CAJ | 학술논문

目的研究注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（益赛普）和甲氨蝶呤治疗类风湿关节炎(RA)的临床疗效和不良反应。方法将46例活动性RA患者采用随机分层抽样法分为益赛普组和甲氨蝶呤组，益赛普组22例，皮下注射益赛普12.5 mg，每周2次；甲氨蝶呤组24例，口服甲氨蝶呤5～ 10mg，每周1次。24周为1个观察周期，观察并比较两组的美国风湿病学会评价标准20％、50％、70％改善(ACR20、ACR50、ACR70)情况及药物的不良反应。结果治疗后24周益赛普组ACR50、ACR70分别为54.5％(12/22)、31.8％(7/22)，甲氨蝶呤组分别为16.7％(4/24)、4.2％（1/24），两组比较差异有统计学意义(P＜0.05)。益赛普组总有效率为86.4％ (19/22)，甲氨蝶呤组为20.8％(5/24)，两组比较差异有统计学意义(P＜0.05)。益赛普组不良反应发生率为22.7％(5/22)，甲氨蝶呤组为50.0％(12/24)，两组比较差异有统计学意义(P＜0.05)，益赛普组胃肠道反应少。结论益赛普治疗RA起效快，疗效可靠，不良反应少，耐受性好。
목적연구주사용중조인Ⅱ형종류배사인자수체-항체융합단백（익새보）화갑안접령치료류풍습관절염(RA)적림상료효화불량반응。방법장46례활동성RA환자채용수궤분층추양법분위익새보조화갑안접령조，익새보조22례，피하주사익새보12.5 mg，매주2차；갑안접령조24례，구복갑안접령5～ 10mg，매주1차。24주위1개관찰주기，관찰병비교량조적미국풍습병학회평개표준20％、50％、70％개선(ACR20、ACR50、ACR70)정황급약물적불량반응。결과치료후24주익새보조ACR50、ACR70분별위54.5％(12/22)、31.8％(7/22)，갑안접령조분별위16.7％(4/24)、4.2％（1/24），량조비교차이유통계학의의(P＜0.05)。익새보조총유효솔위86.4％ (19/22)，갑안접령조위20.8％(5/24)，량조비교차이유통계학의의(P＜0.05)。익새보조불량반응발생솔위22.7％(5/22)，갑안접령조위50.0％(12/24)，량조비교차이유통계학의의(P＜0.05)，익새보조위장도반응소。결론익새보치료RA기효쾌，료효가고，불량반응소，내수성호。
Objective To evaluate and compare the efficacy and adverse effects of recombinant human tumor necrosis factor receptor Ⅱ : IgG Fc protein for injection (etanercept) and methotrexate ( MTX )regimens for rheumatoid arthritis (RA). Methods Forty-six patients were randomly divided into two groups by stratified sampling method:etanercept group,22 patients were treated with 12.5 mg of etanercept,twice times per week by subcutaneous injection;and MTX group,24 patients were treated with 5-10 mg of MTX,once per week by oral administration. The course of treatment lasted 24 weeks in both groups, so as to observe their ACR20, ACR50, ACR70 and adverse effects of the drugs. Results After treated for 24 weeks,ACR50,ACR70 respectively achieved 54.5％ (12/22),31.8％ (7/22) in etanercept group,which were significantly higher than those in MTX group [16.7％(4/24),4.2％( 1/24)]. The total efficacy was 86.4％ (19/22) in etanercept group, 20.8％ (5/24) in MTX group, the difference between the two groups was significant (P ＜ 0.05 ). The incidence of adverse effects was not significant between the two groups [22.7％(5/22) vs. 50.0％ (12/24)](P ＞ 0.05). Conclusion Etanercept has a good efficacy and safety for the treatment of active RA.