Stiff-person syndrome(SPS) is a rare neurologic disorder with autoimmune features.It is characterized by progressive,severe muscle rigidity or stiffness most prominently affecting the spine and lower extremities.It is frequently associated with diabetes and other autoimmune diseases.The diagnosis of SPS is based on clinical grounds,however,aided by electromyography and high serum titers of antibodies against glutamic acid decarboxylase.Intravenous immunoglobulin infusions,plasmapheresis and steroids provide additional and lasting benefit.Moreover,benzodiazepines,baclofen,tiagabine and botulinum toxin A can afford symptomatic relief.

Objective To explore the health inspector effect on the score of hygienic degree of hostels. Methods Using the scale for hygienic degree of hostels, 38 health inspectors from 9 sections in the Bureau for Health Inspection and Supervision of Haidian District in Beijing, scored 621 hostels in the district. The multilevel statistics model has been used to analyze the health inspector effect, of which the index is intra-class correlation (ICC), in the double level model structured by hostels as the level 1 unit and inspectors as the level 2 unit, and in the triple level model structured by hostels as the level 1 unit, inspectors as the level 2 unit and the sections as the level 3 unit. Results In the double level model, ICC of the level 2 unit is 0.142 8. In the triple level model, ICC of the level 2 unit is 0.0000 and ICC of the level 3 unit is 0.154 1. Conclusion There is inspector effect influencing the score of hygienic degree. And the effect seems to be more similar in one section comparing with the other ones.

Objective To explore the basic health state of the hotels in Haidian District. Methods 736 hotels were chosen to investigate on the hygiene state, in Haidian District, Beijing, during Feb.-Jul., 2006, based on the tables for the hygienic quantified and classified management of hotel health supervision. Results The hygienic quantified and classified standard score of 736 hotels was 53.7?22.6, and the standard score of the common hotels, one or two stars hotels and three or more stars hotel were 50.9?21.5, 58.9?24.7, 76.4?17.1. 50 households (6.8%) within them were A degree, 144 households (19.6%) were B degreee, 121 households(16.4%) were C degree and 421 households(57.2%) were D degree. Conclusion The general hygienic state of the hotels should be paid more attention to. The hygienic state changes with the level of the hotels.

OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.

Objective To evaluate the feasibility and significance of CT image-based threedimensional (3D) brachytherapy for cervical cancer.Methods Three-dimensional (3D) plan and twodimensional (2D) plan were designed for 55 CT images of brachytherapy from 12 cervical cancer patients who received radical radiotherapy in 2013.Dosimetric comparison was performed between the 3D plan and 2D plan,and paired t-test,Wilcoxon signed rank test,Pearson correlation analysis,and Spearman correlation analysis were performed.Results A point dose,D90,V100,CI,and CI' in 3D plan were higher than those in 2D plan (P=0.015,0.016,0.000,0.000,0.000).Bladder point dose,rectal point dose,and rectal D2 cm3 in 3D plan were slightly higher than those in 2D plan,but hot spot dose was significantly reduced in 3D plan (P =0.140,0.123,0.214).Bladder D2cm3 was significantly higher than bladder point dose (P =0.000).Sigmoid colon D2cm3 was more correlated with the average doses of the three highest rectal points than rectal D2 cm3 (r =0.314,0.630,P =0.000,0.000).V100 showed a linear relationship with high-risk CTV (r =0.981,P =0.000).Bladder D2cm3 was higher than 430 cGy when the bladder volume was more than 80 cm3 ;small intestinal D2 cm3 did not change significantly when the bladder volume was less than 115 cm3,but decreased significantly once the volume exceeded the value.Conclusions Compared with the traditional 2D plan,the 3D plan for CT image-based cervical cancer brachytherapy significantly increases the target coverage and conformity index,but does not significantly increase the doses to organs at risk.Point dose evaluation is confirmed to be inaccurate.The doses to the bladder,rectum,and small intestine can be adjusted by controlling the bladder volume.

OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

Objective To investigate the expressions of stern cell markers CD133,nestin and CD44 in malignant melanoma and their significance.Methods Tissue samples were obtained from 30 patients with malignant melanoma and 30 patients with intradermal nevus.The expressions of three markers were immunohistochemically detected in the samples.Results In malignant melanoma specimens,the expression rate of CD133,nestin and CD44 was 53.33%(16/30),80.00%(24/30)and 20.00%(6/30),respectively,significantly difierent from that in intradermal nevus specimens [23.33%(7/30),53.33%(1 6/30)and 0,respectively,all P＜0.05].The percentage of cells positive for CD133,nestin and CD44 was 2.98%±5.62%,34.92%±34.89%and 1.28%±3.26%,respectively,in malignant melanoma specimens.0.10%±0.21%,7.26%±13.13%and 0,respectively,in intradermal nevus specimens;there was a significant difierence between the two groups of specimens(all P＜0.05).In malignant melanoma and intradermal nevus,the expression intensity of CD133.nestin and CD44 showed no significant correlation with patients'sex.age or disease course(all P＞0.05).ConclusionsCD133,nestin and CD44 are highly expressed in malignant melanoma,but weakly expressed or absent in intradermal nevus,suggesting that tumor stem cells might exist in malignant melanoma tissue.

