OBJECTIVE: To determine the content of the related substances in azithromycin tablet by HPLC-electrochemical detector.METHODS: The column was Gamma ARP-1/P.The mobile phase consisted of 0.014 mol?L-1 dipotassium hydrogen phosphate/0.020 mol?L-1 sodium hydroxide(pH was adjusted to 11 by phosphoric acid and sodium hydroxide)-acetonitrile(71∶29) at a flow rate of 0.7 mL?min-1.The column temperature was 40 ℃.The injection volume was 50 ?L.Glass carbon working electrode was set at +900 mV.RESULTS: The linear ranges of erythromycin peroxide,deoxyazithromycin,azithromycin impurity A,and N-demethlation azithromycin were 0.15～1.80 ?g(r=0.999),0.09～1.08 ?g(r=0.999),0.23～2.76 ?g(r=0.998) and 0.30～3.60 ?g(r=0.998),respectively.The average recoveries were 98.9%(RSD=1.1%),94.6%(RSD=5.4%),103.4%(RSD=3.4%) and 96.2%(RSD=4.3%),respectively.The contents of the related substances were all below 0.7%.CONCLUSION: The established method is reproducible,sensitive and reliable,and applicable for the detection of the related substances in azithromycin tablets.

Objective To investigate genetic polymorphisms of IRF7/KIAA1542 (rs4963128, rs2246614) and STAT4 (rs7574865) and their relationships with lupus nephritis and various autoantibodies present in Chinese Han population of SLE patients. Methods A total of 748 SLE patients and 750 healthy controls belonging to the Chinese population were enrolled into this study. They were genotyped using MALDI-TOF-MS method. Autoantibodies including anti-SSA, anti-SSB, anti-Sm, anti-RNP and anti-dsDNA were determined either by indirect immunofluorescence or double immunodiffusion methods. Results In the healthy group, rs7574865 (STAT4) T/T, T/G, G/G genotype frequency and T, G allele frequencies were as follows: 9.4% , 45. 6% , 45. 0% , 32. 2% , 67. 8% , the corresponding case group as follows: 17.0% , 48.1%, 34.9%, 41.0%, 59.0%, genotype and allele frequencies were significantly different (x2 = 26.30, P<0.01). Compared with the control group, in the case group, T/T genotype frequency and T allele frequency were significantly increased, and in three genetic models ( additive model, dominant model, recessive model), the genotype frequencies were significant difference (P <0. 01). Two polymorphic loci of rs4963128 and rs2246614 (IRF7/KIAA1542) were not statistically significant (x2 =4.49,5.32,P>0.05) in case group and control group, but the rs2246614 genotype frequencies had a statistically significant in recessive model (P <0. 05) , whereas rs4963128 genotype frequencies was no significant difference in the three genetic model (P=0.068, 0.958, 0.067, respectively). In the clinical subphenotype analysis, IRF7/KIAA1542 (rs4963128) in lupus nephritis group (OR = 2. 69, 95% CI = 1. 89-3. 82, P < 0.01) ,anti-SSA antibody group ( OR = 0. 61, 95% CI = 0. 43-0. 87, P < 0. 05 ) and anti-SSB antibody group ( OR =0. 36, 95% CI = 0. 23-0. 56, P < 0.01) of the analysis were statistically significant. At the same time, IRF7/KIAA1542 (rs2246614) in the joint comparison of positive and negative symptoms were also statistically significant (OR=1.34, 95% CI = 1. 06-1. 69, P < 0. 05). Conclusions This findings provide strong evidence suggesting that STAT4 ( rs7574865 ) is the susceptible factor of SLE in Chinese Han population. However, there is not a significant relationships between IRF7/KIAA1542 (rs4963128, rs2246614) polymorphisms and the risk of SLE, but the associations of IRF7/KIAA1542 (rs4963128, rs2246614) with the a variety of clinical subphenotypes, such as lupus nephritis, joint symptoms and production of anti-SSA antibody and anti-SSB antibody implicates IRF7/KIAA1542 as a putative candidate gene of SLE.

