra-aortic balloon pump(IABP)placement on the occurrence of postoperative atrial fibrillation(POAF)in elderly high-risk patients with coronary artery disease undergoing off-pump coronary artery bypass grafting(CABG).Methods:A retrospective cohort study was conducted, selecting 128 elderly(age≥60 years)patients with coronary artery disease who underwent isolated off-pump CABG and met high-risk criteria(≥2 high-risk factors)at Beijing Tongren Hospital.According to the occurrence of POAF, patients were divided into the POAF group(38 cases)and the non-POAF group(90 cases). Preoperative baseline data, preoperative IABP usage, intraoperative and postoperative indicators were collected and compared between the two groups.Univariate analysis was used to screen for differential variables, and multivariate logistic regression analysis was performed to identify the independent risk factors for POAF, focusing on the role and impact of preoperative IABP placement on POAF occurrence.Results:Among the 128 patients included, the incidence of POAF in patients with preoperative IABP placement was lower than that in patients without preoperative IABP placement[12.12%(4/33) vs.35.79%(34/95), χ2=6.512, P=0.011]; the preoperative IABP usage rate in the POAF group was significantly lower than that in the non-POAF group[10.53%(4/38) vs.32.22%(29/90), χ2=5.488, P=0.019]; the proportion of patients with preoperative left ventricular ejection fraction(LVEF)<40% in the POAF group was significantly higher than that in the non-POAF group[23.68%(9/38) vs.10.00%(9/90), χ2=4.140, P=0.042]; and the preoperative creatinine level in the POAF group was also significantly higher than that in the non-POAF group[(90.62±29.45)μmol/L vs.(81.31±20.18)μmol/L, t=2.066, P=0.041]. Multivariate logistic regression analysis showed that preoperative LVEF<40% was an independent risk factor for POAF occurrence( OR=11.862, 95% CI: 1.083-129.875, P=0.043), while preoperative IABP placement was an independent protective factor for POAF occurrence( OR=0.095, 95% CI: 0.016~0.583, P=0.011). The comparison of intraoperative and postoperative indicators between the two groups showed that multiple indicators in the POAF group were significantly worse than those in the non-POAF group.In terms of intraoperative indicators, the mean graft blood flow(mGF)of the graft vessels in the POAF group was lower[(18.25±8.84)ml/min vs.(21.24±7.13)ml/min, t=2.015, P=0.046], while the pulsatility index(PI)was higher(2.64±1.36 vs.2.18±1.07, t=2.045, P=0.043). In terms of postoperative laboratory indicators, the level of cardiac troponin I(cTnI)on the first postoperative day in the POAF group[(15.69±11.32)μg/L vs.(11.46±10.07)μg/L, t=2.092, P=0.038], the highest postoperative creatinine level[(128.23±74.29)μmol/L vs.(96.18±48.32)μmol/L, t=2.897, P=0.004], and the highest blood lactic acid level within 24 hours[(1.78±0.53)mmol/L vs.(1.54±0.62)mmol/L, t=2.085, P=0.039]were all significantly higher.In terms of postoperative recovery indicators, the duration of vasoactive drug use[(46.41±32.08)h vs.(36.21±22.39)h, t=2.058, P=0.042], mechanical ventilation time[(16.72±11.64)h vs.(12.19±9.68)h, t=2.275, P=0.025], and intensive care unit(ICU)stay time[(73.48±60.20)h vs.(54.89±39.29)h, t=2.070, P=0.040]in the POAF group were all significantly longer.The LVEF before discharge in the POAF group was also significantly lower than that in the non-POAF group[(43.08±16.24)% vs.(48.49±13.08)%, t=1.986, P=0.049]. Conclusions:Preoperative LVEF<40% is an independent risk factor for POAF occurrence after off-pump CABG in elderly high-risk patients with coronary artery disease, and preoperative prophylactic IABP placement can significantly reduce the occurrence of POAF in this population.
