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Interventions for prevention of post-operative recurrence of Crohn's disease

  • Review
  • Intervention




Recurrence of Crohn's disease is common after intestinal resection. A number of agents have been studied in controlled trials with the goal of reducing the risk of endoscopic or clinical recurrence of Crohn's disease following surgery.


To undertake a systematic review of the use of medical therapies for the prevention of post-operative recurrence of Crohn's disease

Search methods

MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched to identify relevant studies. References from selected papers and abstracts from Digestive Disease Week were also searched.

Selection criteria

Randomised controlled trials that compared medical therapy to placebo or other medical agents for the prevention of recurrence of intestinal Crohn's disease were selected for inclusion.

Data collection and analysis

Two authors reviewed all abstracts containing search terms, and those meeting inclusion criteria were selected for full data abstraction. Dichotomous data were summarised using relative risk and 95% confidence intervals. A fixed-effects model was used, and sensitivity analysis performed.

Main results

Twenty-three studies were identified for inclusion. Probiotics were not superior to placebo for any outcome measured. The use of nitroimidazole antibiotics appeared to reduce the risk of clinical (RR 0.23; 95%CI 0.09 to 0.57, NNT=4) and endoscopic (RR 0.44; 95%CI 0.26 to 0.74, NNT = 4) recurrence relative to placebo. However, these agents were associated with higher risk of serious adverse events (RR 2.39, 95% CI 1.5 to 3.7). Mesalamine therapy was associated with a significantly reduced risk of clinical recurrence (RR 0.76; 95% CI 0.62 to 0.94, NNT = 12), and severe endoscopic recurrence (RR 0.50; 95% CI 0.29 to 0.84, NNT = 8) when compared to placebo. Azathioprine/6MP was also associated with a significantly reduced risk of clinical recurrence (RR 0.59; 95% CI 0.38 to 0.92, NNT = 7), and severe endoscopic recurrence (RR 0.64; 95% CI 0.44 to 0.92, NNT = 4), when compared to placebo. Neither agent had a higher risk than placebo of serious adverse events. When compared to azathioprine/6MP, mesalamine was associated with a higher risk of any endoscopic recurrence (RR 1.45, 95% CI 1.03 to 2.06), but a lower risk of serious adverse events (RR 0.51; 95% CI 0.30 to 0.89). There was no significant difference between mesalamine and azathioprine/6MP for any other outcome.

Authors' conclusions

There are insufficient randomised controlled trials of infliximab, budesonide, tenovil and interleukin-10 to draw conclusions. Nitro-imidazole antibiotics, mesalamine and immunosuppressive therapy with azathioprine/6-MP or infliximab all appear to be superior to placebo for the prevention of post-operative recurrence of Crohn's disease. The cost, toxicity and tolerability of these approaches require careful consideration to determine the optimal approach for post-operative prophylaxis.



克隆氏症(Crohn's disease)術後復發的預防

克隆氏症(Crohn's disease)常於腸切除手術之後復發。為了降低內視鏡手術以及克隆氏症臨床復發隨之而來手術的風險,目前已有研究人員針對一些藥物進行對照試驗。




搜尋MEDLINE、EMBASE與the Cochrane Central Register of Controlled Trials,簡稱CENTRAL)找出相關試驗,並由「消化疾病週」(Digestive Disease Week)會議上的重要文獻與摘要所列的參考文獻進行搜尋。




由兩名作者負責檢視所有含搜尋關鍵字的摘要,然後篩選出符合納入條件者以擷取完整資料。二元資料係以相對危險性與95% confidence intervals(CI)加以總結。“ – >建議改為”二分類數據以relative risk與95% confidence intervals(CI)加以總結


總共找到23項符合納入條件的試驗。在所評量的所有指標上,益生菌(probiotics)的功效均未優於安慰劑。相較於安慰劑,nitroimidazole類抗生素可降低根據臨床症狀(RR 0.23;95%CI 0.09 to 0.57,NNT = 4)與經內視鏡檢查(RR 0.44;95% CI 0.26 to 0.74,NNT = 4)確診之復發的危險性,但此藥物的嚴重不良事件危險性較高(RR 2.39,95% CI 1.5 to 3.7)。相較於安慰劑,mesalamine療法可顯著降低根據臨床症狀確診之復發(PP 0.76;95%CI 0.62 to 0.94,NNT = 12)與經內視鏡檢查確診之嚴重復發(RR 0.50;95%CI 0.29 to 0.84,NNT = 8)的危險性。相較於安慰劑,azathioprine/6MP亦可顯著降低根據臨床症狀確診之復發(RR 0.59;95%CI 0.38 to 0.92,NNT = 7)與經內視鏡檢查確診之嚴重復發(RR 0.64;95%CI 0.44to 0.92,NNT = 4)的危險性。此兩種藥物的嚴重不良事件危險性,均未高於安慰劑。相較於azathioprine/6MP組,mesalamine組經內視鏡檢查確診之任何程度復發的危險性較高(RR 1.45;95%CI 1.03 to 2.06),但嚴重不良事件危險性較低(RR 0.51;95%CI 0.30 to 0.89)。在任何其他評估指標上,mesalamine與azathioprine/6MP之間均無顯著差異。


從infliximab、budesonide、tenovil與interleukin10現有的有對照組隨機分組試驗,尚不足以做出任何結論。Nitroimidazole類抗生素、mesalamine 與以azathioprine/6MP或infliximab所進行的免疫抑制療法,對克隆氏症術後復發的預防功效均優於安慰劑。這些療法的費用、毒性與耐受性均須謹慎納入考量,以找出最理想的術後預防療法。


此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。


總結 克隆氏症術後復發的預防 克隆氏症屬於慢性疾病,病患會因腸子發炎而引起腹瀉、體重下降或胃痛等症狀。此疾病常須以手術將發炎部位的腸子切除,但手術部位常會再次發炎。本回顧旨在檢視一些探討克隆氏症手術治療之後,藥物對發炎復發之預防效果的已發表試驗結果,並儘可能將不同試驗的結果加以合併,以比較不同療法的結果。許多藥物均可降低發炎的復發率,包括metronidazole、mesalamine、azathioprine、6mercaptopurine與infliximab,但因其中有些藥物具有嚴重的副作用,使用時必須謹慎衡量該藥物對個別病患的風險與益處。

Plain language summary

Interventions for prevention of post-operative recurrence of Crohn's disease

Crohn's disease is a chronic illness where patients suffer from diarrhea, weight loss or stomach pain resulting from inflammation in the intestine. The illness often requires patients to undergo surgery in order to remove inflamed segments of intestine, but inflammation frequently returns at the site of surgery. This review examines the results of published studies which have looked at the effect of using medication following surgery for Crohn's disease as a mean of preventing the return (recurrence) of inflammation. Where possible, the results of studies were combined to compare the results of different treatments. A number of medications appeared to reduce the recurrence of inflammation, including metronidazole, mesalamine, azathioprine, 6-mercaptopurine and infliximab. Given that some of these medications have significant side-effects, the decision to use them requires a careful balancing of the risks and benefits for each individual patient