1.Data Mining and Analysis on Adverse Drug Events of Novel Agents for Anti-multidrug-resistant Tuberculosis Based on FAERS
Liling ZHAO ; Junxia LI ; Shuang CHEN ; Weiwei ZHAO ; Haipeng YANG ; Ruohan XIE ; Li ZENG
Herald of Medicine 2025;44(9):1456-1464
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
2.Association of school green space exposure combined with outdoor activity duration with screening myopia among primary and secondary school students
XIN Yiliang, TANG Jiawen, ZHANG Xiyan, YANG Ruohan, LI Peixuan, YANG Wenyi, WANG Yan, YANG Jie
Chinese Journal of School Health 2025;46(11):1530-1533
Objective:
To explore the independent and interactive effects of school green space exposure and outdoor activity duration on screening myopia among primary and secondary school students, so as to provide theoretical support for the prevention and control of screening myopia in children and adolescents.
Methods:
From September to November 2023, 117 487 primary and secondary school students from 497 schools were selected using a cluster random sampling method, covering 98 counties (cities, districts) in Jiangsu Province. Data on the students screening myopia status and associated health influencing factors were collected and analyzed. School green space exposure was quantified using the normalized difference vegetation index (NDVI), which was extracted with ArcGIS Pro software; meanwhile, information on students outdoor activity duration was gathered through self reported questionnaires. Multivariate Logistic regression was applied to assess the independent and interactive effects of green space exposure and outdoor activity duration on screening myopia among primary and secondary school students.
Results:
Univariate analysis showed that there were statistically significant differences in screening myopia detection rates among primary and secondary school students of different genders, NDVI groups, every outdoor activity duration, monitoring points, school stages, parents educational level, and whether they lived on campus or had parents with screening myopia ( χ 2=88.91-1 950.08, all P <0.05); as the school age and sedentary time increased, the detection rate of screening myopia in primary and secondary school students also increased ( χ 2 trend =8 410.15, 2 028.91, both P <0.05). Independent effects showed that compared to the low NDVI group, the medium and high NDVI groups had lower risks of screening myopia ( OR =0.93, 0.95, both P <0.05). Compared to those with outdoor activity duration<2 h/d, students with outdoor activity duration≥2 h/d had a lower risk of screening myopia ( OR =0.96, P <0.05). When stratified by school level, compared to the low NDVI group, the medium NDVI group had lower risks of screening myopia in primary and junior high schools (primary school: OR =0.91; junior high school: OR =0.88, both P <0.05). Compared to those with outdoor activity duration<2 h/d, junior high school students with outdoor activity duration≥2 h/d had a lower risk of screening myopia ( OR = 0.90, P <0.05). When stratified by monitoring site, urban primary and secondary school students in the medium and high NDVI groups and those with outdoor activity duration≥2 h/d had lower risks of screening myopia ( OR =0.92, 0.92, 0.93, all P <0.05). Interactive effects showed that when medium or high NDVI was combined with outdoor activity duration≥2 h/d, the risks of screening myopia among primary and secondary school students were lower (medium NDVI×≥2 h/d: OR =0.89; high NDVI×≥ 2 h/d : OR =0.89, both P <0.05), and the combined effect was superior to that of a single factor.
Conclusion
Green space exposure and outdoor activity duration have negative correlations with screening myopia among primary and secondary students, and the combined effect is better than that of a single factor.
