1.Development and verification of a rapid detection method for adalimumab biological activity based on U937-NF-κB-Luc cell line
Chinese Journal of Biologicals 2024;37(1):79-85
Objective To develop and verify a rapid detection method for the biological activity of adalimumab based on U937-NF-κB-Luc cell line. Methods Using U937-NF-κB-Luc cell line as the detection cells,a method for detecting the biological activity of adalimumab was developed based on luciferase luminescence principle. The method was optimized for the concentration of tumor necrosis factor-α(TNF-α)(160 ng/mL as initial concentration,2 times serial dilution,10dilutions),the initial concentration of antibody(2 000 ng/mL,2 times serial dilution,20 dilutions),the dilution multiple of antibody(1. 5,2,3,4 times),the inoculation amount(8 × 103,2 × 104,4 × 104,6 × 104cells/well)and the incubation time(0. 5,1,2,3 h),and verified for the specificity,accuracy,precision and linear range. The relative potency of five batches of adalimumab was detected by using the optimized method and TNF-α neutralization activity method based on L929cells respectively. Results The dose-response curve of adalimumab international standard showed a typical S-type,and the data complied with the four-parameter equation y =(A-D)/[1 +(x/C)B]+ D,R2> 0. 99. The optimum concentration of TNF-α was 5 ng/mL,the initial concentration of antibody was 800 ng/mL,the dilution ratio for adalimumab was 1∶2,the inoculation amount was 2 × 104cells/well,and the induction time was 2 h. Three therapeutic monoclonal antibodies of TNF-α target,such as adalimumab,obtained good dose-response curves,while therapeutic monoclonal antibodies of other non-TNF-α targets did not show this curve. The linear regression equation of the logarithmic value of theoretical potency and the logarithmic value of the corresponding measured potency had a slope of 1. 037,and the relative bias was within the range of ± 12%. The geometric coefficient of variation(GCV)of the relative titer measured value of each sample was less than20%. The theoretical potency ranged from 64% to 156%,showing a good linear relationship with the measured values,and the fitting linear regression equation was y = 1. 037 4 x-0. 023 7,R2= 0. 998 4. There was no significant difference in the relative potency measured results of five batches of adalimumab by the two methods(t = 1. 198,P = 0. 265 1). Conclusion The developed detection method for adalimumab biological activity based on U937-NF-κB-Luc cell line has good specificity,accuracy and precision with short time consumption(3 h),which can be used as a rapid evaluation method for the biological activity of adalimumab.
2.The study of association of serum uric acid level with left ventricular mass and QRS duration in patients with chronic heart failure
Journal of Chinese Physician 2017;19(5):721-724,728
Objective To investigate the association of serum uric acid (UA) level with ventricular hypertrophy,ventricular remodeling,and ventricular electromechanical activity dyssynchrony in patients with chronic heart failure by studying the correlation among left ventricular mass index (LVMI),QRS duration (QRSd) and UA.Methods Four hundred and fifty-three patients were selected in this study.Each patient received examinations of echocardiography,electrocardiogram (ECG),blood routine,and blood biochemistry.According to the different UA level,the patients were divided into group Ⅰ (UA≤360 μmol/ L),group Ⅱ (360 μmol/L < UA≤420 μmol/L),group Ⅲ (420 μmol/L < UA≤480 μmol/L),group Ⅳ (480 μmol/L < UA ≤540 μmol/L),and group Ⅴ (UA > 540 μmol/L).The differences in LVMI,QRSd,Left ventricular ejection fraction (LVEF),and NYHA class among five groups were compared,and the correlation among LVMI,QRSd and UA were analyzed.Results According to the different UA,from groups Ⅰ to Ⅴ,with increase in UA,LVMI values increased,there was significant difference among five groups [(93.89 ±30.25) g/m2,(94.44 ±32.46) g/m2,(101.04 ± 37.22) g/m2,(124.39 ± 63.22)g/m2,and (133.51 ±41.85) g/m2,respectively] (F =17.501,P < 0.01).UA level correlated positively with LVMI (r =0.329 P <0.01).According to the different UA,from groups Ⅰ to Ⅴ,with increase in UA,QRSd prolonged,there was significant difference among five groups [(93.10 ± 14.56) ms,(92.77 ± 21.12)ms,(94.00±19.95)ms,(97.55 ±20.37)ms,and (101.73 ±25.57)ms,respectively] (F=2.516,P < 0.05).UA level correlated positively with QRSd (r =0.167,P < 0.01).According to the different UA,from groups Ⅰ to Ⅴ,with increase in UA,LVEF was reduced [(54.94 ± 10.26) %,(53.06 ±13.43)%,(51.79 ±14.01)%,(45.82±13.90)%,and (4-3.76±12.01)%,respectively] (F=14.299,P < 0.01),and the proportion of NYHA class Ⅳ increased (3.85%,4.29%,4.00%,21.05%,and 67.11%,respectively) (x2 =326.566,P < 0.01).Conclusions With the increase in UA level in patients with chronic heart failure,LVMI value increased,QRSd prolonged,LVEF decreased,and cardiac function reduced.It indicated that the elevated level of UA might reflect the severity of the ventricular remodeling,and ventricular electromechanical activity in dyssynchrony and development of heart failure.
