CAJ | 학술논문

目的探讨在不同治疗方案下RA患者达到和维持治疗目标的情况,并对影响目标治疗的各种因素进行分析.方法采用为时84周的随机、开放、前瞻性研究,入选高活动度RA患者.治疗分为诱导和维持2个阶段.最长36周的诱导期采用DMARDs联合治疗,12周内可以加用小剂量糖皮质激素,达到低疾病活动度者采用随机数字表法随机分为2组(来氟米特单药或者来氟米特联合羟氯喹组)进入维持治疗阶段.如病情复发(DAS28较最低值增加≥0.6)则终止随访.总结患者的临床资料,统计其诱导治疗期间达到低活动度以及维持治疗阶段的疾病复发率,采用Kaplan-Meier方法分析可能的影响因素.结果 42例完成本研究的患者中27例(64％)在诱导治疗阶段达到低活动度;患者的性别、年龄、病程、RF和抗CCP抗体水平、诱导治疗过程中是否使用激素与其诱导阶段达到低活动度无相关性(P＞0.05).无吸烟史患者中85％(11/13)达到低活动度,而有吸烟史者中55％(16/29)达到低活动度,2组间的差异有统计学意义(P＜0.05).23例患者进入维持治疗阶段,其中14例(61％)复发.患者的年龄、病程、吸烟状况、RF和抗CCP抗体水平与其复发无相关性(P＞0.05).诱导缓解方案中含激素者复发率为83％(10/12),不含激素者复发率为36％(4/11),2组之间差异有统计学意义(P=0.021).诱导治疗12周进入维持治疗者复发率为75％(9/12),诱导治疗24周进入维持治疗者复发率为33％(3/9),2组之间差异有统计学意义(P=0.026).结论吸烟可能是RA病情不易控制的危险因素之一.在DMARDs联合治疗基础上采用小剂量糖皮质激素进行桥接治疗可能需要12周以上疗程.维持治疗阶段2组患者的复发率均较高,提示适当延长诱导期治疗,保持治疗目标一段时间后再进行下阶梯治疗有利于减少疾病复发.
목적 탐토재불동치료방안하RA환자체도화유지치료목표적정황,병대영향목표치료적각충인소진행분석.방법 채용위시84주적수궤、개방、전첨성연구,입선고활동도RA환자.치료분위유도화유지2개계단.최장36주적유도기채용DMARDs연합치료,12주내가이가용소제량당피질격소,체도저질병활동도자채용수궤수자표법수궤분위2조(래불미특단약혹자래불미특연합간록규조)진입유지치료계단.여병정복발(DAS28교최저치증가≥0.6)칙종지수방.총결환자적림상자료,통계기유도치료기간체도저활동도이급유지치료계단적질병복발솔,채용Kaplan-Meier방법분석가능적영향인소.결과 42례완성본연구적환자중27례(64％)재유도치료계단체도저활동도;환자적성별、년령、병정、RF화항CCP항체수평、유도치료과정중시부사용격소여기유도계단체도저활동도무상관성(P＞0.05).무흡연사환자중85％(11/13)체도저활동도,이유흡연사자중55％(16/29)체도저활동도,2조간적차이유통계학의의(P＜0.05).23례환자진입유지치료계단,기중14례(61％)복발.환자적년령、병정、흡연상황、RF화항CCP항체수평여기복발무상관성(P＞0.05).유도완해방안중함격소자복발솔위83％(10/12),불함격소자복발솔위36％(4/11),2조지간차이유통계학의의(P=0.021).유도치료12주진입유지치료자복발솔위75％(9/12),유도치료24주진입유지치료자복발솔위33％(3/9),2조지간차이유통계학의의(P=0.026).결론 흡연가능시RA병정불역공제적위험인소지일.재DMARDs연합치료기출상채용소제량당피질격소진행교접치료가능수요12주이상료정.유지치료계단2조환자적복발솔균교고,제시괄당연장유도기치료,보지치료목표일단시간후재진행하계제치료유리우감소질병복발.
Objective To investigate the outcomes of patients with rheumatoid arthritis (RA) treated by different combination of synthetic disease modifying antirheumatic drugs (DMARDs) under the guidance of treat-to-target strategy.Methods Forty-two RA patients with high disease activity were enrolled into this randomized,open-label and prospective study.It was comprised of a maximal 36-week induction phase and then followed by a maintenance phase up to 84 weeks.Combination of synthetic DMARDs was initiated in the induction phase,with or without low dose glucocorticoids (GCs) during the first 12 weeks.Patients who achieved low disease activity (LDA) were randomized into two maintenance groups.An increase of DAS28 by 0.6 was defined as relapse.The patients achieved LDA in the induction phase,relapsed during maintenance phase and possible relevant risk factors were analyzed.Results Twenty-seven (64％) patients achieved LDA during the induction phase.More non-smoking patients achieved LDA than those smoked [85％ (11/13) vs 55％(16/29),P＜0.05].During the maintenance phase,14 (61％) out of 27 patients relapsed.Patients taking GCs during the first 12 weeks had a significantly higher relapse rate compared to those without GC (83％ vs 36％,P=0.021).Patients who entered maintenance phase at week 12 had a significantly higher tendency to relapse compared to those who entered the maintenance phase at week 24 [75％(9/12) vs 33％(3/9),P=0.026].Conclusion Smoking seems to be a risk factor for RA patients who fail to reach LDA.Low dose GCs as a bridge therapy may require a longer duration.High relapse rates in both the maintenance groups indicat that a longer tight induction phase may be appropriate before downstairs therapy.