Objective:To observe the effects of Qingluotongbi granule(QLT) on the changes of cytokines in adjuvant induced arthritis(AIA) model of rats.Methods:The AIA model of rats were induced by complete Freunds adjuvant. Various doses of QLT were given by gavage once daily for 21 days.Results:QLT〔7.2,14.4 g/(kg?d).ig〕markedly decreased the levels of IL-1 and TNF-? in AIA rats.Conclusion:QLT has modulating effects on the alternations of cytokines of AIA model.

ObjectiveTo establish an analytical method with high sensitivity and wide range in biotin-avidin and time-resolved fluoroimmunoassay system for the quantitative detection of antinuclear antibody (ANA)-Ig (GAM).MethodsANA in standard preparation or sample was combined with solid nuclear antigen,biotinylation antibody and the europium(Eu3+)-labelled avidin to form the compounds of solid nuclear antigen-antibody-biotinylation antibody-SA-Eu3+.The fluorescence enhancement fluid was added to dis-sociate the Eu3+,the content of ANA was directly proportional to fluorescence intensity,the BAS-TRFLA was established for the quantitative detection of ANA-Ig (GAM).The sensitivity,specificity,reliability and range of detection were evaluated.Semm of 50 blood donor,105 patients with systemic lupus erythematosus (SLE),109 patients with rheumatoid arthritis(RA),25 patients with PBC,29 patients with Sj(o)gren's syndrome (SS),23 patients with scleroderma,25 patients with MCTD were included in this study.The positive rate was calculated.ResultsThe inner-group difference between high,medium and low densities mixture serum was 3.13％,3.74％ and 5.76％ and the inter-group precision rate was 5.31％,6.25％ and 7.46％ in BAS-TRFLA.The sensitivity of TRFIA was better than that of the ELISA method.The low detection limit was 2.24 U/ml.The mean recovery rate was 100.74％.The results measured by the TRFIA and ELISA methods were closely correlated(R2=0.978).The positive rate of blood donor,and patient with SLE,RA,PBC,SS,scleroderma and MCTD were 0,100％,23％,96％,38％,91％,92％ respectively.When compared with ELISA,the detection range of TRFIA was wider,and stability was better.ConclusionBAS-TRFIA is a stable method for detection of ANA with high sensitive and wide range of detection.It is important for the early diagnosis of autoimmune disease and monitoring the treatment efficacy of autoimmune disease.And this method may be widely used in clinical laboratories in the future.

Objective To develop a method for detecting anti-cyclic citrullinated peptide (anti-CCP)in the serum of rheumatoid arthritis patients. Methods The range of lineage correlation, precision and detection range of time-resolved fluoroimmunoassay (TRFIA) was analyzed. Thirty-two positive serum of antiCCP, and the sera from 50 health blood donors, 32 SLE patients, 26 patients with SS, 10 patients with scleroderma, 20 patients with MCTD and 18 patients with MS were tested in this study. The clinical specificity was assessed. The consistency between TRFIA and ELISA was analyzed by Mc Nemar test. Results Analyzed by SPSS 13.0 statistical software, the intra-batch precision (n=20) rate was 2%, 3% and 4% respectively, and the inter-batch precision (n=8) was 3%, 4% and 7% respectively for 3 different concentrations. The clinical specificity was 98%, 97%, 96%, 100%, 95% and 100% in the sera of healthy blood donors, SL,E, SS,scleroderma, MCTD and MS patients respectively. The correlation coefficient was 0.989.The average recovery rate was 101%, and the sensitivity was 1 U/ml. When compared with ELISA, the detection range of TRFIA was wider and also with betterstability. Conclusion TRFIA is a stable method with high sensitivity and wide detection range. It can be used to detect anti-CCP antibody. It is important for early diagnosis of RA and monitor the curative effect of RA. And this method has potential to be used in clinical diagnosis.

