1.Study on the modeling method of general model of Yaobitong capsule intermediates quality analysis based on near infrared spectroscopy
Le-ting SI ; Xin ZHANG ; Yong-chao ZHANG ; Jiang-yan ZHANG ; Jun WANG ; Yong CHEN ; Xue-song LIU ; Yong-jiang WU
Acta Pharmaceutica Sinica 2025;60(2):471-478
		                        		
		                        			
		                        			 The general models for intermediates quality analysis in the production process of Yaobitong capsule were established by near infrared spectroscopy (NIRS) combined with chemometrics, realizing the rapid determination of notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, ginsenoside Rd and moisture. The spray-dried fine powder and total mixed granule were selected as research objects. The contents of five saponins were determined by high performance liquid chromatography and the moisture content was determined by drying method. The measured contents were used as reference values. Meanwhile, NIR spectra were collected. After removing abnormal samples by Monte Carlo cross validation (MCCV), Monte Carlo uninformative variables elimination (MC-UVE) and competitive adaptive reweighted sampling (CARS) were used to select feature variables respectively. Based on the feature variables, quantitative models were established by partial least squares regression (PLSR), extreme learning machine (ELM) and ant lion optimization least squares support vector machine (ALO-LSSVM). The results showed that CARS-ALO-LSSVM model had the optimum effect. The correlation coefficients of the six index components were greater than 0.93, and the relative standard errors were controlled within 6%. ALO-LSSVM was more suitable for a large number of samples with rich information, and the prediction effect and stability of the model were significantly improved. The general models with good predicting effect can be used for the rapid quality determination of Yaobitong capsule intermediates. 
		                        		
		                        		
		                        		
		                        	
2.Investigation and determination of relative correction factor of pre-vitamin D
Jieming SHI ; Cheng WANG ; Liwen ZHANG ; Shunling DONG ; Jian LE ; Song YUAN ; Yihong LU ; Dandan WANG ; Wankui XU ; Shufeng ZHENG
Drug Standards of China 2024;25(2):147-153
		                        		
		                        			
		                        			Objective:To determine the relative correction factor of pre-vitamin D and simplify the calculation method of vitamin D assay.Methods:By studying the calculation method of vitamin D content in drug standards of various countries,HPLC was used to determine the relative correction factor of pre-vitamin D,and the influencing factors of determination were investigated.Results:The relative correction factors of pre-vitamin D at 254 nm and 265nm wavelength were determined by statistical analysis of 7 laboratories in China.Conclusion:Using the pre-vi-tamin D relative correction factor method to calculate the total amount of vitamin D simplified the experimental steps can be simplified by the pre-vitamin D relative correction factor method to calculate the total amount of vitamin D and the random operating errors can be avoided.The method is rapid and accurate,and lay a solid foundation for further improving the standard of vitamin D preparations.
		                        		
		                        		
		                        		
		                        	
3.18F-FDG PET/CT manifestations of vertebral aggressive hemangioma
Le SONG ; Hui LI ; Weifang ZHANG
Chinese Journal of Medical Imaging Technology 2024;40(9):1400-1404
		                        		
		                        			
		                        			Objective To observe 18F-FDG PET/CT manifestations of vertebral aggressive hemangioma.Methods Totally 24 patients with vertebral aggressive hemangioma were retrospectively enrolled,including 6 cases with lesions in cervical vertebrae,14 cases in thoracic vertebrae and 4 cases in lumbar vertebrae.18F-FDG PET/CT characteristics of lesions were observed,and the maximum standard uptake value(SUVmax)of lesions were compared among lesions with different CT performances.Results Among 24 cases,the lesion limited in vertebral body in 5 cases(5/24,20.83%)but affected vertebral body and appendages in 19 cases(19/24,79.17%).Accompanied vertebral osteolytic destruction and internal residual bone were noticed in 10 cases(10/24,41.67%),simple osteolytic destruction was found in 6 cases(6/24,25.00%),thickened and sparse trabeculae was observed in 4 cases(4/24,16.67%),while 4 cases(4/24,16.67%)without significant bone abnormalities.Compared to adjacent non diseased vertebrae,the radioactive uptake of lesions increased in 12 cases(12/24,50.00%),approached in 9 cases(9/24,37.50%)and decreased in 3 cases(3/24,12.50%).Uniform distribution of radioactivity was noticed in 14 cases(14/24,58.33%),while uneven distribution of radioactivity was found in 10 cases(10/24,41.67%).No significant difference of SUVmax was found between hemangioma lesions(2.50[1.53,4.13])and liver tissue(2.79±0.53)(Z=0.261,P=0.794).SUVmax of lesions with cortical bone destruction was higher than that of those without destruction(P<0.05),of those with fractures was higher than lesions without fractures(P<0.05).Conclusion Vertebral aggressive hemangioma had diverse CT manifestations,with 18F-FDG metabolism similar to liver.Vertebral aggressive hemangioma with cortical bone destruction and fractures had higher metabolism.
		                        		