Objective To investigate the role of muhiplex ligation-dependent probe amplification(MLPA) in identifying fetal aneuploidy of chromosomes 13,18,21,X,and Y. Methods From June 2007 to December 2008,263 samples(prenatal diagnosis group),including amniotic or umbilical cord blood from pregnant women who required prenatal diagnosis,were processed in parallel by MLPA and conventional karyotype to detect fetal aneuploidy.Another 26 samples(fetal death group).ineluding retained abortion and fetal death,were also processed bv MLPA. Results Five cases of 21-trisomy,4 eases of 18-trisomy,1 case of 13-trisomy and 3 cases of 45,X were identified among the prenatal diagnosis group by MLPA,and the results were consistent with karyotype.Two cases of 45,X and 1 case of 18-trisomy were identified among the retained abortion and fetal death group. Conclusions MLPA is a rapid,efficient,simple,reliable and economical technique in detecting most common chromosomal aneuploidies and have important clinical value.

Objective To copy the mouse aging model with D-galactose,and to investigate the role of Schisandra total lignin (SCL)in the mouse brain tissue aging and its mechanism.Methods 50 mice were radomly divided into control group,model group (100 mg·kg-1 ·d-1),low dose (35 mg·kg-1 ·d-1)of SCL group (SCL-L), middle dose (70 mg· kg-1 · d-1 )of SCL group (SCL-M)and high dose (140 mg· kg-1 · d-1 )of SCL group (SCL-H)(n=10).D-galactose (100 mg·kg-1 ·d-1 )was injected into the mice hypodermically for 10 weeks to induce aging models in all the groups except control group,and 35,70,and 140 mg· kg-1 · d-1 SCL were administered for 10 weeks in SCL groups.The learning and memory abilities were measured by the Water Maze test.The expression levels of Bax,Bcl-2,ubiquitin (Ub),microtubule-associated protein light chain 3 (LC3)in the brain tissue of the mice in various groups were observed by Western blotting method. The LC3 protein expressions in mouse brain cortex and hippocampus were observed by immunohistochemistry.Results In learning and memory test,compared with control group,the swimming time of the mice in model group was increased (P<0.05),and the number of errors was increased (P<0.05);compared with model group,the swimming time in SCL-L,SCL-M and SCL-H groups was decreased (P<0.05)and the number of errors was also decreased (P<0.05). Compared with control group,the expression level of Bax was increased (P<0.05),the expression level of Bcl-2 was decreased (P<0.05),the expression levels of Ub and LC3-Ⅱ/LC3-Ⅰ proteins were increased (P<0.05)in model group;compared with model group,the expression level of Bax was decreased (P<0.05),the expression level of Bcl-2 was incerased (P<0.05),and the expression levels of Ub and LC3-Ⅱ/LC3-Ⅰ proteins were decreased (P<0.05)in SCL-L,SCL-M and SCL-H groups.In control group,the neuronal morphology was normal,and none of brown granules were visible in the cytoplasm of mouse brain cortex and hippocampus and the expression of LC3 protein was negative.In model group,the neurons were degeneration,and the number of LC3 protein positive cells in the cerebral cortex and hippocamptal tissue was increased (P<0.05).In SCL-L,SCL-M and SCL-H groups,the number of degenerative neurons was decreased,and the number of LC3 protein positive cells was decreased (P<0.05).Conclusion SCL can inhibit the D-galactose-induced brain tissue aging in the mice, and the mechanism is related to regulating autophagy and inhibiting apoptosis.

Here we discuss whether N terminal sequencing is appropriate as one of the conventional control methods for monoclonal antibody products. We determined the N terminal sequences of two monoclonal antibody products targeting two antigens separately with both Edman degradation and mass peptide spectrometry. We also identified the characteristic peptide fragments with mass spectrometry. Furthermore, we analyzed their heterogeneity with ion exchange chromatography, capillary zone electrophoresis and Imaged Capillary Isoelectric Focusing. Edman degradation method showed that the N terminal 15 amino acids of heavy and light chains of the two monoclonal antibodies were identical. Peptide mass spectrometry demonstrated that T1 peptide fragments of heavy and light chains of the two antibodies were also the same. But in contrast, peptide mapping and the three analytical methods for heterogeneity analysis could effectively identify and differentiate the two antibodies. The N terminal sequences of two monoclonal antibodies are identical because the number of framework sequences of humanized or human monoclonal antibodies is relatively limited, so whether N terminal sequencing analysis could be regulated as one of the practical control methods should be carefully discussed. Our work also proves that the above analytical methods could combinatorially applied to the identification of monoclonal antibody products, and are more objective compared to N terminal sequencing.
Amino Acid Sequence ; Antibodies, Monoclonal ; isolation & purification ; Chromatography, Ion Exchange ; Humans ; Isoelectric Focusing ; Mass Spectrometry ; Peptide Mapping ; Peptides ; Sequence Analysis, Protein ; methods