1.Efficacy of Fufang Lingjiao Jiangya Pills with Different Proportions of Goat Horn Replacing Antelope Horn on Spontaneous Hypertensive Rats
Tengjian WANG ; Wanlu ZHAO ; Yang YU ; Yan LIU ; Kun CAO ; Zheyuan LIN ; Yue WU ; Lilan LUO ; Weizhi LAI ; Zhaohuan LOU ; Qiaoyan ZHANG ; Quanlong ZHANG ; Luping QIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):68-78
ObjectiveTo investigate the optimal ratio of goat horn replacing antelope horn in Fufang Lingjiao Jiangya pills and the blood pressure-lowering mechanism of this medicine. MethodsThe blood pressure-lowering efficacy of Fufang Lingjiao Jiangya pills with varying proportions of goat horn replacing antelope horn was evaluated on spontaneous hypertensive rats (SHR). In this experiment, 50 SHR rats were randomly grouped as follows: model (n=8), captopril (0.01 g·kg-1) (n=6), low-dose blank Fufang Lingjiao Jiangya pills (0.342 g·kg-1) (n=6), high-dose blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1) (n=6), low-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), high-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6), low-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), and high-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6). Additionally, 8 WKY rats were used as the normal group. Drugs were administered by gavage for 4 weeks while an equal volume of distilled water was administered for the normal and model groups. Blood pressure was measured before administration, 3 h post administration, and biweekly thereafter. In the experiment for Fufang Lingjiao Jiangya pills with goat horn replacing antelope horn in different proportions, 48 SHR rats were randomly grouped as follows: model, blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1), antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1), 2× goat horn-containing Fufang Lingjiao Jiangya pills (0.824 g·kg-1), 4× goat horn Fufang Lingjiao Jiangya pills (0.969 g·kg-1), and 6× goat horn Fufang Lingjiao Jiangya pills (1.112 g·kg-1). The normal group included 8 WKY rats, and the normal group and model group received an equal volume of distilled water. The treatment lasted for 2 weeks, and blood pressure was recorded at various time points (pre-administration, 3 h post administration, and on days 4, 7, 10, and 14 of administration). Serum levels of angiotensin-converting enzyme (ACE), angiotensin Ⅱ(Ang Ⅱ), renin, and interleukin-6 (IL-6) were measured by enzyme-linked immunosorbent assay. Histopathological changes in the heart, kidney, and thoracic aorta were observed by hematoxylin-eosin staining. The protein levels of ACE2, angiotensin Ⅱ type 1 receptor (AT1R), and angiotensinogen (AGT) in the kidney tissue were determined by Western blot, while the expression of nuclear factor (NF)-κB p65 and Toll-like receptor 4 (TLR4) in the thoracic aorta tissue was assessed by immunohistochemistry. ResultsCompared with the model group, all treatment groups showed lowered blood pressure (P<0.05, P<0.01), and the 6× goat horn-containing Fufang Lingjiao Jiangya pills group showed consistent blood pressure-lowering effect with the antelope horn-containing Fufang Lingjiao Jiangya pills group. Compared with the normal group, the model group showed elevated serum levels of ACE, Ang Ⅱ, renin, and IL-6, while the elevations were declined in the Fufang Lingjiao Jiangya pills groups (P<0.05, P<0.01). Pathological changes in the heart, kidney, and thoracic aorta were alleviated in all the treatment groups, with the 6× goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups exhibited the best effect. Western blot and immunohistochemistry results showed that all the treatment groups exhibited down-regulated protein levels of AT1R, AGT, NF-κB p65, and TLR4 and up-regulated protein levels of ACE2 (P<0.05, P<0.01) compared with model group, with the 6×goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups showcasing the best effect. ConclusionReplacing antelope horn with 6×goat horn in Fufang Lingjiao Jiangya pills can achieve consistent blood pressure-lowering effect with the original prescription. The prescription may exert the effect by inhibiting the renin-angiotensin-aldosterone system (RAAS) and TLR4/NF-κB signaling pathways.
