CAJ | 학술논문

目的观察人重组白细胞介素-1受体拮抗剂(IL-1Ra)联合甲氨蝶呤治疗活动期类风湿关节炎(RA)患者的疗效.方法 54例经甲氨蝶呤治疗至少12周以上的活动期RA患者,随机接受每日皮下注射IL-1Ra 80 mg或安慰剂,每4周进行随访,按照美国风湿病学会制订的疗效标准评估临床疗效,共24周.应用x2检验比较2治疗组间疗效达到ACR20、ACR50和ACR70的患者比例的差异.应用t检验(参数分析)或者秩和检验(非参数分析)比较2治疗组间基线值变量和28个关节的疾病活动指数(DAS28)的差异.结果在治疗第24周,IL-1Ra联合甲氨蝶呤治疗组中27例(64％)的患者疗效改善达到ACR20,显著高于安慰剂组2例(17％)(P=0.004).IL-1Ra治疗组中,38％的患者疗效改善达到ACR50,17％达到ACR70;而安慰剂组中无一例达到ACR50或ACR70改善.然而,接受IL-1Ra治疗的42例患者中有9例在初始治疗时病情显著改善,但之后却出现疗效下降.结论 IL-1Ra通过阻断IL-1,可有效改善活动期RA患者的临床表现.然而,大约1/5接受IL-1Ra治疗的患者发生继发性失效.
목적 관찰인중조백세포개소-1수체길항제(IL-1Ra)연합갑안접령치료활동기류풍습관절염(RA)환자적료효.방법 54례경갑안접령치료지소12주이상적활동기RA환자,수궤접수매일피하주사IL-1Ra 80 mg혹안위제,매4주진행수방,안조미국풍습병학회제정적료효표준평고림상료효,공24주.응용x2검험비교2치료조간료효체도ACR20、ACR50화ACR70적환자비례적차이.응용t검험(삼수분석)혹자질화검험(비삼수분석)비교2치료조간기선치변량화28개관절적질병활동지수(DAS28)적차이.결과 재치료제24주,IL-1Ra연합갑안접령치료조중27례(64％)적환자료효개선체도ACR20,현저고우안위제조2례(17％)(P=0.004).IL-1Ra치료조중,38％적환자료효개선체도ACR50,17％체도ACR70;이안위제조중무일례체도ACR50혹ACR70개선.연이,접수IL-1Ra치료적42례환자중유9례재초시치료시병정현저개선,단지후각출현료효하강.결론 IL-1Ra통과조단IL-1,가유효개선활동기RA환자적림상표현.연이,대약1/5접수IL-1Ra치료적환자발생계발성실효.
Objective To assess the efficacy of intedeukin (IL)-1Ra,a recombinant human IL-1receptor antagonist,plus methotrexate ( MTX ) in patients with active rheumatoid arthritis ( RA ) refractory to MTX therapy.Methods A total of 54 patients with active RA,who had been taking MTX at a stable dosage,were randomized to receive daily subcutaneous injections of IL-1Ra (80 mg) or placebo.The proportion of patients who had a response as assessed by ACR20,ACR50 and ACR70 was analyzed using Chi-square test measures.Baseline variables and DAS28 were analyzed using Student's t-test (parametric) or Wilcoxon's rank sum test (nonparametric) as appropriate.Results After 24 weeks,more patients achieved clinical benefits treated with IL-1Ra plus MTX compared with MTX alone (64％ vs 17％,P=-0.004) as determined by the ACR20 improvement.In the IL-1Ra group,an ACR50 response was observed in 38％ and an ACR70 response in 17％.None of the patients treated with MTX alone achieved ACR50 or ACR 70 improvement.However,9 of 42 (21％) patients in the IL-1Ra group,who showed therapeutic response initially,had secondary drug failure to IL-1Ra therapy thereafter.A significant increase in mean DAS28 from baseline was found in the nonresponders to IL-1Ra,compared with placebo.Conclusion IL-IRa is effective for the treatment of patients with active RA by blocking IL-1.However,the efficacy of IL-1Ra is lost soon in about one-fifth of patients in soite of initial good resoonse.