		                        		
		                        		
		                        	
4.Single-center study of combined application of ExoSeal vascular closure device after two ProGlide sutures failed in transcatheter aortic valve replacement
Shuo WANG ; Qing-Hou ZHENG ; Hong-Song ZHANG ; Le WANG ; Jie MI ; Liu LI
Chinese Journal of Interventional Cardiology 2024;32(6):338-342
		                        		
		                        			
		                        			Objective This study was to evaluate the application effect of ExoSeal vascular closure device in patients with failed ProGlide suturing after transcatheter aortic valve replacement.Methods Retrospective analysis of 35 patients who underwent TAVR surgery at the Heart Center of the First Hospital of Hebei Medical University from May 2020 to January 2024 and experienced failure in suturing with two ProGlide sutures,and subsequently underwent combined application of the ExoSeal vascular closure device.The efficacy of the ExoSeal vascular closure device was summarized,and the patients'postoperative hemostasis time,manual compression time,lower limb immobilization time,elastic bandage compression time,bleeding volume during compression,postoperative femoral artery complications,and femoral artery ultrasound were observed.The efficacy of the ExoSeal vascular closure device in patients undergoing transcatheter aortic valve replacement was evaluated through the above indicators.Results(1)Postoperative Hemostatic Effect:The time for postoperative hemostasis through the femoral artery was(6.89±2.66)min,the manual compression time was(4.65±1.33)min,the elastic bandage compression time was(3.79±1.57)h,the lower limb immobilization time was(13.74±5.51)h,and the amount of bleeding during compression was(12.74±3.61)g.(2)Complications of the femoral artery:The success rate of hemostasis was 85.7%;there were 4 cases of local bleeding and hematoma requiring hemostasis(11.4%);there was 1 case of pseudoaneurysm,arteriovenous fistula,vascular laceration or retroperitoneal bleeding(2.8%);there were no ipsilateral vascular insufficiency or embolic manifestations,puncture site infection,related nerve injury,surgical or non-surgical techniques for repairing blood vessels.(3)Preoperative and postoperative ultrasound of the femoral artery:There was no significant difference in the average diameter of the common femoral artery and the peak systolic flow velocity of the common femoral artery(both P>0.05).Conclusions The application of the ExoSeal vascular closure device in patients with failed ProGlide suturing during transcatheter aortic valve replacement is safe and effective.
		                        		
		                        		
		                        		
		                        	
5.Distribution of resistance genes and virulence genes in multidrug-resistant Salmonella typhimurium strains
Yufeng ZHANG ; He SONG ; Le YAN ; Pengfei XU ; Ruiqing LIU ; Tiantian TANG ; Xiaoyan WANG ; Huiling DENG ; Kairui LEI
Chinese Pediatric Emergency Medicine 2024;31(11):831-835
		                        		
		                        			
		                        			Objective:To study the distribution of drug resistance genes and virulence genes in multidrug-resistant Salmonella typhimurium strains.Methods:A total of 96 strains of Salmonella typhimurium were collected,and drug sensitivity tests were performed to evaluate the drug resistance and multidrug-resistance of Salmonella typhimurium.Multidrug-resistant Salmonella typhimurium strains were selected to conducted whole genome sequencing,and the distribution of drug resistance genes and virulence genes in the strain were analyzed.Results:Salmonella typhimurium strains had the highest resistance rates to ampicillin and ampicillin/sulbactam,with 89.58% and 76.04%,respectively.Followed by trimethoprim/sulfamethoxazole,ceftriaxone,and aztreonam,with 47.92%,38.54% and 33.33%,respectively,and low resistance rates to ciprofloxacin and levofloxacin,with 8.33% and 4.17%,respectively.Ninety-six strains were all sensitive to carbapenem antibiotics and piperacillin/tazobactam.Fifty-seven strains(59.38%)of Salmonella typhimurium showed multidrug-resistance.Resistance genes were detected in all 57 multidrug-resistant Salmonella typhimurium strains,with higher carrier rates of 98.25%,77.19%,and 59.65% for aac(6')-Iaa,aadA22,and blaTEM-1B,respectively.The multidrug-resistant Salmonella typhimurium strains had the highest carrier rates for invA,sipA,sseL,and sopB.Conclusion:Multidrug-resistant Salmonella typhimurium strains have a high incidence and a high carrier rate for multiple drug resistance genes and virulence genes.The monitoring and prevention of Salmonella typhimurium should be strengthened in the clinic in order to reduce the spreading epidemic of multidrug-resistant strains.
		                        		
