Mantzaris G J, Hatzis A, Petraki K, Spiliadi C, Triantaphyllou G
First Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
Dis Colon Rectum. 1994 Jan;37(1):58-62. doi: 10.1007/BF02047216.
The aim of this study was to compare the efficacy of intermittent therapy with mesalazine enemas and continuous oral mesalazine to maintain remission of distal ulcerative colitis or proctitis.
Thirty-eight patients with distal ulcerative colitis (n = 17) or ulcerative proctitis (n = 21) in clinical, endoscopic, and histologic remission were randomly assigned to receive either oral mesalazine (0.5 g three times/day, Eudragit L coating, n = 19) or intermittent therapy with mesalazine enemas (4 g of 5-aminosalicylic acid enema every third night, n = 19). Both groups were comparable in regard to sex, age, age at disease onset, extent and duration of disease, number and mode of treatment of previous attacks, and time in remission. Patients were reviewed at the beginning of the study and, subsequently, at two-month intervals for 24 months or until a relapse occurred. At each visit, diaries were reviewed and clinical and laboratory assessments were performed. Sigmoidoscopy was carried out and biopsies were obtained by a blinded observer. Histology was assessed without knowledge of the patient's clinical state or treatment category.
At the end of the study, 6 of 19 patients on oral mesalazine (32 percent) and 14 of 19 patients on mesalazine enemas (74 percent) were still in full remission (log rank test: 15.28, P < 0.001). Differences in relapse rates between groups were significant even when data were stratified by extent of disease (P < 0.01). In the oral group, six and seven patients relapsed at 12 and 24 months, respectively. In the enema group, three and two relapses occurred in the first and second year of the study, respectively. All patients complied with the treatment satisfactorily and there were no dropouts.
These results suggest that intermittent therapy with mesalazine enemas is more effective than continuous oral mesalazine in maintaining remission in patients with distal ulcerative colitis and proctitis.
本研究旨在比较美沙拉嗪灌肠间歇疗法与持续口服美沙拉嗪在维持远端溃疡性结肠炎或直肠炎缓解方面的疗效。
38例处于临床、内镜及组织学缓解期的远端溃疡性结肠炎患者（n = 17）或溃疡性直肠炎患者（n = 21）被随机分为两组，分别接受口服美沙拉嗪（0.5 g，每日3次，肠溶包衣，n = 19）或美沙拉嗪灌肠间歇疗法（每三晚使用4 g 5-氨基水杨酸灌肠剂，n = 19）。两组在性别、年龄、发病年龄、疾病范围和病程、既往发作的治疗次数和方式以及缓解时间方面具有可比性。在研究开始时对患者进行评估，随后每两个月评估一次，为期24个月或直至复发。每次就诊时，检查日记并进行临床和实验室评估。进行乙状结肠镜检查，并由一名不知情的观察者获取活检样本。在不知道患者临床状态或治疗类别的情况下评估组织学。
研究结束时，口服美沙拉嗪组19例患者中有6例（32%）仍处于完全缓解状态，美沙拉嗪灌肠组19例患者中有14例（74%）仍处于完全缓解状态（对数秩检验：15.28，P < 0.001）。即使按疾病范围对数据进行分层，两组之间的复发率差异仍具有统计学意义（P < 0.01）。口服组分别有6例和7例患者在12个月和24个月时复发。灌肠组在研究的第一年和第二年分别发生3次和2次复发。所有患者对治疗的依从性良好，无脱落病例。
这些结果表明，在维持远端溃疡性结肠炎和直肠炎患者的缓解方面，美沙拉嗪灌肠间歇疗法比持续口服美沙拉嗪更有效。
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