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This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50 %, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25 % from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80 % and significance level of 2.5 % with a non-inferiority margin of −10 %. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6 % [95 % confidence interval, −1.7 to 26.9 %]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis. [ABSTRACT FROM AUTHOR]

This study aims to investigate the incidence of hepatitis B virus (HBV) reactivation in inflammatory arthritis (IA) patients with HBV infection using anti-tumor necrosis factor (TNF) agents and evaluate the efficacy of antiviral therapy in reducing the risk of viral reactivation in chronic HBV infection. IA patients using anti-TNF agents from six centers were enrolled. Their HBV infection conditions and ALT and HBV-DNA levels were monitored periodically. Among the six chronic hepatitis B patients, HBV reactivation was found in two patients without antivirus prophylaxis and no viral replication was detected in the other four patients with antivirus prophylaxis. In the 31 inactive carriers, the increase of viral load was detected in 6 of 22 (27.3 %) patients without antiviral prophylaxis, and there was no viral reactivation in the other 9 patients with antiviral prophylaxis. HBV reactivation was not found in the 50 patients with resolved HBV infection. It is suggested that anti-TNF therapy might increase the risk of HBV reactivation in patients with chronic HBV infection, and antiviral prophylaxis could effectively decrease the risk. Anti-TNF agents seem to be safe in patients with resolved HBV infection. [ABSTRACT FROM AUTHOR]

To investigate the clinical pattern, survival rate, causes of death and risk factors in a large cohort of Chinese Han patients with systemic sclerosis (SSc). Inpatients treated from 2002 to 2014 were included in this study. Patients were classified into diffuse cutaneous SSc (dcSSc), limited cutaneous SSc (lcSSc), and SSc-overlap syndrome groups. Data were analyzed using Chi-squared tests, Kaplan-Meier curves, log-rank tests, and Cox proportional hazards modeling. Among a total of 201 patients, dcSSc (50.2%) was the major subtype, followed by lcSSc (30.3%) and SSc-overlap (19.4%). Interstitial lung disease (ILD, 148/201, 74%) was the most frequent organ involvement. The overall survival rates were 98% and 95% at 5 and 10 years, respectively. The overall standard mortality ratio (SMR) was 2.22. The most common cause of death was ILD combined with infection (8/16, 50%), followed by kidney failure (2/16, 12.5%). On crude analysis, pulmonary hypertension, ILD, cardiac involvements, renal involvements, and digital ischemia were associated with poor prognosis. On multivariate analysis, pericardial effusion (p = 0.000) and digital ischemia (p = 0.016) were independent prognostic factors of death. The mortality rate of patients with SSc is mildly increased in comparison with the general population. ILD is the most common systemic involvement and the principal cause of death in SSc. Pericardial effusion and digital ischemia are independent factors associated with death. [ABSTRACT FROM AUTHOR]

Whether hyperuricemia is an independent risk factor for hypertension in adults is still under debate. To determine the association between serum uric acid and risk of hypertension in the Chinese population, we conducted a prospective study using the 'Kailuan Corporation cohort.' A total of 39,233 adult subjects with available data on serum uric acid were enrolled from 2006 to 2007. Subjects with established hypertension were excluded and were then grouped based on the gender and baseline quartile serum uric acid into F1-4 for women and M1-4 for men with F1 and M1 being the lowest quartiles. Incidence of newly described primary hypertension was reevaluated in 2010-2011. The median (interquantile range) baseline uric acid (UA) was 290 (243-344) μmol/L in men and 230 (194-274) μmol/L in women. During a 4-year follow-up period, 12,844 subjects (31.31 %) were newly diagnosed with hypertension. The incidence of hypertension was 14.36, 16.57, 19.06, and 22.35 % in F1 to F4 and 33.64, 33.97, 36.54, and 40.74 % in M1 to M4, respectively. Multiple logistic regression analysis showed that the odds ratios (ORs) of incident hypertension were 1.17 [95 % confidence interval (CI) 1.00-1.37, P = 0.055], 1.24 (95 % CI 1.06-1.45, P = 0.009), and 1.20 (95 % CI 1.02-1.41, P = 0.027) in F2 to F4 compared to the F1 and 0.98 (95 % CI 0.91-1.05, P = 0.534), 1.05 (95 % CI 0.98-1.13, P = 0.190), and 1.13 (95 % CI 1.05-1.22, P = 0.002) in M2 to M4 compared to the M1. Elevated level of serum uric acid is associated with an increased risk of hypertension in adults. [ABSTRACT FROM AUTHOR]

To evaluate the diagnosis value of antibodies to phosphatidylserine/prothrombin complex (aPS/PT) in patients with antiphospholipid syndrome (APS) and to determine the clinical features of APS patients with avidity of aPS/PT. Serum samples were collected from 108 APS patients. Sixty patients with pregnancy morbidity, 37 patients with thrombosis without a history of autoimmune diseases, and 89 healthy blood donors were included as the control group. The enzyme-linked immunosorbent assay (ELISA) test was performed to detect the concentration of aPS/PT, including IgG/M, IgG, and IgM forms, in the same serum sample. The chi-square (χ2) test was used to examine the difference of frequencies of antibodies in APS patients and patients with other diseases. Spearman correlation analysis was performed to investigate the relationship between aPS/PT and other clinical/laboratory parameters. aPS/PT was detectable in 68 (63.0%) of the 108 APS patients, 12 (13.2%) of the 91 disease control patients and 1 (1.1%) of the healthy controls. It was strongly correlated with the activity of lupus anticoagulant (LA) (OR 15.952, 95% CI 7.132-35.678; P < 0.001). The frequency of aPS/PT was 56.9% in anti-cardiolipid antibody (aCL)-negative, 60.5% anti-β2 glycoprotein I antibody (aβ2GPI)-negative, and 50.0% in both aCL and aβ2GPI negative APS patients. The IgG aPS/PT was significantly associated with arterial and venous thrombosis. The aPS/PT antibody could play an important role in the diagnosis of APS, especially in patients with negative aCL and aβ2GPI. It was positively related to thrombotic events in APS. [ABSTRACT FROM AUTHOR]