1.Application of Quality Evaluation of Blind Method in Clinical Trials of Traditional Chinese Medicine
Zeyang SHI ; Yuan SUN ; Wenxin MA ; Yuyi WANG ; Zhijun BU ; Xuehui WANG ; Youyou ZHENG ; Jianping LIU ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(3):75-80
		                        		
		                        			
		                        			The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years, randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine (TCM), but the quality of the implementation of blind methods is uneven, and the evaluation criteria have not yet been formed. In this paper, the data collection methods, calculation principles, advantages, and disadvantages of two quantitative quality evaluation methods of blind methods, namely James Blinding Index (JBI) and Bang Blinding Index (BBI), were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time, a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally, the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials. 
		                        		
		                        		
		                        		
		                        	
2.Trends in the distribution of Oncomelania hupensis in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023
Qi MAO ; Caiying SUN ; Anqi LI ; Weiwei LU ; Xihong LÜ ; Xuehui LU ; Yanjun JIN ; Qing YU
Chinese Journal of Schistosomiasis Control 2024;36(2):165-168
		                        		
		                        			
		                        			 Objective To investigate the changes in distribution of Oncomelania hupensis snails in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023, so as to provide insights into formulation of O. hupensis snail surveillance programs. Methods The reports on O. hupensis snail surveillance in Songjiang District, Shanghai Municipality from 2009 to 2023 were collected, and the snail surveillance data in forestlands were extracted. The trends in the proportion of areas with snails in forestlands in total areas with snails, occurrence of frames with living snails and density of living snails were evaluated using a Joinpoint regression model in Songjiang District from 2009 to 2023, and the annual percent change (APC) and average annual percent change (AAPC). Results A total of 40 sites with snails were found in forestlands in 14 administrative villages of 4 townships, Songjiang District, Shanghai Municipality from 2009 to 2023. A total of 39 065 frames were surveyed for snails in settings covering an area of 609 600 m2, and there were 6 084 frames with snails, covering 151 250 m2 snail habitats. A total of 22 210 snails were captured, with the highest density of 260.00 snails/0.1 m2, and 6 262 snails were dissected, with no Schistosoma japonicum infection identified in snails. The proportion of areas with snails in forestlands in total areas with snails appeared a tendency towards a rise in forestlands in Songjiang District, Shanghai Municipality from 2009 to 2023 (APC = AAPC = 24.9%, P > 0.05); however, there were no turning points in the trend curve, with the highest proportion seen in 2009 (53.81%), the lowest in 2011 and 2023 (both 0) and a mean proportion of 24.81%. The occurrence of frames with living snails appeared a tendency towards a rise from 2009 to 2023 (APC = AAPC = 41.5%, P > 0.05); however, there were no turning points in the trend curve, with the highest occurrence in 2009 (53.81%), the lowest in 2011 and 2013 (both 0), and the mean occurrence of 15.57%. In addition, the density of living snails appeared a tendency towards a rise from 2009 to 2023 (APC = AAPC = 55.0%, P > 0.05); however, there were no turning points in the trend curve, with the highest density in 2023 (0.96 snails/0.1 m2), the lowest in 2011 and 2013 (both 0), and a mean density of 0.57 snails/0.1 m2. Conclusions The difficulty in O. hupensis snail control and risk of imported snails appeared a tendency towards a rise in forestlands in Songjiang District, Shanghai Municipality over years from 2009 to 2023. Supervision and assessment prior to seedling transplantation and intensified surveillance post-transplantation are recommended to reduce the risk of O. hupensis snail importation and spread. 
		                        		
		                        		
		                        		
		                        	
3.Surveillance and trend analysis of snails in Songjiang District of Shanghai from 2007 to 2023
Qi MAO ; Caiying SUN ; Anqi LI ; Weiwei LU ; Xihong LYU ; Xuehui LU ; Yanjun JIN ; Qing YU
Shanghai Journal of Preventive Medicine 2024;36(5):444-447
		                        		
