国内团队:小檗碱预防结直肠腺瘤复发
创作:王文东 审核:Lexi 2020年02月01日
  • 纳入891名18-75岁结直肠腺瘤患者,具有1-6处结直肠腺瘤组织学病变,并在研究前6个月内接受完整的息肉切除手术;
  • 其中429名参与者服用小檗碱(0.3克,每日2次),其余462名参与者服用安慰剂作对照,研究随访持续2年;
  • 随访期间小檗碱组中155名参与者(36%)复发腺瘤,安慰剂组中216名参与者(47%)复发腺瘤,未校正复发相对风险比为0.77;
  • 随访期间未发现结直肠癌,最常见的不良事件是便秘,小檗碱组中出现6例,安慰剂组中出现1例。
主编推荐语
Lexi
结直肠腺瘤和结直肠癌的化学预防仍然是一个重要的公共卫生目标。由上海交通大学医学院附属仁济医院房静远团队牵头,国内多家医院机构共同合作完成的最新临床研究,近日在Lancet Gastroenterology & Hepatology发表,探讨了小檗碱预防结直肠腺瘤复发的临床潜力和安全性。该研究发现服用小檗碱(0.3克,每日2次)对降低结直肠腺瘤复发风险有效且安全,可作为息肉切除后化学预防的一种选择。
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Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study

小檗碱与安慰剂相比预防结直肠腺瘤复发:一项多中心、双盲、随机对照研究

10.1016/S2468-1253(19)30409-1

2020-01-08, Article

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Background: Chemoprevention of colorectal adenoma and colorectal cancer remains an important public health goal. The present study aimed to investigate the clinical potential and safety of berberine for prevention of colorectal adenoma recurrence.
Methods: This double-blind, randomised, placebo-controlled trial was done in seven hospital centres across six provinces in China. Individuals aged 18–75 years who had at least one but no more than six histologically confirmed colorectal adenomas that had undergone complete polypectomy within the 6 months before recruitment were recruited and randomly assigned (1:1) to receive berberine (0·3 g twice daily) or placebo tablets via block randomisation (block size of six). Participants were to undergo a first follow-up colonoscopy 1 year after enrolment, and if no colorectal adenomas were detected, a second follow-up colonoscopy at 2 years was planned. The study continued until the last enrolled participant reached the 2-year follow-up point. All participants, investigators, endoscopists, and pathologists were blinded to treatment assignment. The primary efficacy endpoint was the recurrence of adenomas at any follow-up colonoscopy. Analysis was based on modified intention-to-treat, with the full analysis set including all randomised participants who received at least one dose of study medication and who had available efficacy data. The study is registered with ClinicalTrials.gov, number NCT02226185; the trial has ended and this report represents the final analysis.
Findings: Between Nov 14, 2014, and Dec 30, 2016, 553 participants were randomly assigned to the berberine group and 555 to the placebo group. The full analysis set consisted of 429 participants in the berberine group and 462 in the placebo group. 155 (36%) participants in the berberine group and 216 (47%) in the placebo group were found to have recurrent adenoma during follow-up (unadjusted relative risk ratio for recurrence 0·77, 95% CI 0·66–0·91; p=0·001). No colorectal cancers were detected during follow-up. The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group). No serious adverse events were reported.
Interpretation: Berberine 0·3 g twice daily was safe and effective in reducing the risk of recurrence of colorectal adenoma and could be an option for chemoprevention after polypectomy.
Funding: National Natural Science Foundation of China.

First Authors:
Yingxuan Chen,Qin-Yan Gao,Tian-Hui Zou,Bangmao Wang,Side Liu,Jianqiu Sheng,JianLin Ren

Correspondence Authors:
Jing-Yuan Fang

All Authors:
Yingxuan Chen,Qin-Yan Gao,Tian-Hui Zou,Bangmao Wang,Side Liu,Jianqiu Sheng,JianLin Ren,Xiaoping Zou,Zhanju Liu,Yanyan Song,Bing Xiao,Xiao-Min Sun,Xiao-Tan Dou,Hailong Cao,Xiao-Ning Yang,Na Li,Qian Kang,Wei Zhu,HongZhi Xu,Huimin Chen,Xiao-Chuang Cao,Jing-Yuan Fang

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NEJM Journal Watch新闻网站

Berberine for Colorectal Adenoma Chemoprevention

2020-01-28

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Lancet Gastroenterology & Hepatology期刊

Extracting the benefits of berberine for colorectal cancer

2020-01-08

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