1.Determination method of plasma concentrations of 7 anti-tumor drugs and its application
Jinxiu LYU ; Nan YAN ; Wenjun XU ; Jing ZHAO ; Hua ZHU ; Pengzhou HANG
China Pharmacy 2025;36(4):475-481
OBJECTIVE To establish a method for simultaneous determination of 7 anti-tumor drugs (irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate) in human plasma and apply it to the clinic. METHODS After precipitating with a methanol-acetonitrile mixture (1∶ 1, V/V) containing 0.1% formic acid, liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to determine the plasma concentration, using deuterium isotopes of each analyte as internal standards. The chromatography was performed on the Agilent Eclipse Plus C18 column with a gradient elution of water (containing 0.1% formic acid+0.04% 5 mmol/L ammonium formate) as mobile phase A and acetonitrile (containing 0.1% formic acid) as mobile phase B. The flow rate was 0.6 mL/min, and the column temperature was set at 40 ℃ . The sample size was 10 μL, and the analysis lasted for 5.5 min. Electrospray ionization was used in positive and negative ion mode, and multiple reaction monitoring mode was used. The ion pairs used for quantitative analysis were m/z 587.1→167.1 (irinotecan), m/z 360.1→244.1 (capecitabine), m/z 876.4→308.0 (paclitaxel), m/z 830.3→304.2 (docetaxel), m/z 372.1→129.1 (tamoxifen), m/z 284.1→242.1 (letrozole), and m/z 455.0→ 308.0 (methotrexate). A total of 97 patients with malignant tumors in our hospital were selected to measure the plasma concentrations of 7 anti-tumor drugs using the above method. RESULTS The linear ranges of irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate were 2-1 000 ng/mL (r=0.994 3), 20-10 000 ng/mL (r=0.997 5), 2-1 000 ng/mL (r=0.997 9), 1-500 ng/mL (r=0.995 8), 1-500 ng/mL (r=0.995 2), 1-500 ng/mL (r=0.996 4), 10-5 000 (r=0.997 7), respectively. The quantitative lower limits were 2, 20, 2, 1, 1, 1 and 10 ng/mL; RSDs of intra-assay precision were 0.08%-14.86% (n=6). RSDs of inter-batch precision were 1.51%-11.55% (n=3), and the accuracies were 89.17%-114.93% (n=6). The matrix effects ranged from 89.89%-119.74% (n=6). RSDs of the stability tests were 1.98%-14.88% (n=6). The results of E-mail:hangpengzhou@163.com clinical application showed, the average plasma concentrations of irinotecan, capecitabine, paclitaxel and docetaxel were 704.09, 909.40, 36.45, 150.43 ng/mL, respectively. The values of the coefficient of variation were 25.24%, 62.65%, 122.69%, and 92.27%. CONCLUSIONS The established LC-MS/MS method is simple and rapid, and can be used for the simultaneous determination of 7 commonly used anti-tumor drugs in the plasma of patients with malignancy.
2.Research progress on nursing-sensitive quality indicators for acute poisoning patients
Ying LI ; Jing WEI ; Hua XU ; Ya ZHANG ; Xiangguang YIN ; Mingjie ZHAO ; Jing WANG
Chinese Journal of Modern Nursing 2024;30(30):4191-4196
This article provides a review of domestic and international research on nursing-sensitive quality indicators (NSQIs) and evaluation systems for acute poisoning patients. It organizes the indicators into three dimensions based on the "structure-process-outcome" framework. The need for establishing a unified, comprehensive, and nationally suitable system of NSQIs in China is emphasized to standardize nursing practices and improve the monitoring of care quality. Although existing indicators possess some scientific validity, they often overlap with emergency nursing quality evaluation systems or are limited to specific types of poisoning. In addition, large-scale clinical trials to test their practical application and accessibility have yet to be conducted. This review aims to consolidate and analyze NSQIs for acute poisoning patients and provide a foundation and reference for improving the quality of nursing care for these patients.
