1.Signal mining and analysis of adverse drug events of doxycycline based on FAERS database
Yunxia LUO ; Weilin LI ; Xinyu CHEN ; Man'e HE ; Huamin XU ; Yaling LYU ; Jiabing XIE
Chinese Journal of Pharmacoepidemiology 2024;33(8):851-859
		                        		
		                        			
		                        			Objective To mine adverse drug event(ADE)signals of doxycycline using the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,and provide scientific evidence for clinical medication safety.Methods The data from the FAERS database between the first quarter of 2004 and the first quarter of 2024 were extracted.After data cleaning and standardization,ADE reports with doxycycline as the main suspected drug were screened.The system organ class(SOC)of ADE was performed using MedDRA,and the reporting odds ratio method and Medicines and Healthcare products Regulatory Agency method were used to mine ADE signals.The information component method was also used to evaluate signal strength.Results A total of 43 126 ADE reports with doxycycline as the primary suspected drug were collected,involving 14 642 patients,with a higher proportion of female patients(57.32%).There were 555 related ADE signals involving 26 SOC,with the top 5 SOC being gastrointestinal disorders,skin and subcutaneous tissue disorders,injuries,poisonings,and procedural complications,psychiatric disorders,and infections and infestations.The top 5 ADE signals with the highest signal intensity were Hatch reaction,sclerosing cholangitis,esophageal ulcer,gastrointestinal mucosal necrosis,and gastrointestinal injury.Among the ADE signals with the strongest signal strength not listed in the package insert,the top five were sclerosing cholangitis,nephrogenic diabetes insipidus,minimal change glomerular nephritis,diabetes insipidus and Sixth cranial nerve paralysis.Conclusion In clinical practice,particular attention should be paid to the frequent ADEs caused by doxycycline,as well as those not yet documented in the package insert,which involve multiple SOC such as renal and urinary disorders,hepatobiliary diseases,blood and lymphatic system disorders,and endocrine disorders.Therefore,clinical pharmacists should play a key role in assisting clinicians to develop and implement prevention plans for ADEs,thereby improving the safety of doxycycline in clinical use.
		                        		
		                        		
		                        		
		                        	
2.Value of five scoring systems in predicting the severity of hyperlipidemic acute pancreatitis: A comparative analysis
Yuanzhen WANG ; Yaling YUN ; Juan XIE ; Liya HUANG
Journal of Clinical Hepatology 2023;39(6):1391-1397
		                        		
		                        			
		                        			 Objective To investigate the value of pancreatitis activity scoring system (PASS) score, Bedside Index for Severity in Acute Pancreatitis (BISAP) score, Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE-Ⅱ) score, harmless acute pancreatitis score (HAPS), and Ranson score in evaluating the severity and prognosis of hypertriglyceridemia acute pancreatitis (HTGAP). Methods A retrospective analysis was performed for the clinical data of 300 patients with HTGAP who were admitted to General Hospital of Ningxia Medical University from January 2016 to January 2022, and according to the disease severity, these patients were divided into mild acute pancreatitis (MAP) group, moderate-severe acute pancreatitis (MSAP) group, and severe acute pancreatitis (SAP) group. Clinical data and the above scores were compared between the three groups. The chi-square test was used for comparison of categorical data between groups; an analysis of variance was used for continuous data with homogeneity of variance, and the Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups. The receiver operating characteristic (ROC) curve was plotted according to disease severity, and related indicators were compared in terms of the area under the ROC curve (AUC). Results There were significant differences between the three groups in PASS score ( F =219.351, P < 0.01), Ranson score ( χ 2 =83.084, P < 0.01), APACHE-Ⅱ score ( χ 2 =43.388, P < 0.01), and BISAP score ( χ 2 = 50.785, P < 0.01). Compared with the other four scoring systems in evaluating and predicting disease severity, PASS score had the highest sensitivity of 0.945 and the largest AUC of 0.963, followed by Ranson score with a sensitivity of 0.655 and an AUC of 0.819. Conclusion For patients with HTGAP, PASS score can more accurately assess the severity and prognosis of HTGAP patients and thus holds promise for clinical application. 
		                        		
