1.Effect of multiple punctures on quality of inactivated poliomyelitis vaccine made from Sabin strains in 5-dose vial presentation
Chinese Journal of Biologicals 2023;36(4):389-
ObjectiveTo evaluate the effect of multiple punctures on the quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)in 5-dose vials.MethodsPre-puncture samples were sampled by opening the cover from 3batches of sIPV stored for about 24 months and balanced at room temperature at least 20 min;The same three batches of sIPV were punctured for the first to fifth needle on the 0,7,14,21 and 28 d respectively,which were balanced at room temperature at least 20 min before each sampling. After sampling,the remaining samples were returned to 2~8 ℃ for preservation. According to the requirements of enterprise registration standard(YBS01052021),all the samples before and after the fifth needle puncture were tested,and the other 4 needle puncture samples were tested for pH,osmotic molar concentration,aseptic test,bacterial endotoxin,D antigen content of typeⅠ,Ⅱ and Ⅲ virus,appearance,abnormal toxicity,protein content and 2-phenoxyethanol content. The relative change rates of 2-phenoxyethanol content,protein content,osmotic molar concentration and D antigen content of typeⅠ,Ⅱ and Ⅲ virus were calculated. SPSS 20 software was used to analyze the relative change rate of each index by one-way ANOVA,and the effect of multiple punctures on the quality of sIPV was evaluated.ResultsThe result of each test item was in compliance with enterprise registration standard before and after each puncture. There was no significant difference between each puncture on the relative rate of change of 2-phenoxyethanol content,protein content,D-antigen content of typeⅡ and Ⅲ virus(F = 2. 125,1. 155,1. 137 and 1. 882,P = 0. 152,0. 386,0. 393and 0. 190,respectively);There was a significant difference in the relative change rate of osmotic molar concentration and Dantigen content of TypeⅠvirus(F = 4. 750 and 4. 010,P = 0. 021 and 0. 034,respectively). The result of Duncan test showed that compared with the first puncture,the relative change rate of osmotic molar concentration after the second and third puncture showed no significant difference,while that after the fourth puncture showed significant difference and a relatively stable result was observed after the fifth puncture. Regarding the relative rate of change of D-antigen content of TypeⅠvirus,there was no significant difference among the first,second,fourth and fifth punctures,while a significant difference existed between the third and the other four punctures.ConclusionFive punctures within 28 days had no effect on the quality of sIPV in 5-dose vials.
2.Efficacy observation of glutathione on prevention of acute radiation enteritis in pelvic radiation therapy
Zhenchao MA ; Zhenxin ZHOU ; Haibing ZHANG ; Pengtian JI ; Genhua YU
Chinese Journal of Primary Medicine and Pharmacy 2016;23(20):3151-3154
Objective To observe the prevention effect of glutathione on acute radiation enteritis in pelvic radiation therapy.Methods All 80 pelvic tumor patients treated with radiotherapy were randomly assigned to the control group (40 patients)and the treatment group (40 patients)by the number table method.40 cases in the con-trol group treated with radiation were not treated with preventive drugs,but the patients in the treatment group were treated with glutathione.The occurrence time of acute radiation enteritis and the severity of acute radiation enteritis after treatment were evaluated.Results 15.0% of the treatment group suffered from acute radiation enteritis in the second week and 72.5% in the third week.however,62.5% of the control group were suffered from acute radiation enteritis in the second week and 27.5% in the third week.The difference was statistically significant (χ2 =18.775, 15.998,all P <0.001).Glutathione delayed the occurrence time of acute radiation enteritis.The grade 1 and grade 2 acute radiation enteritis effective rate in the treatment group were 77.5% and 17.5%,and that in the control group were 20.0% and 72.5%,the difference between the two groups was significant(χ2 =26.136,24.139,all P <0.001).The glutathione could reduce the incidence of acute radiation enteritis extent.Conclusion Glutathione could delay the occurrence time of acute radiation enteritis and reduce the incidence of acute radiation enteritis extent.It is worth clinical application.
3.Transurethral electric resection plus arterial catheterization chemotherapy for T2a bladder carcinoma
Feng LI ; Jinxian PU ; Zhenxin WANG ; Ling ZHOU ; Jin ZANG
Chinese Journal of General Practitioners 2016;15(8):639-641
Clinical data of 23 patients with T2a bladder cancer admitted from March 2008 to August 2013 were retrospectively analyzed.Among 23 patients,11 cases were treated with transurethral resection (TURBT) plus arterial catheterization chemotherapy (study group) and 12 cases were treated with radical cystectomy (control group).The overall survival time and recurrence free survival time of two groups were compared.Patients in study group were followed up for 20-68 months,recurrence occurred in 5 cases (5/11),including 4 cases of invasive recurrence;patients in control group were followed up for 2 ~86 months,1 case had superficial recurrent and underwent TURBT,2 cases dead due to bladder tumor.During the course of chemotherapy,the main adverse effects were digestive reaction (7/11),fever (4/11),bone marrow suppression (2/11),symptomatic treatment was given,which was tolerated.There were no significant differences in overall survival time and recurrence free survival time between two groups (P > 0.05).The quality of life of study group was better than that of control group (P < 0.05).It is suggested that the arterial interventional chemotherapy combined with transurethral resection for T2a stage invasive bladder cancer has a certain curative effect with the advantage of preservation of bladder function and higher quality of life.
