Child ; Child, Preschool ; Endoscopy, Digestive System ; Female ; Follow-Up Studies ; Humans ; Infant ; Male ; Peptic Ulcer

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.

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.

OBJECTIVE:To provide reference for the establishment of work mode of automatic dispensing system in large-scale integrated pharmacy. METHODS:Introducing the establishment and optimization situation of the automatic pharmacy dispensing system in the outpatient pharmacy of our hospital,changes of related deployment indexes before and after optimization were compared,and the main measures for improving the work efficiency of automatic dispensing system were explored. RE-SULTS:Based on setting and regularly adjusting stored drug varieties,numbers of occupied tracks and unbundled drug factors,de-signing deployment operation mode that the system automatically dispensing preparations to immediate-dispensing and pre-dispens-ing windows,establishing operational specifications and management refinement,the outpatient pharmacy had established automat-ic dispensing system with prescription deployment number more than 12000 pieces/d and optimized work mode. Compared with be-fore optimization,host,auxiliary and smart cabinet varieties were increased in the case of the same number of total staff,immedi-ate-dispensing windows were increased and pre-dispensing windows were decreased. Proportion of full-automatically-dispensed pre-scriptions was increased (up from 41.18% to 48.32%) in the case of total prescription increasing in peak hours,and numbers of hourly prescription deployment were increased in both immediate-dispensing and pre-dispensing windows. Average time to wait for medicine of patients was shortened(down from 5.63 min to 5.18 min),supplemental medicine error and inner errors rate of deploy-ment (down from 0.48% to 0.44%) were decreased (P<0.05). CONCLUSIONS:The established automatic dispensing system mode can meet the needs of prescription deployment in large-scale integrated outpatient pharmacy,and improve the work efficiency by continually optimization.

Chronic Disease ; Female ; Humans ; Lead Poisoning ; complications ; Middle Aged ; Occupational Diseases ; Renal Insufficiency ; chemically induced

Objective: To systematically assess the effectiveness and safety of using acupuncture-moxibustion therapy alone to treat adult overactive bladder (OAB) by taking oral Western medication solely as the control, and to provide evidence-based reference for acupuncture-moxibustion treatment of OAB. Methods: A systemic search was conducted through China National Knowledge Infrastructure (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP), China Biology Medicine Disc (CBM), PubMed, Cochrane Library, and Excerpta Medica Database (EMBASE). RevMan 5.3 was used for meta-analysis. Statistical descriptions were made using standardized mean difference (SMD), confidence interval (CI), and risk ratio (RR). Results: Eight randomized controlled studies were finally recruited and were analyzed after being grouped according to intervention methods. Regarding urinary symptoms, compared with sole use of oral Western medication, acupuncture plus moxibustion can more effectively reduce 24 h urinary frequency [P=0.01, SMD=-0.57, 95％CI (-1.02, -0.12)], 24 h nocturia frequency [P=0.03, SMD=0.49, 95％CI (0.05, 0.94)], and OAB syndrome score (OABSS) [P<0.001, SMD=-3.67, 95％CI (-4.48, -2.86)]. Acupuncture combined with moxibustion and oral Western medication work equivalently in comparing 24 h urinary urgency frequency [P=0.38, SMD=-0.17, 95％CI (-0.57, 0.22)], 24 h urgent incontinence frequency [P=0.25, SMD=0.26, 95％CI (-0.18, 0.70)], and single voiding volume [P=0.22, SMD=1.15, 95％CI (-0.70, 3.00)]. There were no significant differences between acupuncture/electroacupuncture and oral medication in comparing 24 h urinary frequency [P=0.46, SMD=0.07, 95％CI (-0.12, 0.26)], 24 h urinary urgency frequency [P=0.18, SMD=0.70, 95％CI (-1.71, 0.32)], 24 h nocturia frequency [P=0.46, SMD=-0.71, 95％CI (-2.60, 1.17)], 24 h urgent incontinence frequency [P=0.08, SMD=-0.22, 95％CI (-0.48, 0.03)], single voiding volume [P=0.09, SMD=0.17, 95％CI (-0.02, 0.36)], or OABSS [P=0.96, SMD=-0.07, 95％CI (-2.65, 2.52)]. Compared with oral Western medication, moxibustion can more effectively reduce 24 h urinary frequency [P<0.001, SMD=-6.53, 95％CI (-7.65, -5.44)] and 24 h urinary urgency frequency [P<0.001, SMD=-1.6, 95％CI (-2.85, -0.36)]. In comparing the adverse reaction rate, acupuncture-moxibustion was associated with a lower rate compared with oral medication [P=0.002, RR=0.07, 95％CI (0.01, 0.37)], but the difference was statistically insignificant between acupuncture/electroacupuncture and oral medication [P=0.40, RR=0.57, 95％CI (0.16, 2.12)]. Conclusion: Acupuncture-moxibustion is equivalent to the sole use of oral Western medication in improving urinary symptoms in OAB patients and has a higher safety rating.

