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代谢综合征成人中秋水仙碱的疗效:一项初步随机对照试验。

Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial.

机构信息

Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.

Office of the Clinical Director, NICHD, NIH, Bethesda, Maryland.

出版信息

Diabetes Obes Metab. 2019 Jul;21(7):1642-1651. doi: 10.1111/dom.13702. Epub 2019 Apr 2.

Abstract

AIM

To evaluate the efficacy and safety of colchicine for improving metabolic and inflammatory outcomes in people with obesity and metabolic syndrome (MetS).

MATERIALS AND METHODS

Adults with obesity and MetS, but who did not have diabetes, were randomized to colchicine 0.6 mg or placebo capsules twice daily for 3 months. The primary outcome was change in insulin sensitivity (S ) as estimated by insulin-modified frequently sampled intravenous glucose tolerance tests. Secondary outcomes included changes in other metabolic variables and inflammatory markers.

RESULTS

Of 40 participants randomized (21 colchicine, 19 placebo), 37 completed the trial. Compared with placebo, colchicine significantly reduced C-reactive protein (P <0.005), erythrocyte sedimentation rate (P <0.01), white blood cell count (P <0.005), and absolute neutrophil count (P <0.001). Change in S was not significantly different between colchicine and placebo arms (difference: +0.21 × 10 ; CI -1.70 to +2.13 × 10 min mU mL; P = 0.82). However, changes in some secondary outcomes, including homeostatic model assessment of insulin resistance (P = 0.0499), fasting insulin (P = 0.07) and glucose effectiveness (P = 0.08), suggested metabolic improvements in the colchicine versus placebo group. Adverse events were generally mild and similar in both groups.

CONCLUSIONS

This pilot study found colchicine significantly improved obesity-associated inflammatory variables and showed a good safety profile among adults with obesity and MetS who did not have diabetes. These results suggest a larger, adequately powered study should be conducted to determine whether colchicine improves insulin resistance and other measures of metabolic health in at-risk individuals.

摘要

目的

评估秋水仙碱改善肥胖合并代谢综合征(MetS)人群代谢和炎症结局的疗效和安全性。

材料和方法

将肥胖合并 MetS 但无糖尿病的成年人随机分为秋水仙碱 0.6mg 或安慰剂胶囊,每日 2 次,疗程 3 个月。主要结局是通过胰岛素修正的多次静脉葡萄糖耐量试验评估的胰岛素敏感性(S)的变化。次要结局包括其他代谢变量和炎症标志物的变化。

结果

40 名随机分组的参与者(21 名秋水仙碱,19 名安慰剂)中,37 名完成了试验。与安慰剂相比,秋水仙碱可显著降低 C 反应蛋白(P <0.005)、红细胞沉降率(P <0.01)、白细胞计数(P <0.005)和绝对中性粒细胞计数(P <0.001)。秋水仙碱和安慰剂组之间 S 的变化无显著差异(差异:+0.21×10 min mU mL;CI -1.70 至+2.13×10 min mU mL;P = 0.82)。然而,一些次要结局的变化,包括稳态模型评估的胰岛素抵抗(P = 0.0499)、空腹胰岛素(P = 0.07)和葡萄糖效应(P = 0.08),提示秋水仙碱组代谢改善。不良反应一般轻微,两组相似。

结论

本研究发现秋水仙碱可显著改善肥胖相关的炎症指标,在无糖尿病的肥胖合并 MetS 成年人中具有良好的安全性。这些结果表明,应该进行更大规模、充分有力的研究,以确定秋水仙碱是否能改善高危人群的胰岛素抵抗和其他代谢健康指标。

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