1.Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS
Huiqing MIAO ; Kai LIN ; Minghong YAO ; Lijun LIN
China Pharmacy 2024;35(12):1505-1510
		                        		
		                        			
		                        			OBJECTIVE To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients. METHODS Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem (hereinafter referred to as the “Franchised Drug Monitoring System”) and the FDA Adverse Event Reporting System (FAERS), the adverse drug reaction (ADR)/adverse drug event (ADE) reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology, and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio (ROR) method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency (hereinafter referred to as the “MHRA method”). RESULTS Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System, the ratio of male to female was 1∶1.4, the patient’s age was mainly distributed between 18 and 64 years old; ADR/ADE affected 5 systemic organs, with eye organ diseases accounting for 87.7%; among them, there were 9 new and general ADR reports (12.5%) and 4 severe ADR reports (5.6%); ROR method and MHRA method both identified three risk signals: cataracts, glaucoma, and high intraocular pressure. Among the 244 reports received by the FAERS database, the ratio of male to female was 1∶1.5; ADR/ADE damage affected 10 systemic organs, with 46.1% suffering from various injuries, poisoning, and operational complications, and 32.0% suffering from product problems; there were 20 severe ADR reports (8.2%); ROR method and MHRA method both identified 19 risk signals, including implantation complications, medication system issues, etc. CONCLUSIONS When using Fluocinolone acetonide intravitreal implants in clinical practice, in addition to paying attention to eye ADR/ADE such as high intraocular pressure, cataracts, and glaucoma, attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.
		                        		
		                        		
		                        		
		                        	
2.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
		                        		
		                        			
		                        			177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
		                        		
		                        		
		                        		
		                        	
3.Correlation between systemic immune-inflammation index and heart failure in elderly patients with hypertension and nursing guidance: an data analysis based on National Health and Nutrition Examination Survey
Lili DING ; Tingru LI ; Lijun QIAN ; Chaoxiong SHI ; Kai WANG ; Yansong LI ; Miao LU
Journal of Clinical Medicine in Practice 2024;28(6):118-123
		                        		
		                        			
		                        			Objective To explore the relationship of the systemic immune-inflammation index (SII) with heart failure incidence in elderly people with hypertension and its nursing implications. Methods According to the data of the National Health and Nutrition Examination Survey (NHANES) database from 1999 to 2010, a total of 5 607 hypertension patients aged 60 and above were screened out and divided into heart failure group with 437 cases and non-heart failure group with 5 170 cases. All the participants were divided into 
		                        		
		                        	
4.The role of mobile phone addiction and anxiety symptoms in the association between childhood psychological abuse and depressive symptoms among college students
Chinese Journal of School Health 2023;44(11):1665-1669
		                        		
		                        			Objective:
		                        			To explore the role of mobile phone addiction and anxiety symptoms in the relationship between childhood psychological abuse and depressive symptoms among college students, in order to provide a basis for mental health promotion.
		                        		
		                        			Methods:
		                        			From February to May 2023, a stratified random sampling method was used to select 1 799 freshmen to juniors from a university in Wuhu City, Anhui Province. The questionnaire survey was conducted using the 2-item Patient Health Questionnaire (PHQ-2), Child Psychological Maltreatment Scale (CPMS), Mobile Phone Addiction Tendency Scale (MPATS), 2-item General Anxiety Disorder (GAD-2). Correlations among each variable were analyzed, and the chain mediating effect of mobile phone addiction and anxiety symptoms was explored.
		                        		
		                        			Results:
		                        			The detection rate of depressive symptoms among college students was 9.7%, and the positive detection rate of childhood psychological abuse was 28.6%. Depressive symptoms were positively correlated with childhood psychological abuse, mobile phone addiction and anxiety symptoms ( r =0.28, 0.32, 0.27,  P <0.01). Childhood psychological abuse was positively correlated with mobile phone addiction and anxiety symptoms ( r =0.29, 0.71,  P <0.01). Mobile phone addiction and anxiety symptoms were positively correlated ( r =0.30,  P <0.01). Childhood psychological abuse could effectively predict depressiove symptoms, mobile phone addiction and anxiety symptoms ( β =0.08, 0.06, 0.66,  P <0.01). Mobile phone addiction and anxiety symptoms had a chain mediating effect between childhood psychological abuse and depression symptoms, with a total indirect mediating effect (effect=25.27%,  P <0.05), accounting for 72.44% of the total effect.
		                        		