		                        		
		                        		
		                        	
3.Effect of Wine Processing on Odour Formation of Polygonatum cyrtonema Rhizoma by GC-MS
Minmin LIU ; Ying LIU ; Tao ZHANG ; Lanting XIA ; Min HUANG ; Yating XIE ; Yaling DENG ; Aiyuan KANG ; Hongmin REN ; Jinlian ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(17):166-173
		                        		
		                        			
		                        			ObjectiveBy exploring the volatile components, polysaccharide composition and changes in the contents of five carbohydrate components of Polygonatum cyrtonema rhizoma before and after processing, and then the effect of yellow rice wine on the odour formation of P. cyrtonema rhizoma was investigated. MethodThe volatile components of P. cyrtonema rhizoma before and after processing were detected by headspace gas chromatography-mass spectrometry(HS-GC-MS), and sample data were subjected to principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) using SIMCA 14.1, then the differences between these components of P. cyrtonema rhizoma before and after processing were screened according to the principle of variable importance in the projection(VIP) value>1. Crude carbohydrate components in raw and wine-processed P. cyrtonema rhizoma were subjected to oxime and silylation, the carbohydrate components were analyzed by gas chromatography-mass spectrometry(GC-MS/MS), and the relative contents of various components were calculated by peak area normalization, then quantitative analysis of four carbohydrate components was also carried out. ResultA total of 23 volatile components were identified from the raw products and the wine-processed products, including 15 components in raw products and 20 components in wine-processed products. Among them, 2-methylbutyraldehyde and isovaleraldehyde had a sweet odor and their contents increased after processing, but the contents of hexanal and caproic acid decreased, new components such as 2-acetylfuran and 5-methylfuranal were produced after processing. PCA and OPLS-DA results showed that there were significant differences between raw products and the wine-processed products, a total of 13 differential compounds were screened out, of which 7 showed an upward trend in relative content and 6 showed a downward trend. A total of 7 carbohydrate components, including 5 monosaccharides and 2 disaccharides, were identified in raw products and the wine-processed products. The results of determination showed that the contents of fructose, glucose, mannose and sucrose in P. cyrtonema rhizoma increased after wine-processing, and their increases were 4.54, 1.51, 2.93, 3.66 times, respectively. ConclusionAfter processing, the increase of aromatic flavor of P. cyrtonema rhizoma may be related to the increase of the contents of aldehydes such as 2-methylbutyraldehyde and isovaleraldehyde, while the decrease of raw flavor may be related to the decrease of the contents of volatile components such as hexanal and hexanoic acid, the increase of sweet flavor may be related to the increase of the contents of monosaccharides and oligosaccharides such as fructose and sucrose. 
		                        		
		                        		
		                        		
		                        	
4.JAK-STAT signaling pathway and rosacea
Yaling WANG ; Hongfu XIE ; Ji LI ; Ben WANG
Chinese Journal of Dermatology 2023;56(2):169-172
		                        		
		                        			
		                        			Studies have shown that rosacea is related to inflammatory factors, neurovascular function, micro-ecological environment and other factors. The Janus kinase (JAK) -signal transducer and activator of transcription (STAT) signaling pathway involves a variety of inflammatory cytokines, and plays an important role in cell proliferation, differentiation, apoptosis, angiogenesis and immune regulation. This review summarizes the JAK-STAT signaling pathway and explores its potential role in rosacea.
		                        		
		                        		
		                        		
		                        	
5.Prevalence rate and risk factor analysis of nonalcoholic fatty liver disease in 115 female patients with schizophrenia
Ying YU ; Jian ZHAO ; Yaling JIN ; Qun XIE ; Dengfu YAO ; Min YAO
Chinese Journal of Hepatology 2023;31(9):947-953
		                        		
