英夫利西单克隆抗体联合免疫抑制剂短疗程治疗对回结肠型克罗恩病黏膜愈合的疗效

Mucosal healing in ileocolonic Crohn′s diseases with short-term infliximab and immunosuppression combined therapy

目的观察短疗程生物制剂英夫利西单克隆抗体（IFX）联合免疫抑制剂治疗活动性回结肠型 CD 患者的疗效，评价治疗后黏膜愈合情况。方法纳入2013年1月至2014年7月规律注射 IFX次数≥6次的活动期回结肠型 CD 住院患者共40例。治疗第0、2、6周，以5 mg／kg IFX 诱导缓解治疗，在治疗第2周开始合用免疫抑制剂，之后每8周1次维持治疗，治疗第36周为随访终点。治疗前及随访终点比较血 CRP、Hb 水平和临床缓解[（克罗恩病活动指数（CDAI）＜150分）]、黏膜愈合[简化内镜下克罗恩病评分系统（SES-CD）为0～2分]率、部分黏膜愈合（SES-CD 较治疗前下降，但是＞2分）率和深度缓解（同时达到临床缓解和黏膜愈合）率。治疗前后的比较采用配对 t 检验和 Wilcoxon 符号秩和检验。结果治疗第36周，临床缓解率达95．0％（38／40），黏膜愈合率、部分黏膜愈合率和深度缓解率分别为62．5％（25／40）、35．0％（14／40）和62．5％（25／40），仅1例（2．5％）治疗后黏膜炎性反应没有好转。治疗后的 CDAI 为（99．3±29．3）分，低于治疗前的（301．3±73．1）分，差异有统计学意义（t ＝17．2，P ＜0．01）。中位血 CRP 水平为0．8 mg／L（0．1 mg／L，8．1 mg／L），低于治疗前的26．8 mg／L（16．1 mg／L，61．0 mg／L），差异有统计学意义（Z ＝－5．3，P ＜0．01），而血 Hb 水平[（134．0±16．0）g／L]高于治疗前[（117．0±20．0）g／L]，差异有统计学意义（t＝－6．3，P ＜0．01）。中位 SES-CD 为0分（0分，5分），低于治疗前的14分（8分，24分），差异有统计学意义（Z ＝－5．4，P ＜0．01）。结论 IFX 联合免疫抑制剂短疗程（36周）治疗回结肠型 CD 可达到较高的黏膜愈合率和深度缓解率。

Objective To investigate the efficacy of short-term biological agent infliximab and immunosuppression combined therapy in patients with active ileocolonic Crohn′s diseases （CD）and to evaluate the mucosal healing.Methods From January 2013 to July 2014,forty hospitalized patients with active ileocolonic CD received at least six times scheduled infliximab injection were enrolled.At week 0, second,and sixth,infliximab 5 mg/kg was administered to induce remission.From the second week, immunosuppression was added.After that,infliximab 5 mg/kg was administered every eight weeks for maintenance treatment.The 36th week after treatment was the end point of follow-up.Before treatment and at the end point of follow-up,the levels of C-reactive protein （CRP）,hemoglobin （Hb）,clinical remission Crohn′s disease activity index （CDAI）〈 150 points,mucosal healing simplified endoscopic activity score for Crohn′s disease （SES-CD）was 0 to 2,partial mucosal healing （SES-CD decreased,but〉2 ） and deep remission （achieved both clinical remission and mucosal healing）were compared.T test and Wilcoxon rank sum test were performed for comparison before and after treatment.Results At the 36 th week after treatment,the clinical remission rate was 95 .0% （38/40 ）,mucosal healing rate,partial mucosal healing rate and deep remission rate were 62.5 % （25/40）,35 .0% （14/40）and 62.5 % （25/40）, respectively.The mucosal inflammation of only one case （2.5 %）was not improved.After treatment,the＆amp;nbsp;CDAI was 99.3 ±29.3,which was lower than that before treatment （301 .3 ±73.1 ）and the difference was statistically significant （t = 17.2,P 〈0.01 ）.Median blood CRP level was 0.8 mg/L（0.1 mg/L, 8.1 mg/L）,which was lower than that before treatment （26.8 mg/L（16.1 mg/L,61 .0 mg/L））,the difference was statistically significant （Z = - 5 .3,P 〈 0.01 ）.However,the level of Hb （（134.0 ± 16.0）g/L）was higher than that before treatment （（117.0 ±20.0）g/L）,the difference was statistically significant （t=-6.3,P 〈0.01 ）.The median SES-CD was 0 （0,5 ）,which was lower than that before treatment （14（8,24））,and the difference was statistically significant （Z =-5 .4,P 〈0.01 ）.Conclusion The short-term （36 weeks）infliximab and immunosuppression combined therapy can achieve high mucosal healing rate and deep remission rate in active ileocolonic CD patients.