		                        			
		                        			ObjectiveTo analyze the monitoring results and trends of Oncomelania in Songjiang District of Shanghai from 2007 to 2023, and to provide reference for future monitoring work. MethodsThe data of snail monitoring in Songjiang District from 2007 to 2023 were collected, including the location of snail spots, the number of survey frames, the area with snails, the number of frames with snails, the total number of snails, etc. The density of living snails and the occurrence rate of living snail frames were calculated. ResultsFrom 2007 to 2023, a total of 158 snail spots were found in 22 administrative villages in 4 towns in Songjiang District, including 131 emerging snail habitats (82.91%) and 27 reemerging snail habitats (17.09%). The total snail area was 175 980 m2, the number of snail frames was 10 061, and 33 302 snails were captured. The highest density was 260/0.11 m2, and 15 662 snails were dissected. No positive snails were found. The average density of living snails was 0.60/0.11 m2 and the average occurrence rate of living snail frames was 17.99%. The snail areas in different areas were Yexie Town 126 000 m2 (71.60%), Maogang Town 26 470 m2 (15.04%), Xinbang Town 17 040 m2 (9.68%), and Shihudang Town 6 470 m2 (3.68%). The average density of living snails in different areas was 0.89/0.11 m2 in Yexie Town, 0.65/0.11 m2 in Maogang Town, 0.26/0.11 m2 in Shihudang Town and 0.24/0.11 m2 in Xinbang Town. The snail areas of different snail habitats were as follows: woodland 151 250 m2(85.95%), river 13 810 m2(7.85%), ditch 6 910 m2(3.93%), farmland 4 010 m2(2.28%). The average density of living snails in different snail habitats: ditch 1.01/0.11 m2, beach 0.86/0.11 m2, woodland 0.57/0.11 m2, river 0.40/0.11 m2. The occurrence rate of living snail frames in different regions and different snail environment types showed a downward trend and the difference was statistically significant. ConclusionAlthough the snail monitoring indicators such as snail area, average living snail density and average living snail frame occurrence rate in Songjiang District are still at its historically low level, the average living snail density and average living snail frame occurrence rate are still high compared with other regions or the national average. We should focus on the upper reaches and tributaries of the Huangpu River, especially the key areas of seedling transplantation, and strengthen monitoring and supervision to reduce the risk of snail input. 
		                        		
		                        		
		                        		
		                        	
4.CD9 + CD55 low adipose progenitor cells contribute to the development of type 2 diabetes
Hongdong WANG ; Yanhua DU ; Shanshan HUANG ; Xitai SUN ; Haixiang SUN ; Xuehui CHU ; Lei SHEN ; Yan BI
Chinese Journal of Endocrinology and Metabolism 2024;40(10):830-834
		                        		
		                        			
		                        			Adipose progenitor cells(APCs) represent a prominent stromal cellular component of adipose tissue and are now identified as highly heterogenous populations. However, the role of APCs in regulating systemic metabolism remains unknown. Using single cell RNA-sequencing, we investigated the role of the APC subpopulations in regulating development of type 2 diabetes. CD9 + CD55 low APCs are the novel subset identified in this study, which is significantly increased in type 2 diabetic patients. Transplantation of these cells from type 2 diabetic patients into adipose tissue caused glycemic disturbance in mice. Depletion of pathogenic APCs improved obesity-related glycemic disturbance. Collectively, our data provide deeper insights into human APC functionality and highlights APCs as a potential therapeutic target to combat type 2 diabetes. This study has been published in Nature Communications, 2024, 15(1): 4827.
		                        		
		                        		
		                        		
		                        	
5.Clinical efficacy of laparoscopic sleeve gastrectomy in obese adolescents
Xiaodong SHAN ; Saisai ZHU ; Yu YAN ; Xuehui CHU ; Xitai SUN
Chinese Journal of Digestive Surgery 2022;21(12):1567-1572
		                        		