		                        			Conclusions
		                        			Mobile phone addiction and anxiety symptoms play a chain mediating role between childhood psychological abuse and depressive symptoms. Focusing on childhood psychological abuse, mobile phone addiction and anxiety among college students are beneficial for depression symptoms prevention.
		                        		
		                        		
		                        		
		                        	
5.Effects of insulin aspart on the efficacy, ultrasound imaging indicators and maternal and infant outcome in patients with gestational diabetes mellitus
Qing XU ; Lijun KONG ; Miao CHEN
Chinese Journal of Postgraduates of Medicine 2021;44(5):451-456
		                        		
		                        			
		                        			Objective:To analyze the effect of insulin aspart on the islet cell secretion function, ultrasound imaging indicators and maternal and infant outcome in patients with gestational diabetes mellitus (GDM).Methods:The clinical data of 120 patients with GDM in Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University from February 2017 to July 2019 were retrospectively analyzed. Among them, 60 cases were treated with insulin aspart (observation group) and 60 cases were treated with biosynthetic human insulin (control group). The efficacy indexes, ultrasound imaging indexes and maternal and infant outcome were compared.Results:The 2 h postprandial blood glucose (2 h PBG) after breakfast on the third and fifth day of treatment in observation group was significantly lower than that in control group: (6.85 ± 0.87) mmol/L vs. (7.47 ± 1.35) mmol/L and (6.24 ± 0.59) mmol/L vs. (6.60 ± 0.87) mmol/L, and there was statistical difference ( P<0.01); there was no statistical difference in 2 h PBG after breakfast on the first day of treatment and after lunch and dinner on the first, third and fifth day of treatment between 2 groups ( P>0.05). The homeostasis model assessment-insulin resistance index (HOMA-IR) after treatment in observation group was significantly lower than that in control group (2.57 ± 0.25 vs. 3.00 ± 0.35), the homeostasis model assessment- β cell function index (HOMA-β) was significantly higher than that in control group (72.45 ± 12.33 vs. 63.66 ± 10.72), and there were statistical differences ( P<0.01). There were no statistical differences in pre-lunch blood glucose, pre-lunch initial insulin amount, pre-lunch final insulin amount and blood glucose target time between 2 groups ( P>0.05); the incidence of pre-meal hypoglycemia in observation group was significantly lower than that in control group: 8.33% (5/60) vs. 23.33% (14/60), and there was statistical difference ( P<0.05). The umbilical artery and renal artery resistance index (RI), maximum systolic blood flow velocity and end-diastolic blood flow velocity ratio (S/D) after treatment in observation group were significantly lower than those in control group (RI: 0.49 ± 0.16 vs. 0.59 ± 0.15 and 0.69 ± 0.17 vs. 0.76 ± 0.12; S/D: 2.09 ± 0.22 vs. 2.38 ± 0.26 and 5.17 ± 0.45 vs. 5.77 ± 0.63), and there were statistical differences ( P<0.01 or <0.05). There were no statistical differences in gestational age, delivery mode, neonatal body weight and the incidences of macrosomia, neonatal hypoglycemia and neonatal referral between 2 groups ( P>0.05). Conclusions:Insulin aspart can significantly improve the islet cell secretion function and ultrasound imaging indexes in the treatment of GDM, and can reduce the risk of pre-meal hypoglycemia, but the effect on maternal and infant outcome remains to be explored.
		                        		
		                        		
		                        		
		                        	
6.Mid-term efficacy of Dynesys dynamic internal fixation in the treatment of grade I degenerative lumbar spondylolisthesis
Lei MIAO ; Ning MA ; Haoning MA ; Xuanhuo WANG ; Lijun CAI ; Yinong WANG
Chinese Journal of Orthopaedics 2021;41(17):1227-1236
		                        		
