Clinical trial of adalimumab combined with methotrexate in the treatment of patients with rheumatoid arthritis
Objective To observe clinical efficacy and safety of adalimumab(ADA)injection combined with methotrexate(MTX)tablets in the treatment of patients rheumatoid arthritis(RA)and its influences on bone metabolism.Methods According to cohort method,the RA patients were divided into treatment group and control group.The control group was treated with oral MTX tablets(10 mg/once,once/week),while treatment group was given subcutaneous injection of ADA ejection(40 mg/once,once/2 weeks)on basis of control group.Both groups were treated for 24 weeks.The clinical curative effect,symptoms improvement,joint function and serum bone metabolism indexes[bone alkaline phosphatase(B-ALP),bone glaprotein(BGP),carboxyterminal propeptide of type Ⅰ procollagen(PICP)]in the two groups were compared,and safety was evaluated.Results There were 37 cases in control group and 43 cases in treatment group.After treatment,total response rates of treatment group and control group were 93.02％(40 cases/43 cases)and 75.68％(28 cases/37 cases),the difference was statistically significant(P＜0.05).After treatment,morning stiffness time in treatment group and control group were(29.27±7.05)and(48.63±12.25)min,the number of joint swelling were 2.64±0.66 and 4.04±1.09,number of joint tenderness were 4.51±1.12 and 6.23±2.07,levels of serum B-ALP were(20.76±2.82)and(26.41±3.05)U·L-1;levels of serum BGP were(27.45±3.41)and(23.86±3.17)ng·mL-1;levels of serum PICP were(47.39±5.63)and(41.68±5.24)ng·mL-1,the differences were statistically significant(P＜0.05).The adverse drug reactions in treatment group were mainly on headache,pruritus at the injection site,diarrhea and nausea,while which in control group were mainly on diarrhea,anorexia and nausea.The difference in incidence of adverse reactions between treatment group and control group was not statistically significant(11.63％vs 8.11％,P＞0.05).Conclusion Clinical curative effect of ADA injection combined with MTX tablets is significant in RA patients,which can significantly relieve clinical symptoms,promote recovery of joint function,reduce levels of serum rheumatoid factor,relieve inflammatory response and improve bone metabolism.
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