2.Impact of prophylactic intra-aortic balloon pump in elderly high-risk coronary heart disease patients on postoperative newly developed atrial fibrillation after off-pump coronary artery bypass grafting
Wenbo WU ; Ziqiang ZHOU ; Yanjun WANG ; Hongwei QI ; Jiangang ZHAO ; Biao YUAN ; Mingying WU
Chinese Journal of Geriatrics 2025;44(12):1660-1666
Objective:To investigate the impact and clinical value of preoperative intra-aortic balloon pump(IABP)placement on the occurrence of postoperative atrial fibrillation(POAF)in elderly high-risk patients with coronary artery disease undergoing off-pump coronary artery bypass grafting(CABG).Methods:A retrospective cohort study was conducted, selecting 128 elderly(age≥60 years)patients with coronary artery disease who underwent isolated off-pump CABG and met high-risk criteria(≥2 high-risk factors)at Beijing Tongren Hospital.According to the occurrence of POAF, patients were divided into the POAF group(38 cases)and the non-POAF group(90 cases). Preoperative baseline data, preoperative IABP usage, intraoperative and postoperative indicators were collected and compared between the two groups.Univariate analysis was used to screen for differential variables, and multivariate logistic regression analysis was performed to identify the independent risk factors for POAF, focusing on the role and impact of preoperative IABP placement on POAF occurrence.Results:Among the 128 patients included, the incidence of POAF in patients with preoperative IABP placement was lower than that in patients without preoperative IABP placement[12.12%(4/33) vs.35.79%(34/95), χ2=6.512, P=0.011]; the preoperative IABP usage rate in the POAF group was significantly lower than that in the non-POAF group[10.53%(4/38) vs.32.22%(29/90), χ2=5.488, P=0.019]; the proportion of patients with preoperative left ventricular ejection fraction(LVEF)<40% in the POAF group was significantly higher than that in the non-POAF group[23.68%(9/38) vs.10.00%(9/90), χ2=4.140, P=0.042]; and the preoperative creatinine level in the POAF group was also significantly higher than that in the non-POAF group[(90.62±29.45)μmol/L vs.(81.31±20.18)μmol/L, t=2.066, P=0.041]. Multivariate logistic regression analysis showed that preoperative LVEF<40% was an independent risk factor for POAF occurrence( OR=11.862, 95% CI: 1.083-129.875, P=0.043), while preoperative IABP placement was an independent protective factor for POAF occurrence( OR=0.095, 95% CI: 0.016~0.583, P=0.011). The comparison of intraoperative and postoperative indicators between the two groups showed that multiple indicators in the POAF group were significantly worse than those in the non-POAF group.In terms of intraoperative indicators, the mean graft blood flow(mGF)of the graft vessels in the POAF group was lower[(18.25±8.84)ml/min vs.(21.24±7.13)ml/min, t=2.015, P=0.046], while the pulsatility index(PI)was higher(2.64±1.36 vs.2.18±1.07, t=2.045, P=0.043). In terms of postoperative laboratory indicators, the level of cardiac troponin I(cTnI)on the first postoperative day in the POAF group[(15.69±11.32)μg/L vs.(11.46±10.07)μg/L, t=2.092, P=0.038], the highest postoperative creatinine level[(128.23±74.29)μmol/L vs.(96.18±48.32)μmol/L, t=2.897, P=0.004], and the highest blood lactic acid level within 24 hours[(1.78±0.53)mmol/L vs.(1.54±0.62)mmol/L, t=2.085, P=0.039]were all significantly higher.In terms of postoperative recovery indicators, the duration of vasoactive drug use[(46.41±32.08)h vs.(36.21±22.39)h, t=2.058, P=0.042], mechanical ventilation time[(16.72±11.64)h vs.(12.19±9.68)h, t=2.275, P=0.025], and intensive care unit(ICU)stay time[(73.48±60.20)h vs.(54.89±39.29)h, t=2.070, P=0.040]in the POAF group were all significantly longer.The LVEF before discharge in the POAF group was also significantly lower than that in the non-POAF group[(43.08±16.24)% vs.(48.49±13.08)%, t=1.986, P=0.049]. Conclusions:Preoperative LVEF<40% is an independent risk factor for POAF occurrence after off-pump CABG in elderly high-risk patients with coronary artery disease, and preoperative prophylactic IABP placement can significantly reduce the occurrence of POAF in this population.