4.Expression of PTEN and VEGF gene in laryngeal squamous cell carcinoma and their clinical significance
Zhenxin ZHANG ; Weirong ZHOU ; Xiaoxia QIU ; Peng DA ; Zhixia WANG
Chinese Archives of Otolaryngology-Head and Neck Surgery 2006;0(08):-
OBJECTIVE To investigate the expression of PTEN and VEGF gene in laryngeal squamous cell carcinoma and their clinical significance. METHODS The expression of PTEN and VEGF gene were examined by using immunohistochemical S-P staining method in 10 cases of normal tissues, 20 cases of para-tumor tissues and 60 cases of LSCC. RESULTS The positive rates of PTEN in normal tissues, para-tumor tissues and LSCC were 100.0 %, 95.0 %, and 70.0 % respectively (P<0.05),and VEGF protein showed positive expression of 20.0 %,50.0 %,73.3% in normal, para-tumor and LSCC tissues with statistical significance(P<0.05), In LSCC, the expression of PTEN and VEGF was positively correlated with TNM stage, differentiation of tumor, cervical and distant metastasis of lymph node, 3-year survive rate of patients(P<0.05),No significant association was observed in expression of PTEN and VEGF with tumor location,patient's age and sex(P>0.05). Spearman correlation analysis revealed that PTEN was negatively correlated with VEGF expression(?=-0.3948, P=0.0018). CONCLUSION The aberrant expression of PTEN and VEGF may play a role in occurrence, progression and metastasis of LSCC.
5.Appraisal of electronic administration analysis system used for pre-hospital records
Changchun LIN ; Zhenxin ZHANG ; Lin WANG ; Jun WU ; Jielian CHEN ; Yafeng XU ; Dantong ZHOU
Chinese Journal of Emergency Medicine 2008;17(7):690-692
Objective To study the value of electronic administration analysis system used for pre-hospitalrecords in comparison with statistic data processed manually. Method The data of 'first aid medical records'collected from June 26, 2007 to December 26, 2007 in Wuxi Emergency Center, Wuxi, China were taken for anal-ysis. The items for comparison included the average number of emergency patients monthly, percentage of intra-venous infusion, proportion of ECG and blood oxygen saturation monitoring, rate of blood glucose measurement,number of pre-hospital treatment, frequency of using medical devices and time taken for answer to inquires. Thecomparison was carried out between statistic data processed manually and those processed electronically. ResultsBetween two different methods of statistic process, there were no significant in all items ( P > 0.05) except theshorter time required for electronic process to answer the inquires (P<0.01). Conclusions The electronic ad-ministration analysis system for the records of emergency patients is fully developed to meet the expectation in termsof quick answer to inquries with credibly and precisely numerical values.
6.Risk factors of cardiovascular and cerebrovascular accidents in patients undergoing maintenance hemodialysis
Jiawei JIANG ; Wei FAN ; Hong CHU ; Zhenxin WANG ; Ling ZHOU
Chinese Journal of General Practitioners 2020;19(9):829-834
Objective:To investigate the risk factors of cardiovascular and cerebrovascular events in patients undergoing maintenance hemodialysis (MHD).Methods:A total of 285 patients undergoing MHD in the Blood Purification Center of Yixing People′s Hospital from May 2013 to March 2018 were enrolled, including 137 patients with cardiovascular and cerebrovascular events and 148 patients without cardiovascular and cerebrovascular events. The demographic and clinical data of patients were retrospectively reviewed. The age, systolic blood pressure, duration of dialysis and prevalence of atherosclerosis were compared between the two groups; the risk factors of cardiovascular and cerebrovascular events were analyzed by multivariate logistic regression.Results:There were significant differences in age, systolic blood pressure, duration of dialysis and prevalence of atherosclerosis; serum creatinine, serum phosphorus, hs-CRP and triglyceride levels between the two groups ( P<0.05). Multivariate logistics analysis showed that age ≥50 years ( B=0.42, 95 %CI 1.06-3.06, P=0.03), duration of dialysis≥24 months ( B=0.85, 95 %CI: 1.23-3.79, P=0.01), atherosclerosis ( B=0.58, 95 %CI: 1.13-4.02, P=0.04), hypertension ( B=0.23, 95 %CI: 1.34-9.25, P<0.01), diabetic kidney disease (DKD) ( B=0.36, 95 %CI:1.19-8.27, P<0.01) , increased hs-CRP ( B=0.83, 95 %CI: 1.12-3.90, P<0.01), high serum phosphorus ( B=0.91, 95 %CI: 1.06-1.54, P<0.01) and elevated TG ( B=0.50, 95 %CI: 1.08-5.57, P<0.01) were independent risk factors for cardiovascular and cerebrovascular events in MHD patients. Early and active intervention of these risk factors may improve the clinical prognosis of MHD patients. The Cox survival curve showed that the probability of cardiovascular and cerebrovascular events increased when the duration of dialysis was>12 months, and it increased more significantly when the duratio n>24 months. Conclusion:The older age, dialysis duration, comorbidities of atherosclerosis, hypertension, DKD, and elevated serum hs-CRP, phosphorus, triglyceride may increase the probability of cardiovascular and cerebrovascular events for MHD patients.