2.Distribution of traditional Chinese medicine constitution and construction of a risk prediction model in patients with impaired awareness of hypoglycemia
Zhijia SHEN ; Qiaoyan LIU ; Zhijie QIAN ; Wentao SHI ; Limei YIN ; Lu XU
Chinese Journal of Practical Nursing 2025;41(15):1157-1167
Objective:To explore the distribution of Traditional Chinese Medicine constitution among patients with impaired awareness of hypoglycemia (IAH) and identify risk factors for IAH in patients with diabetes mellitus, to develop a risk prediction model. The aim is to validate the models′ predictive accuracy to facilitate early prevention and treatment of IAH.Methods:A case control study employing convenience sampling model was conducted on 1351 hospitalized patients with diabetes mellitus in the endocrinology departments of Changshu Hospital Affiliated to Nanjing University of Chinese Medicine and Affiliated Hospital of Jiangsu University, between August 2021 and December 2023. Traditional Chinese medicine constitution types were determined using the Traditional Chinese Medicine Constitution Classification and Judgment (ZYYXH/T157-2009). Data were divided into training and test sets at a ratio of 7∶3. Two prediction models were developed: Model 1, a conventional IAH prediction model for patients with diabetes mellitus, and Model 2, an IAH prediction model for patients with diabetes mellitus incorporating traditional Chinese medicine constitution. Nomograms were drawn for both models. The Hosmer-Lemeshow goodness-of-fit test, calibration curve, receiver operating characteristic (ROC) curve, and area under the curve (AUC) were calculated to evaluate the effectiveness of models 1 and 2. The improvement in prediction performance between Models 1 and 2 was assessed using Delong test, AUC, net reclassification improvement (NRI), integrated discrimination improvement (IDI), and decision curve analysis (DCA).Results:The study included 1 283 patients with diabetes mellitus, including 578 males and 705 females, aged (59.61 ± 14.09) years. The incidence of IAH among patients with diabetes mellitus was 20.50% (263/1283), with yang deficiency constitution being the most prevalent traditional Chinese medicine constitution type, at 47.53% (125/263). Multivariate analysis revealed that age, body mass index, course of diabetes, neurological hypoglycemia symptoms, hypoglycemia symptoms and severe hypoglycemia history were the influencing factors of Model 1 (all P<0.05); age, body mass index, neurological hypoglycemic symptoms, hypoglycemic symptoms, history of severe hypoglycemia, and traditional Chinese medicine constitution were the influencing factors of Model 2 (all P<0.05). The Hosmer-Lemeshow goodness-of-fit test showed a good fit of Model 2 [training set ( χ2=8.48, P>0.05), test set ( χ2=3.92, P>0.05)]. The Delong test results showed that the AUC for Model 2 was 0.96 for both the training and test sets, significantly higher than the AUCs of the 0.90 and 0.91 for Model 1 ( Z=-7.27, -3.70, both P<0.01). Furthermore, NRI was 0.66 ( 95%CI 0.53-0.79, P<0.01) and IDI was 0.02 (95% CI 0.01-0.03, P<0.05) for Model 2. Comparative analysis of clinical utility demonstrated that the net benefit of Model 2 for predicting IAH in patients with diabetes mellitus surpassed that of Model 1 across threshold probabilities ranging from 5% to 100%. Conclusions:The study constructed a nomogram prediction model included traditional Chinese medicine constitution with good predictive performance for IAH in patients with diabetes mellitus, and is of significant clinical value for identifying high-risk IAH populations.IAH patients mainly have a biased constitution, indicating that medical staff can reduce the incidence of IAH by improving the patients′ constitution.
3.Latent profile analysis of nutrition literacy among young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity and its relationship with dietary motivation
Xiangjie SHEN ; Wei YIN ; Qiaoyan LIU ; Songmei CAO ; Houjuan ZU ; Huiying SHA ; Jingjing WANG
Chinese Journal of Nursing 2025;60(16):1974-1980
Objective To investigate the potential categories of nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity,and analyze the relationship between various latent categories and dietary motivation,so as to provide references for clinical working staff to develop relevant dietary intervention strategies.Methods A convenient sampling method was used to enroll 270 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity from the endocrine department of a tertiary general hospital in Zhenjiang City,Jiangsu province,using basic information questionnaire,Nutrition Literacy Measurement Scale for Chinese adults,and the Regulation of Eating Behaviors Scale to collect data,using latent profile analysis to extract nutrition literacy potential categories,with general data and potential categories as independent variables,dietary motivation as the dependent variable for univariate analysis and multiple linear regression analysis.Results A total of 262 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity completed the survey,and their nutrition literacy could be divided into 3 potential categories:low nutrition literacy group(16.41%),transformation dilemma group(54.96%),and middle and high nutrition literacy group(28.63%).The results of multiple linear regression analysis showed that residency style,potential categories of nutrition literacy and presence of diabetic complications were the influencing factors of dietary motivation in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity(P<0.05).Conclusion There was a group heterogeneity in nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity.Clinical working staff should provide targeted interventions based on the patient's potential categories of nutrition literacy to stimulate ongoing motivation to maintain a healthy diet.