3.Individualized surgical treatment strategy for children with anomalous aortic origin of coronary artery
Kai LUO ; Jinghao ZHENG ; Wei ZHANG ; Zhongqun ZHU ; Yanjun PAN ; Xiaomin HE ; Qi SUN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(02):263-268
Objective To summarize and explore the individualized surgical treatment strategy and prognosis of anomalous aortic origin of coronary artery (AAOCA). Methods The clinical data of children with AAOCA admitted to Shanghai Children's Medical Center from March 2018 to August 2021 were retrospectively analyzed. Results A total of 17 children were enrolled, including 13 males and 4 females, with a median age of 88 (44, 138) months and a median weight of 25 (18, 29) kg. All patients received operations. The methods of coronary artery management included coronary artery decapitation in 9 patients, coronary artery transplantation in 5 patients and coronary artery perforation in 3 patients. One patient with severe cardiac insufficiency (left ventricular ejection fraction 15%) received mechanical circulatory assistance after the operation for 12 days. No death occurred in the early postoperative period, the average ICU stay time was 4.3±3.0 d, and the total hospital stay was 14.4±6.1 d. All the children received regular anticoagulation therapy for 3 months after discharge. The median follow-up time was 15 (13, 24) months. All patients received regular anticoagulation therapy for 3 months after discharge. No clinical symptoms such as chest pain and syncope occurred again. The cardiac function grade was significantly improved compared with that before operation. Imaging examination showed that the coronary artery blood flow on the operation side was unobstructed, and no restenosis occurred. Conclusion AAOCA is easy to induce myocardial ischemia and even sudden cardiac death. Once diagnosed, operation should be carried out as soon as possible. According to the anatomic characteristics of coronary artery, the early effect of individualized surgery is satisfactory, and the symptoms of the children are significantly improved and the cardiac function recovers well in the mid-term follow-up.
4.Cellular and cytokine immune responses during varicella zoster virus reactivation of herpes zoster infection
Yanjun LAI ; Guochao ZHANG ; Xiang WANG ; Qi GAO ; Lisi LIANG ; Yang LIANG ; Yucong YANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(1):150-154
Objective To study changes in immune cells and cytokines during the reactivation stage of varicella-zoster virus(VZV)in patients with herpes zoster.Methods A total of 50 patients with herpes zoster and 30 healthy individuals were selected from Xi'an Ninth Hospital between May 2022 and October 2022.Flow cytometry was used to detect the proportion of peripheral blood CD3+cells,CD4+cells,CD8+T cells,B cells and NK cells,as well as levels of cytokines IL-2,IFN-γ,IL-10 and IL-6.We analyzed the immune mechanism of VZV reactivation stage in herpes zoster patients.Results Compared with the healthy control group,the proportion of CD3+cells and CD4+T cells in herpes zoster patients decreased significantly;the proportion of NK cells significantly increased;the levels of IFN-γ,IL-10 and IL-6 significantly increased;the proportion of CD8+T cells,B cells and IL-2 content showed an increasing trend,but there was no significant difference.In addition,the severity of neurological involvement in herpes zoster patients might affect changes in cytokine levels.Conclusion During the reactivation period of VZV,changes in the proportion of immune cells and cytokine expression levels are closely related to the occurrence and development of herpes zoster.