		                        			
		                        			Objective:To investigate the incidence rate and risk factors of nonalcoholic fatty liver disease (NAFLD) in patients with schizophrenia (SCZ).Methods:The incidence rate of NAFLD in 115 females with SCZ over 40 years of age with complete clinical data was analyzed with the consent of the Ethics Committee of Nantong Fourth People's Hospital. A physical examination report of healthy subjects ( n = 95, female, age 40 years old or older) was taken as the control group. Natural language processing technology was used to extract relevant data from the patient's electronic medical record system. Body mass index, alanine aminotransferase, triglycerides, low-density lipoprotein, leptin, and adiponectin were used to establish a human NAFLD-related model. Logistic regression analysis was used to evaluate the psychiatric symptoms, and physiological and biochemical indexes for the predictive value of NAFLD in female patients with SCZ. Results:The prevalence of NAFLD was significantly higher in the SCZ group (55.7%, 64/115) than that in the control group (26.3%, 25/95) ( χ2 = 18.335, P < 0.001). The prediction model showed that age, alanine aminotransferase, triglycerides, low-density lipoprotein, leptin, adiponectin, and body mass index were significantly correlated with NAFLD in females with SCZ. In the natural language processing search language model, arousal intensity (movements: uncontrolled running behavior) and emotional apathy were strongly linked to female patients with SCZ with NAFLD. Age, alanine aminotransferase, triglycerides, low-density lipoprotein, leptin, and body mass index were risk factors for SCZ to develop NAFLD, and adiponectin levels and uncontrolled running behavior were protective factors. Conclusion:The incidence rate of NAFLD is high in middle-aged and elderly females with SCZ. Natural language processing can help to automatically identify the risk factors for SCZ combined with NAFLD and has predictive and auxiliary diagnostic value.
		                        		
		                        		
		                        		
		                        	
6.Establishment and optimization of inductively coupled plasma mass spectrometry (ICP-MS) for the determination of aluminum residues
Yizhou XIE ; Yaling DING ; Jialin CHU ; Wenhu HUANG ; Yang GAO ; Xiao JIANG ; Tingting LU ; Kuilin LU
Chinese Journal of Blood Transfusion 2022;35(1):82-85
		                        		
		                        			
		                        			【Objective】 To establish and optimize a method for the determination of aluminum (Al) residue by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 Nitric acid solution was used to treat samples and standards. The concentration of nitric acid solution and equipment parameters were optimized, and the specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision of the optimized detection method were investigated to confirm whether it was suitable for the determination of Al residue in human serum albumin. 【Results】 The concentration of nitric acid was 5%, and digest time was 4 h. The equipment condition of ICP-MS was as follows: RF power: 1600 W, sampling depth: 10 mm, atomizer / carrier gas flow rate: 1.0 L/ min, compensation flow rate: 0.5 L/ min, experimental mode: standard mode, integration time: 0.2 s, data acquisition: 3 times. Specificity: The recoveries of Al: 92% (high concentration, RSD=3.5%), 98% (low concentration, RSD=4.9%). Linearity: In the range of (0~40) μg/L, the correlation coefficient between concentration and optical energy signal (CPS) of standard / sample were higher than 0.999 0. Accuracy/ Repeatability: The recoveries of sample (3 concentration): 108% (RSD=4.7%), 110% (RSD=4.9%) and 110% (RSD=2.8%). The detection limit was 0.006 μg/L, and the quantitation limit was 0.019 μg/L. Intermediate precision: personnel factor and date factor, P>0.05, RSD (12 times)=2%. Comparison between ICP-MS and atomic absorption spectrometry (AAS): the deviation between ICP-MS and AAS was 8%, and that of samples was 3%, with no significant difference noticed between the two methods. 【Conclusion】 After optimization, ICP-MS method has shown good performance in terms of specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision, and is suitable for the determination of Al residue in human albumin products of our company.
		                        		
		                        		
		                        		
		                        	
7.Matrix effect on the determination of Potency in Recombinant Coagulation Factor Ⅷ for injection
Jialin CHU ; Yaling DING ; Wenhu HUANG ; Jiajun WU ; Xiao JIANG ; Yang GAO ; Xun LIU ; Shenghua DU ; Yizhou XIE
Chinese Journal of Blood Transfusion 2022;35(12):1262-1265
		                        		
		                        			
		                        			【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.
		                        		
