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英夫利昔单抗维持治疗肛周克罗恩病的长期疗效。

Long-term efficacy of infliximab maintenance therapy for perianal Crohn's disease.

机构信息

Department of Lower Gastroenterological Surgery, Hyogo College of Medicine, Mukogawacho 1-1, Nishinomiya, Hyogo 6638501, Japan.

出版信息

World J Gastroenterol. 2011 Mar 7;17(9):1174-9. doi: 10.3748/wjg.v17.i9.1174.

Abstract

AIM

To assess the long-term efficacy of seton drainage with infliximab maintenance therapy in treatment of stricture for perianal Crohn's disease (CD).

METHODS

Sixty-two patients with perianal CD who required surgical treatment with or without infliximab between September 2000 and April 2010 were identified from our clinic's database. The activities of the perianal lesions were evaluated using the modified perianal CD activity index (mPDAI) score. The primary endpoint was a clinical response at 12-15 wk after surgery as a short-term efficacy. Secondary endpoints were recurrence as reflected in the mPDAI score, defined as increased points in every major element. The clinical responses were classified as completely healed (mPDAI = 0), partially improved (mPDAI score decreased more than 4 points), and failure or recurrence (mPDAI score increased or decreased less than 3 points).

RESULTS

There were 43 males and 19 females, of whom 26 were consecutively treated with infliximab after surgery as maintenance therapy. Complete healing was not seen. Failure was seen in 10/36 (27.8%) patients without infliximab and 4/26 (15.4%) patients with infliximab (P = 0.25). Partial improvement was seen in 26/36 (72.2%) patients without infliximab and 22/26 (88.5%) patients with infliximab (P = 0.25). Short-term improvement was achieved in 48/62 (77.4%) patients. Although the mPDAI score improved significantly with surgery regardless of infliximab, it decreased more from baseline in patients with infliximab (50.0%) than in those without infliximab (28.6%), (P = 0.003). In the long-term, recurrence rates were low regardless of infliximab in patients without anorectal stricture. In patients with anorectal stricture, cumulative recurrence incidences increased gradually and exceeded 40% at 5 years regardless of infliximab. No efficacy of infliximab treatment was found (P = 0.97). Although the cumulative rate of ostomy creation was also low in patients without stricture and high in patients with stricture, no protective efficacy was found with infliximab treatment (P = 0.6 without stricture, P = 0.22 with stricture).

CONCLUSION

Infliximab treatment was demonstrated to have short-term efficacy for perianal lesions. Long-term benefit with infliximab was not proven, at least in patients with anorectal stricture.

摘要

目的

评估挂线引流联合英夫利昔单抗维持治疗对肛周克罗恩病(CD)狭窄的长期疗效。

方法

我们从诊所数据库中确定了 2000 年 9 月至 2010 年 4 月期间因需要手术治疗而接受或未接受英夫利昔单抗治疗的 62 例肛周 CD 患者。采用改良肛周 CD 活动指数(mPDAI)评分评估肛周病变活动度。主要终点为术后 12-15 周的临床反应,作为短期疗效。次要终点为 mPDAI 评分反映的复发,定义为每个主要项目的分数增加。临床反应分为完全愈合(mPDAI=0)、部分改善(mPDAI 评分降低超过 4 分)和失败或复发(mPDAI 评分增加或降低少于 3 分)。

结果

共 43 例男性和 19 例女性,其中 26 例术后连续接受英夫利昔单抗维持治疗。未见完全愈合。无英夫利昔单抗组 10/36(27.8%)患者出现失败,有英夫利昔单抗组 4/26(15.4%)患者出现失败(P=0.25)。无英夫利昔单抗组 26/36(72.2%)患者部分改善,有英夫利昔单抗组 22/26(88.5%)患者部分改善(P=0.25)。62 例患者中有 48 例(77.4%)短期改善。无论是否使用英夫利昔单抗,手术均可显著改善 mPDAI 评分,但有英夫利昔单抗组(50.0%)的下降幅度大于无英夫利昔单抗组(28.6%)(P=0.003)。长期来看,无论是否使用英夫利昔单抗,无肛门直肠狭窄的患者复发率均较低。在有肛门直肠狭窄的患者中,累积复发率逐渐增加,无论是否使用英夫利昔单抗,5 年内均超过 40%。未发现英夫利昔单抗治疗有疗效(P=0.97)。尽管无狭窄的患者造口术累积发生率较低,而有狭窄的患者较高,但英夫利昔单抗治疗无保护作用(无狭窄时 P=0.6,有狭窄时 P=0.22)。

结论

英夫利昔单抗治疗对肛周病变有短期疗效。但至少在有肛门直肠狭窄的患者中,未证明英夫利昔单抗有长期获益。

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