Rosenberg J L, Wall A J, Levin B, Binder H J, Kirsner J B
Gastroenterology. 1975 Jul;69(1):96-9.
To determine the efficacy of azathioprine in the treatment of ulcerative colitis, a 6-month double blind trial was carried out. Thirty patients with chronic ulcerative colitis who required the equivalent of at least 10 mg of prednisone per day over the 3 months prior to entering the study were randomized into placebo and azathioprine (1.5 mg per kg) treatment groups. Reduction of steriods was a major objective of the trial. Age and sex distribution, number of bowel movements, sense of well being, steroid dosage, and findings on proctoscopy, rectal biopsy, and colon X-ray initially were similar in the two groups. No side effects were associated with azathioprine. Although steroid dose was lower (p less than 0.05) in the azathioprine group at the termination of the study, no difference between the two groups could be detected in the number of bowel movements, sense of well being, and findings on proctoscopy during the first 3 weeks compared with the last 3 and during the first 3 months compared with the last 3. Although azathioprine does not confer dramatic benefit upon patients with chronic ulcerative colitis who require steroids, it does permit reduction of steroid dosage without apparent worsening of the disease. Its major value in ulcerative colitis may be in facilitating significant decreases or complete discontinuance of steroids.
为确定硫唑嘌呤治疗溃疡性结肠炎的疗效，进行了一项为期6个月的双盲试验。30例慢性溃疡性结肠炎患者在进入研究前的3个月中每天需要相当于至少10毫克泼尼松的剂量，他们被随机分为安慰剂组和硫唑嘌呤（每千克1.5毫克）治疗组。减少类固醇用量是该试验的主要目标。两组患者的年龄和性别分布、排便次数、幸福感、类固醇剂量以及直肠镜检查、直肠活检和结肠X光检查结果最初相似。硫唑嘌呤未出现副作用。虽然在研究结束时硫唑嘌呤组的类固醇剂量较低（p小于0.05），但与最后3周相比，前3周以及与最后3个月相比，前3个月两组在排便次数、幸福感和直肠镜检查结果方面均未发现差异。虽然硫唑嘌呤对需要类固醇治疗的慢性溃疡性结肠炎患者没有显著益处，但它确实可以减少类固醇用量而不会使病情明显恶化。它在溃疡性结肠炎中的主要价值可能在于有助于大幅减少或完全停用类固醇。