		                        			
		                        			Objective:To investigate the mid-term efficacy of Dynesys internal fixation and posterior lumbar interbody fusion (PLIF) in the treatment of grade I degenerative lumbar spondylolisthesis.Methods:From June 2014 to June 2016, 68 cases, in which 35 males and 33 females aged from 44-74 (55.3±7.5), of grade I degenerative lumbar spondylolisthesis treated using Dynesys internal fixation were retrospectively analyzed. There were 8 cases of L 3, 52 cases of L 4 and 8 cases of L 5 with an average visual analogue scale (VAS) of 4.5±2.1. At the same time, 72 patients were treated with posterior lumbar interbody fusion (PLIF). There were 37 males and 35 females aged from 46-76 (56.8±7.2), with 9 cases of L 3, 53 cases of L 4 and 10 cases of L 5. The VAS of this group was 4.4±2.3. The operative time, intraoperative blood loss, postoperative drainage volume and complications were compared between the two groups. Range of motion (ROM), disc height of stable segment and upper adjacent segment, adjacent segment degeneration between the two groups were evaluated. ASD, Oswestry disability index (ODI) score and Japanese Orthopaedic Association (JOA) score were also compared between the two groups. Results:The patients in both groups were followed up. The follow-up time of Dynesys group was 50-74 months, average 64.2±18.3 months, and the follow-up time of PLIF group was 55-79 months, average 65.2±15.5 months. The operation time [(120.5±21.0) min vs. (132.5±27.0) min, t=2.924, P=0.004], intraoperative bleeding [(312.5±80.7) ml vs. (352.5±84.5) ml, t=2.861, P=0.005] and postoperative drainage [(120.3±45.8) ml vs. (140.2±50.2) ml; t=2.446, P=0.016] in Dynesys group were significantly better than those in PLIF group. The differences were statistically significant. There was no significant difference in postoperative ROM of stable segment, ROM of upper segment, disc height of stable segment and adjacent segment between the two groups before operation. At 5 years postoperatively, there was statistically significant difference between the stable segment ROM (4.3°±1.6° vs. 0; t=22.809; P<0.001) and the upper segment ROM (10.5°±2.1° vs. 12.8°±2.2°; t=6.329, P<0.001). At 5 years postoperatively, ODI scores of the two groups were (11.25%±8.12%, 16.53%±9.23%), and JOA scores were (22.60±2.20, 19.01±2.34), which were significantly improved compared with those before surgery, with statistically significant differences (ODI: t=3.585, P<0.001; JOA: t=9.340, P<0.001). There was no significant difference in the incidence of symptomatic ASD between the two groups (8.8% vs. 16.7%, χ2=1.284, P=0.257) , but there was significant difference in the incidence of X-ray ASD between the two groups (2.9% vs. 13.9%, χ2=4.043, P=0.044) . Conclusion:Compared with PLIF, Dynesys internal fixation for degenerative lumbar spondylolisthesis is a minimally invasive, safe and effective surgical method to retard ASD; Compared with PLIF, adjacent segment degeneration can be reduced using Dynesys internal fixation.
		                        		
		                        		
		                        		
		                        	
7.Security evaluation of exosome derived from human umbilical cord mesenchymal stem cells
Jun LUO ; Lijun DING ; Qiang ZHOU ; Yiwen HAN ; Wenling MIAO
International Journal of Laboratory Medicine 2017;38(24):3371-3373,3376
		                        		
		                        			
		                        			Objective To explore the security of exosome derived from human umbilical cord mesenchymal stem cell(huc-MSC-exosome)as a kind of biological product on clinical application.Methods huc-MSC-exosome were separated by ultea centrifuge. CD9 and CD63 expression of huc-MSC-exosome were tested by Western-blot.Nanoparticle analysis was used to detect the size and concentration of huc-MSC-exosome.Hemolytic experiment,systemic anaphylaxis and blood routine test were used to verify the self-safety of huc-MSC-exosome.Results huc-MSC-exosome expressed specific markers of exosome,CD9 and CD63.Moreover,huc-MSC-exosome cannot result in hemolysis,systemic anaphylaxis reaction and abnormality of blood routine test.Conclusion Exosome derived from human umbilical cord mesenchymal stem cell has general signs of exosomes and possesses the certainly security,which may provide the experimental evidence for huc-MSC-exosome clinical application.
		                        		