Objective To evaluate the distribution and drug resistance of bacteria causing neonatal infectious pneumonia in Jiaxing,and to provide a therapy for clinical doctor to make a correct diagnosis,choose reasonable anti-biotics and avoid abuse of antibiotics.Methods Took expectoration from trachea in condition of asepsis to conduct culture and perform drug-sensitive test from 3025 cases.Results Totally 1 156 strains of aerobic bacteria were iso-lated.875 strains were gram negative bacilli(75.7%),269 strains were gram positive cocci(23.3%),and 12 strains were fungi(1.0%).Klebsiella pneumoiae,Escherichia coil,Acinetobacter baumanni,Enterobacter cloacae were com-mon in gram negative bacilli( respectively 178 cases,151 cases,87 cases,113 cases) .The proportion of the Staphylo-coccus aureus was the largest in gram positive cocci(245 cases) .The results showed that gram-negative bacilli were resistant to cefazolin, ampicillin, piperacillin and sensitive to meropenem, imipenem, piperacillin-tazuobatanna and cefoperazone-sulbactam.The drug resistance was severe of ESBL-positive.Staphylococcus aureus was resistant to penicillin, ampicillin, erythrocin, clindamycin and sensitive to linezolid, vancomycin, nitrofurantoin.Conclusion Gram-negative bacilli are the main bacteria in neonatals with infectious pneumonia.The drug resistance is severe.It is important to make a standard management and isolation.

Innate lymphoid cell is a type of newly discovered innate immune cell , which can function as adaptive T cells . Based on the transcription factors and the expression of effector cytokines , innate lymphoid cells can be categorized into three sub-groups:ILC1, ILC2 and ILC3.The inflammatory factors these produced by ILC play an important role in the development of inflamma -tory bowel disease (IBD), but ILC3 can secrete IL-22, which promotes the restoration of intestinal epithelial cells .Exploring the func-tion of ILC has a great significance in the treatments of IBD .This article reviews their phenotype , function and also relationship with IBD.

ObjectiveTo investigate the protective mechanism of Ginsenoside Rb1 on apoptosis of primary cultured cerebral cortical neurons caused by hypoxia.MethodsThe anti apoptosis effect of Ginsenoside Rb1 on primary cultured neurons was observed by methods of the primary culture of cerebral neurons of postnatal rats in free serum with neurobasal medium supplied with 2% B27 supplement, trypan blue exclusion, hypoxic culture of neurons, Hoechst 33342 staining and immunocytochemistry.ResultsAt concentrations of 10μg/ml,50μg/ml and 100μg/ml, the Ginsenoside Rb1 dropped apoptosis rate of cerebral cortical neurons induced by hypoxia (in 100 μg/ml,P<0.05),and increased Bcl-2 protein expression (except 10μg/ml,P<0.05) and decreased Bax protein expression (except 10μg/ml,P<0.05—P<0.001) in the cerebral cortical neurons induced by hypoxia, improved the ratio of Bcl-2/Bax (except 10 μg/ml,P<0.05).ConclusionGinsenoside Rb1 is able to prevent hypoxic neurons from apoptosis in primary cultured cerebral cortical neurons from 50—100 μg/ml. The effect of anti apoptosis is through up regulation of Bcl-2 protein expression and down regulation of Bax-2 protein expression.