摘要
Abstract
Objective To observe the clinical efficacy and safety of adalimumab(AD A)injection combined with methotrexate(MTX)tablets in the treatment of patients with rheumatoid arthritis(RA),and the effects of joint function,serum rheumatoid factor(RF),anti-citrullinated peptide(CCP)antibody and tumor necrosis factor-α(TNF-α).Methods The RA patients were divided into control group and treatment group according to cohort method.All patients were given intra-articular injection of prednisolone acetate injection at initial dose of 5 mg every time,once every week for 4 weeks,and then adjusted dose every 2 weeks according to the disease conditions.On this basis,the control group received oral MTX tablets 10 mg once a week,and the treatment group was combined with subcutaneous injection of ADA injection 40 mg twice a week.Both groups were treated continuously for 3 months.The clinical efficacy,clinical characteristics(swollen joint count,tender joint count,morning stiffness time),joint function[disease activity scale(DAS)-28 score,joint pain degree score],serum RF,anti-CCP antibody and TNF-α levels before and after treatment were compared between the two groups.Results The treatment group and control group included 52 and 45 cases,respectively.After treatment,the total effective rates of treatment group and control group were 92.31％(48 cases/52 cases)and 75.56％(34 cases/45 cases),respectively,and the difference was statistically significant(P＜0.05).After treatment,the swollen joint counts in treatment group and control group were 4.31±1.08 and 5.56±1.25;the tender joint counts were 6.19±1.68 and 7.92±1.43;the morning stiffness times were(44.47±11.06)and(58.63±12.46)min;the DAS28 scores were(2.67±0.73)and(3.35±0.86)points;the joint pain scores were(2.47±0.76)and(3.29±0.85)points;serum RF levels were(80.25±24.31)and(114.46±27.63)U•mL-1;serum anti-CCP antibody levels were(7.41±1.48)and(9.90±1.72)RU•mL-1;the levels of serum TNF-α were(24.16±6.33)and(34.92±7.98)pg•mL-1.Compared with control group,the above indexes of treatment group had statistical significance(all P＜0.001).The adverse drug reactions in the treatment group mainly included loss of appetite,headache and erythema at the injection site.The adverse drug reactions in the control group included loss of appetite and nausea and vomiting.The total incidences of adverse drug reactions in the treatment group and the control group were 5.77％and 4.44％,respectively,and the difference was not statistically significant(P＞0.05).Conclusion The treatment of RA with ADA injection combined with MTX tablets is more effective than using MTX tablets alone,and the former one can more significantly improve joint function and reduce levels of inflammatory markers,and without increasing the incidences of adverse drug reactions.关键词
阿达木单抗注射液/甲氨蝶呤片/类风湿关节炎/关节功能/类风湿因子/抗瓜氨酸肽抗体Key words
adalimumab injection/methotrexate tablet/rheumatoid arthritis/joint function/rheumatoid factor/anti-citrulline peptide antibody分类
医药卫生