5.Trends in the distribution of Oncomelania hupensis in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023
Qi MAO ; Caiying SUN ; Anqi LI ; Weiwei LU ; Xihong LÜ ; Xuehui LU ; Yanjun JIN ; Qing YU
Chinese Journal of Schistosomiasis Control 2024;36(2):165-168
Objective To investigate the changes in distribution of Oncomelania hupensis snails in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023, so as to provide insights into formulation of O. hupensis snail surveillance programs. Methods The reports on O. hupensis snail surveillance in Songjiang District, Shanghai Municipality from 2009 to 2023 were collected, and the snail surveillance data in forestlands were extracted. The trends in the proportion of areas with snails in forestlands in total areas with snails, occurrence of frames with living snails and density of living snails were evaluated using a Joinpoint regression model in Songjiang District from 2009 to 2023, and the annual percent change (APC) and average annual percent change (AAPC). Results A total of 40 sites with snails were found in forestlands in 14 administrative villages of 4 townships, Songjiang District, Shanghai Municipality from 2009 to 2023. A total of 39 065 frames were surveyed for snails in settings covering an area of 609 600 m2, and there were 6 084 frames with snails, covering 151 250 m2 snail habitats. A total of 22 210 snails were captured, with the highest density of 260.00 snails/0.1 m2, and 6 262 snails were dissected, with no Schistosoma japonicum infection identified in snails. The proportion of areas with snails in forestlands in total areas with snails appeared a tendency towards a rise in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023 (APC = AAPC = 24.9%, P > 0.05); however, there were no turning points in the trend curve, with the highest proportion seen in 2009 (53.81%), the lowest in 2011 and 2023 (both 0) and a mean proportion of 24.81%. The occurrence of frames with living snails appeared a tendency towards a rise from 2009 to 2023 (APC = AAPC = 41.5%, P > 0.05); however, there were no turning points in the trend curve, with the highest occurrence in 2009 (53.81%), the lowest in 2011 and 2013 (both 0), and the mean occurrence of 15.57%. In addition, the density of living snails appeared a tendency towards a rise from 2009 to 2023 (APC = AAPC = 55.0%, P > 0.05); however, there were no turning points in the trend curve, with the highest density in 2023 (0.96 snails/0.1 m2), the lowest in 2011 and 2013 (both 0), and a mean density of 0.57 snails/0.1 m2. Conclusions The difficulty in O. hupensis snail control and risk of imported snails appeared a tendency towards a rise in forestlands in Songjiang District, Shanghai Municipality over years from 2009 to 2023. Supervision and assessment prior to seedling transplantation and intensified surveillance post-transplantation are recommended to reduce the risk of O. hupensis snail importation and spread.
6.Surveillance and trend analysis of snails in Songjiang District of Shanghai from 2007 to 2023
Qi MAO ; Caiying SUN ; Anqi LI ; Weiwei LU ; Xihong LYU ; Xuehui LU ; Yanjun JIN ; Qing YU
Shanghai Journal of Preventive Medicine 2024;36(5):444-447
ObjectiveTo analyze the monitoring results and trends of Oncomelania in Songjiang District of Shanghai from 2007 to 2023, and to provide reference for future monitoring work. MethodsThe data of snail monitoring in Songjiang District from 2007 to 2023 were collected, including the location of snail spots, the number of survey frames, the area with snails, the number of frames with snails, the total number of snails, etc. The density of living snails and the occurrence rate of living snail frames were calculated. ResultsFrom 2007 to 2023, a total of 158 snail spots were found in 22 administrative villages in 4 towns in Songjiang District, including 131 emerging snail habitats (82.91%) and 27 reemerging snail habitats (17.09%). The total snail area was 175 980 m2, the number of snail frames was 10 061, and 33 302 snails were captured. The highest density was 260/0.11 m2, and 15 662 snails were dissected. No positive snails were found. The average density of living snails was 0.60/0.11 m2 and the average occurrence rate of living snail frames was 17.99%. The snail areas in different areas were Yexie Town 126 000 m2 (71.60%), Maogang Town 26 470 m2 (15.04%), Xinbang Town 17 040 m2 (9.68%), and Shihudang Town 6 470 m2 (3.68%). The average density of living snails in different areas was 0.89/0.11 m2 in Yexie Town, 0.65/0.11 m2 in Maogang Town, 0.26/0.11 m2 in Shihudang Town and 0.24/0.11 m2 in Xinbang Town. The snail areas of different snail habitats were as follows: woodland 151 250 m2(85.95%), river 13 810 m2(7.85%), ditch 6 910 m2(3.93%), farmland 4 010 m2(2.28%). The average density of living snails in different snail habitats: ditch 1.01/0.11 m2, beach 0.86/0.11 m2, woodland 0.57/0.11 m2, river 0.40/0.11 m2. The occurrence rate of living snail frames in different regions and different snail environment types showed a downward trend and the difference was statistically significant. ConclusionAlthough the snail monitoring indicators such as snail area, average living snail density and average living snail frame occurrence rate in Songjiang District are still at its historically low level, the average living snail density and average living snail frame occurrence rate are still high compared with other regions or the national average. We should focus on the upper reaches and tributaries of the Huangpu River, especially the key areas of seedling transplantation, and strengthen monitoring and supervision to reduce the risk of snail input.
