1.Incidence Rate of Overexpressing AmpC ?Lactamases in Cefoxitin-resistant Gram-negative Bacillus and Study on Drug-resistance and Genotype of Plasmid-mediated AmpC ?-Lactamases
Fuying FENG ; Wangping HU ; Xiangyue YANG ; Yabin ZHANG ; Xinlan HU ; Rongying GUO
Chinese Journal of Nosocomiology 2006;0(06):-
87%. CONCLUSIONS The surveillance of overexpressing AmpC ?-lactamases in cefoxitin-resistant Gram-negative bacillus must be enhanced.The therapy of infections caused by related bacillus should make imipenem and meropenem a chief choice.DHA-1,CMY-2 and CMY-22 AmpC enzymes are found in Fuzhou.
2.The clinical effect of free anterior lateral thigh flap with cutaneous nerve on repair and reconstruction after radical operation of tongue cancer
Heping YANG ; Yuehui WANG ; Yangbo NING ; Xinlan YAN ; Hanlin YANG
Journal of Chinese Physician 2021;23(11):1619-1622
Objective:To evaluate the clinical effect of free anterior lateral thigh flap (ALTF) with cutaneous nerve on repair and reconstruction after radical operation of tongue cancer.Methods:79 patients with tongue cancer who underwent radical resection in the stomatology department of Hunan Provincial People′s Hospital from October 2015 to October 2020 were selected and divided into observation group (38 cases) and control group (41 cases) according to the treatment method. The observation group was reconstructed with free ALTF with cutaneous nerve, and the control group was reconstructed with free ALTF without cutaneous nerve. The survival of the flap was observed and the function and morphology of the reconstructed tongue were evaluated.Results:All flaps survived and had good blood supply; the blood supply was good, the wounds healed in the first stage, and there were no cases of infection and arterial crisis. The appearance of the reconstructed tongue was plump and showed mild atrophy. The observation group was significantly better than the control group in terms of language clarity, masticatory efficiency, sensory excellence rate and University of Washington Quality of Life questionnaire (UW-QOL) score ( P<0.05). Conclusions:The ALTF with cutaneous nerve for repair and reconstruction after radical operation of tongue cancer, can significantly improve the reconstruction of tongue sensory function and the quality of life of patients.
3.RRM1 expression in tissue microarray and prognosis analysis in non-small cell lung cancer.
Riqiang LIAO ; Jiaying LIN ; Guibin QIAO ; Xinlan LUO ; Jingji YANG ; Yujuan HUANG ; Yilong WU
Chinese Journal of Lung Cancer 2006;9(5):423-427
BACKGROUNDRRM1 may be a prognostic factor in non-small cell lung cancer (NSCLC). The aim of this study is to evaluate RRM1 expression and prognosis in NSCLC by the means of tissue microarray.
METHODSA total of 417 paraffin-embedded specimens of NSCLC from Lung Cancer Study Center in Guangdong Provincial People's Hospital were collected and tissue microarray was constructed. RRM1 expression was detected by SP method and its correlation with prognosis was evaluated.
RESULTSNo statistic difference was found in RRM1 expression in different gender, age, tumor site, histology, differentiation, T stage, N stage, M stage and pTNM stage groups (P > 0.05). Univariate analysis showed that RRM1 was not an independent prognostic factor (P > 0.05). At the multivariate analysis, differentiation and N stage were considered independent prognostic factors.
CONCLUSIONSRRM1 expression detected by immunohistology is not an independent prognostic factor in NSCLC. TNM stage is still the best prognostic factor up to now.
4.Research progress of CYP450 genes expressed in brain involved in the metabolism of endogenous substances
Xinlan YANG ; Dan LV ; Lianfeng ZHANG
Chinese Journal of Comparative Medicine 2018;28(1):113-117
Cytochrome P450 (CYP450) is a superfamily of heme-thiolate proteins, which is involved in the metabolism and activation of various endogenous and exogenous substances, including food, drugs and pollutants. Previous studies of the CYP450 genes mainly focused on their function in drug metabolism. However, in recent years, studies have found that CYP450 are also involved in the development and progression of various diseases, including Parkinson's disease (PD), cancer, cardiomyopathy and heart failure (HF). By far, the process and related mechanisms of CYP450 in the metabolism of endogenous substances in brain tissues has not been clarified yet. In this paper, we summarized the research progress of CYP450 genes involved in the metabolism of endogenous substances, in order to provide a new idea for the exploration of the functions of CYP450 genes expressed in the brain.