3.Data Mining and Analysis on Adverse Drug Events of Novel Agents for Anti-multidrug-resistant Tuberculosis Based on FAERS
Liling ZHAO ; Junxia LI ; Shuang CHEN ; Weiwei ZHAO ; Haipeng YANG ; Ruohan XIE ; Li ZENG
Herald of Medicine 2025;44(9):1456-1464
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
4.Euglycemic diabetic ketoacidosis caused by dapagliflozin in patient with diabetes mellitus during perioperative period of cardiac surgery
Haipeng YANG ; Shuang CHEN ; Weiwei ZHAO ; Liling ZHAO ; Ruohan XIE ; Junxia LI
Adverse Drug Reactions Journal 2023;25(4):248-250
A 43-year-old male patient with type 2 diabetes mellitus underwent off-pump coronary artery bypass grafting due to coronary atherosclerotic heart disease. Dapagliflozin was stopped 24 hours before the operation, fasting and discontinuing oral medication started at 8: 00 pm 1 day before the operation. On the day of surgery, blood gas analysis and blood glucose were normal before undergoing cardiopulmonary bypass. Tracheal intubation was successfully removed 7 hours after operation. Blood glucose and anion gap were 11.2 mmol/L and 13 mmol/L, respectively on the 2nd day after operation. The treatments of hypoglycemic, antihypertensive and lipid-regulating drugs and normal diet were restored. On the morning of the 3rd day after operation, the patient developed symptoms such as shallow rapid breathing, poor appetite, excessive urine, and irritability. Blood gas analysis showed pH 7.05, arterial partial pressure of carbon dioxide (PaCO 2) 11 mmHg, base excess -24.5 mmol/L, actual bicarbonate 21.7 mmol/L; blood glucose 10.4 mmol/L, potassium 5.3 mmol/L, and routine urine test showed ketone body (+++) in urine. Treatments such as fluid replacement, electrolyte correction, and acid-base balance, and insulin therapy were given. Ten hours later, the blood gas analysis showed pH 7.44, PaCO 2 32 mmHg, alkali residual -2.5 mmol/L, actual bicarbonate 21.7 mmol/L, anion gap 12 mmol/L, blood glucose was 6.7 mmol/L, and routine urine test showed ketone body (++) in urine. The patient′s symptoms were gradually improved on the 4th day after the operation and then metformin, acarbose, and insulin injection were given for blood glucose management. It was considered that the patient had ketoacidosis, which might be associated with dapagliflozin. Then the hypoglycemic regimen was adjusted to oral metformin 0.85 g twice daily, acarbose 50 mg twice daily, and glimepiride 2 mg twice daily on the 15th day after operation. After that, the fasting blood glucose in the patient was maintained at 8.2-10.6 mmol/L, the postprandial blood glucose was maintained at 8.2-13.1 mmol/L, and the glycosylated hemoglobin was 7.3%. The patient′s ketoacidosis did not recur.
5.Euglycemic diabetic ketoacidosis caused by dapagliflozin in patient with diabetes mellitus during perioperative period of cardiac surgery
Haipeng YANG ; Shuang CHEN ; Weiwei ZHAO ; Liling ZHAO ; Ruohan XIE ; Junxia LI
Adverse Drug Reactions Journal 2023;25(4):248-250
A 43-year-old male patient with type 2 diabetes mellitus underwent off-pump coronary artery bypass grafting due to coronary atherosclerotic heart disease. Dapagliflozin was stopped 24 hours before the operation, fasting and discontinuing oral medication started at 8: 00 pm 1 day before the operation. On the day of surgery, blood gas analysis and blood glucose were normal before undergoing cardiopulmonary bypass. Tracheal intubation was successfully removed 7 hours after operation. Blood glucose and anion gap were 11.2 mmol/L and 13 mmol/L, respectively on the 2nd day after operation. The treatments of hypoglycemic, antihypertensive and lipid-regulating drugs and normal diet were restored. On the morning of the 3rd day after operation, the patient developed symptoms such as shallow rapid breathing, poor appetite, excessive urine, and irritability. Blood gas analysis showed pH 7.05, arterial partial pressure of carbon dioxide (PaCO 2) 11 mmHg, base excess -24.5 mmol/L, actual bicarbonate 21.7 mmol/L; blood glucose 10.4 mmol/L, potassium 5.3 mmol/L, and routine urine test showed ketone body (+++) in urine. Treatments such as fluid replacement, electrolyte correction, and acid-base balance, and insulin therapy were given. Ten hours later, the blood gas analysis showed pH 7.44, PaCO 2 32 mmHg, alkali residual -2.5 mmol/L, actual bicarbonate 21.7 mmol/L, anion gap 12 mmol/L, blood glucose was 6.7 mmol/L, and routine urine test showed ketone body (++) in urine. The patient′s symptoms were gradually improved on the 4th day after the operation and then metformin, acarbose, and insulin injection were given for blood glucose management. It was considered that the patient had ketoacidosis, which might be associated with dapagliflozin. Then the hypoglycemic regimen was adjusted to oral metformin 0.85 g twice daily, acarbose 50 mg twice daily, and glimepiride 2 mg twice daily on the 15th day after operation. After that, the fasting blood glucose in the patient was maintained at 8.2-10.6 mmol/L, the postprandial blood glucose was maintained at 8.2-13.1 mmol/L, and the glycosylated hemoglobin was 7.3%. The patient′s ketoacidosis did not recur.