		                        		
		                        		
		                        	
8.Effect of Jianchangbang Braising Method on Formation of Odor of Polygoni Multiflori Radix Based on HS-GC-MS
Tao ZHANG ; Yaling DENG ; Xiyong CHEN ; Xianwen YE ; Minmin LIU ; Yating XIE ; Ying LIU ; Min HUANG ; Quan WAN ; Qing ZHANG ; Fangcheng YAO ; Jinlian ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(14):134-141
		                        		
		                        			
		                        			ObjectiveBy comparing the difference of volatile components of the decoction pieces before and after being processed by braising method of Jianchangbang and steaming method included in the 2020 edition of Chinese Pharmacopoeia, the influence of processing methods on the flavor formation of Polygoni Multiflori Radix (PMR) was compared. MethodHeadspace-gas chromatography-mass spectrometry (HS-GC-MS) was used to detect the volatile components of 30 batches of PMR samples from 3 origins with 3 processing methods. The GC was performed under programmed temperature (starting temperature of 40 ℃, rising to 150 ℃ at 5 ℃·min-1, and then rising to 195 ℃ at 10 ℃·min-1) with high purity helium as carrier gas and the split ratio of 10∶1. Mass spectrometry conditions were electron impact ion source (EI) and the detection range of m/z 50-650, the peak area normalization method was used to calculate the relative mass fraction of each component. The chromaticity values of different processed products were measured by a precision colorimeter, the relationship between chromaticity values and relative contents of volatile components was investigated by OriginPro 2021, principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed on the sample data by SIMCA14.1. The differential components of different processed products of PMR were screened according to the principle of variable importance in the projection (VIP) value>1.5, and the material basis of different odor formation of PMR and its processed products was explored. ResultA total of 59 volatile components were identified, among which 34 were raw products, 33 were braised products, and 27 were steamed products. PCA and OPLS-DA results showed that there were significant differences between the three, but there was no significant difference between samples from different origins of the same processing method. Color parameters of a*, b*, E*ab had no significant correlation with contents of volatile components, while L* was negatively correlated with contents of 2-methyl-2-butenal, 2-methyltetrahydrofuran-3-one and 2,3-dihydro-3,5-dihydroxy-6-methyl-4(H)-pyran-4-one (P<0.05). The contents of pungent odor components such as caproic acid, nonanoic acid and synthetic camphor decreased after processing, while the contents of sweet flavor components such as 2-methyl-2-butenal, furfural and 5-hydroxymethylfurfural increased after processing, and the contents of furfural, 5-methyl-2-furanmethanol, 5-hydroxymethylfurfural and other aroma components in the braised products were significantly higher than that in the steamed products. ConclusionHS-GC-MS can quickly identify the volatile substance basis that causes the different odors of PMR and its processed products. The effect of processing methods on the odor is greater than that of origin. There is a significant correlation between the color parameter of L* and contents of volatile components, the "raw" taste of PMR may be related to volatile components such as caproic acid, pelargonic acid and synthetic camphor, the "flavor" after processing may be related to the increase of the contents of 2-methyl-2-butenal, furfural, 5-hydroxymethylfurfural, methyl maltol and furfuryl alcohol. 
		                        		
		                        		
		                        		
		                        	
9.Multicenter cross-sectional investigation on the cleaning status and influencing factors of skin cleaning outside the wound in adult trauma patients
Qixia JIANG ; Yaling WANG ; Xie YIJIE ; Xiaoqing LIU ; Juan XU ; Meichun ZHENG ; Huan FENG ; Weiwei WANG ; Hongling SUN ; Shoulin ZHU ; Wenjuan LI ; Ning ZHAO
Chinese Journal of Burns 2021;37(5):429-436
		                        		
