[A clinical study of femoral head osteonecrosis in patients with systemic lupus erythematosus.].

OBJECTIVE: To investigate the clinical features of osteonecrosis of the femoral head (ONFH) in patients with systemic lupus erythematosus (SLE). METHODS: The consecutive 461 SLE patients who underwent inpatient care in China-Japan Friendship Hospital were reviewed, the clinical data of 32 cases complicated with ONFH and 64 without ONFH as control was studied. RESULTS: The incidence of ONFH in 461 SLE patients was 6.94%. 65.63% of the ONFH was diagnosed within the first 3 years of SLE. It was found that the incidence of vasculitis, osteoporosis, high level of blood platelet, serum low density lipoprotein cholesterol (LDL-C) and fibrinogen was higher in SLE patients with ONFH than that in SLE patients without ONFH (P < 0.05). When compared with controls, the ONFH initial glucocorticoid dosage and accumulative dosage of glucocorticoid within the first month or six months were significantly higher in SLE patients with ONFH (P < 0.05). There was no significant difference between two groups in sex, age, duration of SLE, dental ulcer, Raynaud's phenomenon, hypocalcemia, renal diseases, hypertension, anemia, positive anticardiolipin antibodies and immunosuppresive treatment (P > 0.05). CONCLUSION: The incidence of ONFH in patients with SLE is relatively high within the first 3 years of SLE. The SLE patients with ONFH are more likely to have such clinical features as vasculitis, osteoporosis, high level of blood platelet, serum LDL-C and fibrinogen and exposed to high-dose glucocorticoid therapy.

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial.

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.