CAJ | 학술논문

目的探讨短期使用重组人Ⅱ型肿瘤坏死因子受体一抗体融合蛋白(rhTNFR:Fc,益普赛)与甲氨蝶呤(MTX)、环磷酰胺(CTX)联合治疗类风湿关节炎(RA)的有效性和安全性.方法对84例患者随机分为实验组和对照组,仅有56例患者完成了本实验.实验组给予益赛普皮下注射治疗3个月,每周2次,每次25 mg;同时给予MTX治疗,每周1次,每次7.5～15 mg;CTX每3周1次,每次200 mg,3个月后给予空白模拟益赛普,继续接受MTX和CTX维持治疗.对照组给予益赛普皮下注射治疗,剂量及方法同实验组,同时给予空白模拟MTX和CTX对照,疗程为1年,随时观察并记录治疗过程中的任何不良事件,在0、2、4、8、12、24、36、52周监测其血常规、红细胞沉降率(ESR)、肝功能、肾功能、类风湿因子(RF)、抗环瓜氨酸肽(CCP)抗体.结果实验组和对照组在ACR20,ACR70,ESR及CRP实验室指标均较入组时有明显改善,但两组问差异无统计学意义(P>0.05).治疗12周实验组停用益赛普时,两组的上述指标均进一步改善.疗程满36周时,实验组较对照组的各项指标仍持续好转,相关抗体水平浓度较对照组差异有统计学意义(P<0.05),两组间的不良反应率差异无统计学意义.结论短期益赛普与MTX、CTX联合治疗RA,可以减少益赛普的疗程,有效地缓解RA的症状和降低抗体水平,并不增加不良反应,具有较好的安全性.
목적 탐토단기사용중조인Ⅱ형종류배사인자수체일항체융합단백(rhTNFR:Fc,익보새)여갑안접령(MTX)、배린선알(CTX)연합치료류풍습관절염(RA)적유효성화안전성.방법 대84례환자수궤분위실험조화대조조,부유56례환자완성료본실험.실험조급여익새보피하주사치료3개월,매주2차,매차25 mg;동시급여MTX치료,매주1차,매차7.5～15 mg;CTX매3주1차,매차200 mg,3개월후급여공백모의익새보,계속접수MTX화CTX유지치료.대조조급여익새보피하주사치료,제량급방법동실험조,동시급여공백모의MTX화CTX대조,료정위1년,수시관찰병기록치료과정중적임하불량사건,재0、2、4、8、12、24、36、52주감측기혈상규、홍세포침강솔(ESR)、간공능、신공능、류풍습인자(RF)、항배과안산태(CCP)항체.결과 실험조화대조조재ACR20,ACR70,ESR급CRP실험실지표균교입조시유명현개선,단량조문차이무통계학의의(P>0.05).치료12주실험조정용익새보시,량조적상술지표균진일보개선.료정만36주시,실험조교대조조적각항지표잉지속호전,상관항체수평농도교대조조차이유통계학의의(P<0.05),량조간적불량반응솔차이무통계학의의.결론 단기익새보여MTX、CTX연합치료RA,가이감소익새보적료정,유효지완해RA적증상화강저항체수평,병불증가불량반응,구유교호적안전성.
Objective To study the efficiency and safety of short-term combination therapy with e-tanercept, methotrexate and eyclophosphamide in the patients with active rheumatoid arthritis. Methods Eighty-four patients with rheumatoid arthritis were included into this study. However, only fifty-six patients were treated with either twice-weekly subcutaneous etanercept, weekly oral MTX and CTX injection every three weeks or twice-weekly subcutaneous etanercept only. The American College of Rheumamatology (ACR) criteria for improvement was used for clinical efficacy assessment and the following laboratory papameters were analyzed:blood routine test, ESR, liver enzymes and renal function parameters, RF and anti-CCP antibody at baseline and the 2,4,8,12,24,36,52 weeks .At the same time ,all the adverse events were monitored throughout the study. Results The improvement of patients who received etanercept shortly, MTX and CTX periodically was as rapid as that of the patients who only received etanercept in ACR20, ACRYO, ESR and CRP (P>0.05). At the end of 36 weeks treatment, the level of anti-CCP antibody in the control group was higher than that of the test group. There was no significant difference between the two groups in adverse events (P<0.05). Conclusion The efficacy and safety of treatment with etanercept, methotrexate and cyclophosphamide in the patients with active rheumatoid arthritis is good.