Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine.
作者： T. Tang , S. R. Targan , Z.-S. Li , C. Xu , V. S. Byers
DOI: 10.1111/J.1365-2036.2010.04515.X
关键词:
摘要: Aliment Pharmacol Ther 2011; 33: 194–202 Summary Background Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, prevents colitis in animal models. Aim To determine efficacy safety HMPL-004 patients with mild-to-moderate ulcerative colitis. Methods A randomised, double-blind, multicentre, 8-week parallel group study was conducted using 1200 mg/day compared 4500 mg/day slow release mesalazine (mesalamine) granules mild-to-moderately active colitis. Disease activity assessed at baseline every 2 weeks for clinical response, 8 weeks by colonoscopy. Results One hundred twenty five centres China were randomised dosed. Clinical remission response seen 21% 76% HMPL-004-treated patients, 16% 82% mesalazine-treated patients. By colonoscopy, 28% 74% 24% 71% respectively. There no significant difference between two treatment groups. Conclusion may be efficacious alternative
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