Highly bioavailable curcumin derivative ameliorates Crohn's disease symptoms: A randomized, double-blind, multicenter study
Highly bioavailable curcumin derivative ameliorates Crohn's disease symptoms: A randomized, double-blind, multicenter study
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高生物利用度姜黄素衍生物可改善克罗恩病症状：一项随机、双盲、多中心研究
DOI：
10.1093/ecco-jcc/jjaa097
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发表时间：
2020
影响因子：
8
通讯作者：
Hanai H
中科院分区：
文献类型：
--
作者：
Sugimoto K;Ikeya K;Bamba S;Andoh A;Yamasaki H;Mitsuyama K;Nasuno M;Tanaka H;Matsuura A;Kato M;Ishida N;Tamura S;Takano R;Tani S;Osawa S;Nishihira J;Hanai H
新的姜黄素衍生物Theracurmin®的吸收率比天然姜黄素粉末高27倍。Theracurmin®是核因子-κB的抑制剂，其介导炎性细胞因子的表达。Theracurmin®对人类炎症性肠病的影响尚未探讨，因此，我们研究了Theracurmin®在克罗恩病患者中的疗效和安全性。MethodsIn this randomized，double-blinded study performed at 5 independent medical centers in Japan，Theracurmin®（360 mg/day，n = 20）或安慰剂（n = 10）被给予活动性轻度至中度克罗恩病患者12周。 通过评估临床和内窥镜缓解，肛门病变愈合和炎症标记物的血液水平来评估该药物的疗效。ResultsIn Theracurmin®组，在第12周相对于第0周观察到临床疾病活动显著减少（p = 0.005）。 在意向治疗分析中，第4、8和12周的临床缓解率分别为35%、40%和40%，显著高于安慰剂组（均为0%;分别为p= 0.033、p = 0.020和p =0.020）。 此外，Theracurmin®组在第12周时观察到内镜下克罗恩病严重程度降低（p=0.032）。 Theracurmin®和安慰剂组的内镜缓解率分别为15%和0%。Theracurmin®组在第8周观察到肛门病变显著愈合（p =0.017）。 在任何一组中没有观察到严重的不良事件在整个study.ConclusionsTheracurmin®显示出显着的临床和内镜疗效与积极的轻中度克罗恩病患者有利的安全性。临床试验UMIN注册IDUMIN 000015770。
Background & AimsThe new curcumin derivative Theracurmin®has a 27–fold higher absorption rate than natural curcumin powder. Theracurmin®is an inhibitor of nuclear factor-κB, which mediates the expression of inflammatory cytokines. The effect of Theracurmin®on inflammatory bowel disease in humans has not been explored; therefore, we investigated the efficacy and safety of Theracurmin®in patients with Crohn’s disease.MethodsIn this randomized, double-blinded study performed at 5 independent medical centers in Japan, Theracurmin®(360 mg/day, n = 20) or placebo (n = 10) was administered to patients with active mild-to-moderate Crohn’s disease for 12 weeks. The agent’s efficacy was assessed by evaluating clinical and endoscopic remission, healing of anal lesions, and blood levels of inflammatory markers.ResultsIn the Theracurmin®group, a significant reduction in clinical disease activity was observed in week 12 relative to that in week 0 (p = 0.005). On intention-to-treat analysis, clinical remission rates were 35%, 40%, and 40% at weeks 4, 8, and 12, respectively, which were significantly higher than those in the placebo group (all 0%;p = 0.033,p = 0.020, andp = 0.020, respectively). Furthermore, reduction in endoscopic Crohn’s disease severity (p = 0.032) was observed at week 12 in the Theracurmin®group. The endoscopic remission rates were 15% and 0% in the Theracurmin®and placebo groups, respectively. Significant healing of anal lesions (p = 0.017) was observed at week 8 in the Theracurmin®group. No serious adverse events were observed in either group throughout the study.ConclusionsTheracurmin®shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn’s disease.Clinical trial UMIN registration IDUMIN000015770.