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口服纳米维生素 D 补充剂可降低溃疡性结肠炎的疾病活动度:一项双盲随机平行组安慰剂对照试验。

Oral Nano Vitamin D Supplementation Reduces Disease Activity in Ulcerative Colitis: A Double-Blind Randomized Parallel Group Placebo-controlled Trial.

机构信息

Department of Gastroenterology.

Department of Immunopathology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

J Clin Gastroenterol. 2019 Nov/Dec;53(10):e409-e415. doi: 10.1097/MCG.0000000000001233.

Abstract

INTRODUCTION

Vitamin D possesses anti-inflammatory properties and could be beneficial in ulcerative colitis (UC).

METHODS

We studied the effect of oral nano vitamin D3 supplementation on disease activity in active UC [ulcerative colitis disease activity index (UCDAI)≥3]. Patients with active UC and vitamin D <40 ng/mL were randomized to receive either oral nano vitamin D (60,000 IU/d×8 d) or placebo. They were evaluated for disease activity (UCDAI scores, C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin) at baseline and reassessed at 4 weeks. The response was defined as a 3-point reduction in UCDAI score at 4 weeks and reduction in inflammatory markers.

RESULTS

The median vitamin D levels increased from 15.4 to 40.83 mg/dL in vitamin D group (P≤0.001) and marginally from 13.45 to 18.85 mg/dL (P=0.027) in controls. The 3-point reduction in UCDAI was seen more often in vitamin D group as compared with the control (53% vs. 13%; P=0.001). Increase in vitamin D levels correlated with reduction in UCDAI score (P≤0.001; ρ=-0.713), C-reactive protein (P≤0.001; ρ=-0.603), and calprotectin (P=0.004; ρ=-0.368). Patients who achieved target vitamin D of >40 ng/mL (n=17) more often had a 3-point reduction in UCDAI (80% vs. 20%; P≤0.001) and reduction in grade of severity from 60% to 35% (P=0.038). Vitamin D administration (odds ratio, 9.17; 95% confidence interval, 2.02-41.67) and baseline histologic activity (odds ratio, 1.92; 95% confidence intervals, 1.2-3.08) independently predicted response.

CONCLUSIONS

Oral nano vitamin D supplementation in active UC is associated with a reduction in disease activity and severity grade and is seen more often in those who achieved a target vitamin D level of 40 ng/mL.

摘要

简介

维生素 D 具有抗炎特性,对溃疡性结肠炎(UC)可能有益。

方法

我们研究了口服纳米维生素 D3 补充剂对活动期 UC[溃疡性结肠炎活动指数(UCDAI)≥3]患者疾病活动的影响。维生素 D <40ng/ml 的活动期 UC 患者被随机分为口服纳米维生素 D(60,000IU/d×8d)或安慰剂组。基线时评估疾病活动度(UCDAI 评分、C 反应蛋白、红细胞沉降率和粪便钙卫蛋白),并在 4 周时重新评估。4 周时 UCDAI 评分降低 3 分且炎症标志物降低定义为有反应。

结果

维生素 D 组的中位维生素 D 水平从 15.4 升至 40.83mg/dL(P≤0.001),对照组从 13.45 升至 18.85mg/dL(P=0.027),但仅略有升高。与对照组相比,维生素 D 组更常出现 UCDAI 降低 3 分(53%比 13%;P=0.001)。维生素 D 水平升高与 UCDAI 评分降低相关(P≤0.001;ρ=-0.713)、C 反应蛋白(P≤0.001;ρ=-0.603)和钙卫蛋白(P=0.004;ρ=-0.368)。达到 >40ng/ml 目标维生素 D 水平的患者(n=17)更常出现 UCDAI 降低 3 分(80%比 20%;P≤0.001)和严重程度从 60%降至 35%(P=0.038)。维生素 D 治疗(比值比,9.17;95%置信区间,2.02-41.67)和基线组织学活动(比值比,1.92;95%置信区间,1.2-3.08)独立预测反应。

结论

口服纳米维生素 D 补充剂治疗活动期 UC 可降低疾病活动度和严重程度,在达到 40ng/ml 目标维生素 D 水平的患者中更常见。

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