Andrographis paniculata Extract (HMPL-004) for Active Ulcerative Colitis

作者：Sandborn William J^*; Targan Stephan R; Byers Vera S; Rutty Dean A; Mu Hua; Zhang Xun; Tang Tom

来源：American Journal of Gastroenterology, 2013, 108(1): 90-98.

DOI：10.1038/ajg.2012.340

OBJECTIVES: Andrographis paniculata has in vitro inhibitory activity against TNF-alpha, IL-1 beta and NF-kappa B. A pilot study of A. paniculata extract (HMPL-004) suggested similar efficacy to mesalamine for ulcerative colitis.
METHODS: A randomized, double-blind, placebo-controlled trial evaluated the efficacy of A. paniculata extract (HMPL-004) in 224 adults with mild-to-moderate ulcerative colitis. Patients were randomized to A. paniculata extract (HMPL-004) 1,200 mg or 1,800 mg daily or placebo for 8 weeks.
RESULTS: In total, 45 and 60% of patients receiving A. paniculata 1,200 mg and 1,800 mg daily, respectively, were in clinical response at week 8, compared with 40% of those who received placebo (P = 0.5924 for 1,200 mg vs. placebo and P = 0.0183 for 1,800 mg vs. placebo). In all, 34 and 38 % of patients receiving A. paniculata 1,200 mg and 1,800 mg daily, respectively, were in clinical remission at week 8, compared with 25 % of those who received placebo (P = 0.2582 for 1,200 mg vs. placebo and P = 0.1011 for 1,800 mg vs. placebo). Adverse events developed in 60 and 53 % of patients in the A. paniculata 1,200 mg and 1,800 mg daily groups, respectively, and 60 % in the placebo group.
CONCLUSIONS: Patients with mildly to moderately active ulcerative colitis treated with A. paniculata extract (HMPL-004) at a dose of 1,800 mg daily were more likely to achieve clinical response than those receiving placebo.

• 出版日期2013-1