Objective To review the performance of the IFCC enzyme reference methods in China laboratories and to evaluate the competence of enzyme reference measurement in China.Methods The Intemational Federation of Clinical Chemistry and Laboratory Medicine(IFCC)enzyme reference methods were performed in 8 China laboratories.Reference procedures were developed by each laboratory and the performances were evaluated.The Clinical and Laboratory Stadards Institute(CLSI)EP-5 protocol was used for the evaluation of precision and certified reference materials(CRMS)were used for the verification of trueness.Seven of the 8 laboratories participated in the 2006 IFCC external quality assessment program for reference laboratories(RELA)for the assessment of the measurement performance.Results Within-run CVs of less than 1.5%and between-run CVs of less than 2%were achieved bv all the China laboratories.Results on CRMs by some of the laboratories agreed with the certified value within the stated uncertainty.In the 2006 RELA,the averages and the interlaboratory CVs of the China laboratories were similar to those of international laboratories.Conclusion A preliminary enzyme reference method laboratory network has been established in China.

Objective To evaluate the efficacy and safety of domestic human recombinant FSH (rhFSH) in women with anovulation of WHO groupⅡ. Methods A randomized, blind, parallel-controlled, non-inferiority and multicenter study was performed. A total of 534 admitted to 13 hospitals from May 2008 to August 2009. There were 531 women with ovulatory disorder was included in the statistical analysis, were randomly divided into test group (domestic rhFSH, n=352) and control group (imported rhFSH, n=179). Percentage of cycle with mature follicle, ovulation rate, clinical pregnancy rate, multiple pregnancy rate, ovarian hyperstimulation syndrome (OHSS) and adverse events were observed. Results No statistical significant differences (P>0.05) were observed between the two groups in terms of the efficiency on mature follicle [91.8%(323/352) versus 88.8%(159/179)], ovulation rate [91.3%(295/323) verus 90.6%(144/159)], clinical pregnancy rate [19.2%(62/323) verus 18.2%(29/159)], the number of the follicles<14 mm, the level of serum LH and progesterone, the thickness of endometrium on the day of hCG administration. The number of follicle≥18 mm and 14 mm≤follicle<18 mm and the level of serum estradiol on the day of hCG in the test group were significantly higher than those in the control group (P<0.05). The number of days of rhFSH administration in the test group was significantly less than that in the control group [(9.8±2.2) versus (11.4± 0.6) days, P<0.05], the dosage of rhFSH was significantly lower than that in the control group [(879 ± 419) versus (1 043 ± 663) U, P<0.05]. The multiple pregnancy rate in the test group was significantly higher than that in the control group [21% (13/62) versu 10% (3/29), P<0.05]. The incidence of OHSS and adverse events were similar between the two groups (P>0.05), and no other adverse events were observed in test group during treatment. Conclusion Ovarian stimulation with domestic rhFSH is effective, safe and economical in women with anovulation of WHO groupⅡ.

Objective:To study the patterns of tocilizumab (TCZ) use, its efficacy and safety in patients with rheumatoid arthritis (RA) in routine clinical practice.Methods:A total of 407 patients with RA were enrolled from 23 centers and treated with TCZ within 8 weeks prior to the enrollment visit, and were followed for 6-month. The patterns of TCZ treatment at 6 months, the effectiveness and safety outcomes were recorded. Statistical analysis was performed using SAS version 9.4.Results:A total of 396 patients were included for analysis, in which 330 (83.3%) patients received TCZ combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and 16.7%(66/396) received TCZ monotherapy. At baseline, TCZ was initiated in 56.6%(224/396) and 9.6%(38/396) of patients after failure of DMARDs and other biological agents (bDMARDs) respectively. During the 6-month follow-up period, the mean frequency of TCZ administration was (3.7±1.6), the mean TCZ dosage was (7.4±1.2) mg/kg, and the mean interval between doses was (40±13) days. 120(25.8%) patients were on TCZ treatment at the end of the study. Improvements in disease activity, systemic symptoms and patient report outcomes were observed at the end of the study. 22.7%(90/396) patients experienced at least one treatment related adverse event, and 8 patients experienced at least one serious adverse event.Conclusion:This study demonstrates that TCZ treatment is effective in patients with RA when being treated for 6 months with an acceptable safety profile. The duration of TCZ treatment needs to be extended.

BACKGROUNDBone damage around the joints is one of the major pathophysiological mechanisms that leads to rheumatoid arthritis (RA) chronic disability. Serum tartrate-resistant acid phosphatase 5b (TRACP-5b) is secreted by osteoclasts, its activity can be used as a clinically relevant bone resorption marker. The aim of this study was to test whether the measurement of serum levels of TRACP-5b in patients with RA would correlate with measures of disease activity and with responses to therapy.

