Objective To compare the safety of recombinant human tumor necrosis factor-Fc (rhTNFR:Fc) and other DMARDs,in patients with rheumatoid arthritis (RA),ankylosing spondylitis (AS),juvenile idiopathetic arthritis (JIA) or psoriatic arthritis (PsA).Methods Patients who received rhTNFR:Fc 25 mg twice weekly from May 2006 to March 2009 were involved in this open-lable study.Safety assessments were carried out at regular intervals.Results Of the 2014 patients enrolled in the open-label trial,1388,421 and 232 were RA,AS or other diseases,such as JIA and P.sA respectively.Frequent adverse events included injection-site reactions (2.67％),rash (1.87％) and hyperamino transferase (1.80％) in RA patients.Similarly,injection-site reactions (5.23％),hyperaminotransferase (2.38％) and rash (0.71％) were frequent in AS patients.Upper respiratory infection was most frequent among infectious adverse events.There were no reports of patients with serious adverse events,dead case,TB infection and malignancies.Conclusion rhTNFR:Fc has shown a favourable safety profile in Chinese rheumatic disease patients.

To optimize the growth condition for the established gene engineer bacteria express cardiac troponin-I(cTnI) and to obtain purified cTnI as an antigen to produce clinical assay kits used in acute myocardial injury(AMI) diagnosis.Plackett Burman Design(PBD) was applied to select the factors which effect the expression of cTnI in Escherichial coli(E.coli) mostly.Induction time,pH and KCl were proved influenced expression of cTnI notably.Afterward,Response Surface Methodology(RSM) as second step to optimize the selected three factors,an equation was deduced to predict the percent of cTnI.In the most optimized condition,the percent of cTnI can reach to 26% of total cell protein.The procedures of purification included ammonium sulfate deposition and DEAE Cellulose ion exchange chromatography.SDS-PAGE shows that purified cTnI contain one band.cTnI could be used to immune animals as an antigen to produce monoclonal antibodies with high affinity and specificity.It maybe as calibrators to harmony the difference assays of cTnI measurement in clinical.

Objective To evaluate the efficacy and safety of infliximab plus methotrexate combination therpy in Chinese with rheumatoid arthritis patients.Methods This was a double-blind placebo-controlled phaseⅢclinical trial,173 patients who had active rheumatoid arthritis were randomised to placebo(n=86)or infliximab(n=87)group on a background of a stable dosage of methotrexate.Patients were assessed at weeks 0,2,6,14 and 18.Results At week 2,the American College of Rheumatology(20)response criteria,which represent a 20% improvement from baseline,the same results with swollen joint count,tender joint count,du- ration of morning stiffness,VAS score,CRP,ESR were achieved in 52.9% of patients,compared with 14.0% of patients receiving placebo plus methotrexate.A 20% improvement was achieved in 75.9% of infliximab plus methotrexate at week 18,compared with 48.8% of patients on placebo plus methotrexate(P=0.0003).A 50% improvement was achieved in 43.7% of infliximab plus methotrexate at week 18,compared with 25.6% of pa- tients on placebo plus methotrexate(P=0.011).Infliximab was well-tolerated;withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections were similar to those in the placebo group.There was only one case of tuberculosis in the treatment group.Conclusion Treatment with infliximab plus methotrexate is more effective than methotrexate alone in patients with active rheumatoid arthritis.It has rapid onset of effect and the efficacy is persistent.

Objective To investigate the effect of recombinant adenovirus mediatied human endostatin (rAD-GFP-ES)on rats with collagen typeⅡinduced arthritis(CIA),and explore the mechanism of inflamma- tion and cytokines inhibition on rats CIA.Methods The rAD-GFP-ES was amplified and purified.The model of rat CIA was induced by intradermal injection of typeⅡcollagen combined with complete Freund's adjuvant(CFA). On the second day after the injection,the therapeutic administration of rAD-GFP-ES(1?10~(11)pfu?kg~(-1)?week~(-1)?4 weeks)were performed to the rats.The mean arthritis index(AI)was scored every week since then.The relative concentrations of ES,IL-I?,TNF-?in sera collected at the fourth week were evaluated by western blotting. Results①The titer of the purified rAD-GFP-ES and rAD-GFP was 6.6?10~(12)pfu/ml and 4.8?10~(12)pfu/ml,re- spectively(A_(260nm)/A_(280nm)＞1.3).②The concentration of ES in sera of the group treated with rAD-GFP-ES was 2.4-lold higher compared to the normal group.③The mean arthritis index of the group treated with rAD-GFP- ES was much lower than that of the model group.The administration of rAD-GFP-ES could significantly de- creas the production of IL-1?and TNF-?in sera.Conclusions①The rAD-GFP-ES is efficiently expressed in vivo.②The rAD-GFP-ES has an inhibitory effect on the arthritis index of rat CIA.③IL-1?and TNF-?are involved in the pathogenesis of RA.The rAD-GFP-ES has an inhibitory effect on the expression of IL-1?and TNF-?in rat CIA.