		                        			
		                        			Objective:To investigate the status and influencing factors of skin cleaning outside wound (hereinafter referred to as skin) in adult trauma patients.Methods:A multicenter cross-sectional investigation was conducted. From September 1 to 30, 2020, a total of 952 adult trauma patients who met the inclusion criteria were admitted to wound care clinics or trauma surgery wards of 13 military or local Grade Ⅲ Level A hospitals, including the General Hospital of the Eastern Theater Command of People's Liberation Army and the Army Medical Center, etc. A self-designed questionnaire on cleaning status of skin in trauma patients was released through the "questionnaire star" website to investigate basic information such as gender, age, education level, living status, and self-care ability, trauma information such as cause of injury, wound duration, trauma site, trauma depth, wound pain, wound peculiar smell, and wound cleaning solution, and skin cleaning status after injury such as whether to clean or not, cleaning method, cleaning frequency, cleaning duration in each time, or reasons for not cleaning. The patients who cleaned skin regularly after injury were included in cleaning group, and the other patients were included in no cleaning group. The basic information, trauma information, and skin cleaning status after injury of patients in 2 groups were investigated. Data were statistically analyzed with chi-square test, and binary multivariate logistic regression analysis was performed on indicators with statistically significant differences between the two groups to screen the independent influencing factors of skin cleaning in trauma patients.Results:A total of 952 questionnaires were received, and the recovery rate was 100%. Three invalid questionnaires were eliminated, and 949 valid questionnaires were obtained, with an effective rate of 99.68%. In 949 patients, there were 461 (48.6%) males and 488 (51.4%) females, aged 18-100 (50±18) years. Most patients were less than 60 years old, lived with their families, and could take care of themselves completely. Nearly half of the patients were with junior high school or below education level. The main causes of injury were sharp cutting injury and falling injury, the wound duration was 2-365 days, most of the injured parts were limbs and trunk, the wound depth was mostly full-thickness injury, and most patients had wound-related pain and no peculiar smell and used 5 g/L iodophor to clean the wound. Totally 684 (72.1%) patients cleaned their skin after injury, mainly by scrubbing with warm water, the cleaning frequency was mainly once or twice a week, and the cleaning time was mainly 10 or 15 min for each time. Totally 265 (27.9%) patients didn't clean their skin after injury, and the main causes for not cleaning were following the doctor's advice, followed by worrying about wound infection and loss of self-care ability. There were significantly statistical differences in constituent ratios of education level, self-care ability, cause of injury, wound pain, and wound peculiar smell of patients in 2 groups ( χ2=12.365, 24.519, 22.820, 9.572, 92.342, P<0.01). Education level, self-care ability, cause of injury, wound pain, and wound peculiar smell were potential influencing factors of skin cleaning in patients. Binary multivariate logistic regression analysis showed that self-care ability, wound pain, and wound peculiar smell were independent influencing factors of skin cleaning in patients (odds ratio=1.51, 0.52, 3.72, 95% confidence interval=1.08-2.12, 0.42-0.89, 2.66-5.22, P<0.05 or P<0.01). Conclusions:Self-care ability, wound pain, and wound peculiar smell are independent influencing factors of skin cleaning in adult trauma patients.
		                        		
		                        		
		                        		
		                        	
10.The symptoms and influencing factors of patients with esophageal cancer in postoperative rehabilitation
MIAO Yan ; XIE Qin ; LI Yaling ; LUO Chunyan ; LENG Xuefeng ; HAN Yongtao
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2020;27(01):52-56
		                        		
		                        			
		                        			Objective    To analyze the symptom characteristics and influencing factors in order to provide reference for symptom management of patients with esophageal cancer after operation. Methods    A total of 216 esophageal cancer patients, including 180 males and 36 females with an average age of 63.7±8.3 years, who underwent surgical operation in our hospital from March to October 2018 were recruited and investigated with self-designed symptom questionnaire at 1 month after surgery. Results    The top five symptoms were acid reflux (48.6%), cough (42.6%), dysphagia (40.7%), hoarseness (12.0%), and diarrhea (11.6%). Women were more prone to acid reflux (OR=2.053), fatigue (OR=1.932), chest pain (OR=3.681), sleep disturbance (OR=2.419), abdominal pain (OR=3.882), nausea (OR=3.014) and vomiting (OR=2.505). Patients over 60 years were more prone to dysphagia (OR=2.274). Patients with lower thoracic esophageal cancer had a higher incidence of dysphagia compared with patients with carcinoma of esophagogastric junction (OR=0.326). Patients who had neoadjuvant chemotherapy were more likely to suffer acid reflux (OR=1.594). Open surgery (OR=3.681) and neoadjuvant radiotherapy (OR=2.495) were the risk factors of chest pain. Conclusion    There are many symptoms in patients with esophageal cancer after operation, and the occurrence of symptoms is closely related to gender, age, tumor location, surgical procedure and neoadjuvant chemoradiotherapy.
		                        		
		                        		
		                        		
		                        	
            
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