		                        		
		                        		
		                        	
6.Clinical application of four-hook needle combined with holographic image in robot-assisted partial nephrectomy for completely intrarenal tumors
Qiubo XIE ; Yu ZHOU ; Lei GAO ; Zhong TU ; Jian SONG ; Renhao WANG ; Xiang LI ; Guan ZHANG ; Le ZHANG ; Tiejun PAN
Chinese Journal of Urology 2024;45(5):343-347
		                        		
		                        			
		                        			Objective:To investigate the safety and efficacy of four-hook needle combined with holographic image in robot-assisted partial nephrectomy for completely intrarenal tumors.Methods:The clinical data of 8 patients with completely intrarenal tumors treated by robot-assisted partial nephrectomy with four-hook needle combined with holographic image admitted to General Hospital of Central Theater Command from October 2023 to December 2023 were retrospectively analyzed. There were 6 males and 2 females, with average age of (44.5±12.0) years old. Tumors of 6 cases were in the left side and 2 cases in the right side. The maximum diameter of the tumor was (23.2±8.1) mm. The R. E.N.A.L. score was (9.0±1.4). The preoperative serum creatinine (Scr) was (73.1±14.7) μmol/L. CT-guided four-hook needle was used to locate the edge of completely intrarenal tumor before surgery. During the operation, the tumor was precisely resected under the guidance of hologram and four-hook needle. Perioperative data of patients were collected and analyzed.Results:All the tumor were successfully resected under the guidance of four-hook needle and hologram without conversion to radical nephrectomy or open surgery. The mean operative time was (117.0±14.5) min, the mean hot ischemia time was (20.2±5.1) min, the mean intraoperative blood loss was (75.0±17.3) ml, and the average hospitalization time was (9.5±1.3) days.The one week postoperative Scr was (73.2±14.8) μmol/L, which had no significant difference with that of before operation ( P=0.952). None of them received blood transfusion. The pathology results of 8 patients were clear cell renal cell carcinoma, and the surgical margins were negative. Conclusions:For completely intrarenal tumors, the four-hook needle combined with the hologram can guide the surgeon to quickly locate the tumor, accurately resect the tumor, reduce perioperative complications, and is safe and effective.
		                        		
		                        		
		                        		
		                        	
7.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
		                        		
		                        			
		                        			Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
		                        		
		                        		
		                        		
		                        			Pregnancy
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		                        			Child
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		                        			Humans
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		                        			Female
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		                        			Glycated Hemoglobin
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		                        			Cohort Studies
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		                        			Diabetes Mellitus/diagnosis*
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		                        			Sensitivity and Specificity
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		                        			ROC Curve
		                        			
		                        		
		                        	
8.Anatomical study and clinical application of endoscopic transoral lateral skull base surgery.
Huan Kang ZHANG ; Jing LI ; Xiao Wen JIANG ; Shuai LI ; Kai XUE ; Xi Cai SUN ; Quan LIU ; Ye GU ; Wan Peng LI ; Xiao Le SONG ; Hong Meng YU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(5):521-527
9.The characteristics and correlations of vaginal flora in women with cervical lesions.
Ming Xuan ZHANG ; Jia Hao WANG ; Le ZHANG ; Jia Xin YAN ; Cai Hong WU ; Rui Xin PEI ; Yuan Jing LYU ; Li SONG ; Meng CUI ; Ling DING ; Zhi Lian WANG ; Jin Tao WANG
Chinese Journal of Oncology 2023;45(3):253-258
		                        		