METHODSFifty-six patients were randomly assigned to receive recombinant human cytotoxic tlymphocyte-associated antigen-4 immunoglobulin (RhCTLA4-Ig), infliximab or methotrexate (MTX). The clinical and serologic indicators of RA activity were evaluated at baseline and at 24 weeks. Serum TRACP-5b was measured by Enzyme-linked Immunosorbent Assay (ELISA) at 0, 12 and 24 weeks. Hand X-rays were obtained at baseline.

RESULTSAt baseline, the levels of TRACP-5b correlated with the severity of X-ray damage, disease duration (r = 0.332, P = 0.012), and tender joint count (r = 0.408, P = 0.002). The 24 weeks values of TRACP-5b for RhCTLA4-Ig group and infliximab group differed significantly from the baseline values in each group (P < 0.05; P < 0.05), whereas only the value for RhCTLA4-Ig group differed significantly from the 24 weeks value for the MTX group (P < 0.01). Considering the two biologics-treated groups together, the TRACP-5b levels at 24 weeks differed significantly from the baseline values only in those patients who reached an ACR70 level (P < 0.05).

CONCLUSIONSMeasurement of serum TRACP-5b in RA patients reflects clinical and radiological measures of disease activity, treatment with certain biologics, and degree of response to therapy. TRACP-5b should be investigated further as a potential biomarker to predict response to therapy, including slowing of radiographic progression.

Acid Phosphatase ; blood ; Adolescent ; Adult ; Antibodies, Monoclonal ; therapeutic use ; Arthritis, Rheumatoid ; blood ; drug therapy ; Biomarkers ; blood ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Infliximab ; Isoenzymes ; blood ; Male ; Methotrexate ; therapeutic use ; Middle Aged ; Osteoclasts ; metabolism ; Pilot Projects ; Tartrate-Resistant Acid Phosphatase ; Young Adult

Ankylosing spondylitis is a chronic immunoinflammatory disease that mainly affects the spine and the sacroiliac joint， the mechanism of which is closely related to signaling pathways， such as osteoprotegerin （OPG）/receptor activator of nuclear factor-κB （RANK）/RANK ligand， mitogen-activated protein kinase （MAPK）， Wnt/β-catenin （β-catenin）， phosphoinositide 3- kinase/protein kinase B/mammalian target of rapamycin （PI3K/Akt/mTOR）. Traditional Chinese medicine has the characteristics of multiple components and targets， and is widely used for the treatment of autoimmune diseases due to its low toxicity， strong specificity， and high efficacy. This review found that monomers and compounds of traditional Chinese medicine can exert anti ankylosing spondylitis effects by intervening in the aforementioned signaling pathways， regulating immune inflammatory responses， and inhibiting biological processes such as bone destruction， ectopic osteogenic differentiation， cell apoptosis， and autophagy.

As an important complementary form of decoction pieces of traditional Chinese medicine（TCM）， TCM dispensing granules has the advantages of being free of decoction， easy to take， easy to carry and easy to be dispensed， which greatly improves the capacity of emergency services of TCM and is more in line with the needs of modern society. With the end of the pilot project of TCM dispensing granules， the market has been fully liberalized， the competition has been intensified， and it is in the transition period of switching between the new standard and the old one， and there are some problems such as the shortage of varieties， the change of specifications and the difference of quality， and the production enterprises are facing new opportunities and challenges. Based on this， the authors intend to systematically sort out the policies and regulations， enterprise layout and standard formulation since the pilot of TCM dispensing granules. In view of the problems in the post-pilot stage and from the perspective of survival and development of enterprises， it is suggested that enterprises should establish a quality control system for the whole industry chain of TCM dispensing granules to reduce process costs and increase enterprise competitiveness， further increase the investment in scientific research， overcome the key technical problems of difficult varieties， actively and orderly promote the research of national standards， in order to ensure the integrity of clinical formula varieties， and establish and improve the efficacy evaluation mechanism of TCM dispensing granules， build a consistency evaluation system between TCM dispensing granules and decoction pieces. Government departments should strengthen the guidance， fully mobilize the enthusiasm of scientific research institutions， enterprises and hospitals， and explore the establishment of "government-industry-study-research-application" mode to promote the development of TCM dispensing granule industry.