ABSTRACT
Objective:To explore the clinical application and long-term safety of hydroxychloroquine sulfate (HCQ) in the treatment of rheumatic diseases.Methods:A multi-center cross-sectional study was conducted between August 2017 and August 2018 in a random sample of eleven medical institutions of rheumatology and immunology in China. Patients who took HCQ for more than 3 months were enrolled into this study. The cumulative dose and long-term side effects of HCQ were recorded. The changes of laboratory indexes before and after treatment with HCQ were analyzed. Categorical variables were presented with counts and proportions, and evaluated by Chi-square test. Continuous parametric data were presented as Mean±standard deviation, and evaluated by Student's t test or Mann-Whitney U test. P-values less than 0.05 were considered statistically significant. Results:A total of 886 patients with rheumatic diseases were enrolled into this study, including 505 cases with systemic lupus erythematosus (57.0%), 210 cases with rheumatoid arthritis (23.7%), 80 cases with Sj?gren's syndrome (9.0%), 57 cases with undifferentiated connective tissue disease (6.4%), 12 cases of systemic vasculitis (1.4%), 10 cases of mixed connective tissue disease (1.1%), 7 cases of myositis (0.8%) and 5 cases with systemic sclerosis (0.6%). The most common long-term side effects of HCQ was skin or mucous lesions (12.4%) and vision problems (8.0%). Other adverse reactions included problems of digestive system (3.0%), nervous system (2.1%), musculoskeletal system (1.1%) and cardiovascular system (0.9%). 140 cases (15.8%) had stopped taking HCQ during the treatment. More than half of them decided to stop taking medicine by themselves. Fifty-four patients (6.1%) stopped using HCQ due to side effects while 24 of them took it again, and another 12 patients (1.4%) stopped the drug due to remission of illness. Patients were divided into three groups according to the cumulative dose of HCQ: less than 500 g, 500-1 000 g and more than 1 000 g respectively. There was significant difference in the incidence of long-term side effects among the three groups ( χ2=6.382, P=0.041). The last group (more than 1 000 g) suffered the highest incidence of long-term adverse reactions (37.1%). No severe adverse drug reactions were observed in this study. Conclusion:Hydroxychloroquine is widely used in the treatment of rheumatic diseases. The incidence of long-term side effects is 20.4%, is 6.1% lead to drug withdrawal, which are especially related to the cumulative doses. It should be adjusted properly according to the clinical application.
ABSTRACT
Objective To investigate the detection rate of anti-SSA60 and SSB antibodies in sera of patients with systemic lupus erythematosus (SLE).The correlation of anti-SSA and SSB antibodies with SLE clinical outcome was also investigated.Methods This study included 251 cases of SLE diagnosed in our hospital between 2007 and 2010.ELISA and double immunodiffusion method was used to detect the sera antiSSA60 and SSB antibodies.The patients were closely monitored for three years in terms of clinical and laboratory parameters and the presence of associated Sj(o)gren' s syndrome (SS).Statistical analysis were performed using student t test or x2 test.Results ① The detection rate of anti-SSA60 antibody in serum of patients with SLE was 65.3％.The detection rate of anti-SSB antibody in serum of patients with SLE was 28.3％; ② During the three-year follow up,patients with anti-SSA60 (29.3％,48 cases) or SSB antibodies (35.2％,25 cases) were more likely to have dry mouth and eyes and later developed SS (P＜0.05); ③ Patients with anti-SSA60 antibody were more likely to develop serositis (20.7％ vs 8.0％),neuropsychiatric lupus erythematosus (NPLE)(18.9％ vs 8.0％),and hematuria (35.4％ vs 21.8％)(P＜0.05).Patients with negative anti-SSB antibody were more likely to have fever (43.7％ vs 57.8％,x2=4.082,P＜0.05); ④ Patients positive for anti-SSB antibody were also positive for anti-Sm antibody (50.7％ vs 32.8％,x2=6.956,P＜0.05);⑤ Younger patients were more likely to have anti-SSA60 and SSB antibodies in their sera (P＜0.05); ⑥Patients positive for anti-SSA60 antibody had higher SLE disease activity index (SLEDAI) than patients with negative anti-SSA60 antibody [(17±9) vs (15±7),t=2.389,P＜0.05].Patients positive for anti-SSB antibody had higher level of IgG [(18±7) vs (16±6) g/L,t=2.304,P=0.023],and lower level of CRP than patients negative for anti-SSB antibody [(14±20) vs (21±33) mg/L,t=-2.173,P=0.031].Conclusion Patients positive for anti-SSA60 antibody have higher SLEDAI and more severe clinical outcomes.Patients with antiSSA or anti-SSB antibody are more likely to develop dry mouth and eyes which eventually leads to SS.