There have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed to evaluate the use of anti-tuberculous therapy for the maintenance of remission in Crohn's disease.
To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease.
We searched the Inflammatory Bowel Disease Trials Register, the Cochrane Controlled Trials Register and MEDLINE from 1966 to 1998 (supplemented by a manual search of Index Medicus from 1966 to 1994). We also searched for abstracts in Gut, Gastroenterology, and The American Journal of Gastroenterology from 1990 to 1996. Date of most recent search: August 1998.
Randomized trials of anti-tuberculous therapy in patients with Crohn's disease.
Data collection and analysis
Data on the number of patients maintaining remission for each treatment group were abstracted. These data were pooled to yield Mantel-Haenszel odds ratios and numbers needed to treat for maintenance of remission in treated versus control groups.
A total of seven randomized trials which included 355 patients were identified. Two trials used anti-tuberculous therapy (clofazimine or clofazimine, rafmpin, ethambutol, and dapsone) in combination with corticosteroids to induce remission. Maintenance therapy consisted of the anti-tuberculous agents without corticosteroids. Control patients received corticosteroids to induce remission but no anti-tuberculous therapy.
The analysis of all seven trials yielded an odds ratio for maintenance of remission of 1.36 (95% CI 0.87-2.13). Removing the two studies that were published as abstracts did not significantly affect this result: the pooled odds ratio was 1.14 (95% CI 0.71-1.83).
The two trials reported as abstracts were excluded from subgroup analyses because they did not include any information on adjunct therapy.
Subgroup analysis of the two trials which used steroids to induce remission yielded an odds ratio for maintenance of remission of 3.37 (95% CI 1.38-8.24). The number needed to treat was three. However, these two trials included only 89 patients, and the results should be interpreted with caution.
The remaining three trials compared the combination of anti-tuberculous therapy and 'standard therapy' with 'standard therapy alone'. The pooled odds ratio was 0.70 (95% CI 0.39-1.25).
Anti-tuberculous therapy may be effective in maintaining remission in patients with Crohn's disease when remission has been induced with corticosteroids combined with anti-tuberculous therapy. However, the results which support this conclusion come from a subgroup of only two trials with small numbers of patients and should be interpreted with caution. Use of this therapy cannot be recommended on the basis of this evidence.
搜尋1966年至1998年 Inflammatory Bowel Disease Trials Register、 Cochrane Controlled Trials Register 及MEDLINE， (並輔以人工搜尋1966年至1994年Index Medicus)。同時搜尋1990年至1996年Gut、Gastroenterology及The American Journal of Gastroenterology的摘要。最近一次搜尋在1998年8月。
擷取每一治療組中維持緩解效果的病患人數。這些數據會被彙整計算出 MantelHaenszel勝算比(odds ratios)和在治療組相對對照組治療以維持緩解效果需要的病患數目。
納入共355名患者7個隨機性試驗。有2個試驗使用抗結核藥物治療 (clofazimine 或 clofazimine, rafmpin, ethambutol, 和dapsone)搭配類固醇治療來產生緩解效果。維持性治療包括使用抗結核藥物不加類固醇。對照組的患者使用類固醇產生緩解效果，但沒接受抗結核藥物治療。針對這7個試驗分析得到維持緩解效果的勝算比為1.36 (95%信賴區間 0.87至2.13)。去除兩個僅以摘要發表的試驗後分析沒有顯著影響結果：彙集的勝算比為1.14(95%信賴區間 0.71至1.83)。因這兩個僅以摘要發表的試驗沒有收納任何輔助治療的資訊，所以這兩個試驗未包含到次群組分析。兩個使用類固醇造成來緩解試驗進行次群體分析得到維持緩解效果的勝率比為3.37(95%信賴區間1.38至8.24)，兩組有差別需要進行治療的患者數為3。但這兩個試驗只納入89名病患，所以應該謹慎解釋試驗結果。其餘的3個試驗則是比較抗結核治療加上“標準療法”與標準療法比較，彙集的勝算比值為0.70(95%信賴區間0.39至1.25)。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。