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大麻素类药物治疗克罗恩病轻中度患者的效果与安慰剂相比:随机对照试验的系统评价和荟萃分析。

Effect of cannabinoids in mild-to-moderate cases of Crohn's disease as compared to placebo: a systematic review and meta-analysis of randomised controlled trials.

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Patna, Bihar, India.

出版信息

J Basic Clin Physiol Pharmacol. 2024 Feb 27;35(1-2):15-24. doi: 10.1515/jbcpp-2023-0137. eCollection 2024 Jan 1.

Abstract

INTRODUCTION

In view of limited treatment options (those too may fail) for Crohn's disease, cannabinoids have been tried as a therapeutic. However, their efficacy is not unequivocally established. This systematic review and meta-analysis was planned to pool data from randomised controlled trials (RCTs) evaluating effect of cannabinoids in Crohn's disease with an intention to take this uncertainty away.

CONTENT

Following literature search in Medline, EMBASE, Scopus and Google Scholar databases, RCTs assessing the effect of cannabinoids on mild-to-moderate Crohn's disease in adults were included. Crohns' disease activity index (CDAI), QoL (Quality of life), number participants achieving full remission and serum CRP at eight weeks of treatment were the outcomes considered for meta-analysis. Quality of studies was assessed using Cochrane's RoB2 tool. Random effect model was applied for meta-analysis. Heterogeneity was assessed by Cochrane 'Q' statistics and I test. Sensitivity analysis was performed to identify the major contributor(s) to heterogeneity and assess robustness of the results.

SUMMARY

Risk of bias for the four included studies varied from 'low' to 'some concern'. Overall effect estimate (SMD -0.92; 95 % CI -1.80, -0.03) indicated a statistically significant effect of cannabinoids as compared to control (p<0.05) on CDAI score. Effect of cannabinoids on rest of the outcome parameters was comparable to that of placebo. Magnitude of heterogeneity for different outcome parameters ranged from 'low' to 'substantial'.

OUTLOOK

Cannabinoids were superior to placebo for favourably affecting the disease severity in terms of CDAI score. However, no statistically significant difference was found between the two for improving QoL, causing full disease-remission and reducing inflammatory markers. The results must be interpreted with caution in view of relatively high heterogeneity among the studies.

摘要

简介

鉴于对克罗恩病的治疗选择有限(这些选择也可能失败),因此已尝试将大麻素作为一种治疗方法。然而,其疗效尚未得到明确证实。本系统评价和荟萃分析旨在汇总评估大麻素对成人克罗恩病疗效的随机对照试验(RCT)的数据,旨在消除这种不确定性。

内容

在 Medline、EMBASE、Scopus 和 Google Scholar 数据库中进行文献检索后,纳入了评估大麻素对成人轻度至中度克罗恩病影响的 RCT。荟萃分析考虑了治疗 8 周后的克罗恩病活动指数(CDAI)、生活质量(QoL)、达到完全缓解的参与者人数和血清 CRP。使用 Cochrane 的 RoB2 工具评估研究质量。应用随机效应模型进行荟萃分析。通过 Cochrane 'Q'统计量和 I 检验评估异质性。进行敏感性分析以确定异质性的主要来源,并评估结果的稳健性。

总结

纳入的四项研究的偏倚风险从“低”到“存在一定担忧”不等。与对照组相比,大麻素的总体效果估计值(SMD -0.92;95%CI -1.80,-0.03)表明在 CDAI 评分上具有统计学意义的效果(p<0.05)。大麻素对其余结局参数的影响与安慰剂相当。不同结局参数的异质性程度范围从“低”到“中度”。

展望

与安慰剂相比,大麻素在改善 CDAI 评分方面更有利于改善疾病严重程度。然而,在改善生活质量、引起完全疾病缓解和降低炎症标志物方面,两者之间没有发现统计学上的显著差异。鉴于研究之间存在较高的异质性,必须谨慎解释这些结果。

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