Objective To study the macrophage colony-stimulating factor(M-CSF)expression levels of serum and synovial fluids from patients with spondyloarthropathy(SPA)and its contribution to the pathogen- esis of SpA.Methods Eleven SpA synovial tissue samples were compared to those from peripheral blood mononuclear cells(PBMC)of 10 normal subjects using a 1176 gene array.M-CSF was detected in both serum samples and synovial fluids by enzyme linked immunosorbent assay(ELISA).Two groups of AS subjects were tested.The first group consisted of 41 ankylosing spondylitis(AS)patients who had not been treated with bio- logics.The second group consisted of 13 subjects whose serum samples were collected before and 14 weeks af- ter initiation of infliximab.These were compared to serum samples from 28 normal subjects,and synovial fluid samples from 15 SpA patients.Results Expression of M-CSF could be detected in both serum samples and synovial fluids.The concentration of M-CSF in the group of 41 AS patients not treated with biologics correlated with the Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)values(r=0.41,P=0.004).Treatment of infliximab in AS patients led to a significant decrease in the values of BASDAI(P=0.000 07),but no signif- icant change in the serum M-CSF values.Conclusion M-CSF is a promising candidate for research on the mechanisms of SpA and its signaling on pathway in SpA is different from tumor necrosis factor(TNF)-?,and it may provide new basis for developing new anti-biologics for SpA.

Objective To discuss the midterm results of modular femoral prosthesis in total hip revision surgery for bone defects.Methods From December 2001 to June 2006,by using Link-MP modular femoral prosthesis for muhiple reasons(48 with asepsis loosening,seven with infections using two-stage revision procedure,one with fracture of proximal femur and one with periprosthetie fracture), total hip revision surgery was carried out in 56 eases including 24 males and 32 females with age range of 38-77 years(mean age 58.8years).Causes for revision included sterile prothesis loosening in 48 cases, infection of hip prosthesis in seven and peripheral fracture of femoral stem fracture prosthesis in one.Re- vision for infected femur was all at stageⅡ.Of 56 cases with femoral stem prosthesis loosening,30 had loosening of primary cemented prosthesis and 26 of uncemented prosthesis.According to the Mallory bone defect classification,five eases were with typeⅡbone defect,21 with typeⅢA,28 with typeⅢB and two with typeⅢC.Bone grafting was performed in 12 cases and wire or cable cerelage in 28.Fracture of great trochanter was found in two cases,fracture of femoral stem in three and perforation of femoral stem in one.Results A total of 52 eases half year after operation were followed up for mean 31.78 months (8-56 months).No migration of distal femoral stem was found in all eases except for one ease had 1.5 cm subsidence of proximal femoral stem.The Harris hip score was preoperative 46 scores(21-52)and post- operative 89(79-94).There found no significant limb discrepancy,thigh pain or dislocation.Conclu- sions Total hip revision surgery for femoral bone defect using modular femoral prosthesis has optimal midterm result especially in its advantages of regulating limb length,offset,anteversion,which can help us match the proximal femur with distal femur and achieve initial and long-term stability.

ObjectiveTo explore the effectiveness and practicability of training technique in hemiplegia.Methods313 stroke patients with hemiplegia were divided randomly into the control group and training group, and treated with integrative training technique for hemiplegia impairment during 3 months. Locomotor recovery and the performance of activities of daily living (ADL) of patients in two groups were assessed before and after one, two and three months training respectively, using Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM) and the scale of impairment in community rehabilitation.ResultsAfter treatment, FMA, FIM and the scale of impairment in community rehabilitation of the patients in the training group improved significantly ( P<0.001), the effectiveness was better than that of the control group ( P<0.05～0.001).The scales of FMA and FIM were proportional to the scale of impairment in community rehabilitation.ConclusionThe training technique for hemiplegia has ideal rehabilitation effectiveness.