7.Behavior of cartilage-derived microtissue and ability of cartilage formation in three-dimensional dynamic and static culture conditions
Wei LIU ; Hongyu JIANG ; Jiajie CHEN ; Yuyang GAO ; Yanjun GUAN ; Zhibo JIA ; Ying JIAO ; Zhen HUA ; Gehan JIANG ; Ying HE ; Aiyuan WANG ; Jiang PENG ; Jianhong QI
Chinese Journal of Tissue Engineering Research 2024;28(25):4022-4026
BACKGROUND:Compared with traditional two-dimensional culture,three-dimensional microtissue culture can show greater advantages.However,more favorable cultivation methods in three-dimensional culture still need to be further explored. OBJECTIVE:To evaluate the cell behavior of microtissue and its ability to promote cartilage formation under two three-dimensional culture methods. METHODS:Cartilage-derived microcarriers were prepared by chemical decellularization and tissue crushing.DNA quantification and nuclear staining were used to verify the success of decellularization,and histological staining was used to observe the matrix retention before and after decellularization.The microcarriers were characterized by scanning electron microscopy and CCK-8 assay.Cartilage-derived microtissues were constructed by combining cartilage-derived microcarriers with human adipose mesenchymal stem cells through three-dimensional static culture and three-dimensional dynamic culture methods.The cell viability and chondrogenic ability of the two groups of microtissues were detected by scanning electron microscopy,live and dead staining,and RT-qPCR. RESULTS AND CONCLUSION:(1)Cartilage-derived microcarriers were successfully prepared.Compared with before decellularization,the DNA content significantly decreased after decellularization(P<0.001).Scanning electron microscope observation showed that the surface of the microcarrier was surrounded by collagen,maintaining the characteristics of the natural extracellular matrix of cartilage cells.CCK-8 assay indicated that microcarriers had no cytotoxicity and could promote cell proliferation.(2)Scanning electron microscopy and live and dead staining results showed that compared with the three-dimensional static group,the three-dimensional dynamic group had a more extended morphology of microtissue cells,and extensive connections between cells and cells,between cells and matrix,and between matrix.(3)The results of RT-qPCR showed that the expressions of SOX9,proteoglycan,and type Ⅱ collagen in microtissues of both groups were increased at 7 or 14 days.The relative expression levels of each gene in the three-dimensional dynamic group were significantly higher than those in the three-dimensional static group at 14 days(P<0.05).At 21 days,the three-dimensional static group had significantly higher gene expression compared with the three-diomensional dynamic group(P<0.001).(4)The results showed that compared with three-dimensional static culture microtissue,three-dimensional dynamic culture microtissue could achieve higher expression of chondrogen-related genes in a shorter time,showing better cell viability and chondrogenic ability.
