A Comparison of the Efficacy and Safety of Balsalazide (Basazyde(superscript ®)) and Mesalamine (Asacol(superscript ®)) for the Treatment of Acute Exacerbation of Ulcerative Colitis

比較使用Balsalazide (Basazyde)和Mesalamine (Asacol)來治療急性惡化潰瘍性結腸炎的效果和安全性

陳建彰(Chien-Chang Chen) ； 許自齊(Tzu-Chi Hsu) ； 王輝明(Hwei-Ming Wang) ； 金台明(Tai-Ming King) ； 吳登強(Deng-Chyang Wu) ； 陳自諒(Tzu-Liang Chen) ； 陳啟益(Chi-Yi Chen) ； 高愛文(Ai-Wen Kao)

《中華民國大腸直腸外科醫學會雜誌》 17卷3期 (2006/09) Pp. 63-70

https://doi.org/10.6312/SCRSTW.2006.17(3).09501

摘要

目的　這是一個隨機、多所醫學中心參與、雙盲、雙仿的研究，來評估在八個星期中使用Balsalazide (Basazyde)和Mesalamine(Asacol)來治療急性惡化潰瘍性結腸炎的效果和安全性。
方法　參與治療的對象是有急性惡化潰瘍性結腸炎的病患，而且經乙狀結腸鏡檢查有二到四級的徵狀。病患隨機接受Balsalazide(750mg/cap，3# tid)或Mesalamine (400mg/tab，2# tid)的治療。總共有52位病患加入這個研究，其中有40位完成八個星期的治療。功效和安全性在八個星期的治療之後被評估。
結果　在Mesalamine組中17位有8位(47.1%)，在Balsalazide組中23位有10位(43.5%)病人的症狀完全解除。經乙狀結腸鏡觀察的改善程度在Balsalazide組(82.35%)顯著的比Mesalamine 組(47.83%)好。在Balsalazide組24位病人中有17位(70.8%)，而在Mesalamine組28位病人中有18位(64.3%)發生不良反應的事件。在臨床上例行的實驗室檢查和生命徵象在兩組都沒有顯著的變化。
結論　這個研究證實在八個星期中每天使用6.75公克Balsalazide來治療急性惡化潰瘍性結腸炎是安全的，可被接受的，而且是有效的。因此證明用Balsalazide來治療急性惡化潰瘍性結腸炎是有效的。

關鍵字

Balsalazide Basazyde(上标 ®) ； Mesalamine Asacol(上标 ®) ； 潰瘍性結腸炎

並列摘要

Purpose. This is a randomized, multi-center, double-dummy, and active-controlled study to evaluate the efficacy and safety of balsalazide as compared to mesalamine for a treatment period of eight weeks in patients with acute exacerbation of ulcerative colitis.
Methods. Subjects with acute exacerbation of ulcerative colitis and had symptomatic grade 2~4 ulcerative colitis after being checked by sigmoidoscopic examination were recruited for the study. Subjects were randomized to received balsalazide (750 mg/cap, 3# tid) and mesalamine (400 mg/tab, 2# tid). Fifty-two subjects were enrolled into the study, forty of them completed eight weeks treatment. Efficacy and safety were evaluated after eight weeks treatment.
Results. Complete remission occurred in 8 of 17 (47.1%) patients in the balsalazide group and 10 of 23 (43.5%) patients in the mesalamine group. Sigmoidoscopic improvement is more significant in the balsalazide group (82.35%) than mesalamine group (47.83%). Adverse event was experienced in 17 of 24 patients (70.8%) in the balsalazide group and 18 of 28 patients (64.3%) in the mesalamine group. There were no clinically significant changes in routine laboratory assessments and vital signs in either treatment groups.
Conclusion. This study confirmed that 8 weeks of treatment with 6.75g daily of balsalazide is safe, well tolerated, and effective for acute ulcerative colitis. Balsalazide is therefore proven to be an effective treatment in the management of ulcerative colitis.

並列關鍵字

Balsalazide Basazyde(superscript ®) ； Mesalamine Asacol(superscript ®) ； Ulcerative colitis