1.Impact of Intracoronary Administration of Eptifibatide on Coronary No-reflow and Myocardium Perfusion in Patients With Acute Myocardial Infarction
Ling XUE ; Weili WU ; Xiaoqian JIA ; Haiwei XUE ; Jinsheng DUAN ; Jun PAN ; Xuezhe LI ; Xianghua FU
Chinese Circulation Journal 2016;31(9):862-865
Objective: To evaluate the impact of intracoronary administration of eptifibatide oncoronary no-reflow and myocardium perfusion in patients with ST-elevation myocardial infarction (STEMI) at percutaneous coronary intervention (PCI). Methods: A total of 80 STEMI patients with emergent PCI were randomly divided into 2 groups: Eptifibatide group, the patients received intracoronary administration of eptiifbatide and Control group, the patients received the same volume of normal saline.n=40 in each group. The baseline condition, post-operative vascular recanalization, changes of platelet aggression at pre- and post-medication were compared between 2 groups. Echocardiography was examined at immediately and 24 weeks after operation;myocardial infusion imaging was examined at l week after operation. All patients were followed-up for 24 weeks to observe the incidence of major adverse cardiovascular events (MACE). Results: Compared with Control group, Eptifibatide group showed increased ratios of post-operative TIMI grade 3 (72.5%vs 92.5%) and myocardium perfusion (70.0% vs 90.0%), bothP<0.05; decreased post-operative and 2h post-medicinal platelet aggression and they were both lower than Control group at the same period, allP<0.05. Eptiifbatide group had obviously improved LVEDD and LVEF at 24-week than 1-week after PCI and they were both superior to Control group, allP<0.05. There were 7 (17.5%) patients in Eptiifbatide group and 7 (7.5%) in Control group suffering from small bleeding events, P>0.05; no severe bleeding eventand no in-hospital thrombocytopeniaoccurred. MACE occurrence rates during 24-week follow-up period were 12.5% vs 22.5%, P>0.05. Conclusion: Intracoronary administration of eptiifbatide in STEMI patients at emergent PCI could effectively improve coronary blood lfow,increase myocardium perfusion and enhance cardiac function without severe bleeding events.
2.Comparison and bias analysis of BUN, Cr and UA between two different biochemical analysis systems
Hui Lü ; Zhanfeng LAI ; Haiwei LI ; Liwen LIN ; Xue QIN ; Shan LI
Chinese Journal of Laboratory Medicine 2012;35(6):550-553
Objective To discuss the comparability of blood urea nitrogen (BUN),creatinine (Cr),uric acid (UA) results and provide basis for result concordance in different biochemical systems.Methods The within-run precision and the between-day precision for the median and high values of quality control materials were tested in Beckman LX-20 and Hitachi 7600 chemistry analyzer respectively,and the evaluation criteria were according to the precision requirement of manufacturer and our laboratory.According to American Clinical and Laboratory Standards Institute (CLSI) document EP9-A2,serum BUN,Cr,UA from 40 patients were detected by Hitachi 7600 chemistry analyzer as experimental method and by Beckman LX-20 chemistry analyzer as comparative method.The relative bias ( SE%) between experimental method and comparative method was calculated and the concordance of biochemical analysis system was determined according to EQA requirements and acceptable performance criteria Results The between-run and between-day precision coefficients of variation for BUN,Cr and UA in two biochemical analysis systems were lower than the precision requirement of manufacturer and our laboratory.In Hitachi 7600 chemistry analyzer,the SE% for BUN at three levels of medical decision were 9.4%,2.0% and 0.8%,the SE% for Cr were 7.3%,3.8% and 2.8%,the SE% for UA were 7.9%,1.7% and 1.2%.Two biochemical analysis systems were not comparable in BUN analysis because SE% of serum BUN levels detected by Hitachi 7600 at low medical decision level exceeded the specified range.The remaining items between two biochemical analysis systems were concordant.Conclusion While the same test is detected by more than two systems in one laboratory,it is necessary to do method comparison and bias evaluation for concordance in order to ensure the comparability among test results.
3.Region Ⅵ lymph nodes dissection in treatment of 38 cases with cN0 papillary thyroid carcinoma
Jiayong HU ; Haiwei ZHANG ; Yonghua ZHOU ; Yu XUE ; Tiran ZHANG ; Qingwen LIU
Journal of Endocrine Surgery 2013;7(1):8-10
Objective To discuss the significance of region Ⅵ lymph nodes dissection in treatment of patients with clinical cervical nodes negative(cN0)papillary thyroid carcinoma(PTC).Methods Clinical data of 38 cases of cN0 PTC treated with region Ⅵ lymph nodes dissection were retrospectively analyzed.The related literature was reviewed.The cervical nodes dissection scope and the key operation points in treatment of cN0 PTC were discussed.Results No permanent recurrent laryngeal nerve injury or parathyroid damage happened.14 cases(36.84%)had occult lymph node metastasis to region Ⅵ lymph nodes.After more than 5 years of follow-up,all the cases had excellent life quality.3 cases(7.89%)were found lymph node metastasis to lateral cervical region and they were given functional neck dissection.No recurrence or metastasis occurred to the 3 cases during more than 2 years of follow-up.Conclusion Region Ⅵ lymph node dissection in treatment of cN0 PTC is safe,reliable,and with less complications.
4.Analysis of Impurities in Peptide Drug Bivalirudin Based on Three Kinds of Separation Principle Technology
Jing YIN ; Wanting WANG ; Yihong LU ; Shuqiang ZHAO ; Haiwei SHI ; Bin DI ; Minhua XUE ; Ling CAO
Chinese Journal of Modern Applied Pharmacy 2024;41(5):626-635
OBJECTIVE
To establish HPLC methods with different separation principles to analyze the relevant impurities in the APIs of bivalirudin from seven enterprises, to provide a basis for the comprehensive control of related substances of bivalirudin.
METHODS
Reversed-phase high performance liquid chromatography(RP-HPLC) was used to separate and analyze 11 kinds of impurities. Hydrophilic chromatography(HILIC)-HPLC was used to control four process impurities. Polymers were determined by size exclusion chromatography(SEC)-HPLC.
RESULTS
The established RP-HPLC could effectively separate the principal component and 11 impurities, the correction factors of 11 impurities were between 0.8−1.2, the detection concentration of bivalirudin was 0.1 μg·mL−1, and the detection limit was 0.004%. The established HILIC-HPLC could effectively separate the principal components and four process impurities, and the detection concentration of bivalirudin was 0.3 μg·mL−1, and the detection limit was 0.01%. Under SEC-HPLC conditions, the polymer and bivalirudin peaked sequentially, the resolution of the two was 2.9, the detection concentration of bivalirudin was 6 ng·mL−1, and the detection limit was 0.000 6%. Fifteen kinds of known impurities and polymers in 15 batches of samples from 7 enterprises were calculated by the self-control method of principal components, and the impurity contents from different enterprises had a certain correlation with their production processes.
CONCLUSION
The three different principles of the method have good specificity, high sensitivity, good durability, and reliable results, and can be used for quality control of substances related to bivalirudin.