4.Distribution of traditional Chinese medicine constitution and construction of a risk prediction model in patients with impaired awareness of hypoglycemia
Zhijia SHEN ; Qiaoyan LIU ; Zhijie QIAN ; Wentao SHI ; Limei YIN ; Lu XU
Chinese Journal of Practical Nursing 2025;41(15):1157-1167
Objective:To explore the distribution of Traditional Chinese Medicine constitution among patients with impaired awareness of hypoglycemia (IAH) and identify risk factors for IAH in patients with diabetes mellitus, to develop a risk prediction model. The aim is to validate the models′ predictive accuracy to facilitate early prevention and treatment of IAH.Methods:A case control study employing convenience sampling model was conducted on 1351 hospitalized patients with diabetes mellitus in the endocrinology departments of Changshu Hospital Affiliated to Nanjing University of Chinese Medicine and Affiliated Hospital of Jiangsu University, between August 2021 and December 2023. Traditional Chinese medicine constitution types were determined using the Traditional Chinese Medicine Constitution Classification and Judgment (ZYYXH/T157-2009). Data were divided into training and test sets at a ratio of 7∶3. Two prediction models were developed: Model 1, a conventional IAH prediction model for patients with diabetes mellitus, and Model 2, an IAH prediction model for patients with diabetes mellitus incorporating traditional Chinese medicine constitution. Nomograms were drawn for both models. The Hosmer-Lemeshow goodness-of-fit test, calibration curve, receiver operating characteristic (ROC) curve, and area under the curve (AUC) were calculated to evaluate the effectiveness of models 1 and 2. The improvement in prediction performance between Models 1 and 2 was assessed using Delong test, AUC, net reclassification improvement (NRI), integrated discrimination improvement (IDI), and decision curve analysis (DCA).Results:The study included 1 283 patients with diabetes mellitus, including 578 males and 705 females, aged (59.61 ± 14.09) years. The incidence of IAH among patients with diabetes mellitus was 20.50% (263/1283), with yang deficiency constitution being the most prevalent traditional Chinese medicine constitution type, at 47.53% (125/263). Multivariate analysis revealed that age, body mass index, course of diabetes, neurological hypoglycemia symptoms, hypoglycemia symptoms and severe hypoglycemia history were the influencing factors of Model 1 (all P<0.05); age, body mass index, neurological hypoglycemic symptoms, hypoglycemic symptoms, history of severe hypoglycemia, and traditional Chinese medicine constitution were the influencing factors of Model 2 (all P<0.05). The Hosmer-Lemeshow goodness-of-fit test showed a good fit of Model 2 [training set ( χ2=8.48, P>0.05), test set ( χ2=3.92, P>0.05)]. The Delong test results showed that the AUC for Model 2 was 0.96 for both the training and test sets, significantly higher than the AUCs of the 0.90 and 0.91 for Model 1 ( Z=-7.27, -3.70, both P<0.01). Furthermore, NRI was 0.66 ( 95%CI 0.53-0.79, P<0.01) and IDI was 0.02 (95% CI 0.01-0.03, P<0.05) for Model 2. Comparative analysis of clinical utility demonstrated that the net benefit of Model 2 for predicting IAH in patients with diabetes mellitus surpassed that of Model 1 across threshold probabilities ranging from 5% to 100%. Conclusions:The study constructed a nomogram prediction model included traditional Chinese medicine constitution with good predictive performance for IAH in patients with diabetes mellitus, and is of significant clinical value for identifying high-risk IAH populations.IAH patients mainly have a biased constitution, indicating that medical staff can reduce the incidence of IAH by improving the patients′ constitution.