		                        			
		                        			Objective:To investigate the clinical efficacy of laparoscopic sleeve gastrectomy in obese adolescents.Methods:The retrospective and descriptive study was conducted. The clinical data of 37 obese adolescents who were admitted to Drum Tower Hospital Affiliated to Nanjing University Medical School between July 2016 and August 2020 were collected. There were 18 males and 19 females, aged 18(range, 13?19)years. All patients underwent laparoscopic sleeve gastrec-tomy. Observation indicators: (1) surgical and postoperative situations; (2) follow-up. The patients were followed up by outpatient review to detect body weight, blood glucose, blood lipid, blood pressure, nutrition situation and related complications at 3, 6 and 12 months after operation. The follow-up was up to August 2021. Measurement data with normal distribution were represented as Mean± SD. Repeated measurement data were analyzed by Repeated Measures Anova. Measurement data with skewed distribution were represented by M(range). Count data were expressed as absolute numbers or percentages. Results:(1) Surgical and postoperative situations. All 37 patients under-went laparoscopic sleeve gastrectomy successfully, the operative time was (50±7)minutes, the volume of intraoperative blood loss was (53±17)mL, and the duration of postoperative hospital stay was (3.0±0.5)days. Of the 37 patients, 2 cases had puncture infection. There was no complication such as bleeding occurred. (2) Follow-up. Of the 37 patients, 35, 31 and 22 cases were followed up at postoperative 3, 6 and 12 months, respectively. There was no anemia, malnutrition, trace element deficiency or other nutrition-related complications during the follow-up, and there was no death. The body mass, body mass index, homeostasis model assessment-insulin resistance, triglyceride, total cholesterol, systolic pressure, diastolic pressure, vitamin D, folate of the 37 patients were (117±19)kg, (40±5)kg/m 2, 6.59(range, 2.84?28.02), (1.6±0.7)mmol/L, (4.5±0.7)mmol/L, (141±22)mmHg (1 mmHg=0.133 kpa), (84±18)mmHg,(14±5)μg/L, (10±5)μg/L before the surgery, and (81±15)kg, (27±4)kg/m 2, 2.69(range, 1.08?9.71), (0.9±0.5)mmol/L, (4.5±0.7)mmol/L, (115±15)mmHg, (70±11)mmHg, (23±10)μg/L, (9±5)μg/L at postoperative 12 months. There were significant differences in the time effect of above indicators ( Ftime=214.14, 160.37, 12.66, 11.77, 2.90, 18.08, 11.32, 8.61, 5.04, P<0.05). The percentages of excess of body mass index lost of the 37 patients were 48%±19%, 77%±28% and 89%±24% at postoperative 3, 6 and 12 months, the percentages of excess weight loss were 42%±13%, 63%±17% and 75%±18%, the percentages of total body weight loss were 18%±5%, 26%±6% and 34%±7%, respectively. There were significant differences in the time effect of above indicators ( Ftime=83.96, 107.24, 109.06, P<0.05). The hemoglobin A1c was 4.8%, 5.0%, 5.1% and 4.9%, 5.2%, 5.2% in the 2 patients with type 2 diabetes at postoperative 3, 6 and 12 months, respectively, and they were relieved without drug treatment. Conclusion:Laparoscopic sleeve gastrectomy has definite short-term clinical efficacy in the treatment of adolescent obesity, which can effectively reduce excess body weight and improve the metabolic complications of insulin resis-tance, dyslipidemia and hypertension.
		                        		
		                        		
		                        		
		                        	
6.Preparation and Quality Evaluation of Imperatorin Ultradeformable Liposomes Gel
Xuehui CUI ; Shihong CHEN ; Jindi QIU ; Junfeng BAN ; Nannan YANG ; Qingchun NI ; Zhaoyan PAN ; Qingchun XIE ; Yanzhong CHEN ; Zhufen LYU
China Pharmacy 2020;31(9):1074-1079
		                        		
		                        			
		                        			OBJECTIVE:To prepare Imperatorin ultradeformable liposomes gel (IMP-UDLs-Gel),and to evaluate its quality. METHODS:Based on single factor test ,using 12 h accumulative penetration amount (Q12h)as evaluation index ,the proportion of carbomer 940,glycerol and propyl glycol in formulation of IMP-UDLs-Gel were investigated by orthogonal test. The optimal formulation was screened. The quality of IMP-UDLs-Gel prepared with the optimal formulation was evaluated. RESULTS :The optimal formulation of IMP-UDLs-Gel included carbomer 940 proportion of 1%,glycerol proportion of 15% and propyl glycol proportion of 10%. Q12 h of IMP-UDLs-Gel was (11.543±0.241)μg/cm2;the appearance was milky white and translucent ;the particle size was (93.13±1.68)nm,PDI was 0.268±0.012,Zeta potential was (-24.96±1.99)mV;pH was 7.32±0.03; viscosity was (45.37±1.27)g·s;steady flow was (0.727±0.002)μg·h/cm2,lag time was (4.358±0.175)h,apparent permeability coefficient was 1.392×10-3 cm/h,and it has good physical and optical stability. CONCLUSIONS :The preparation method is stable and feasible ,and the prepared IMP-UDLs-Gel has good adhesion ,stability and transdermal property.
		                        		
