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迟释型磷脂酰胆碱治疗溃疡性结肠炎的有效性:一项荟萃分析。

Delayed-Release Phosphatidylcholine Is Effective for Treatment of Ulcerative Colitis: A Meta-Analysis.

机构信息

Medical Center Baden-Baden, Baden-Baden, Germany.

Institute of Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry, RWTH University Hospital Aachen, Aachen, Germany.

出版信息

Dig Dis. 2021;39(5):508-515. doi: 10.1159/000514355. Epub 2021 Jan 13.

Abstract

BACKGROUND

Phosphatidylcholine (PC) is intrinsically missing in intestinal mucus of patients with ulcerative colitis. Topical supplementation with delayed intestinal release PC formulations is assumed to compensate this lack. Three monocenter randomized controlled trials (RCTs) with a 30% PC-containing lecithin were successful, whereas 1 trial with >94% PC-containing lecithin failed.

OBJECTIVES

Evaluation of 30% PC-containing lecithin provided in a delayed intestinal release formulation for treatment efficacy of ulcerative colitis was evaluated by meta-analysis of 3 RCTs.

METHODS

Meta-analysis of 3 studies was performed using RevMan 5.3 software. Odds ratio (OR) and 95% Cl were calculated for remission, clinical and endoscopic improvement, histology, and life quality. p values <0.05 were accepted as significant.

RESULTS

The meta-analysis of 3 RTCs with 160 included patients with ulcerative colitis verified that PC improved the rate of remission (OR = 9.68), as well as clinical (OR = 30.58) and endoscopic outcomes (OR = 36.73). Within the available patient population, also histology and quality of life became better. All effects were significant over placebo. Achieved remission was maintained in a higher percentage of patients under intestinal-release PC formulation than placebo. The profile of adverse events was identical to the placebo population.

CONCLUSIONS

A 30% PC-containing lecithin in delayed intestinal release formulation improves clinical and endoscopic outcomes, histologic activity, and quality of life in patients with ulcerative colitis. For the patients, lack of adverse events is an important consideration.

摘要

背景

磷脂酰胆碱(PC)在溃疡性结肠炎患者的肠道粘液中本质上是缺失的。假设局部补充具有延迟肠道释放的 PC 制剂可以弥补这种缺乏。三项含有 30%PC 的卵磷脂的单中心随机对照试验(RCT)取得了成功,而含有>94%PC 的卵磷脂的一项试验失败了。

目的

通过对三项 RCT 的荟萃分析,评估延迟肠道释放制剂中含有 30%PC 的卵磷脂治疗溃疡性结肠炎的疗效。

方法

使用 RevMan 5.3 软件对三项研究进行荟萃分析。计算缓解率、临床和内镜改善、组织学和生活质量的优势比(OR)和 95%置信区间(CI)。p 值<0.05 被认为具有统计学意义。

结果

对三项包含 160 例溃疡性结肠炎患者的 RCT 的荟萃分析证实,PC 提高了缓解率(OR=9.68),以及临床(OR=30.58)和内镜结果(OR=36.73)。在可获得的患者人群中,组织学和生活质量也得到了改善。所有效果均显著优于安慰剂。与安慰剂组相比,接受肠道释放 PC 制剂的患者中达到缓解的比例更高。不良反应的发生情况与安慰剂组相同。

结论

延迟肠道释放制剂中含有 30%PC 的卵磷脂可改善溃疡性结肠炎患者的临床和内镜结果、组织学活动和生活质量。对于患者而言,缺乏不良反应是一个重要的考虑因素。

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