Objective:To investigate the relationship between neutrophil/lymphocyte (NLR), red blood cell distribution width (RDW), platelet/lymphocyte (PLR), platelet mean volume (MPV), platelet hematocrit (PCT) and platelet distribution width (PDW) and the disease activity of Takayasu arteritis (TA).Methods:A retrospective analysis was conducted on 86 TA patients (TA group) in Anzhen hospital from January 2017 to June 2019. Meanwhile, 85 healthy controls (control group) whose age and gender matched with TA were selected from the health examination center of Beijing Anzhen hospital. The blood samples were collected to measure the neutrophil/lymphocyte (NLR), red blood cell distribution width (RDW), platelet/lymphocyte (PLR), platelet mean volume (MPV), platelet hematocrit (PCT) and platelet distribution width (PDW) by resistance method. TA activity was determined according to the national institutes of health (NIH) score and India TA clinical activity score (ITAS2010). Spearman correlation analysis was used to evaluate the relationship between whole blood cell count indicators and ESR and hs-CRP. ROC curve was used to determine the threshold of TA disease activity.Results:The NLR, RDW and PDW in the TA group were higher than those in the control group [3.00 (1.78-3.48) vs. 1.76 (1.34-2.01), 14.10 (13.00-14.83) vs. 13.08 (12.50-13.35) and 13.65 (11.20-16.00) vs. 12.24 (11.20-13.20), P<0.000 1]. MPV and PCT in the TA group were lower than those in the control group [10.06±1.11 vs. 10.44±0.83 and 0.25 (0.20-0.28) vs. 0.27 (0.23-0.31), P = 0.011 and 0.014, respectively]. RDW and PCT in the active group of TA patients were both higher than those in the inactive group [14.61 (13.38-15.48) vs. 13.81 (12.88-14.33) and 0.27±0.07 vs. 0.23±0.06], with P values of 0.007 and 0.008, respectively. PCT in the active group of TA patients was positively correlated with ESR ( r=0.33, P=0.002). The optimal RDW threshold for determining the activity of TA disease was 14.150 (sensitivity was 55.0%, specificity was 100.0%, area under ROC curve was 0.802). The optimal threshold for judging the activity of TA disease by PCT was 0.245 (sensitivity was 66.7%, specificity was 92.3%, area under ROC curve was 0.84). The optimal threshold for PLR to determine the activity of TA disease was 131.257 (sensitivity was 71.7%, specificity was 76.9%, area under ROC curve was 0.714). Conclusion:RDW and PCT may be helpful to judge the activity of TA, however, the other indexes of whole blood cell count were not closely related to the activity of TA.

Objective:This study mainly discussed the clinical characteristics, autoimmune status and lymphocyte subsets of patients with Takayasu arteritis (TA) without hormone and immunosuppressive therapy, in order to provide guidance for immunotherapy.Methods:Using cross-sectional study, twenty-nine patients with TA admitted to the Department of Rheumatology and the Department of Vasculitis of Beijing Anzhen Hospital from January 2018 to November 2019 were selected, including 28 females and 1 male, with the middle age of 39 year. These patients met the diagnostic criteria of American Society of Rheumatology for TA, and were not treated with hormone and immunosuppressant. Clinical data of these patients were collected, and the immunological indexes and lymphocyte subsets of peripheral blood were detected simultaneously. At the same time, the immunological indexes and peripheral blood lymphocyte subsets of 21 healthy normal people were detected as control. Chi square test, independent sample t test and nonparametric test were used for analysis. Results:Among the 29 patients with TA, 28 were female, 26 were in the active stage of disease; the main manifestations of systemic symptoms were malaise (62.07%) and headache (41.38%), the main manifestations of vascular symptoms were bruits and pulse weakening (68.97%), and the most of Numano type was V type (79.31%). The absolute value of total T (CD3) lymphocytes [(1 337.14±312.46)μl vs (1 139.95±340.96)μl, t=2.120, P=0.039], the percentage [46.29%±6.55% vs 36.55%±7.42%, t=4.903, P<0.000 1] and the absolute value [(815.52±194.11)μl vs (571.44±187.55)μl, t=4.450, P<0.000 1] of helper T (CD4) lymphocytes, the ratio of CD4/CD8 [1.83 (1.41-2.30) vs 1.32 (1.03-1.39), Z=3.401, P=0.001] were higher compared with those of healthy controls, while the percentage of natural killer (NK) cells (CD56) [10.71%(6.45%-14.30%) vs 14.57%(10.87%-18.47%), Z=2.408, P=0.016] decreased. The complement C3 [1.16 (1.02-1.31) g/L vs 1.05 (0.93-1.15) g/L, Z=2.383, P=0.021] in patients with TA was higher than those in healthy controls and immunoglobulin (Ig) G [11.97 (8.74-14.43) g/L vs 14.37 (13.11-15.47) g/L, Z=3.017, P=0.003] in patients with TA was lower than those in healthy controls. Compared with the control group, the ESR [19.31 (9.50-28.50) mm/h vs 3.71 (2.00-5.00) mm/h, Z=5.338, P<0.000 1], hs-CRP [6.52 (0.32-8.62) mg/L vs 0.73 (0.35-1.07) mg/L, Z=2.983, P=0.003] and Q-CRP [8.73 (1.03-7.72) mg/L vs 0.57 (0.08-0.98) mg/L, Z=4.263, P<0.000 1] of patients with TA were all increased. Conclusions:The autoimmunity of patients with TA without hormone or immunosuppressant treatment is in active state, and the total T-lymphocytes and helper T-lymphocytes in peripheral blood are significantly increased in order to cope with the inflammatory response of the systemic artery vessels.