摘要目的 比较中重度克罗恩病(CD)诱导缓解治疗中,英夫利西单抗(IFX)与肠内营养(EN)的疗效及成本.方法 采用前瞻性设计方案,人选2010年6月至2012年1月的中重度活动期CD患者,随机分为IFX组及EN组,分别以IFX、EN诱导缓解治疗.分析两组患者诱导缓解率、诱导缓解时间、治疗成本及达到诱导缓解时生活质量及营养状况改善情况.克罗恩病活动指数(CDAI)＜150分定义为疾病缓解,221 ～ 450分为中度活动期、＞450分为重度活动期.生活质量评估使用炎症性肠病生存质量问卷(IBDQ).结果 EN组入选52例,IFX组48例.EN组患者诱导缓解率低于IFX组[67.3％(35/52)比87.5％(42/48),P=0.017].IFX组平均诱导缓解时间短于EN组[(11.00±8.35)d比(33.94±14.60)d,P＜0.001].达到诱导缓解时,两组平均诱导缓解所需费用相比,差异无统计学意义(P =0.351)；EN组治疗后的体重指数(BMI)提高值大于IFX组[(1.32±0.29)kg/m2比(0.51±0.07) kg/m2,P＜0.001]；IFX组IBDQ评分升高值大于EN组[(42.74±27.50)分比(7.57±22.77)分,P＜0.001].对于CDAI＜ 280分的患者,使用EN与IFX诱导缓解率的差异无统计学意义[85.7％(24/28)比81.8％(18/22),P=0.718],而EN诱导缓解的费用显著低于IFX组[(1.61±0.59)万元／例比(2.29±1.19)万元／例,P=0.021].对于CDAI≥280分的患者,IFX组诱导缓解率显著高于EN组[92.3％(24/26)比45.8％(11/24),P＜0.001],两组治疗费用的差异无统计学意义[(3.53±2.75)万元／例比(3.26±0.21)万元／例,P=0.739].结论 对于中等严重度的患者(CDAI＜ 280分),使用EN治疗可以较低的治疗费用获得与IFX相当的诱导缓解率.但对于病情较重的患者(CDAI≥ 280分),使用IFX可以取得比EN更高的诱导缓解率,此时使用EN的治疗费用并不低于IFX.IFX在诱导缓解时效及改善生活质量方面优于EN,EN在诱导缓解的同时改善营养状况优于IFX.

abstractsObjective To compare the induction of remission and cost-effectiveness of enteral nutrition (EN) and infliximab (IFX) in moderate-to-severe active Crohn's disease (CD).Methods Moderate-to-severe active CD patients were divided into IFX group and EN group.Remission rate,time to remission and treatment cost were compared between the two groups.Clinical remission was defined as Crohn's disease activity index (CDAI) ＜ 150.The quality of life was evaluated by inflammatory bowel disease questionnaire of quality of life(IBDQ).Results A total of 100 patients were analyzed,including 48 patients in IFX group and 52 patients in EN group.IFX group had higher remission rate [87.5％(42/48) vs 67.3％ (35/52),P =0.017] and shorter time to remission [(11.00 ± 8.35) days vs (33.94 ±14.60) days,P ＜ 0.001] than EN group.Treatment costs before remission were similar in two groups(P =0.351).The increase of IBDQ scores before and after treatment in IFX group was much higher than that of EN group(42.74 ± 27.50 vs 7.57 ± 22.77,P ＜ 0.001).Similarly,patients in EN group had greater increase of body mass index (BMI) than that of IFX group [(1.32 ± 0.29) kg/m2 vs (0.51 ± 0.07) kg/m2,P ＜ 0.001].For patients with CDAI ＜ 280,remission rate was not significantly different [85.7％ (24/28)vs 81.8％ (18/22),P =0.718] between the two groups,while treatment cost in EN group was less than that of IFX group [(16.1 ± 5.9) × 103 RMB vs (22.9 ± 11.9) × 103 RMB,P =0.021].Conclusions For patients with severe CD (CDAI ≥ 280),IFX has higher remission rate,shorter time to remission and comparable treatment cost than EN.But for patients with CDAI ＜ 280,EN group has comparable remission rate to IFX group with lower cost.