5.Latent profile analysis of nutrition literacy among young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity and its relationship with dietary motivation
Xiangjie SHEN ; Wei YIN ; Qiaoyan LIU ; Songmei CAO ; Houjuan ZU ; Huiying SHA ; Jingjing WANG
Chinese Journal of Nursing 2025;60(16):1974-1980
Objective To investigate the potential categories of nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity,and analyze the relationship between various latent categories and dietary motivation,so as to provide references for clinical working staff to develop relevant dietary intervention strategies.Methods A convenient sampling method was used to enroll 270 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity from the endocrine department of a tertiary general hospital in Zhenjiang City,Jiangsu province,using basic information questionnaire,Nutrition Literacy Measurement Scale for Chinese adults,and the Regulation of Eating Behaviors Scale to collect data,using latent profile analysis to extract nutrition literacy potential categories,with general data and potential categories as independent variables,dietary motivation as the dependent variable for univariate analysis and multiple linear regression analysis.Results A total of 262 young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity completed the survey,and their nutrition literacy could be divided into 3 potential categories:low nutrition literacy group(16.41%),transformation dilemma group(54.96%),and middle and high nutrition literacy group(28.63%).The results of multiple linear regression analysis showed that residency style,potential categories of nutrition literacy and presence of diabetic complications were the influencing factors of dietary motivation in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity(P<0.05).Conclusion There was a group heterogeneity in nutrition literacy in young and middle-aged patients with type 2 diabetes mellitus combined with overweight or obesity.Clinical working staff should provide targeted interventions based on the patient's potential categories of nutrition literacy to stimulate ongoing motivation to maintain a healthy diet.
6.Chinese Translation of the Stanford Expectations of Treatment Scale and Its Application Evaluation on Traditional Chinese Medicine for Diarrhea-Predominant Irritable Bowel Syndrome with Liver-Constraint and Spleen-Deficiency Syndrome
Shibing LIANG ; Yingying ZHANG ; Zhijie WANG ; Zeyu YU ; Mei HAN ; Huijuan CAO ; Guoyan YANG ; Shihuan CAO ; Hongjie CHENG ; Qiaoyan ZHANG ; Youzhu SU ; Yufei LI ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(19):1994-2001
ObjectiveTo adapt the Stanford Expectations of Treatment Scale(SETS) into Chinese(C-SETS) and test the feasibility, validity and reliability of its application in patients with diarrhea-predominant irritable bowel syndrome(IBS-D) with liver-constraint and spleen-deficiency syndrome treated with traditional Chinese medicine(TCM). MethodsWe obtained authorisation from the developer of the SETS, and followed the principle of "two-way translation" to translate the SETS by literal translation and back translation to form the C-SETS. Ninety-six IBS-D patients with liver-constraint and spleen-deficiency syndrome were enrolled as respondents and filled out C-SETS before receiving treatment; the feasibility was assessed by the recall rate, completion rate and the duration of filling out the scale; the reliability was assessed by Cronbach's α; the structural validity was assessed by exploratory and confirmatory factor analysis, and the content validity was assessed by correlation analysis. ResultsThe C-SETS consists of 10 items, with the 1st, 3rd, and 5th rating items constituting the Positive Expectations subscale, and the 2nd, 4th, and 6th rating items constituting the Negative Expectations subscale, each of which is rated on a 7-point Likert Scale. The recall of C-SETS was 100%(96/96), the completion rate was 89.58%(86/96); Cronbach's α for the Positive and Negative Treatment Expectations subscales were 0.845 and 0.854, respectively; exploratory factor analysis showed that the coefficient of commonality for all six entries was larger than 0.4, and that the six entries could be used by both factors to explain 77.092% of the total variance; validation factor analysis showed that the goodness-of-fit index, comparative fit index, root mean square of approximation error, canonical fit coefficient, and chi-square degrees of freedom ratio took the values of 0.943, 1.003, 0, 0.943, and 0.626, respectively; and the results of Spearman's analysis suggested that the C-SETS had good content validity. ConclusionThe C-SETS has well feasibility, reliability, and validity, which initially proves that it can be used as a tool to assess the treatment expectation of patients with IBS-D with liver-constraint and spleen-deficiency syndrome before receiving TCM treatment.