6.Predictive value of endoscopic features of early gastric cancer for non-curative outcome of endoscopic resection
Ruohan GUO ; Xi WU ; Long ZOU ; Weixun ZHOU ; Tao GUO ; Qiang WANG ; Yunlu FENG ; Qingwei JIANG ; Kun ZHANG ; Ruinan LIU ; Luolin WANG ; Aiming YANG
Chinese Journal of Digestive Endoscopy 2021;38(10):806-810
Objective:To explore the endoscopic features of early gastric cancer (EGC) related to non-curative endoscopic resection, and to construct an assessment model to quantify the risk of non-curative resection.Methods:From August 2006 to October 2019, 378 lesions that underwent endoscopic resection and were diagnosed pathological as EGC in the Department of Gastroenterology, Peking Union Medical College Hospital were included in this case-control study.Seventy-eight (20.6%) non-curative resection lesions were included in the observation group, and 234 lesions which selected from 300 lesions of curative resection were included in the control group according to the difference of operation year ±1 with the observation group, and the ratio of 1∶3 of the observation group to the control group. Univariate and multivariate logistic regression analysis were performed to explore the risk factors for non-curative resection. The independent risk factor with the minimum β coefficient was assigned 1 point, and the remaining factors were scored according to the ratio of their β coefficient to the minimum. A predictive model was established to analyze the 378 lesions.The non-curative resection rates of lesions of different scores were calculated. Results:Univariate analysis showed that the lesion diameter, the location, redness, ulcer or ulcer scar, fold interruption, fold entanglement, and invasion depth observed with endoscopic ultrasonography (EUS) were associated with non-curative resection of EGC lesions ( P<0.05), and contact or spontaneous bleeding may be associated with non-curative resection ( P=0.068). Multivariate logistic regression analysis showed that submucosal involvement (VS confined to the mucosa: β=0.901, P=0.011, OR=2.46, 95% CI: 1.23-4.92), lesion diameter of 3-<5 cm (VS <3 cm: β=0.723, P=0.038, OR=2.06, 95% CI: 1.04-4.09), lesion diameter of ≥5 cm (VS <3 cm: β=2.078, P=0.003, OR=7.99, 95% CI: 2.02-31.66), location in the upper 1/3 of the stomach (VS lower 1/3: β=1.540, P<0.001, OR=4.66, 95% CI: 2.30-9.45), and fold interruption ( β=2.287, P=0.008, OR=1.93, 95% CI: 0.95-3.93) were independent risk factors for non-curative resection of EGC lesions. The factor of lesion diameter of 3-<5 cm and submucosal involvement were assigned 1 point respectively, location in the upper 1/3 of the stomach was assigned 2 points, diameter of ≥5 cm and fold interruption were assigned 3 points respectively, and other factors were assigned 0 point. Then the analysis of 378 lesions showed that the probability of non-curative resection at ≥2 points was 41.9% (37/93), 4 times as much as that at 0 [11.5% (25/217)]. Conclusion:EGC lesions with diameter ≥3 cm, located in the upper 1/3 of the stomach, interrupted folds or submucosal involvement are highly related to non-curative resection. The predictive model based on these factors achieves satisfactory efficacy, but it still needs further validation in larger cohorts.
7.Pulmonary embolism with chronic obstructive pulmonary disease
Ruohan YANG ; Guiqing LIU ; Chaosheng DENG
Chronic Diseases and Translational Medicine 2021;07(3):149-156
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease. The incidence of COPD is growing annually in China, and it is a significant and growing public health burden. Multivariate analysis showed that COPD was one of the independent risk factors for the occurrence of pulmonary embolism (PE), and the incidence of PE was significantly higher in COPD patients than in normal subjects. However, PE is often overlooked in patients with acute exacerbation of COPD (AECOPD) because there are many similarities in clinical symptoms between PE and AECOPD, which are difficult to distinguish, resulting in the failure of timely treatment and poor prognosis. Therefore, it is of great significance to understand the clinical manifestations, diagnosis, and treatment of COPD combined with PE for making a more accurate diagnosis, providing timely and effective treatment, and improving the prognosis of such patients.