3.Epidemic characteristics and spatial heterogeneity of hemorrhagic fever with renal syndrome in Hubei Province from 2005 to 2021,China
Yang WU ; Tian LIU ; Jing ZHAO ; Man LIU ; Ye-Qing TONG ; Xu-Hua GUAN ; Hong-Bing PEI
Chinese Journal of Zoonoses 2024;40(7):678-688
This study was aimed at summarizing the epidemiological characteristics and spatial-temporal changes of hemorrhagic fever with renal syndrome(HFRS)in Hubei Province,China from 2005 to 2021,to provide scientific evi-dence for HFRS prevention and control.Data on individual HFRS cases and population information in Hubei Province from 2005 to 2021 were collected from the China Disease Pre-vention and Control Information System.The temporal,spa-tial,and demographic distribution characteristics of HFRS cases are described,and statistical methods such as medians,rates,and composition ratios were used for analysis.Joinpoint re-gression and Spearman's rank correlation were used to analyze the temporal trends in incidence rates or composition ratios.Global autocorrelation and hotspot analysis were conducted for spatial clustering analysis.Binary logistic regression was per-formed to analyze risk factors for HFRS mortality.A total of 5 790 HFRS cases were reported from 2005 to 2021,including 117 deaths.The average annual incidence rate was 0.57 per 100 000 population,and the case fatality rate was 2.02%.The overall incidence rate of HFRS in Hubei Province showed an increasing trend(AAPC=4.05%,95%CI:1.32%-6.78%),whereas the case fatality rate showed a decreasing trend over the years(r,=-0.72,P=0.002).HFRS exhibited a bimodal pattern,with peaks in the spring/summer months(May to July)and in the autumn/winter months(November to January of the following year).The incidence rate during the autumn/winter peak was slightly higher than that in the spring/summer peak.The incidence rate in males was higher than in females(RR=2.96,95%CI:2.79-3.14).The three age groups with the highest incidence rates were 60-64 years(747 cases,1.55 per 100 000),65-69 years(515 cases,1.39 per 100 000),and 55-59 years(762 cases,1.23 per 100 000).The incidence rate(2005:0.05 per 100 000;2021:0.08 per 100 000)and proportion(2005:2.69%;2021:1.94%)of HFRS cases in individuals 14 years or younger showed no significant trend over the years(AAPC=0.14%,95%CI:-0.03%-0.31%;AAPC=-3.64%,95%CI:-8.79%-1.50%).The incidence rate(2005:0.58 per 100 000;2021:1.59 per 100 000)and proportion(2005:14.80%;2021:44.31%)in the age group of 60 years or a-bove showed an increasing trend over the years(AAPC=10.52%,95%CI:4.38%-16.66%;AAPC=175.98%,95%CI:143.20%-208.75%).HFRS cases exhibited significant spatial clustering(P<0.05).The hotspots of HFRS in Hubei Province shifted from the northern region(Xiangyang,Suizhou,Jingmen)in 2005-2007 to the southern region(Qianjiang,Xiantao,Tianmen,Jingzhou)in 2020-2021.Older age(OR=1.02,95%CI:1.01-1.04)and the period of 2005-2008 versus 2017-2021(OR=0.98,95%CI:0.97-0.99)were associated with relatively higher risk of HFRS mortality.In recent years,the HFRS epidemic in Hubei Province has continued to escalate,and areas such as Qianjiang City and other ares in the middle and lower reaches of the Yangtze River have experienced high incidence rates.The population 60 years of age or above is gradually becoming more susceptible to the disease.Targeted measures should be implemented to curb the rising trend of HFRS.
