In recent years, the biopharmaceutical industry has grown rapidly, and the market size of monoclonal antibody drugs has increased significantly. Accurate structural characterization and quality control are the supporting technologies for the development of monoclonal antibody drugs. As a significant post-translational modification of antibody drugs, glycosylation has an important influence on its efficacy, stability, and immunogenicity. The existing literature usually uses liquid chromatography-mass spectrometry to perform major glycosylation modifications of monoclonal antibody drugs. Characterization, there are few studies on low-abundance glycosylation, but the characterization and control of low-abundance glycosylation cannot be ignored. In this study, we have established a qualitative and quantitative analysis technology for N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs. This method has a short sample processing time and high sensitivity. It can not only characterize the main glycoforms of three monoclonal antibody drugs (adalimumab, bevacizumab, and trastuzumab) but also can quantify low-abundance N-glycans. The results of the study showed that the main glycoforms specified in the Pharmacopoeia could be detected in different batches of monoclonal antibody drugs, but the content of N-glycans in different batches of samples is not identical. After that, we analyzed the N-glycans connection sites and glycoforms at the intact glycopeptide level, further enriching the N-glycans structure information of the monoclonal antibody. The qualitative and quantitative analysis technology of N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs can realize the in-depth characterization and control of glycosylation modification of monoclonal antibody drugs.

The research and development of monoclonal antibodies (mAbs) is a rapidly developing field. From the first generation of murine mAbs to the fourth generation of fully human mAbs, the efficacy and safety of mAbs in the treatment of various diseases have been continuously improved. In order to regulate the development and evaluation of mAbs, drug regulatory agencies and pharmacopeias of America and China have tried to issue feasible test procedures and acceptance criteria for quality evaluation of mAbs and biosimilars. Mass spectrometry (MS) technique with high sensitivity, resolution, selectivity, and specificity has become an important tool to evaluate the quality characteristics of monoclonal antibody-related products or specify mAb quality. The research of MS-based monoclonal antibody study involves structure characterization, impurity analysis, pharmacokinetics/pharmacodynamics (PK/PD), etc. This review focuses on the current quality control requirements of mAb related products and the development of MS technique for mAb quality characterization and specification. It is expected to provide information and references for evaluating the quality of monoclonal antibodies under research and development.

Objective To investigate the efficacy of butylphthalide on elderly patients with acute cerebral infarction and its effect on serum uric acid,c-reactive protein,and hemorheology.Methods Elderly patients (86 cases) with acute cerebral infarction in Xi'an No.1 Hospital from January 2015 to December 2015 were randomly divided into two groups.The control group was treated with conventional symptomatic treatment of acute cerebral infarction,observation group added with butylphthalide soft capsules.The NIHSS score and efficacy of the two groups,the serum uric acid,c-reactive protein,and the change of hemorheology before and after treatment were compared.Results The effective rate of observation group was 90.70％,significantly higher than that of control group 72.09％ (P ＜ 0.05);The NIHSS score,serum uric acid and c-reactive protein levels,blood viscosity and platelet aggregation rate of two groups after treatment were significantly lower (P ＜ 0.05),the Barthel index were significantly increased (P ＜ 0.05),and the change of observation group were more significant (P ＜ 0.05).Conclusion Butylphthalide has high curative effect on elderly patients with acute cerebral infarction,can reduce the level of serum uric acid,c-reactive protein and the degree of nerve function defect,improve the hemorheology and life self-care activities ability,which can protect the brain.

Objective:To understand the current situation of hospital violence medical students experienced during the internship period and their professional identity.Method:With the method of cluster sampling,a questionnaire survey was conducted among 500 medical students from a medical college in Ganzhou,to understand the characteristics of hospital violence and compare the difference between the medical students who experienced violence and those not.Results:The effective recovery rate of questionnaire was 90.8％,of which 61.4％ of medical students had witnessed hospital violence,8.1％ of students had experienced hospital violence;the hospital violence that medical students experienced were characterized by low frequency and emotional violence.The overall score of personal identity was (117.05 ± 19.65),was in a medium level.Among the comparison of personal identity between the medical students who had experienced violence and those not,there was a significant difference in occupational cognition dimension (P ＜ 0.01),but there was no significant difference in the total score and other four dimensions (P ＞ 0.05).Conclusion:We should pay attention to the current situation of hospital violence that students experienced and their professional attitude,carry out targeted training and psychological counseling to improve their ability to respond to hospital violence and enhance their professional identity.

