Gionchetti P, Rizzello F, Venturi A, Ferretti M, Brignola C, Miglioli M, Campieri M
Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna, Italy.
Dis Colon Rectum. 1998 Jan;41(1):93-7. doi: 10.1007/BF02236902.
The aim of our study was to compare the efficacy and safety of oral mesalazine with mesalazine suppositories in patients with active ulcerative proctitis.
A four-week, randomized, single-blind trial was performed in 58 patients with active, histologically confirmed ulcerative proctitis (< or = 15 cm) to evaluate the efficacy and safety of oral 800-mg mesalazine tablets taken three times per day (n = 29) compared with 400 mg of mesalazine suppositories administered three times per day (n = 29). Patients were evaluated at study entry and after two and four weeks. Efficacy evaluations included a disease activity index, which represents a score with four variables: stools frequency, rectal bleeding, mucosal appearance, and physician's assessment of disease severity. Histologic activity was also assessed at study entry and after two and four weeks in accordance with the criteria by Truelove and Richard. Safety assessment included clinical laboratory parameters and adverse event reports.
There were no significant differences with regard to baseline comparisons of demographics and severity between the two treatment groups. Improvement in mean disease activity index score was significantly greater with suppositories compared with oral mesalazine, both at two-week and four-week visits (mean disease activity index scores at baseline, two, and four weeks: suppositories = 7.7, 2.59, and 1.48; tablets = 7.42, 5.72, and 3.48, respectively (P < 0.001)). The rate of histologic remission was significantly greater with suppositories compared with tablets both at two and four weeks (P < 0.01). There were no significant differences in adverse events or clinical laboratory results between treatment groups.
Results of this study indicate that treatment with mesalazine suppositories produces earlier and significantly better results than oral mesalazine in the treatment of active ulcerative proctitis.
本研究旨在比较口服美沙拉嗪与美沙拉嗪栓剂治疗活动性溃疡性直肠炎患者的疗效和安全性。
对58例经组织学确诊的活动性溃疡性直肠炎（≤15 cm）患者进行了一项为期四周的随机单盲试验，以评估每日三次服用800 mg美沙拉嗪片剂（n = 29）与每日三次使用400 mg美沙拉嗪栓剂（n = 29）的疗效和安全性。在研究开始时以及两周和四周后对患者进行评估。疗效评估包括疾病活动指数，该指数由四个变量组成：大便频率、直肠出血、黏膜外观以及医生对疾病严重程度的评估。还根据Truelove和Richard的标准在研究开始时以及两周和四周后评估组织学活性。安全性评估包括临床实验室参数和不良事件报告。
两个治疗组在人口统计学和严重程度的基线比较方面没有显著差异。与口服美沙拉嗪相比，栓剂在两周和四周随访时平均疾病活动指数评分的改善明显更大（基线、两周和四周时的平均疾病活动指数评分：栓剂分别为7.7、2.59和1.48；片剂分别为7.42、5.72和3.48（P < 0.001））。在两周和四周时，栓剂的组织学缓解率均明显高于片剂（P < 0.01）。治疗组之间在不良事件或临床实验室结果方面没有显著差异。
本研究结果表明，在治疗活动性溃疡性直肠炎方面，美沙拉嗪栓剂治疗比口服美沙拉嗪产生更早且明显更好的效果。