4.Characteristic Analysis of Adult Acute Myeloid Leukemia Patients with PTPN11 Gene Mutation
Li SHENG ; Ya-Jiao LIU ; Jing-Fen ZHOU ; Hong-Ying CHAO ; Hai-Ying HUA ; Xin ZHOU ; Xiao-Hong ZHAO
Journal of Experimental Hematology 2024;32(4):1063-1070
Objective:To investigate the incidence of PTPN11 gene mutation and its associated gene mutations in adult patients with acute myeloid leukemia(AML),and analyze its clinical characteristics.Methods:Second-generation sequencing and Sanger sequencing were used to detect 51 gene mutations,and multiplex-PCR was used to detect 41 fusion genes from 451 newly diagnosed adult AML patients admitted to Affiliated Hospital of Jiangnan University,Changzhou Second People's Hospital,Wuxi People's Hospital and Wuxi Second People's Hospital from January 2017 to July 2022.Results:Among 451 primary adult AML patients,the PTPN11 gene mutation was detected in 34 cases,and the mutation rate was 7.5%.In the 34 patients,37 PTPN11 alterations were found,which were exclusively missense mutations affecting residues located within the N-SH2(31 cases)and PTP(6 cases)domains and clustered overwhelmingly in exon 3.The platelet count of PTPN11 mutation patients was 76.5(23.5,119.0)× 109/L,which was significantly higher than 41.0(22.0,82.5)×109/L of wild-type patients(P<0.05).While,there were no significant differences in sex,age,peripheral white blood cell count,hemoglobin,and bone marrow blast between PTPN11 mutation and wild-type patients(P>0.05).In FAB subtypes,PTPN11 mutations were mainly distributed in M5,followed by M2 and M4,less frequently in M3 and M6.There was no significant difference in the distribution of FAB subtypes between PTPN11 mutation and wild-type patients(P>0.05).A total of 118 AML patients were detected positive fusion gene,among which patients with PTPN11 mutations had a higher incidence of positive MLL-AF6 than wild-type ones(P<0.01).97.1%of 34 patients with PTPN11 mutations were accompanied by other mutations,in descending order,they were respectively NPM1(38.2%),NRAS(32.4%),FLT3-ITD(32.4%),DNMT3A(32.4%)and KRAS(23.5%),etc.Conclusion:PTPN11 mutation has a certain incidence in AML patients and is clustered overwhelmingly in exon 3.ALL of them are exclusively missense mutations,and most often present in conjunction with NPM1 mutations.FAB typing of PTPN11 mutation is mostly manifested as M5 subtype,which is associated with higher platelet counts.
5.Testis-sparing microsurgery for benign testis tumor:A report of 16 cases
Lei YU ; Jing ZHAO ; Hong-Qiang WANG ; Pei-Hong ZHOU ; Jian-Hua MEN ; Gang WANG ; Qiang LI ; Yu PAN ; Wen-Xin LI ; Lin QIAN ; Shen-Qian LI ; Pei-Tao WANG ; Tao JING
National Journal of Andrology 2024;30(3):209-216
Objective:To investigate the safety and clinical effect of testis-sparing microsurgery(TSMS)in the treatment of benign testis tumor(BTT).Methods:We retrospectively analyzed the clinical data on 16 cases of BTT treated in the Department of Andrology of the Affiliated Hospital of Qingdao University from October 2020 to February 2023.The median age of the patients was 23 years.All the tumors were unilateral,7 in the left and 9 in the right side,with a median diameter of 1.85 cm(1.0-3.5 cm).The patients all underwent color Doppler flow imaging(CDFI),MRI,semen analysis and examination of serum T,alpha-fetoprotein(AFP),human chorionic gonadotropin(HCG)and lactate dehydrogenase(LDH),followed by TSMS.The boundaries between the tumors and normal testis tissue were accurately identified under the microscope,and the tumors and the adjacent normal testis tissue 2 mm from their margins were excised completely.Bipolar coagulation forceps were used for wound hemostasis to maximally preserve the normal testis tissue.The resected specimens were subjected to fast frozen pathology intraoperatively,and the patients were followed up for 14-40 months by regular scrotal CDFI,MRI and examinations of serum T and semen parameters.Results:The levels of serum T,AFP,HCG and LDH and semen parameters were all within the normal range preoperatively.TSMS were successfully completed in all the cases,and all were pathologically confirmed as BTT according to the latest edition of WHO Classification of Tumors:Urinary and Male Genital Tumors.CDFI showed normal blood supply within the testis tissue at 1 month after surgery.No signs of intra-testicu-lar tumor residue,recurrence or metastasis,nor significant changes in the levels of serum T,AFP,HCG or LDH or semen parameters were observed during the follow-up as compared with the baseline.Natural conception was achieved in 2 cases at 16 and 18 months re-spectively after surgery.Conclusion:BTT can be differentially diagnosed by CDFI and MRI before surgery and confirmed by histo-pathology.TSMS can achieve complete excision of the tumor,maximal sparing of the normal testis tissue and thereby effective preserva-tion of male fertility.