		                        		
		                        		
		                        	
7.Analysis of fluoride level in tea leachate from Shijiazhuang City from 2017 to 2019
Wenxiu HU ; Huan ZHANG ; Jinsa ZHOU ; Xuehui LIU ; Feifei GUO ; Suju SUN
Chinese Journal of Endemiology 2020;39(12):901-905
		                        		
		                        			
		                        			Objective:To understand the content of fluorine in tea leachate in Shijiazhuang City.Methods:From 2017 to 2019, different varieties of tea (including 7 varieties of green tea, scented tea, dark tea, oolong tea, black tea, white tea, and yellow tea) with high sales volume were purchased at the Shijiazhuang Tea Market. The fluoride content in tea was determined by fluoride ion selective electrode method through different soaking time (5, 10, 15, 20 min) and soaking times (1, 2, 3 times).Results:A total of 82 tea samples were detected, including 25 kinds of green tea (30.49%), 5 kinds of scented tea (6.10%), 11 kinds of dark tea (13.41%), 17 kinds of oolong tea (20.73%), 15 kinds of black tea (18.29%), 7 kinds of white tea (8.54%) and 2 kinds of yellow tea (2.44%). After soaking for 20 min, the fluorine contents in tea leachate of green tea, oolong tea, black tea, and dark tea (40.63, 65.43, 26.39, 58.90 mg/kg) were significantly higher than those in 5 min(23.09, 32.24, 15.77, 32.00 mg/kg, P < 0.05). Taking the fluorine content of the tea leachate soaking for 20 min as the total fluorine content, oolong tea was the highest, with a median of 65.43 mg/kg; black tea was the lowest, with a median of 26.39 mg/kg; The fluorine contents of oolong tea, dark tea and scented tea were significantly higher than that of black tea( P < 0.05). With the increase of soaking times of green tea, oolong tea, black tea, dark tea and white tea, the fluorine contents in tea leachate decreased significantly ( P < 0.05). Conclusions:In this study, the content of fluorine in the oolong tea is the highest, and the lowest is black tea. It is suggested that local residents in Shijiazhuang should drink black tea.
		                        		
		                        		
		                        		
		                        	
8.Efficacy and complications of intravesical instillation of BCG for prevention of recurrence of moderate and high-risk non muscle invasive bladder cancer
Weibing SUN ; Zhiyu LIU ; Quanlin LI ; Xishuang SONG ; Xiangbo KONG ; Chunxi WANG ; Qifu ZHANG ; Qingguo ZHU ; Changfu LI ; Wanhai XU ; Guanghai YU ; Cheng ZHANG ; Jinyi YANG ; Tianjia SONG ; Jiye ZHAO ; Qizhong FU ; Lixin WANG ; Quanzhong DING ; Xuehui CAI ; Chuize KONG
Chinese Journal of Urology 2019;40(1):14-19
		                        		
		                        			
		                        			Objective To assess the efficacy and side effects of intravesical instillation of BCG after transurethral resection of the bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC) patients.Methods The clinical data of patients treated with BCG 120 mg per course induced perfusion or more after TURBT from December 2013 to October 2016 in 18 hospitals of northeast China region,were analyzed retrospectively.The first part,data of 106 patients with moderate,high-risk NMIBC were collected.A total of 83 patients were male,while the other 23 patients were female.The average age was 66.7 years old.The clinical staging were T1 in 86(81.1%) cases,Ta in 20(18.9%) cases and carcinoma in situ in 6 (5.7%) patients.Intravesical instillation of BCG was executed after transurethral resection of the bladder tumor.The incidence rate of recurrence and progression during more than 6 months' follow-up time were observed.Multivariate analyses were done by using logistic analysis and Cox proportional hazards regression model with Kaplan-Meier method.The second part,treatment compliance of 276 patients with bladder cancer,including moderate/high-risk NMIBC in 263 cases,moderate/high-risk NMIBC followed with renal pelvis/ureteral carcinoma in 8 cases were and moderate/high-risk NMIBC with renal pelvis/ureteral carcinoma in 5 cases who treated with BCG after the surgeries,were observed.Patients consisted of 211 males and 65 females with average age of 68.3 years.Results With a median follow-up of 12 months,9 (8.5%) patients experienced tumor recurrence and 2 (1.9%) patients were found progression in the first part.The one-year cancer free recurrence rate of the patients was 91.5%.Statistically significant prognostic factors for recurrence identified by multivariable analyses were prior recurrence of the tumors (OR =3.214,95%CI0.804-12.845,P =0.099).In the second port,an incidence rate of adverse effects was 64.1% (177/276).The Ⅲ/Ⅳ degree complications were occurred in 11 patients and satisfactory outcomes achieved with active treatment.A total of 36 patients withdrawal with the major causes were recurrence and progression of bladder tumor in 12 cases (4.4 %),9 cases (3.3 %) with economic reasons and 11 cases (4.0%) with serious complications.Conclusions NMIBC patients treated with intravesical BCG therapy have approving cancer free recurrence rates and acceptable adverse effects.Prior recurrence may be prognostic factor of recurrence after intravesical BCG therapy.
		                        		