5.Detection of Nine WADA Prohibited GHRPs and GHS Using the HPLC-MS/MS Method and Their Stability in Human Urine
Li SHEN ; Xinlan YANG ; Lisi ZHANG ; Chunji HE ; Xinmiao ZHOU ; Youxuan XU ; Kuan YAN
Chinese Journal of Sports Medicine 2018;37(5):420-426
Objective To introduce a practical high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS)method for the detection of seven growth hormone-releasing peptides (GHRPs)including GHRP-1,GHRP-2,GHRP-4,GHRP-5,GHRP-6,Hexarelin and Alexamorelin and two growth hormone secretagogues(GHS)including anamorelin and ipamorelin,and study the stability of these nine substances in the human urine.Method The urine samples were purified and extracted by a solid phase extraction procedure using Oasis(R) WCX column.The urine was first centrifuged and taken out 1 mL into a small column,cleaned by 5% NH4OH and 20% CH3CN respectively,eluated using the mixture of water and acetomitrile(1/3)with 2% formic acid,blow-dried in the nitrogen at 35℃ and finally redissolved to be injected into the LC-MS/MS.Result The limits of detection were between 0.01~0.5 ng/mL accordingly.The spiked recoveries at the low concentration(1 ng/mL),medium concentration(2 ng/mL)and high concentration(10 ng/mL)ranged between 40% and 76%.The intra-and interday precisions of the target substances at these three concentrations were all less than 15%.The indoor temperature,refrigeration condition and multigelation were observed to have significant impact on the anamorelin,GHRP-2,GHRP-4 and GHRP-5.Conclusion The method established in this study is simple,and its specificity and sensitivity meets the international standard and technical documents for laboratories set up by the Wworld Anti-Doping Agency.It has been applied in our routine work.Multigelation should be avoided in the transport,detection and long-term laboratory storage of urine samples.
6.Kinetic metrics of 68Ga-FAPI-04 in patients with pancreatic cancer identified by total-body PET/CT dynamic imaging
Ruohua CHEN ; Xinlan YANG ; Yanmiao HUO ; Yining WANG ; Xiaofeng YU ; Ling Yee NG ; Chaojie ZHENG ; Haitao ZHAO ; Lianghua LI ; Yun ZHOU ; Gang HUANG ; Jianjun LIU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2022;42(12):729-733
Objective:To investigate the kinetic metrics of 68Ga-fibroblast activation protein inhibitor (FAPI)-04 in pancreatic cancers and normal organs by using total-body PET dynamic imaging. Methods:From December 2020 to December 2021, 68Ga-FAPI-04 total-body PET/CT dynamic imaging were performed on 6 pancreatic cancer patients (3 males, 3 females, median age 55.5 years) in Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University. Images were respectively analyzed. Manual delineations of volume of interests (VOIs) on multiple normal organs and pathological lesions were performed and time-to-activity curves (TACs) were generated. A reversible two-tissue compartment model (2TCM) was fitted for each tissue TAC. Rate constants including K1, k2, k3 and k4, and the total volume of distribution ( Vt) were obtained and compared by tissue types. Wilcoxon rank sum test and Spearman correlation analysis were used for data analysis. Results:Kinetic metrics varied significantly among normal organs and pancreatic cancer lesions ( z values: 2.00-1 240.00, all P<0.05). The highest K1 among lesions was observed in primary tumor (0.30 min -1), which was observed in the spleen (1.42 min -1) among normal organs. The highest k2 among lesions was observed in peritoneal metastases (0.24 min -1), which was observed in the spleen (2.59 min -1) among normal organs. Primary tumor showed the highest k3 of 0.17 min -1 among lesions, and the pancreas had the highest k3 of 0.16 min -1 among normal organs. Primary tumor had the highest k4 of 0.03 min -1 among lesions, and the heart, lungs, parotid glands had high k4(0.06 min -1) among normal organs. Vt were higher in pathological lesions compared to normal organs, with the highest in primary tumor (13.78 ml/cm 3). There were correlations between Vt in lesions and SUV mean( rs=0.86, P<0.001) or SUV max ( rs=0.77, P<0.001). Conclusion:The rate constants including K1, k2, k3 and k4, and Vt of 68Ga-FAPI-04 vary among normal organs and lesions.
7.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.