6.Longitudinal intussusception versus end-to-side vasoepididymostomy:Comparison of their recanalization rates
Lu-Gang ZHAO ; Hong CHEN ; Gui-Hua LIU ; Cong FANG ; Xiao-Yan LIANG ; Jing ZHANG
National Journal of Andrology 2024;30(11):1002-1008
Objective:To compare the recanalization rate of 2-suture longitudinal intussusception vasoepididymostomy(LIVE)with that of4-suture end-to-side vasoepididymostomy(ESVE).Methods:This retrospective case-control study included 127 cases of obstructive azoospermia(OA)treated by LIVE(n=87)or ESVE(n=40)in our Center of Reproductive Medicine from October 2013 to July 2024.We analyzed the clinical data and compared the age,testis volume,level of serum follicle-stimulating hormone(FSH),operation time and postoperative recanalization rate between the two groups.Results:Spermatozoa were observed in 90(70.9%)of the 127 cases after surgery.There were no statistical differences in age,testis volume and FSH between the two groups of patients(all P>0.05),and nor were there any serious surgical complications.The operation time was significantly longer in the ESVE than in the LIVE group(22.0[20.0-25.8]vs 17.0[15.0-23.0]min,P<0.05),while the postoperative recanalization rate remarkably higher in the former than in the latter group(85.0%vs 64.4%,P<0.05).Vasoepididymostomy was performed at the caput epididymis in 11 cases,with a higher recanalization rate in the ESVE than in the LIVE group(50.0%[1/2]vs 33.3%[3/9]).Conclusion:ESVE achieved a higher postoperative recanalization rate than LIVE in the treatment of OA,but its advanta-ges need further investigation.
7.Consistency of chemical constituents between formula granules and standard decoction of Coptidis Rhizoma
Dai-Liang ZHANG ; Xin-Na DONG ; Lei SHI ; Xiao-Di DONG ; Yong-Qiang LIN ; Rong-Fei ZHANG ; Jing-Hua ZHANG ; Yuan-Cheng YAO ; Feng-Chao ZHANG ; Gui-Yun CAO ; Zhao-Qing MENG
Chinese Traditional Patent Medicine 2024;46(9):2851-2858
AIM To investigate the consistency of chemical constituents between formula granules and standard decoction of Coptidis Rhizoma.METHODS Eighteen batches of standard decoctions were prepared,after which the extraction rate and contents,transfer rates of magnolflorine,jatrorrhizine,columbamine,epiberberine,coptisine,palmatine,berberin were determined,HPLC characteristic chromatograms were established.RESULTS There were 11 common peaks in the characteristic chromatograms of 18 batches of standard decoctions and 24 batches of formula granules with the similarities of 0.861-1.000,which were clusterd into two categories.The formula granules and standard decoction demonstrated approximated extraction rate and contents,transfer rates of index constituents.CONCLUSION The chemical constituents between formula granules and standard decoction of Coptidis Rhizoma display good consistency,which can provide references for the quality control,process research and clinical application of the former.
8.Background, design, and preliminary implementation of China prospective multicenter birth cohort
Si ZHOU ; Liping GUAN ; Hanbo ZHANG ; Wenzhi YANG ; Qiaoling GENG ; Niya ZHOU ; Wenrui ZHAO ; Jia LI ; Zhiguang ZHAO ; Xi PU ; Dan ZHENG ; Hua JIN ; Fei HOU ; Jie GAO ; Wendi WANG ; Xiaohua WANG ; Aiju LIU ; Luming SUN ; Jing YI ; Zhang MAO ; Zhixu QIU ; Shuzhen WU ; Dongqun HUANG ; Xiaohang CHEN ; Fengxiang WEI ; Lianshuai ZHENG ; Xiao YANG ; Jianguo ZHANG ; Zhongjun LI ; Qingsong LIU ; Leilei WANG ; Lijian ZHAO ; Hongbo QI
Chinese Journal of Perinatal Medicine 2024;27(9):750-755
China prospective multicenter birth cohort (Prospective Omics Health Atlas birth cohort, POHA birth cohort) study was officially launched in 2022. This study, in collaboration with 12 participating units, aims to establish a high-quality, multidimensional cohort comprising 20 000 naturally conceived families and assisted reproductive families. The study involves long-term follow-up of parents and offspring, with corresponding biological samples collected at key time points. Through multi-omics testing and analysis, the study aims to conduct multi-omics big data research across the entire maternal and infant life cycle. The goal is to identify new biomarkers for maternal and infant diseases and provide scientific evidence for risk prediction related to maternal diseases and neonatal health.
