CAJ | 학술논문

目的比较英夫利西升阶梯及降阶梯治疗克罗恩病(CD)的疗效差别.方法本研究为2007年9月至2010年12月在中山大学附属第一医院进行的前瞻性开放性研究.升阶梯组纳入经常规治疗[糖皮质激素(简称激素)和(或)免疫抑制剂]无效或激素依赖的活动性CD患者.降阶梯组纳入未进行过激素或免疫抑制剂治疗的活动性CD患者.第0、2、6周给予英夫利西(5 mg/kg)作为诱导缓解,随后每隔8周给予相同剂量维持,临床及内镜随访30周.分别在开始治疗后10周及30周评价两组患者的临床症状和内镜下黏膜愈合的情况.结果共纳入符合入选标准的患者41例,其中升阶梯组24例,降阶梯组17例.两组患者在治疗前病程(P=0.006)、合并用药(P ＜0.001)及疾病严重程度(P=0.011)方面的差异有统计学意义.治疗10周及30周时,升阶梯组的临床缓解率分别为45.8％ (11/24)及58.3％ (14/24),内镜下黏膜愈合率分别为33.3％ (8/24)及54.2％ (13/24)；降阶梯组的临床缓解率分别为70.6％( 12/17)及82.4％( 14/17),内镜下黏膜愈合率分别为35.3％(6/17)及52.9％ (9/17).两组患者在10周及30周的临床缓解率、内镜下黏膜愈合率方面的差异均无统计学意义.升阶梯组和降阶梯组不良事件的发生率分别为41.7％(10/24)及29.4％(5/17),差异均无统计学意义(P=0.422).结论英夫利西升阶梯和降阶梯治疗均可使超过半数的CD患者在治疗30周时达到临床及内镜下缓解,降阶梯治疗可能更有利于快速缓解症状.
목적 비교영부리서승계제급강계제치료극라은병(CD)적료효차별.방법 본연구위2007년9월지2010년12월재중산대학부속제일의원진행적전첨성개방성연구.승계제조납입경상규치료[당피질격소(간칭격소)화(혹)면역억제제]무효혹격소의뢰적활동성CD환자.강계제조납입미진행과격소혹면역억제제치료적활동성CD환자.제0、2、6주급여영부리서(5 mg/kg)작위유도완해,수후매격8주급여상동제량유지,림상급내경수방30주.분별재개시치료후10주급30주평개량조환자적림상증상화내경하점막유합적정황.결과 공납입부합입선표준적환자41례,기중승계제조24례,강계제조17례.량조환자재치료전병정(P=0.006)、합병용약(P ＜0.001)급질병엄중정도(P=0.011)방면적차이유통계학의의.치료10주급30주시,승계제조적림상완해솔분별위45.8％ (11/24)급58.3％ (14/24),내경하점막유합솔분별위33.3％ (8/24)급54.2％ (13/24)；강계제조적림상완해솔분별위70.6％( 12/17)급82.4％( 14/17),내경하점막유합솔분별위35.3％(6/17)급52.9％ (9/17).량조환자재10주급30주적림상완해솔、내경하점막유합솔방면적차이균무통계학의의.승계제조화강계제조불량사건적발생솔분별위41.7％(10/24)급29.4％(5/17),차이균무통계학의의(P=0.422).결론 영부리서승계제화강계제치료균가사초과반수적CD환자재치료30주시체도림상급내경하완해,강계제치료가능경유리우쾌속완해증상.
Objective To compare the efficacy of step-up and top-down infliximab therapy on patients with Crohn's disease (CD).Methods A prospective and open-label study was performed by the First Affiliated Hospital of SUN Yat-sen University during September 2007 to December 2010.Active CD patients who were refractory to steroid/immunomodulator or who were steroid-dependent were enrolled into step-up group.Active CD patients who had no steroid or immunomodulator therapy before were enrolled into top-down group. All patients were intravenously infused with infliximab of 5 mg/kg body weight in an induction regimen of 3 doses at week 0,2 and 6,followed by maintenance dosing every 8 weeks beginning at week 14.The clinical and endoscopic follow up lasted 30 weeks.Clinical symptoms and mucosal healing status under endoscopy were evaluated by follow-up at week 10 and 30.Results Forty-one CD patients were enrolled,with 24 in step-up group and 17 in top-down group. There were significant differences in disease duration (P =0.006),combination therapy (P ＜ 0.001 ) and severity of disease ( P =0.011 ) in baseline between step-up and top-down groups.At week 10 and 30 during treatment,the clinical remission rates in step-up group were 45.8％ (11/24) and 58.3％ (14/24) respectively; the mucosal healing rates in step-up group were 33.3％ (8/24) and 54.2％ (13/24) respectively; the clinical remission rates in topdown group were 70.6％ ( 12/17)and 82.4％ (14/17) respectively; and the mucosal healing rates in topdown group were 35.3％ (6/17) and 52.9％ (9/17) respectively.No significant differences in clinical remission and mucosal healing rates at both week 10 and 30 were observed between the two groups.The prevalences of adverse events in step-up and top-down group were 41.7％ (10/24) and 29.4％ (5/17)respectively ( P =0.422).Conclusion Both step-up and top-down infliximab therapy can induce remission in more than half of CD patients,while top-down therapy might be more benefitiary to symptom and endoscopic remission.