Chiba Mitsuro, Tsuji Tsuyotoshi, Nakane Kunio, Tsuda Satoko, Ishii Hajime, Ohno Hideo, Watanabe Kenta, Ito Mai, Komatsu Masafumi, Sugawara Takeshi
Chief of the Inflammatory Bowel Disease Section at Akita City Hospital in Japan.
Chief of the Gastrointestinal Endoscopy Section at Akita City Hospital in Japan.
Perm J. 2017;21:17-009. doi: 10.7812/TPP/17-009.
Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologics. No previous study has focused on a plant-based diet in an induction phase of CD treatment.
To investigate the remission rate of infliximab combined with a plant-based diet as first-line (IPF) therapy for CD.
This was a prospective single-group trial conducted at tertiary hospitals. Subjects included consecutive adults with a new diagnosis (n = 26), children with a new diagnosis (n = 11), and relapsing adults (n = 9) with CD who were naïve to treatment with biologics. Patients were admitted and administered a standard induction therapy with infliximab (5 mg/kg; 3 infusions at 0, 2, and 6 weeks). Additionally, they received a lacto-ovo-semivegetarian diet. The primary end point was remission, defined as the disappearance of active CD symptoms at week 6. Secondary end points were Crohn Disease Activity Index (CDAI) score, C-reactive protein (CRP) concentration, and mucosal healing.
Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction. The remission rates by the intention-to-treat and per-protocol analyses were 96% (44/46) and 100% (44/44), respectively. Mean CDAI score (314) on admission decreased to 63 at week 6 (p < 0.0001). Mean CRP level on admission (5.3 mg/dL) decreased to 0.2 (p < 0.0001). Mucosal healing was achieved in 46% (19/41) of cases.
IPF therapy can induce remission in most patients with CD who are naïve to biologics regardless of age or whether they have a new diagnosis or relapse.
约30%的克罗恩病（CD）患者对生物制剂无反应。既往尚无研究聚焦于CD治疗诱导期的植物性饮食。
探讨英夫利昔单抗联合植物性饮食作为CD一线（IPF）治疗的缓解率。
这是一项在三级医院进行的前瞻性单组试验。研究对象包括新诊断的成年患者（n = 26）、新诊断的儿童患者（n = 11）以及初治的复发成年患者（n = 9）。患者入院后接受英夫利昔单抗标准诱导治疗（5 mg/kg；在第0、2和6周各输注1次）。此外，他们还接受了蛋奶素饮食。主要终点为缓解，定义为第6周时活动性CD症状消失。次要终点为克罗恩病活动指数（CDAI）评分、C反应蛋白（CRP）浓度和黏膜愈合。
2例新诊断的成年患者因肠梗阻退出治疗方案。意向性分析和符合方案分析的缓解率分别为96%（44/46）和100%（44/44）。入院时平均CDAI评分（314）在第6周降至63（p < 0.0001）。入院时平均CRP水平（5.3 mg/dL）降至0.2（p < 0.0001）。46%（19/41）的病例实现了黏膜愈合。
IPF治疗可使大多数初治的CD患者诱导缓解，无论其年龄、是新诊断还是复发。
