英夫利西治疗62例克罗恩病疗效观察

Clinical efficacy of infliximab in the treatment of 62 cases with Crohn＇s disease

目的评价英夫利西治疗CD患者的疗效及安全性。方法回顾性分析2009年2月至2013年3月使用英夫利西治疗的62例CD患者的临床资料，选取英夫利西治疗后第14周（英夫利西注射3次后）和本研究随访终点（2013年3月）2个观察点。观察英夫利西治疗后第14周的CRP水平、克罗恩病活动指数（CDAI）评分情况及临床缓解情况。在随访终点，观察英夫利西治疗后的临床缓解情况、肛瘘闭合情况、结肠黏膜愈合情况及不良反应。正态分布数据用j±S表示，t检验比较治疗前后差异。非正态分布数据用中位数（下四分位数，上四分位数）表示，Wilcoxon非参数检验比较治疗前后差异。结果剔除4例注射未满3次的患者、1例失访的患者、9例术后预防复发的患者，共有48例处于活动期的CD患者纳入疗效研究。第14周时，48例患者的CRP为1．9（0．5，5．4）mg／L，与治疗前的28．9（6．4，51．1）mg／I。相比下降（Z=-5．468，P〈0．01）；CDAI评分为87．0±35．8，与治疗前（245．1±59．1）相比显著下降（t=18．579，P〈0．01）。第14周时，46例CD活动患者达到临床缓解，缓解率为95．8％。随访终点时，仍有38例患者维持临床缓解，缓解率为79．2％。有26例患者在英夫利西治疗前有活动性肛瘘，7例（26．9％）肛瘘完全闭合，17例（65．4％）部分闭合，2例（7．7％）无反应。15例患者在英夫利西治疗≥6次后肠镜复查，治疗后简化CD内镜评分（SES—CD）为3（O，5），较治疗前[8（7，9）]下降（z=-3．306，P=0．001）。48例CD活动患者中22例采用上阶梯治疗，26例采用下阶梯治疗。第14周时，上阶梯治疗组有20例（90．9％）、下阶梯治疗组有26例（100．0％）进入临床缓解；随访终点时，上阶梯治疗组有14例（63．6％）、下阶梯治疗组有24例（92．3％）维持临床缓解。26例肛瘘患者中2例无反应者均为上阶梯治疗组，完全闭合者7例均为下阶梯治疗组。62例患者中有5例发生不良反应，其中3例为急性输液反应，1例为迟发性输液反应，1例发生贫血。结论英夫利西在控制CD患者炎性反应活动、诱导临床缓解、促进肛瘘闭合及黏膜愈合方面体现出较好的疗效。对部分高危CD患者使用下阶梯治疗也显现了较好的疗效。

Objective To evaluate the treatment of Crohn＇s disease （CD）. Methods clinical efficacy and safety of infliximab （IFX） in the From February 2009 to March 2013, the clinical data of 62 CD patients with IFX treatment were retrospectively analyzed. At week 14th after IFX injection and the end of follow-up of this study （March 2013） were two observation points. At week 14th after IFX injection （three times of IFX injection）, C reactive protein （CRP） level, Crohn＇s disease activity index （CDAI） score and clinical remission were investigated. At the end of follow-up, clinical remission, fistula closure, mucosal healing and side effects were inspected. Normal distribution data were expressed as x± s, which were compared with t test. Non normal distribution data were expressed as M （QL-Qu） and compared with Wilcoxon test. Results Four cases without complete three times of IFX injection and one case lost to follow-up were eliminated. And nine postoperation cases with IFX treatment to prevent recurrence after surgery were excluded. A total of 48 cases of CD in active period were enrolled in this study on efficacy. At week 14th , CRP level of 48 patients [1.9（0.5,5.4） mg/L] decreased compared with that before treatment [28. 9（6. 4,51.1） mg/L] （Z=-5.468, P〈0.01）; CDAI score （87.0±35.8） also decreased compared with that before treatment （245.1±59.1） （t= 18. 579, P〈0. 01）. At week 14th, 46 patients in active period achieved clinical remission and the remission rate was 95.8%. By the end of follow-up, 38 patients were still in remission period and the remission rate was 79. 2%. Among 26 patients with anal fistula before IFX treatment, seven cases （26. 9%） were completely closed, 17 cases （65.4%） was partially closed and two cases was responseless. Fifteen patients were reviewed by colonoscopic examination after more than six times of IFX treatment. The median of simple endoscopic score for Crohn＇s disease （SES-CD） was 3 （0, 5） after treatment, which decreased compared with that before treatment （8 （7,9）, Z=- 3. 306, P = 0. 001）. Twenty-two of 48 cases in active period received, step-up strategy and 26 cases received with top down strategy. At week 14th, 20 cases （90. 9%） of group with step-up strategy and 26 cases （100.0%） of group with top down strategy were in remission period. By the end of follow-up, 14 cases （63.6%） of group with step up strategy and 24 cases （92.3%） of group with top-down strategy maintained remission. Among 26 cases with anal fistula, two cases without response were treated with step-up strategy and seven cases with complete closure were all with top-down strategy. Among 62 patients, five had side effects, three of whom had acute infusion reaction, one had delayed infusion reaction and the other had anemia. Conclusions IFX had good clinical efficacy in controlling inflammation, inducing clinical remission, promoting fistula closure and mucosal healing in CD patients. For some CD patients with high risk, the initial top-down strategy showed good clinical efficacy.