Objective To obtain the normal values of four-phase rhinomanometry specific parameters of normal adult Chinese and analyze the correlation between four-phase rhinomanometry and acoustic rhinometry measurement results. Methods Eighty-five normal adults were recruited. The HRR2 four-phase rhinomanometer was used to acquire the effective resistances in inspiration, expiration and total breathing process (Reffin, Reffex, Refft) and vertex resistance in the process of inspiration and expiration (Vrin and Vrex). The Eecovisian acoustic rhinometry was used to measure the minimum cross-sectional area (MCA) and the nasal volume of 0-5 cm nasal cavity (V5). Results Reffin (x-±s) was (1.28±1.02) Pa/(cm3·s) for male, (1.55±1.03) Pa/(cm3·s) for female;Reflex (x-±s) was (1.43±1.07) Pa/(cm3·s) for male, (1.75±1.14) Pa/(cm3·s) for female;Refft (x-±s) was (1.34±0.99) Pa/(cm3·s) for male, (1.62±1.03) Pa/(cm3·s) for female;Vrin (x-±s) was (1.31±1.03) Pa/(cm3·s) for male;(1.60±1.03) Pa/(cm3·s) for female, Vrex (x-±s) was (1.46±1.04) Pa/(cm3·s) for male, (1.82·1.17) Pa/(cm3·s) for female. No statistically significant difference was found between men and women(r=0.661、-0.397、0.127、0.649、-0.684, P>0.05, respectively). There was no significant correlation between Reffin, Reffex, Refft, Vrin, Vrex and age, height, weight, head circumference, body surface area, body mass index (P>0.05, respectively). However, there was significant correlation between Reffin, Reffex, Refft, Vrin, Vrex and MCA, V5 (P<0.05, respectively). Conclusions The results of four-phase rhinomanometry show significant correlation to acoustic rhinometry.

OBJECTIVETo investigate clinical effects and mechanism of Tangweikang (TWK) in treating diabetic gastroparesis.

METHODSNinety diabetic gastroparesis patients were randomly assigned to 3 groups. Besides conventional hypoglycemic treatment, the 30 patients in the treated group were given TWK and the 30 in the control group were given Domperidone additionally, while to the 30 in the blank group, no additional drug was given. The clinical efficacy and the changes in level of motilin and gastric emptying rate were observed.

RESULTSTWK showed significant effects in improving clinical symptoms of patients, increasing gastric emptying rate, promoting gastrointestinal kinetics, shortening gastric emptying time and was beneficial to the control of blood sugar, including the 2 h post-prandial blood sugar and fructosamine. The curative rate and total effective rate in the treated group were 63.33% (19/30) and 93.33% (29/30) respectively, significantly different to those in the control group 26.67% (8/30) and 63.33%, also different to those in the blank group 23.33% (3/ 30) and 10.00%, respectively (P < 0.01). The clinical efficacy in the treated group was superior to that in the other two groups.

CONCLUSIONTWK has favorable therapeutic efficacy in treating DGP.

Aged ; Antiemetics ; therapeutic use ; Diabetes Complications ; drug therapy ; Domperidone ; therapeutic use ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Gastroparesis ; drug therapy ; etiology ; Humans ; Male ; Middle Aged ; Phytotherapy ; Treatment Outcome

Recombination plasmid pMM085 possessed both immunogens heat-labile enterotoxin(LT) and fimbriae antigen K88 of enterotoxigenic Escherichia coli (ETEC). Althouth vaccine strain MM-3 carrying pMM085 had good effect to protect piglets against diarrhea due to ETEC infections,it was not ideal live vaccine for pMM085 bringing chloramphenicol resistance gene (cat). To solve the problem,the host-plasmid balanced lethal system was introduced which including the replacement of cat gene by asd gene and transformation the new plasmid to the strain X6097 which asd gene was knocked out in its chromosome. Considering pMM085 was a big plasmid (23kb) and traditional genetic manipulations was not easy to carry on,?-Red recombination system was adopt in this work to realize the replacement of cat gene by asd gene. The results indicated that ?-Red recombination system was convenient and efficient to reconstruct big plasmid.