摘要
Abstract
Objective To observe the clinical efficacy of tofacitinib injection combined with cyclophosphamide injection in the treatment of systemic lupus erythematosus(SLE)patients and its impact on serum tumor marker levels.Methods The SLE patients were randomly divided into the control group and the treatment group by random number table.The control group received intravenous infusion of cyclophosphamide injection,500 mg per dose,once two weeks for 12 weeks,then changed to once four weeks for 48 weeks.The treatment group was treated with subcutaneous tofacitinib injection,160 mg per dose,once a week for 48 weeks,in addition to the treatment given to the control group.Clinical efficacy,complement C3 and C4,immunoglobulin(Ig)A,IgG,IgM,24-hour urine protein quantification(24 h Upro),systemic lupus erythematosus disease activity index(SLEDAI),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),antinuclear antibodies(ANA),anti-dsDNA,serum carcinoembryonic antigen(CEA),alpha-fetoprotein(AFP),carbohydrate antigen 125(CA125),carbohydrate antigen 153(CA153)and carbohydrate antigen 199(CA199)levels were compared between the two groups,and safety was evaluated.Results A total of 86 patients were enrolled in the study,with 2 patients dropping out during the study.Finally,42 patients from each group were included in the analysis.After treatment,the total effective rates in the treatment and control groups were 85.71％(36 cases/42 cases)and 64.29％(27 cases/42 cases),respectively,with a statistically significant difference(P＜0.05).After treatment,the C3 levels in the treatment and control groups were(0.99±0.06)and(0.92±0.09)g·L-1;C4 levels were(0.39±0.10)and(0.26±0.11)g·L-1;IgA levels were(2.34±0.37)and(2.79±0.41)g·L-1;IgG levels were(14.01±4.27)and(16.78±4.73)g·L-1;IgM levels were(1.53±0.45)and(1.96±0.55)g·L-1;24 h Upro levels were(2.35±1.01)and(3.64±1.31)g;SLEDAI scores were(4.34±1.05)and(7.28±1.10)points;CRP levels were(5.13±1.98)and(8.09±1.27)mg·L-1;ESR levels were(31.09±4.22)and(38.44±5.59)mm·h-1;ANA levels were(155.84±17.63)and(187.37±20.15)U·mL-1;anti-dsDNA levels were(112.05±16.92)and(129.84±19.25)U·mL-1;CEA levels were(1.42±0.51)and(1.77±0.64)ng·mL-1;AFP levels were(9.23±2.17)and(10.78±2.42)ng·mL-1;CA125 levels were(10.25±2.79)and(11.89±3.21)kU·L-1;CA153 levels were(9.34±2.41)and(10.90±2.02)kU·L-1;CA199 levels were(12.13±2.99)and(13.77±3.40)U·mL-1,all of which showed statistically significant differences(all P＜0.05).The main adverse drug reactions in the treatment group were upper respiratory infections and allergic dermatitis;in the control group,they were upper respiratory infections,nausea and vomiting.The total incidence of adverse drug reactions in the treatment and control groups was 11.90％(5 cases/42 cases)and 14.27％(6 cases/42 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Tofacitinib injection combined with cyclophosphamide injection shows better efficacy than cyclophosphamide injection alone in the treatment of SLE patients,with more significant improvement in disease activity,immune function and tumor marker levels.关键词
泰它西普注射剂/环磷酰胺注射剂/系统性红斑狼疮/肿瘤标志物Key words
tofacitinib injection/cyclophosphamide injection/systemic lupus erythematosus/tumor marker分类
医药卫生
