1.Improving Medical Care Quality and Strengthening Hospital Infection Management
Chinese Journal of Nosocomiology 2006;0(08):-
OBJECTIVE To understand the current situation in management of nosocomial infections in hospitals,and provide rational preventive measures in order to improve the medical care quality.METHODS An observatory study was conducted and reasonable suggestions were preferred referring to foreign nosocomial infections modes.RESULTS Problems were found to a different extent in administration of nosocomial infections.Most alarming problems were shortages of rules and regulations,and deficiency of infection propaganda and administration coordination.CONCLUSIONS Strengthening management of nosocomial infections is one of the key issues for improvement of the medical care quality and should be paid special attention.
2.Clinical analysis of early treatment of explosion deafness.
Chinese Journal of Industrial Hygiene and Occupational Diseases 2009;27(5):306-307
Adolescent
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Adult
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Blast Injuries
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complications
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Deafness
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etiology
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therapy
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Female
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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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Treatment Outcome
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Young Adult
3.Development of mass spectrometry technique for quality assessment of monoclonal antibodies
Wen-wen ZHU ; Meng-lin LI ; Jin-lan ZHANG
Acta Pharmaceutica Sinica 2020;55(12):2843-2853
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.
4.N-Glycans and intact glycopeptide-based characterization of N-glycosylation of monoclonal antibody drugs
Meng-lin LI ; Wen-wen ZHU ; Jin-lan ZHANG
Acta Pharmaceutica Sinica 2021;56(9):2360-2366
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.
5.More emphasis on pathobiological behavior of hepatic tumors.
Chinese Journal of Surgery 2010;48(15):1121-1124
6.Therapeutic Effect of Recombinant Human Interleukin-11 on Thrombopenia in Children with Acute Non-Lymphocytic Leukemia after Chemotherapy
qiong, MENG ; quan, WEN ; wan-hai, FU
Journal of Applied Clinical Pediatrics 2004;0(09):-
Objective To explore the preventive and therapeutic effect of recombinant human interleukin-11(rhIL-11) on thrombocytopenia in children with non-lymphocytic leukemia after chemotherapy.Methods Sixteen children who had non-lymphocytic leukemia were divided into 2 groups by randomization,including a therapeutic group and a control group.RhIL-11[50 ?g/(kg?d)] was injected subcutaneously 24 h after chemiotherapy in the therapeutic group,and applied consecutively 10-14 days,and the control group was treated without RhIL-11.Duration of the thrombocytopenia,infusion of blood platelet,diversity of blood platelets counts and adverse effect were observed of the 2 groups.Differences between groups were examined using statistics analysis.Results There were 16 case-times(59.3%) in the therapeutic group that of could be cured without platelet transfusion,but that of control group only had 3 case-times(14.3%);the diffe-rence between 2 groups was significant(P
7.Effect of Acupoints Stimulation with Silver Spike Point Therapy on Insomnia
Yi CHEN ; Meng LIU ; Wen-ge SONG
Chinese Journal of Rehabilitation Theory and Practice 2006;12(6):517-518
ObjectiveTo observe the effect of acupoints stimulation with silver spike point therapy on insomnia.Methods60 patients with insomnia were randomly divided into the trial group and control group with 30 cases in each group. Patients of the trial group were treated by acupoints stimulation with silver spike point therapy and patients of control group were treated only with Clonopin. All patients of two groups were tested with Self-Rating Scale of Sleep (SRSS) before and after treatment.ResultsThe curative effect rate of the trial group was 86.6%; that of the control group was 60%; the curative effect of the trial group was superior to the control group (P<0.05). SRSS difference of the trial group pre-and post-treatment was 12.79±3.20; that of the control group was 10.1±3.89. There was also a significant difference between two groups (P<0.01).ConclusionThe silver spike point therapy has the better curative effect on insomnia than Clonopin.
8.Effects of internal and external biliary drainage on inducible nitric oxide synthase mRNA expression of Kupffer cell and serum tumor necrosis factor-alpha in rats with obstructive jaundice
Ying MENG ; Yunsheng YANG ; Wen LI
Chinese Journal of Digestion 2008;28(10):669-672
Objective To study the effects of internal and external biliary drainage on inducible nitric oxide synthase (iNOS) mRNA expression of Kupffer cells and serum tumor necrosis factor-alpha (TNF-α) in rats with obstructive jaundice. Methods Forty-eight male Sprague-Dawley rats were randomly assigned to obstructive jaundice (OJ), sham operation (SH), internal biliary drainage (ID) and external biliary drainage (ED) groups with 12 each. Kupffer cells were isolated by in situ hepatic perfusion and digestion with collagenase type Ⅳ, and purified by cell culture attachment. The expression of iNOS mRNA of Kupffer cells was detected by reverse transcription polymerase chain reaction (RT-PCR) and the serum TNF-α concentration was measured using ELISA method. Results The serum TNF-α level was increased in OJ group[ (110.84±26.3) pg/ml ]compared with SH group [-(88.4±17.9) pg/ml, (P=0.045)]. The TNF-α level in ID group[ (89.8±28. 3) pg/ml ]was significantly lower than that in ED group[ (118.64±22.7) pg/ml, (P=0. 011) ]and OJ group (P=0. 059). Expression of iNOS mRNA of Kupffer cells was significantly higher in OJ group (0. 824± 0. 24) compared with SH group (0. 384±0.35,P=0. 005). After relieving the OJ, the iNOS mRNA expression in ED group (0. 974± 0.48) was not suppressed (P=0. 321). On the contrary, the iNOS mRNA expression in ID group was suppressed and significantly lower than that in ED group (0. 59±0. 35) (P=0. 016). Conclusions Internal biliary drainage is superior to external drainage in terms of reversing the elevated serum TNF-α and in suppressing the iNOS mRNA expression of Kupffer cells in rats with obstructive jaundice.
10.Research and application of nano-hydroxyapatite/polyamide 66 biocomposites
Congyou WEN ; Chunyang MENG ; Dianming JIANG
Chinese Journal of Tissue Engineering Research 2014;(3):464-469
BACKGROUND:The nano-hydroxyapatite has obvious advantages in bone repairing and reconstruction, but its clinical application is limited for its low osteoinductive activity and poor mechanical properties. To overcome these defects, researchers, based on the bionics principles, composite nano-hydroxyapatite with inorganic or/and organic materials to get various biomimetic composite materials.
OBJECTIVE:To review the research and application of nano-hydroxyapatite/polyamide 66 biocomposites. METHODS:A computer-based search of PubMed database was undertaken with the keywords of“nano, hydroxyapatite, polyamide 66”in English to retrieve the relevant articles published from January 1987 to
December 2012. Simultaneously, the relevant articles between January 1987 to December 2012 were searched in CNKI database with the key words of“nano, hydroxyapatite, polyamide 66”in Chinese. A total of 93 literatures were retrieved, and final y 56 standard literatures were included.
RESULTS AND CONCLUSION:The nano-hydroxyapatite/polyamide 66 biocomposites have appropriate thermostability and mechanical properties as wel as good biocompatibility. So far, the research and application of nano-hydroxyapatite/polyamide 66 biocomposites mainly focus on artificial vertebral body, lamina, and cage. The satisfactory clinical effects of the biocomposites show their broad clinical application prospects. However, there are stil many problems to be solved. For example, there are no detailed long-term fol ow-up data concerning osteogenic induction and degradation. Additional y, current studies focus on the bio-safety of materials in the aspects of cytology and histology rather than at the molecular level.