7.Hydroxynonenal alleviates neonatal sepsis-induced acute lung injury by inhibiting endothelial cell pyrosis
Zhouyou WU ; Ting LI ; Tengwei ZHANG ; Qiaoyan FANG ; Liu YANG ; Qiao LI
The Journal of Practical Medicine 2024;40(2):195-201
Objective To explore the role of 4-hydroxynonenal(HNE)in alleviating acute lung injury(ALI)induced by neonatal sepsis by inhibiting the focal death of endothelial cells(ECs).Methods Newborn mice were randomly divided into five groups:(1)Sham operation group(Sham group),(2)sham operation mice receiving HNE treatment group(Sham + HNE group),(3)cecal serosity(CS group),and(4)CS-treated GS-DMD-/-mice group(CS + GSDMD-/-group).The degree of lung injury was evaluated by lung histopathology and lung wet/dry weight ratio.The ECs of mice were isolated and divided into the Ctrl group,LPS + ATP group,LPS + ATP + HNE-L group and LPS + ATP + HNE-H group.Western blot was used to evaluate the expression of HNE and caspase-1 pathway.Results Compared with CS group,the lung tissue scores of CS + HNE group and CS + GSDMD-/-group were significantly decreased(P<0.05),and the ratio of wet to dry weight of lung tissues was significantly decreased(P<0.05).Compared with the CS group,the 72-hour survival rates of mice in the CS + HNE group and CS + GSDMD-/-group were significantly improved(P<0.05).The expressions of GSDMD-N,C-caspase-1,NLRP3,IL-18 and IL-1β in lung ECs of the CS + HNE group and CS + GSDMD-/-group were signifi-cantly lower than those of the CS group(P<005).Compared with the Ctrl cells,LPS + ATP significantly decreased the cell viability(P<0.05)and increased the protein expressions of GSDMD,C-caspase-1,NLRP3,IL-18 and IL-1β(P<0.05),and these effects were also inhibited by HNE.Conclusion HNE can inhibit the focal death of lung ECs cells by inhibiting NLRP3/caspase-1 signal transduction,and improve ALI in septic mice.
8.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.
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.Prognostic predictive value of detecting minimal residual disease in acute myeloid leukemia after 2 courses of hypomethylating agents combined with low-dose induction chemotherapy
Haoyue CHEN ; Chunhua LIU ; Qiaoyan HAN
Journal of Leukemia & Lymphoma 2023;32(4):215-220
Objective:To explore the prognostic predictive value of detecting minimal residual disease (MRD) after 2 courses of hypomethylating agents (HMA) combined with low-dose induction chemotherapy in patients with acute myeloid leukemia (AML).Methods:The data of 43 newly diagnosed AML patients treated by HMA combined with low-dose induction chemotherapy in Jingjiang People's Hospital of Jiangsu Province from January 2016 to January 2021 were retrospectively analyzed, and the bone marrow MRD levels were detected by multiparametric 10-color flow cytometry (MFC) after 1 course and 2 courses of chemotherapy. Patients were divided into three groups according to MRD levels: the group with negative MRD after 1 course of induction chemotherapy (MRD-1 group), the group with negative MRD after 2 courses of induction chemotherapy (MRD-2 group), and the group without negative MRD after 2 courses of induction chemotherapy (MRD+ group). Kaplan-Meier method was used to draw the progression-free survival (PFS) and overall survival (OS) curves of all patients and each group, and log-rank test was performed to compare them; the influencing factors for OS were analyzed using univariate and multivariate Cox proportional hazards models.Results:Among the 43 patients, 17 patients (39.5%) were in the MRD-1 group, 14 patients (32.6%) were in the MRD-2 group, and 12 patients (27.9%) were in the MRD+ group. There were no statistical differences among the 3 groups in gender, age, hemoglobin level at initial diagnosis, white blood cell count, platelet count, lactate dehydrogenase level, disease subtype, WT1 expression, karyotype, and genetic risk stratification (all P > 0.05). The median follow-up was 15 months (1-67 months). Survival analysis showed a median OS time of 21 months (95% CI 15 months -not reached) in 43 patients and a median PFS time of 12 months (95% CI 9-18 months) in 29 patients included in the PFS analysis; PFS and OS in the MRD-1 and MRD-2 groups were better than those in the MRD+ group (all P < 0.01), and the differences in PFS and OS between the MRD-1 and MRD-2 groups were not statistically significant (both P > 0.05); the median PFS time was 5 months (95% CI 2 months-not reached) in the MRD+ group, the median PFS time was 15 months (95% CI 7 months-not reached) in the MRD-1 group, and the median PFS time was 18 months (95% CI 11 months-not reached) in the MRD-2 group; the median OS time in the MRD+ group was 9 months (95% CI 7 months-not reached), the median OS time was not reached in the MRD-1 group, and the median OS time was 38 months (95% CI 38 months-not reached) in the MRD-2 group. Multivariate Cox regression analysis showed that age ( HR = 1.080, 95% CI 1.004-1.160, P = 0.038), MRD status (MRD-1 vs. MRD+: HR = 0.125, 95% CI 0.031-0.507, P = 0.004; MRD-2 vs. MRD+: HR = 0.146, 95% CI 0.037-0.577, P = 0.006) were independent influencing factors for OS in AML patients. Conclusions:The survival is good in AML patients with MRD negative conversion after both 1 course and 2 courses of HMA combined with low-dose induction chemotherapy, and both are better than that in patients with positive MRD after 2 courses of chemotherapy.

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