8.Effect and Mechanism of Qixian Tongluo Formula on Contralateral Corticospinal Tract Remodeling and Motor Functional Recovery in Rats with Cerebral Infarction
Shengqiang ZHOU ; Dahua WU ; Bo LI ; Yanjun CHEN ; Jia HUANG ; Qi WANG ; Wen ZENG ; Lingjuan TAN ; Yihui DENG ; Fang LIU
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(9):1319-1328
Objective To observe the effect of Qixian Tongluo Formula on contralateral corticospinal tract(CST)remodeling and motor functional recovery in rats with cerebral infarction,and to explore its potential molecular mechanism from the perspective of regulating factors related to never remodeling.Methods The rat middle cerebral artery occlusion(MCAO)model was established by silk thread ligation.Fifty model rats were randomly divided into model group,citicoline group(0.054 g·kg-1),Qixian Tongluo Formula low-,medium-and high-dose(7.83,15.66,31.32 g·kg-1)groups,and sham operation group,with 10 rats in each group.The intervention administration was started on the 3rd day after operation once a day for 26 consecutive days.On the 3rd,14th and 28th day after operation,the gross motor function was evaluated by Longa score,and the fine motor function was evaluated by beam-walking test(BWT)score.The contralateral motor cortex was injected with the nerve tracer biotin dextran amine(BDA)on the 14 th day after operation to anterogradely trace the CST.On the 28th day after operation,the expression of axonal growth associated protein-43(GAP-43)and BDA positive fibers in the contralateral motor cortex and cervical spinal cord were detected by immunohistochemistry.The co-localization areas of BDA positive fibers and presynaptic marker protein vesicular glutamate transporter 1(VGLUT1)in the cervical spinal cord gray matter were detected by immunofluorescence.The expressions of brain-derived neurotrophic factor(BDNF),glial cell-derived neurotrophic factor(GDNF),nerve growth factor(NGF)and nerve remodeling-associated inhibitory factor[Nogo-A,oligodendrocyte myelin glycoprotein(OMgp)and myelin-associated glycoprotein(MAG)]in the contralateral motor cortex were detected by Western Blot.Pearson correlation analysis was used to analyze the correlation between Longa score or BWT score and BDA/VGLUT1 co-localization area,respectively.Results Compared with the sham operation group,rats in the model group had obvious symptoms of motor function deficits,and the Longa scores were significantly increased(P<0.01)and the BWT scores were significantly decreased(P<0.05,P<0.01)at each time point.The expression of GAP-43 in the contralateral motor cortex and cervical spinal cord was up-regulated(P<0.05),the number of edge-crossing fibers from the posterior funiculus in cervical cord was increased(P<0.05),the co-localization area of BDA/VGLUT1 in the gray matter of the cervical spinal cord was increased(P<0.05),the expressions of BDNF,GDNF and NGF in the contralateral motor cortex were up-regulated(P<0.05),while the expressions of Nogo-A,OMgp and MAG were down-regulated(P<0.05).Compared with the model group,the Longa scores in each administration group on the 14th and 28th day after MCAO operation were significantly decreased(P<0.01),the BWT scores were significantly increased(P<0.01),the expression of GAP-43 in the contralateral motor cortex and cervical spinal cord was significantly up-regulated(P<0.01).The number of edge-crossing fibers from the posterior funiculus in cervical cord was significantly increased(P<0.01),the co-localization area of BDA/VGLUT1 in the gray matter of the cervical spinal cord was significantly increased(P<0.01).The expressions of BDNF,GDNF and NGF in the contralateral motor cortex were significantly up-regulated(P<0.01,P<0.05),while the expressions of Nogo-A,OMgp and MAG were significantly down-regulated(P<0.05),and the most significant effect was observed in the high dose group.The Longa score was negatively correlated with the co-localization area of BDA/VGLUT1(r=-0.89,P<0.01),and the BWT score was positively correlated with the co-localization area of BDA/VGLUT1(r=0.84,P<0.01).Conclusion Qixian Tongluo Formula can improve motor function through promoting contralateral CST remodeling in MCAO rats after cerebral infarction,and the molecular mechanism may be related to the regulation of the expression of nerve remodeling-associated factor in the contralateral motor cortex.
9.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.
10.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.

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