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.

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

BACKGROUNDAdjacent segment degeneration could seriously affect the long-term prognosis of lumbar fusion. Dynamic fixation such as the interspinous fixation, which is characterized by retaining the motion function of the spinal segment, has obtained satisfactory short-term effects in the clinical setting. But there are few reports about the biomechanical experiments on whether dynamic fixation could prevent adjacent segment degeneration.

METHODSThe surgical segments of all 23 patients were L4/5. Thirteen patients with disc herniation of L4/5 underwent Wallis implantation surgery, and 10 patients with spinal stenosis of L4/5 underwent posterior lumbar interbody fusion (PLIF). L3-S1 segmental stiffness and displacement were measured by a spine stiffness gauge (SSG) device during surgery when the vertebral plate was exposed or during spinal decompression or internal fixation. Five fresh, frozen cadavers were used in the self control experiment, which was carried out in four steps: exposure of the vertebral plate, decompression of the spinal canal, implantation of a Wallis fixing device, and PLIF of L4/5 after removing the Wallis fixing device. Then, L3-S1 segment stiffness was measured by an SSG device.

RESULTSThe experiments showed that the average stiffness of the L4/5 segment was (37.1 ± 8.9) N/mm after exposure of the vertebral plate, while after spinal decompression, the average stiffness fell to (26.2 ± 7.1) N/mm, decreasing by 25.8% (P < 0.05). For the adjacent segments L3/4 and L5/S1, their stiffness showed no significant difference between the L4/5 segment decompression and the exposure of the vertebral plate (P > 0.05). After Wallis implantation of L4/5, the stiffness of the cephalic adjacent segment L3/4 was (45.8 ± 10.7) N/mm, which was 20.5% more than that after the exposure of the vertebral plate (P < 0.05); after L4/5 PLIF surgery, the stiffness of L3/4 was (35.3 ± 10.7) N/mm and was decreased by 12.4% more than that after the exposure of the vertebral plate (P < 0.05). The stiffness of the cephalic adjacent segment L3/4 after fixation in the Wallis group was significantly higher than that of the PLIF group (P < 0.05). Cadaver experiments showed that the stiffness of the cephalic adjacent segment in the Wallis group was significantly higher than that of the PLIF group after L4/5 segment fixation (P < 0.05); the stiffness of the L5/S1 segment showed no significant difference between PLIF surgery and Wallis implantation (P > 0.05).

CONCLUSIONSAfter interspinous (Wallis) fixation, the stiffness of the cephalic adjacent segment increased. After PLIF with pedicle screw fixation, the stiffness of the cephalic adjacent segment decreased. An interspinous fixation system (Wallis) has a protective effect for cephalic adjacent segments for the immediate post-operative state.

Adult ; Bone Screws ; Female ; Humans ; Lumbar Vertebrae ; surgery ; Male ; Middle Aged ; Spinal Fusion ; instrumentation ; methods

OBJECTIVETo investigate the protective effects of recombinant SCR15-18 domain of human soluble complement receptor type 1 (sCR1-SCR-15-18) in rats underwent myocardial ischemia and reperfusion (I/R).

METHODSSprague-Dawley rats were randomly divided into three groups (n = 12 each group): sham (SO); 30 min ischemia/3h reperfusion (I/R) and I/R plus sCR1-SCR15-18 (15 mg/kg before I/R, sCR1). Serum LDH, CK and cardiac myeloperoxidase (MPO) activity were measured. Infarct size, myocardial histopathological changes and myocardial C3c were also compared among groups.

RESULTSInfarct size [(16.1 +/- 3.3)% vs. (22.9 +/- 3.0)%, infarct zone/left ventricular mass, P < 0. 05] and CK [(2532.5 +/- 597.1) U/L vs. (3400.9 +/- 534.9) U/L, P < 0. 05] and LDH [(5436.2 +/- 611.3) U/L vs. (6572.0 +/- 476.3) U/L, P < 0. 05] as well as MPO activity in infarct zone [(0.81 +/- 0.14) U/g vs. (1.12 +/- 0.13) U/g, P < 0.05] were significantly decreased post sCR1 compared to I/R group. sCR1 also significantly attenuated histological myocardial injury and reduced the deposition of C3c in infarct zone.

CONCLUSIONsCR1-SCR15-18 protein exerts cardioprotective effects in this rat I/R model.

Animals ; Creatine Kinase ; metabolism ; Disease Models, Animal ; Humans ; L-Lactate Dehydrogenase ; metabolism ; Myocardial Reperfusion Injury ; metabolism ; pathology ; prevention & control ; Peroxidase ; metabolism ; Rats ; Rats, Sprague-Dawley ; Receptors, Complement ; therapeutic use ; Receptors, Complement 3b ; metabolism ; Recombinant Proteins ; therapeutic use