5-氨基水杨酸锌胶囊治疗活动性溃疡性结肠炎的多中心随机双盲临床研究

Evaluation on different dosage of 5-aminosalicylic acid zinc enteric-coated capsule in treatment of active ulcerative colitis： multi-centre randomized double-blind double-dummy controlled trial

目的探索5-氨基水杨酸锌结肠溶胶囊治疗溃疡性结肠炎（活动期）的疗效、安全性及合适剂量。方法采用多中心、随机、双盲双模拟、剂量反应和阳性对照设计，将2004年3月至9月上海瑞金医院等6家医院108例活动性溃疡性结肠炎患者随机分为5-氨基水杨酸锌高剂量组和低剂量组（每天给予5氨基水杨酸锌结肠溶胶囊2次，每次分别为1g和0．5g）以及对照组（每天3次给予奥沙拉秦钠胶囊，每次1g），每组36例，疗程均为8周。随访记录评估三组患者的临床症状和肠镜检查情况，并记录治疗过程中的不良反应。结果5氨基水杨酸锌高剂量组和低剂量组临床疗效有效率分别为68．97％和45．45％，对照组为62．86％，组间差异无统计学意义（P〉0．05）。肠镜检查5-氨基水杨酸锌高剂量组和低剂量组痊愈率分别为51．72％和21．21％，有效率分别为82．76％和69．70％，高剂量组优于低剂量组（P=0．023），但与对照组（分别为34．29％和88．57％）相比差异无统计学意义（P〉0．05）。不良反应主要是腹泻，5-氨基水杨酸锌高剂量组为2．8％（1／36），低剂量组未发生不良反应，对照组为2．89／（1／36）。结论5-氨基水杨酸锌高剂量组能有效治疗活动期溃疡性结肠炎，疗效与对照组相当，安全性相似，但试验药有减少用药次数的优点。

Objective To evaluate the efficacy and safety of two kinds of dosage of 5 aminosalicylic acid zinc enteric-coated capsule in treatment of active ulcerative colitis （UC）. Methods The multicentre, double blind, dosage reaction and contrast trial was conducted in six hospitals during March 2004 to Sep. 2004. One hundred and eight patients with UC were randomly allocated into the high dosage （n=36, 1 g,bid） and the low dosage （n： 36, 0. 5 g, bid） of 5-aminosalicylic acid zinc enteric-coated capsule groups, and the Olsalazine sodium group （n： 36, 1 g, rid） with a 8 week treatment. The efficacy and adverse events of 5-aminosalicylic acid zinc enteric coated capsule were evaluated based on the clinical presentations and endoscopic findings. Results The clinical efficacy was 68.97 % in high dosage group, 45.45% in low dosage group and 62.86% in Olsalazine sodium group with no significant difference （P〉0.05）. The endoscopic examination showed that the healing rate of UC in high dosage group and low dosage group was 51.72% and 21.21%, respectively, whereas the efficacy rate was 82. 76% and 69. 70% respectively. The results showed that high dosage was more effective than low dosage （P=0. 023）, but was similar to Olsalazine sodium （healing rate of 34. 29% and effective rate of 88.57% ,P〉0.05）. Diarrhea was main adverse event, which was accounted for 2.8%（1/36） in high dosage group and 2.8% （1/36） in the Olsalazine sodium group. There was no adverse event in low dosage group. Conclusions 5-aminosalicylic acid zinc enteric-coated capsule is an effective agent in treatment of UC, especially in high dosage. It is similar to Olsalazine sodium in treatment of UC, and has advantages in reducing medication times.