9.Effect of safflower yellow pigment injection combined with alprostadil on patients after coronary artery bypass grafting
Xin-Hua ZHANG ; Chun-Mei REN ; Li-Jie JIANG ; Wei-Guang YANG ; Hong-Ling SU ; Jing-Yu ZHAO
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(5):590-593
Objective:To investigate the effect of safflower yellow pigment injection combined with alprostadil on patients after coronary artery bypass grafting(CABG).Methods:A total of 92 patients with coronary heart disease who received CABG in Department of Cardiovascular Surgery,Handan Central Hospital between September 2018 and September 2020 were selected.According to order of admission,they were divided into control group(n=46,from September 2018 to Sep-tember 2019,routine therapy+alprostadil after CABG)and study group(n=46,from October 2019 to September 2020,safflower yellow pigment injection based on control group),both groups were treated for 28d.On 3d after drug withdraw-al,therapeutic effect,cardiac function indexes,four myocardial enzyme spectrum and perioperative indexes were compared between two groups.Results:On 3d after drug withdrawal,compared with control group,patients in study group had sig-nificant higher total effective rate(73.9%vs.91.3%),left ventricular ejection fraction(LVEF)[(55.77±4.48)%vs.(62.18±4.21)%](P=0.028,<0.001),and significant lower left atrial diameter(LAD)[(36.83±3.45)mm vs.(32.09±3.23)mm],left ventricular end-diastolic diameter(LVEDd)[(49.04±4.65)mm vs.(43.83±5.24)mm],levels of creatine kinase(CK)[(125.13±14.21)U/L vs.(62.56±8.42)U/L],lactate dehydrogenase(LDH)[(203.58±31.63)U/L vs.(156.07±22.26)U/L],aspartate aminotransferase(AST)[(44.25±12.98)U/L vs.(35.41±12.37)U/L]and creatine kinase isoenzyme MB(CK-MB)[(28.11±9.84)U/L vs.(17.59±7.41)U/L](P<0.001 all).Conclusion:The combination of safflower yellow pigment injection and alprostadil can improve the thera-peutic effect and heart function,and reduce myocardial injury in patients after CABG.
10.Predictive value of artery blood flow parameters for fetal distress in mid-pregnancy fetus with oligohydramnios
Hui ZHONG ; Jing ZHAO ; Li-Na HE ; Hua JIN ; Ya-Yi LUO
Chinese Medical Equipment Journal 2024;45(5):60-66
Objective To predict fetal distress in oligohydramnios fetuses in mid-pregnancy by monitoring the blood flows in middle cerebral artery,renal artery and umbilical artery by means of ultrasound.Methods Totally 104 mid-pregnancy women with oligohydramnios in some hospital from January 2020 to May 2022 were selected retrospectively,and were divided into a distress group(n=43)and a non-distress group(n=48)based on the presence of fetal distress.Logistic multivariate regression was used to analyze the risk factors for the occurrence of fetal distress;the predictive value for fetal distress was assessed with ROC curves;a Bayesian network model was constructed and validated.Results The independent risk factors for fetal distress included abnormal findings in fetal movement,fetal cardiac monitoring,lipid levels and blood rheology indices and abnormal parameters of middle cerebral artery,renal artery,and umbilical artery(P<0.05).Higher predictive efficiency could be obtained for fetal distress when the blood flow parameters of middle cerebral artery,renal artery and umbilical artery were combined than only the parameters of only one artery were involved in.The Bayesian network model predicted an increase in the incidence of fetal distress from 49.9%to 61.50%when the probability of abnormality in all the three artery parameters was 100%,which proved to gain a high net benefit.Conclusion For mid-pregnancy women combined monitoring of the blood flow parameters of middle cerebral artery,renal artery and umbilical artery may predict fetal distress effectively.[Chinese Medical Equipment Journal,2024,45(5):60-66]

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