背景:阿达木单抗单药治疗可以抑制肠道炎症并诱导活动性克罗恩病的缓解,但有一些局限性。对于轻度至中度克罗恩病(CD)患者,建议使用独家肠内营养(EEN)。但是实施是具有挑战性的。
目的:评价阿达木单抗联合部分肠内营养(PEN)在克罗恩病诱导治疗中的效果。
方法:设计一项前瞻性队列研究,选择我院56例符合肠内营养(EN)治疗标准的活动性CD患者。收集所有患者的基线资料,包括年龄、年龄、性和其他一般信息。粪便钙卫蛋白的变化,C反应蛋白(CRP),白蛋白(Alb),血红蛋白(Hb),血小板(Plt),红细胞沉降率(ESR),克罗恩病活动指数评分(CDAI),在第0周(W0)时,比较了阿达木单抗联合肠内营养(ADA+EN)组(N=37)和阿达木单抗组(ADA)(N=19)之间的简单内镜评分(SES-CD)和体重指数(BMI),以及第12周(W12)时的治疗结果.此外,评价两组治疗前后的差异。然后根据肠内营养摄入量将ADA+EN组分为阿达木单抗联合专有肠内营养亚组(ADA+EEN)和阿达木单抗联合部分营养亚组(ADA+PEN)。粪便钙卫蛋白的变化,CRP,Alb,Hb,Plt,ESR和CDAI,在第0周(W0)和第12周(W12)比较ADA+EEN组和ADA+PEN组之间的SES-CD和BMI。评价两组治疗前后的差异。评估两种治疗方法对患者生活质量的影响,营养恢复和身体成分,ADA+EN组患者需要完成炎症性肠病问卷(IBDQ),EQ-5D-5L,EuroQol视觉模拟量表(EQ-VAS)和身体成分分析。共有28名患者在第0周和第12周完成了所有问卷和身体成分分析,包括ADA+EEN组的10名患者和ADA+PEN组的18名患者。分别。IBDQ的差异,在第0周(W0)和第12周(W12)的治疗结果之间比较了两组之间的EQ-5D-5L和身体成分分析。此外,评价两组治疗前后的差异。
结果:这些调查的指标,如钙卫蛋白,Hb,Plt,ESR,Alb,BMI,CRP,ADA+EN组治疗前后CDAI、SES-CD评分差异有统计学意义(p<0.01)。然而,粪便钙卫蛋白,Hb,ADA组SES-CD评分及Alb评分与W0至W12无统计学差异(p>0.05)。治疗后ADA+EN组粪便钙卫蛋白和CDAI评分明显低于ADA组。ADA+PEN组与ADA+EEN组治疗前后各因子差异均有统计学意义(p<0.05)。然而,在第12周,两组之间没有显着差异(p>0.05)。
结论:阿达木单抗联合EN在内窥镜检查和临床缓解方面比ADA单药治疗更有效。通过比较研究的指标,如钙卫蛋白,Hb,Plt,ESR,CRP和SES-CD评分,研究证明,阿达木单抗联合部分肠内营养或专有肠内营养对诱导的克罗恩病具有相同的缓解作用.生物制剂与部分营养的结合可提高医嘱依从性,心理负担和生活质量。因此,阿达木单抗联合部分营养可作为CD诱导缓解的一线治疗方案。
BACKGROUND: Adalimumab monotherapy can suppress gut inflammation and induce remission in active Crohn\'s disease but has some limitations. Exclusive enteral nutrition (EEN) is recommended for patients with mild to moderate Crohn\'s disease (CD), but implementation is challenging.
OBJECTIVE: To evaluate the effectiveness of adalimumab combined with partial enteral nutrition (PEN) in the induction therapy for Crohn\'s disease.
METHODS: A prospective cohort
study was designed and a total of 56 patients with active CD who met the criteria for enteral nutrition (EN) treatment in our hospital were selected. The baseline data of all patients were collected including age, sex and other general information. The changes in fecal calprotectin, C-reactive protein (CRP), albumin(Alb), hemoglobin (Hb), platelets (Plt), erythrocyte sedimentation rate (ESR), Crohn\'s disease activity index score (CDAI), simple endoscopic score (SES-CD) and body mass index (BMI) were compared between the adalimumab combined with enteral nutrition (ADA+EN) group (N = 37) the adalimumab group (ADA) (N = 19) at week 0 (W0) and treatment outcomes at week 12(W12). Additionally, the differences between the two groups before and after treatment were evaluated. Then the ADA+EN group was divided into an adalimumab combined with exclusive enteral nutrition subgroup (ADA+EEN) and an adalimumab combined with partial nutrition subgroup (ADA+PEN) according to enteral nutrition intake. The changes in fecal calprotectin, CRP, Alb, Hb, Plt, ESR and CDAI, SES-CD and BMI were compared between the ADA+EEN group and the ADA+PEN group at week 0 (W0) and treatment outcomes at week 12(W12). The differences between the two groups before and after treatment were evaluated. To evaluate the effectiveness of the two treatments on patients\' quality of life, nutritional recovery and body composition, patients in the ADA+EN group were needed to complete the Inflammatory Bowel Disease Questionnaire (IBDQ), EQ-5D-5L, the EuroQol visual analogue scale (EQ-VAS) and body composition analysis.A total of 28 patients completed all questionnaires and body composition analyses at week 0 and week 12, including 10 patients in the ADA+EEN group and 18 patients in the ADA+PEN group, respectively. The differences of in IBDQ, EQ-5D-5L and body composition analysis were compared between the two groups at week 0 (W0) and treatment outcomes at week 12(W12). Additionally, the differences between the two groups before and after treatment were evaluated.
RESULTS: These investigated indexes such as calprotectin, Hb, Plt, ESR, Alb, BMI, CRP, CDAI and SES-CD scores were significantly different before and after treatment in the ADA+EN group (p < 0.01). However, fecal calprotectin, Hb, SES-CD scores and Alb in the ADA group were not statistically significantly different from W0 to W12 (p > 0.05). The fecal calprotectin and CDAI scores in the ADA+EN group were significantly lower than those in the ADA group after treatment. The differences in all factors before and after treatment between the ADA+PEN group and the ADA+EEN group were statistically significant (p < 0.05). However, there was no significant difference between the two groups at week 12 (p > 0.05).
CONCLUSIONS: Adalimumab combined with EN are more effective than ADA monotherapy in terms of endoscopy and clinical remission. By comparing the investigated indicators such as calprotectin, Hb, Plt, ESR ,CRP and SES-CD scores, it was proven that adalimumab combined with partial enteral nutrition or exclusive enteral nutrition has the same remission effect in induced Crohn\'s disease. The combination of biological agents and partial nutrition can improve medical order compliance, psychological burden and quality of life. Therefore, adalimumab combined with partial nutrition can be used as the first-line treatment for CD induced remission.