8.Pulmonary embolism with chronic obstructive pulmonary disease
Ruohan YANG ; Guiqing LIU ; Chaosheng DENG
Chronic Diseases and Translational Medicine 2021;07(3):149-156
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease. The incidence of COPD is growing annually in China, and it is a significant and growing public health burden. Multivariate analysis showed that COPD was one of the independent risk factors for the occurrence of pulmonary embolism (PE), and the incidence of PE was significantly higher in COPD patients than in normal subjects. However, PE is often overlooked in patients with acute exacerbation of COPD (AECOPD) because there are many similarities in clinical symptoms between PE and AECOPD, which are difficult to distinguish, resulting in the failure of timely treatment and poor prognosis. Therefore, it is of great significance to understand the clinical manifestations, diagnosis, and treatment of COPD combined with PE for making a more accurate diagnosis, providing timely and effective treatment, and improving the prognosis of such patients.
9.Non-alcoholic fatty liver disease and liver transplantation
Pengcheng ZHANG ; Kefeng DOU ; Zhaoxu YANG ; Ruohan ZHANG ; Hongtao ZHANG ; Wei PENG ; Yanbing CAO ; Weimin LI
Chinese Journal of Hepatobiliary Surgery 2020;26(2):155-157
Non-alcoholic fatty liver disease (NAFLD) is characterized by increased fat depositions in the liver while the patients do not have drinking history.NAFLD has a prevalence of 10% ~40% in global,25% ~26% in Western populations.From 2004 to 2013,the numbers of new patients on the waitlist who had NASH increased by 170% in America.The prevalence of NAFLD in China is 20%.With the decrease of HBV and HCV and the increase of diabetes mellitus type 2 and obesity,NAFLD will become the most common chronic liver disease in China over the next 20 years.NAFLD related end-stage liver disease will become the most common indication of liver transplantation.In this paper,the epidemiological features,pathogenesis,indication and prognosis of liver transplantation are reviewed.
10.Study on Protective Effect of Total Flavonoids from the Leaves of Mongolian Medicine Choerospondias axillaris on Myocar- dial Ischemia Reperfusion Injury Model Rats
Jia YIN ; Ruohan YANG ; Xiaodong ZHAO ; Haiyun ZHAO ; Jiwei LIU ; Yumei YANG
China Pharmacy 2019;30(16):2253-2257
OBJECTIVE: To investigate the protective effect of total flavonoids from the leaves of Choerospondias axillaris (TFLC) on myocardial ischemia reperfusion injury (MIRI) model rats. METHODS: Male SD rats were randomly divided into sham operation group, model group, positive control group (verapamil, 0.02 g/kg), TFLC low-dose and high-dose groups (0.1, 0.4 g/kg), with 10 rats in each group. Administration groups were intragastrically given relevant medicine (2 mL/100 g); sham operation group and model group were given constant volume of normal saline intragastrically, once a day, for consecutive 7 d. After last medication, MIRI model was induced by modified ligation method. The times and duration of ventricular tachycardia (VT) and ventricular fibrillation (VF) in rats were recorded with biological function experiment system during reperfusion period.The activity of CK and contents of TNF-α, IL-6, NF-κB and NO in serum were determined by ELISA double antibody clip art assay. The morphological characteristics of myocardial tissue was observed by HE staining. The myocardial infarction scope (i.e. the ratio of myocardial tissue mass to ventricular mass) was measured by TTC method. RESULTS: Compared with sham operation group, the times and duration of VT and VF were increased or prolonged significantly in model group; CK activity, serum contents of TNF-α, IL-6 and NF-κB were enhanced or increased significantly, while NO content was decreased significantly (P<0.05 or P<0.01). Obvious myocardial infarction focus, serious cell structure damage, disorderly muscle fibers arrangement, cell nucleus pyknosis and accompanied inflammatory cell infiltration were all observed in cardiac tissue; the mass of infarcted myocardial tissue and ventricular as well as the scope of myocardial infarction increased significantly (P<0.01). Compared with model group, the times and duration of VT and VF were decreased or shortened significantly in administration groups; CK activity, serum contents of TNF-α, IL-6, NF-κB were decreased significantly, while NO content was increased significantly (P<0.05 or P<0.01). The above symptoms of myocardial injury were improved;the mass of infarcted myocardial tissue and ventricular as well as the scope of myocardial infarction was significantly reduced (P<0.05 or P<0.01). CONCLUSIONS: TFLC can relieve MIRI-induced ischemic arrhythmia and myocardial damage, reduce the release of inflammatory factors, promote the recovery of myocardial and endothelial cell function, reduce the scope of myocardial infarction and has a certain protective effect.


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