7.Fe-Co/ZIF-8@SLC-0111-HA composite nanoplatform enhances feasibility of tumor chemodynamic therapy
Zhenxin WANG ; Peng ZHOU ; Fuchao CHU ; Dazhen ZHANG ; Feng YUAN
Chinese Journal of Tissue Engineering Research 2024;28(29):4612-4619
BACKGROUND:The low catalytic activity and lack of targeting of commonly used metal ions have severely limited the clinical application of chemodynamic therapy in tumor treatment.On the other hand,although the composite nanoplatforms are endowed with tumor-targeting functions by surface functionalization,the lack of tumor microenvironment acidity also severely weakens the efficacy of chemodynamic therapy. OBJECTIVE:To prepare novel composite nanoplatforms and assess their feasibility to enhance the effects of chemodynamic therapy at the cellular level. METHODS:SLC-0111-loaded zeolite imidazole framework-8 doped with divalent iron ions(Fe2+)and divalent cobalt ions(Co2+)(Fe-Co/ZIF-8@SLC-0111)was synthesized by ion-exchange reaction and self-assembly,and loaded with hyaluronic acid(HA)by electrostatic adsorption,followed by obtaining the target nanoparticles Fe-Co/ZIF-8@SLC-0111-HA(abbreviated as FC-S).Meanwhile,nanoparticles Fe-Co/ZIF-8-HA(abbreviated as FC)without SLC-0111 were synthesized by the same method.The nanocomposite platform was tested for particle size,zeta potential,surface morphology,in vitro reactive oxygen species generation,and ability to consume glutathione.Human osteosarcoma cell MG-63 and mouse fibroblast cell L929 were used as experimental subjects.The cytotoxicity of FC-S was detected by CCK-8 assay.Human osteosarcoma cell MG-63 was used as the experimental object to detect the cell internalization of FC-S.In addition to H2O2,the effects of FC-S and FC on intracellular pH,carbonic anhydrase 9 protein expression,cell viability and apoptosis,intracellular reactive oxygen species and glutathione content,and mitochondrial membrane potential were investigated. RESULTS AND CONCLUSION:(1)The FC-S composite nanoplatform was successfully prepared with a well-defined rhombic dodecahedral structure,uniform size and good dispersion.Its particle size was about 323 nm;zeta potential was about-11.1 mV,and the nanoplatform had a certain reactive oxygen species generation capacity in vitro.(2)FC-S nanoplatforms accumulated intracellularly in a time-dependent manner and could successfully escape from lysosomes.When the mass concentration of FC-S was≤20 μg/mL,there was no obvious cytotoxicity to MG-63 cells and L929 cells,and 20 μg/mL FC-S was selected to act on MG-63 cells in subsequent experiments.(3)Compared with FC group,the protein expression of carbonic anhydrase 9 in MG-63 cells in FC-S group was decreased(P<0.01);the intracellular acidic environment was enhanced;the content of reactive oxygen species was increased(P<0.001);the mitochondrial damage was aggravated;the number of dead cells was increased,and the apoptosis rate was increased(P<0.001).(4)The results indicate that FC-S,as a novel composite nanoplatform,can effectively improve the weakly acidic microenvironment in tumor cells and enhance the level of intracellular reactive oxygen species production,thus enhancing the efficacy of chemodynamic therapy.
8.Standardized Operational Protocol for Human Brain Banking in China.