CX-conjugated antigen(BSA-CX) were produced by methods of EDC.The spleen cells of BALB/C mouse immunized by BSA-CX were fused with SP2/0 plasmacytoma cells using PEG4000,and selected cultured with HAT and HT medium.A hybridoma cell line of 2H8-B1-F4 was secreened for specificity to CX,and cloned by limited dilution method for 3 times,which secrete high affinity and stable monoclonal antibodies against CX with indirect ELISA. The antibody was characterized by IgG1 isotype, the titers of antibody in cell supernatant and ascites were 1∶1000 and 1∶4?10~5,respectively.The mAb against CX was selective toward dicloxacillin, oxacillin with cross-reactivity of about 19.6% and 21.3%,which can be used to detect CX residues by competitive ELISA.

0.05).However,phosphor-ERK and phosphor-STAT3,NF-?B were higher in CVB_3 group than those in control groups(P

Objective To investigate the clinical feature and antibiotic resistance profile of K.pneumoniae isolates from patients for better management of K.pneumoniae infections.Methods Nonduplicate K.pneumoniae strains were collected from January to December in 2015.K.pneumoniae strains were identified by VITEK 2-Compact 60 and tested for antimicrobial susceptibility by KirbyBauer method.Results A total of 753 strains ofK.pneumoniae were included,most (40.9％,308/753) of which were isolated from sputum,followed by urine (18.2％,137/753).Most of the strains were from old patients at least 60 years of age (40.8％,307/753),and primarily from intensive care units (16.7％,126/753) and Department of Respiratory Medicine (13.7％,103/753).Respiratory tract infection was found in 144 patients,of which 71.5％ (103/144) were due to K.pneumoniae.More than half of the K.pneumoniae strains were resistant to piperacillin (66.3 ％),cefazolin (60.8 ％) and cefitroxime (59.4 ％).Only a few strain were resistant to imipenem (2.4 ％) and meropenem (2.0).ESBLs were produced in 410 (54.4 ％) of the 753 strains,and 29 (3.9 ％) strains were carbapenem-resistant,492 (65.3 ％) strains were resistant to multiple antimicrobial agents.Conclusions Clinical K.pneumoniae isolates are highly resistant to most of the antimicrobial agents tested.The strains were mostly isolated from sputum and urine,and positive for ESBLs.MDR K.pneumoniae sWains are emerging.K.pneumoniae isolates are still very susceptible to carbapenems in vitro.

In view of the predominance problems in present experimental teaching of medical microbiology, we reformed the experimental contents and experimental teaching methods,to establish an entire experimental curriculum teaching system to be suitable for seven-year system and long educational system students,which manifests the creative teaching idea.

Objective To explore the efficacy of ketogenic diet( KD) in the treatment of status epi-lepticus( SE) and whether KD could protect the brain,and propose a new thought on SE patients′reasonably individualized treatment, brain protection and prognosis improvement. Methods From Sep 2013 to Jan 2015,all the patients diagnosed as SE were advised to apply KD treatment; the patients who refused KD treatment were included in the control group,while the patients who accepted KD treatment were included in the treatment group. Based on the SE treatment principles,the control group applied traditional anti-convulsive therapy,while the treatment group applied traditional therapy combined with KD treatment. Before the treat-ment and after the epilepsy control,the patients′ serum was collected to test neuron specific enolase( NSE) and S100βlevels,and the duration of epilepsy control was recorded. Results The treatment group included a total of 10 patients; 3 patients had a good efficacy and obtained seizure-free after the treatment; clinical seizures declined significantly in 6 patients. The treatment group′s overall response rate was 9/10,which was higher than that of the control group(5/8)(P<0. 01). The treatment group′s duration to gain efficacy was shorter than that of the control group[(5. 2 ± 2. 9) d vs. (9. 8 ± 1. 5) d,P<0. 01]. After the treatment,the patients′NSE and S100β in both groups were significantly decreased than those before the treatment ( P<0. 001 or P<0. 05). After the treatment,the serum NSE and S100β of the patients in the treatment group were lower than those in the control group,with statistically significant difference(P<0. 05). Conclusion Frequent epileptic seizures and SE would impair the patient′s brain. Controlling the epileptic seizures actively could lower the severity of brain injury. KD could effectively control the epileptic seizure and had neuropro-tective effects.

Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Tricuspid Valve Stenosis ; etiology