3.A diagnostic meta-analysis:fiberoptic ductoscope versus galactography for the diagnostic value of nipple discharge
Minggang FU ; Sha LIU ; Liying GUO
The Journal of Practical Medicine 2015;(12):2010-2013
Objective To evaluate the diagnostic efficiency of fiberoptic ductoscope versus galactography for nipple discharge. Methods Literatures on comparing the diagnostic value of galactography with fiberoptic ductoseope (FDS) on the nipple discharge were searched from the Cochrane library, Evidence based medicine (EBM ),PubMed,China Vip database, and 8 studies were intaked. Then the data was analyzed by software Metadisc1.4 and Review Manager5.1. Results There are 1170 patients in the 8 studies. The pooled estimates for sensitivity of FDS and galactography was 82%, 78%, and the pooled estimates for specificity was 51%, 50%, respectively. The weighted AUC (area under curve) was 0.776, 0.705, Q*values was 0.715, 0.657, respectively. The sensitivities and specificity of the 2 methods were not significantly different. The overall diagnostic efficacy of FDS was better than that of galactography. Conclusion FDS is better than galaetography in the diagnostic value of nipple discharge.
4.Reflections on development of clinical engineering
Jiandong YIN ; Qiyong GUO ; Xianzheng SHA
Chinese Medical Equipment Journal 2003;0(11):-
With the rapid development of society and the increasing improvement of living standard,people shows increasing demand for high quality of medical care so that more and more advanced medical instruments are applied to disease prevention,diagnosis and treatment.Thanks to the development of the professional medical technology,a new branch of medicine-clinical engineering has emerged.The history,current situation and future development of clinical engineering are mainly expounded.
6.Characterization of circulating microRNA and its clinical application
Yujuan ZHANG ; Sha GUO ; Wei CUI
Chinese Journal of Laboratory Medicine 2014;37(12):964-968
MicroRNAs (miRNAs) are small noncoding regulatory RNAs ranging in size from 17 to 25 nucleotides which participate many physiological and pathological processes.MicroRNA could also stably exist in peripheral blood,and the detection of circulating microRNA is of great significance for disease diagnosis and prognosis.As so far,there is no unified method and standard for detection of microRNA,which is the major reason for discrepant results between different studies.However,circulating microRNA,as a new disease detection biomarker,has stable properties,convenient detection and high accuracy features,so it till has an important potential value in clinical applications.
7.Therapeutic potentiaI and infIuencing factors of mesenchymaI stem ceIIs on retinaI diseases
International Eye Science 2015;(3):459-463
· As a member of the stem cells family, mesenchymal stem cells ( MSCs ) have been proved to be effective on the repair of tissue injury. Although the specific mechanism is still unclear, MSCs do have a promising future in retinal disease therapy.The results of the current research are diverse.We still have an urgent and long way to explore the details of MSCs.So it’s significant for further understanding of MSCs to analyze the possible mechanism and influencing factors.
8.A new aurone glycoside from Veratrum dahuricum (Turcz.) Loes. f.
Jing-gong GUO ; Yin-sheng CHEN ; Jing LI ; Tian-xiao WANG ; Sha-sha LI ; Yue CONG
Acta Pharmaceutica Sinica 2015;50(3):337-339
To study the chemical constituents of Veratrum dahuricum (Turcz.) Loes. f., a new aurone glycoside named as (Z)-7, 4'-dimethoxy-6-hydroxyl-aurone-4-O-β-glucopyranoside was isolated from the 95% ethanol extracts of the rhizomes and roots of Veratrum dahuricum (Turcz.) Loes. f. by repeated column chromatography on silica gel and recrystallization. Its structure was established by extensive spectroscopic analyses, and its cytotoxicities against HepG-2, MCF7 and A549 cell lines were measured in vitro.
Benzofurans
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isolation & purification
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Cell Line, Tumor
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Glycosides
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isolation & purification
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Humans
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Plant Roots
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chemistry
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Plants, Medicinal
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chemistry
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Rhizome
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chemistry
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Veratrum
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chemistry
9.Target value of parathyroid hormone in hemodialysis patients
Zongli DIAO ; Wang GUO ; Sha LIU ; Wenhu LIU
Chinese Journal of General Practitioners 2017;16(6):474-477
The target value of intact parathyroid hormone (iPTH) in main international guidelines is not consistent completely.Furthermore,the evidence levels of clinical studies these guidelines based on are generally low and most of them are based on observational studies.Some studies even showed that there was no association between iPTH level and clinical outcomes.This review focuses on the following three points for reassessing iPTH target value: comparison of iPTH target value in main international guidelines,the difference of iPTH target value in large clinical studies and reasons for the difference.
10.Methods for the prevention of internal jugular vein malposition of peripherally inserted central catheter in patient with limited neck motion
Yanxian HE ; Sha XIAO ; Zhenhui GUO ; Fang LI
Chinese Journal of Clinical Nutrition 2014;22(5):317-320
Objective To evaluate the methods for the prevention of internal jugular vein malposition of peripherally inserted central catheter (PICC) in patient with limited neck motion.Methods 210 patients who underwent PICC placement using ultrasound-guided modified Seldinger technique were divided into observation group (n =106) and control group (n =104) with a random number table.Ultrasound probe compression on the internal jugular vein was used in the observation group,while finger compression was used in the control group.The 2 groups were compared in terms of incidence of internal jugular vein malposition,accuracy of PICC tip position in X-ray,and incidence of complications.Results Incidence of PICC malposition was significantly lower in the observation group than the control group [3 (2.8%) vs.36 (34.6%),P =0.000].The accuracy of PICC tip position in both groups was 100%.No complication was observed in the observation group,while the rate of complication in the control group was 4.8%,with a statistically significant difference (P =0.022).Conclusion The ultrasound probe compression method can significantly lower the incidence of internal jugular vein malposition of PICC and is safer than the finger compression method.