A Pilot Study to Evaluate the Safety and Efficacy of an Oral Dose of (-)-Epigallocatechin-3-Gallate-Rich Polyphenon E in Patients With Mild to Moderate Ulcerative Colitis
A Pilot Study to Evaluate the Safety and Efficacy of an Oral Dose of (-)-Epigallocatechin-3-Gallate-Rich Polyphenon E in Patients With Mild to Moderate Ulcerative Colitis
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DOI：
10.1097/mib.0b013e31828f5198
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发表时间：
2013-08-01
影响因子：
4.9
通讯作者：
McClain, Craig J.
中科院分区：
文献类型：
--
作者：
Dryden, Gerald W.;Lam, Allan;McClain, Craig J.
背景：绿茶及其主要多酚成分 (-)-表没食子儿茶素-3-没食子酸酯 (EGCG) 具有强大的抗炎作用，可预防炎症性疾病和癌症。对动物和人类细胞系的研究为这些说法提供了合理的支持。吸收不良导致 EGCG 口服后全身生物利用度较低，但结肠粘膜暴露较高。方法：在一项双盲、安慰剂对照试点研究中，轻度至中度溃疡性结肠炎 (UC) 患者被随机分配每日口服 Polyphenon E 剂量（每日 400 毫克或 800 毫克总 EGCG，分次给药）或安慰剂组。第 56 天通过 UC 疾病活动指数和炎症性肠病问卷来衡量疗效。 结果：20 名患者以 4:1 的比例随机接受积极治疗或安慰剂。 19 名受试者接受了 >1 剂量的研究药物（15 名 Polyphenon E，4 名安慰剂）。研究开始时，治疗组的平均 UC 疾病活动指数得分为 6.5 ± 1.9，安慰剂组为 7.3 +/- 1.7。治疗 56 天后，Polyphenon E 组的缓解率为 66.7%（15 例中的 10 例），而安慰剂组的缓解率为 0%（4 例中的 0 例）（P = 0.03）。积极治疗的缓解率为 53.3%（15 例中的 8 例），而安慰剂组的缓解率为 0%（4 例中的 0 例）（P = 0.10）。 Polyphenon E 治疗仅产生轻微副作用。结论：Polyphenon E 治疗对 5-氨基水杨酸和/或硫唑嘌呤耐药的患者产生治疗效果。该药物有望成为治疗轻度至中度活动期 UC 患者的新选择。
Background:Green tea and its main polyphenolic component, (-)-epigallocatechin-3-gallate (EGCG), exert powerful anti-inflammatory effects that are protective against both inflammatory diseases and cancer. Research with animal and human cell lines provide plausible support for these claims. Poor absorption results in low systemic bioavailability of EGCG after oral administration but high colonic mucosal exposure.Methods:Patients with mild to moderate ulcerative colitis (UC) were randomized to daily doses of oral Polyphenon E (400 mg or 800 mg of total EGCG daily, administered in split doses) or placebo in a double-blinded, placebo-controlled pilot study. Response was measured by the UC disease activity index and the inflammatory bowel disease questionnaire on day 56.Results:Twenty patients were randomized to active therapy or placebo in a 4:1 ratio. Nineteen subjects received >1 dose of study medication (15 Polyphenon E, 4 placebo). The mean UC disease activity index score at study entry was 6.5 1.9 in the treatment group and 7.3 +/- 1.7 in the placebo group. After 56 days of therapy, the response rate was 66.7% (10 of 15) in the Polyphenon E group and 0% (0 of 4) in the placebo group (P = 0.03). The active treatment remission rate was 53.3% (8 of 15) compared with 0% (0 of 4) for placebo (P = 0.10). Polyphenon E treatment resulted in only minor side effects.Conclusions:Administration of Polyphenon E resulted in a therapeutic benefit for patients who were refractory to 5-aminosalicylic and/or azathioprine. This agent holds promise as a novel option for the treatment of patients with UC with mild to moderately active disease.