Wenying QIU ; Hanlin ZHANG ; Aimin BAO ; Keqing ZHU ; Yue HUANG ; Xiaoxin YAN ; Jing ZHANG ; Chunjiu ZHONG ; Yong SHEN ; Jiangning ZHOU ; Xiaoying ZHENG ; Liwei ZHANG ; Yousheng SHU ; Beisha TANG ; Zhenxin ZHANG ; Gang WANG ; Ren ZHOU ; Bing SUN ; Changlin GONG ; Shumin DUAN ; Chao MA
Neuroscience Bulletin 2019;35(2):270-276
Brain
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pathology
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China
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Humans
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Organ Preservation
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standards
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Tissue Banks
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ethics
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standards
9.Efficacy of basiliximab in the treatment of 87 cases of steroid-refractory or steroid-dependent acute graft-versus-host disease.
Zhen Xin HE ; Rong Li ZHANG ; Wei Hua ZHAI ; Qiao Ling MA ; Ai Ming PANG ; Dong Lin YANG ; Yi HE ; Jia Lin WEI ; Xin CHEN ; Er Lie JIANG ; Si Zhou FENG ; Ming Zhe HAN
Chinese Journal of Hematology 2022;43(2):120-127
Objective: To evaluate the efficacy and prognosis of basiliximab in the treatment of steroid-refractory or steroid-dependent acute graft-versus-host disease (SR/SD-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) . Methods: Clinical data of 87 patients with SR/SD-aGVHD in the skin, intestine, and liver after allo-HSCT at the Institute of Hematology & Blood Diseases Hospital Transplantation Center from January 2015 to December 2018 were retrospectively analyzed. The administration plan of basiliximab was as follows: 20 mg for adults and children weighing ≥35 kg and 10 mg for children weighing<35 kg. The drug was administered once on the 1st, 4th, and 8th days, respectively, and then once weekly. The efficacy was evaluated on the 7th, 14th, 21st, and 28th days after basiliximab treatment. Results: ①There were 51 males (58.6%) and 36 females (41.4%) , with a median (range) age of 34 (4-63) years. There were 54 cases of classic aGVHD, 33 of late aGVHD, 49 of steroid-refractory aGVHD, and 38 of steroid-dependent aGVHD. ②Thirty-five patients (40.2%) achieved complete remission (CR) , 23 (26.4%) achieved partial remission (PR) , and 29 had no remission (NR) . The total effective rate[overall response rate (ORR) ] was 66.7% (58/87) . ③The ORR of the classic and late aGVHD groups was 77.8% (42/54) and 48.5% (16/33) , respectively. ④The median (range) follow-up time was 154 (4-1813) days, the 6-month overall survival (OS) rate of the 87 patients was 44.8% (95% CI 39.5%-50.1%) and the 1-year OS was 39.4% (95%CI 34.2%-44.3%) . ⑤After treatment with basiliximab, the 6-month OS in the CR (35 cases) , PR (23 cases) , and NR (29 cases) groups was 80.0% (95%CI 73.2%-86.8%) , 39.1% (95%CI 28.9%-49.3%) , and 6.9% (95%CI 2.2%-11.6%) , respectively (χ(2)=34.679, P<0.001) , and the 1-year OS was 74.3% (95%CI 66.9%-81.7%) , 30.4% (95%CI 20.8%-40.0%) , and 3.4% (95%CI 0%-6.8%) , respectively (χ(2)=43.339, P<0.001) . The OS of the classic and late aGVHD groups was 57.4% (95%CI 50.7%-64.1%) and 24.2% (95%CI 16.7%-31.7%) , respectively (χ(2)=9.109, P=0.004) , and the 1-year OS was 51.9% (95%CI 45.1%-58.7%) and 18.2% (95%CI 11.5%-24.9%) , respectively (χ(2)=9.753, P=0.003) . ⑥Univariate and multivariate analyses showed that late aGVHD (OR=3.121, 95%CI 1.770-5.503, P<0.001) , Minnesota score high-risk group before medication (OR=3.591, 95%CI 1.931-6.679, P<0.001) , active infection before medication (OR=1.881, 95%CI 1.029-3.438, P=0.040) , and impairment of important organ function caused by non-GVHD (OR=3.100, 95%CI 1.570-6.121, P=0.001) were independent risk factors affecting the efficacy of basiliximab. Conclusion: Basiliximab has good efficacy and safety for SR/SD-aGVHD, but not in patients with late aGVHD, high-risk group of Minnesota score, and infection or impaired function of important organs.
Acute Disease
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Adult
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Basiliximab/therapeutic use*
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Child
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Female
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Graft vs Host Disease/drug therapy*
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Hematopoietic Stem Cell Transplantation/adverse effects*
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Humans
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Male
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Middle Aged
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Retrospective Studies
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Steroids/therapeutic use*