		                        			
		                        			Objective: To explore the characteristics and correlations of vaginal flora in women with cervical lesions. Methods: A total of 132 women, including 41 women diagnosed with normal cervical (NC), 39 patients with low-grade cervical intraepithelial neoplasia (CIN 1), 37 patients with high-grade cervical intraepithelial neoplasia (CIN 2/3) and 15 patients with cervical squamous cell carcinoma (SCC), who came from the gynecological clinic of Second Hospital of Shanxi Medical University during January 2018 to June 2018, were enrolled in this study according to the inclusive and exclusive criteria strictly. The vaginal flora was detected by 16S rDNA sequencing technology. Co-occurrence network analysis was used to investigate the Spearman correlations between different genera of bacteria. Results: The dominant bacteria in NC, CIN 1 and CIN 2/3 groups were Lactobacillus [constituent ratios 79.4% (1 869 598/2 354 098), 63.6% (1 536 466/2 415 100) and 58.3% (1 342 896/2 301 536), respectively], while Peptophilus [20.4% (246 072/1 205 154) ] was the dominant bacteria in SCC group. With the aggravation of cervical lesions, the diversity of vaginal flora gradually increased (Shannon index: F=6.39, P=0.001; Simpson index: F=3.95, P=0.012). During the cervical lesion progress, the ratio of Lactobacillus gradually decreased, the ratio of other anaerobes such as Peptophilus, Sneathia, Prevotella and etc. gradually increased, and the differential bacteria (LDA score >3.5) gradually evolved from Lactobacillus to other anaerobes. The top 10 relative abundance bacteria, spearman correlation coefficient>0.4 and P<0.05 were selected. Co-occurrence network analysis showed that Prevotella, Peptophilus, Porphyrinomonas, Anaerococcus, Sneathia, Atopobium, Gardnerella and Streptococcus were positively correlated in different stages of cervical lesions, while Lactobacillus was negatively correlated with the above anaerobes. It was found that the relationship between vaginal floras in CIN 1 group was the most complex and only Peptophilus was significantly negatively correlated with Lactobacillus in SCC group. Conclusions: The increased diversity and changed correlations between vaginal floras are closely related to cervical lesions. Peptophilus is of great significance in the diagnosis, prediction and early warning of cervical carcinogenesis.
		                        		
		                        		
		                        		
		                        			Female
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		                        			Humans
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		                        			Vagina/microbiology*
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		                        			Uterine Cervical Neoplasms/genetics*
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		                        			Uterine Cervical Dysplasia
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		                        			Cervix Uteri
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		                        			Lactobacillus/genetics*
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		                        			Papillomavirus Infections
		                        			
		                        		
		                        	
10.A pre-conception cohort study of fertility and its related factors among couples with the intention of conception.
He Qing SONG ; Feng Yun YANG ; Yong Mei WU ; Shou Le WU ; Jiang Man LE ; Hai Qi WANG ; Li Feng ZHANG ; Dong Xiao YIN ; Hong JIANG
Chinese Journal of Preventive Medicine 2023;57(2):179-186
		                        		
		                        			
		                        			Objective: To describe fertility and explore factors associated with it among pre-conception couples of childbearing age. Methods: Based on the pre-conceptional offspring trajectory study of the School of Public Health of Fudan University, couples of childbearing age who participated in the pre-conception physical examination in Shanghai Jiading District from 2016 to 2021 were recruited and followed up. Couples' time to pregnancy (TTP) was analyzed and Cox proportional hazards regression model was used to explore the factors associated with TTP. Kaplan-Meier was used to calculate each menstrual cycle's cumulative pregnancy rate. Results: A total of 1 095 preconception couples were included in the analysis, the M(Q1,Q3)of TTP was 4.33 (2.41, 9.78) menstrual cycles. Age of women (FR=0.90, 95%CI: 0.85-0.95, P<0.001), women who were overweight or obese before pregnancy (FR=0.36, 95%CI: 0.24-0.55, P<0.001), women who were exposed to second-hand smoking (FR=0.63, 95%CI: 0.44-0.92, P=0.016), women whose home or office had been renovated in the past 2 years and had a particular smell (FR=0.46, 95%CI: 0.26-0.81, P=0.008) were risk factors for impaired fertility. Regular menstrual cycles (FR=1.64, 95%CI: 1.16-2.31, P=0.005), females who often drank tea/coffee (FR=1.55, 95%CI: 1.11-2.17, P=0.011) and males who took folic acid before conception (FR=2.35, 95%CI: 1.38-4.23, P=0.002) were associated with better fertility. The cumulative pregnancy rate of 3, 6, and 12 menstrual cycles was 37.6%, 64.4%, and 78.4%, respectively. Conclusion: Older couples, overweight or obesity before pregnancy, irregular menstruation, exposure to secondhand smoke and decoration pollutants in females are associated with impaired fertility. Frequent tea/coffee drinking before pregnancy in females and taking folic acid before pregnancy in males are associated with shortened conception time.
		                        		
		                        		
		                        		
		                        			Pregnancy
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		                        			Male
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		                        			Humans
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		                        			Female
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		                        			Cohort Studies
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		                        			Overweight/complications*
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		                        			Coffee
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		                        			Intention
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		                        			China/epidemiology*
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		                        			Fertility
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		                        			Obesity/complications*
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		                        			Tea
		                        			
		                        		
		                        	
            
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