		                        		
		                        		
		                        	
8.The using status quo and analysis of POCT glucose meter
Miao WANG ; Ranyun ZHOU ; Xinglong YANG ; Wenxia CHEN ; Qingling GUO ; Lijun ZENG ; Qianlin YANG ; Fan JIA ; Xin WANG ; Haihan WU ; Shiping SONG
Chinese Journal of Laboratory Medicine 2016;39(8):643-645
		                        		
		                        			
		                        			Objective To investigate the problems during using, standard and quality management of the POCT glucose meters in hospital, to analyze the solutions, and to provide reference data for improving the test level of POCT in hospital.Methods The amount, brand and application of portable glucose meters in the hospital were obtained by 3 rounds of surveillance from May to July in 2013.All of those glucose meters were taken part in external quality assessment of Clinical Laboratory Center of National Health and Family Planning Commission.The test results of those glucose meters were compared with that of automatic biochemical analyzer, the comparison results were then analyzed.Results The POCT glucose meters possessed 5 brands in our hospital, and the amount and type of glucose meters in some clinical departments were often changed.When 4 brands which were detected as quality control samples by ministry of health, the accuracy of detection results of 3 concentration of brand Ⅲ were substandard, the CV% of two levels were 11.9%and 10.1%respectively, the remaining 3 brands were in line with the requirements.The qualified percentages of 3 times of comparison were 85.0%, 92.0%and 97.4%.Conclusions The hospital should select the brand of portable glucose meters reasonably, correct use of glucose meters, and it is very necessary to build indoor and interstitial quality evaluation system, at the same time, suggesting the hospital to establish the POCT quality management team, to carry out the instrument comparison periodically, so to guarantee the accurate, reliable results of POCT in hospital.
		                        		
		                        		
		                        		
		                        	
9.CT imaging and pathological features of maxillofacial malignant myoepithelioma
Ning CAI ; Yue DONG ; Fanrong CHENG ; Liang HU ; Lijun WANG ; Yanwei MIAO ; Ailian LIU
Journal of Practical Radiology 2016;32(7):1020-1022,1032
		                        		
		                        			
		                        			Objective To evaluate CT imaging and pathological features of maxillofacial malignant myoepithelioma (MME). Methods A total of eight patients with pathologically confirmed MME of the maxillofacial region were underwent non-enhanced and contrast-enhanced CT scans.CT features of the lesions were assessed as follows:location,number,shape,size,enhancement pattern and CT number on non-enhanced and contrast-enhanced scan.CT features were compared with the pathological results.Results All the lesions were unilateral,in which mixed type with clear cells and spindle cells in 5 cases,mixed type with epithelioid cells and plas-ma cells in 2 cases,and clear cell type in one case.8 cases were manifested as lobulated mass.On non-enhanced scan,the density of all the lesions were hetergeneous with cystic area,1 case with calcification and 2 cases with bone destruction.On the contrast-en-hanced CT,all the lesions were showed hetergeneously moderate or obvious enhancement,and cystic,line and crack areas without the enhancement were observed.Minor vessel and spiculate protuberance of marginal zone on the arterial phase were observed in most le-sions.Conclusion MME has different pathological subtypes and characteristic CT features.CT is an effective method to diagnose MME.
		                        		
		                        		
		                        		
		                        	
10.Curative effect of endoscopic push-radial dissection for patients with benign esophageal stricture (with video)
Kefeng HU ; Guoliang YE ; Yanping JIN ; Lihua GUO ; Lijun QIN ; Xinjun ZHANG ; Min MIAO ; Jinfeng WEN ; Tuo ZHENG ; Liqin XU
Chinese Journal of Digestive Endoscopy 2016;(1):37-39
		                        		
		                        			
		                        			Objective To evaluate the feasibility and efficacy of endoscopic push?radial dissection (EPRD)for benign esophageal stricture(BES). Methods Clinical data of 24 patients diagnosed as having BES who received EPRD were analyzed. The procedure and efficacy were evaluated. Results All 24 patients underwent EPRD successfully with mean operation time being 32 min(15?45 min).The mean esophageal stric?ture incision length was 3?? 2 cm (1?? 0?8?? 0 cm).No severe complications related to EPRD occurred, or trans?ferred for surgery. Patients were followed up for 1?5 months (mean 2?? 8 months). Dysphagia was relieved signif?icantly during the follow?up in 23 patients where endoscopy could go through smoothly. But dysphagia re?oc?curred in one patient 2 weeks after the operation, who underwent a second EPRD and stent implantation, then dysphagia was relieved. Conclusion EPRD is safe, feasible and effective for benign esophageal stricture.
		                        		
		                        		
		                        		
		                        	
            

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