		                        		
		                        		
		                        	
9.Analysis of risk factors for spontaneous intestinal perforation in extremely premature infants/extremely low birth weight infants
Zhifeng HUANG ; Shan JIANG ; Panpan SUN ; Xueyu CHEN ; Xuehui ZHENG ; Yanliang YU ; Chun CHEN ; Qiuting LU ; Bingchun LIN ; Chuanzhong YANG
Chinese Journal of Neonatology 2019;34(5):358-362
		                        		
		                        			
		                        			Objective To analyse the risk factors associated with spontaneous intestinal perforation (SIP) in extremely premature infants/extremely low birth weight infants. Method From January 2015 to December 2018, infants with gestational age (GA)<28 weeks or birth weight (BW)<1000 g admitted to our neonatal intensive care unit were enrolled to the retrospective nested case-control study.The clinical data of SIP infants (SIP group) and infants with the same GA but without SIP (control group) were randomly selected and compared. Multivariable Logistic regression was used to analyse the risk factors of SIP. Result A total of 409 extremely premature infants/extremely low birth weight infants were born during the study period. Among them, 25 SIP infants and 55 controls were enrolled. The incidence of SIP in infants with GA 22~25 weeks was 11.8%(16/136), which is higher than infants with GA 26~27 weeks (2.0%, 5/247) (χ2=16.057, P<0.001). The incidence of SIP in infants with BW 400~749 g was 13.0%(14/108), which is higher than infants with BW 750~999 g (3.4%, 8/236) (χ2=11.343, P=0.001). Multivariate Logistic regression analysis showed that twins (OR=4.153, 95%CI 1.392~12.384, P=0.011), umbilical veins catheterization (OR=15.942, 95%CI 1.026~247.789, P=0.048) and ibuprofen use within 3 days after birth (OR=15.387, 95%CI 1.519~155.883, P=0.021) were independent risk factors of SIP. Conclusion The smaller the GA and BW, the higher the incidence of SIP. Twins,umbilical veins catheterization and ibuprofen use early after birth may be independent risk factors of SIP.
		                        		
		                        		
		                        		
		                        	
10.Relationship between CYP2C19 gene polymorphism and clopidogrel resistance after PCI in patients with coronary heart disease/
Yanhua LI ; Xuehui YU ; Liangchen HU ; Hongbo HUO ; Long ZHANG ; Weiwei SUN ; Wenzheng BAI
Chinese Journal of cardiovascular Rehabilitation Medicine 2019;28(1):13-16
		                        		
		                        			
		                        			Objective :To explore influence of CYP2C19 gene polymorphism on clopidogrel resistance after percutane‐ous coronary intervention (PCI) in patients with coronary heart disease (CHD).Methods :A total of 100 CHD pa‐tients ,who were treated and received PCI in our hospital ,were selected .There were 24 cases with clopidogrel re‐sistance (CR ,CR group) and 76 cases without CR (NCR ,NCR group).According to CYP2C19 genotype ,patients were divided into rapid metabolism CYP2C19*1/*1 (n=49) ,medium metabolism CYP2C19*1/*2 (n=28) and*1/*3 (n=11) ,and slow metabolism CYP2C19*2/*2 (n=9) and *2/*3 (n=3).Relationship among differ‐ent genotypes ,CR ,maximum platelet aggregation rate (MPA) and incidence of major adverse cardiovascular events (MACE) were analyzed .Results :With rapid metabolism CYP2C19*1/*1 as the base ,there was significant rise in CR risk in medium metabolism (CYP2C19*1/*2 and *1/*3 ,OR=4. 16 ,5. 03 , P<0.05 both) and slow metab‐olism (CYP2C19*2/*2 and *2/*3 ,OR=7.04 ,17. 6 , P<0.01 both ) ,medium metabolism increased by 4. 16 and 5. 03 times respectively ,while slow metabolism increased by 7. 04 and 17. 60 times respectively .Compared with rapid metabolism genotype ,there were significant rise in MPA and incidence rate of MACE in medium and slow me‐tabolism genotypes , P<0.05 or <0. 01 ;incidence rate of MACE in CR group was significantly higher than that of NCR group (20. 8% vs.5. 3%, P=0.02).Conclusion : CYP2C19 gene polymorphism possesses certain influence on CR after PCI in CHD patients .Those with medium or slow metabolism genotypes are more likely to suffer from CR ,higher MPA and incidence rate of MACE .
		                        		
		                        		
		                        		
		                        	
            
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