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多中心临床治疗试验入组时影响%CDT状态的因素:来自COMBINE研究的经验

Factors affecting %CDT status at entry into a multisite clinical treatment trial: experience from the COMBINE Study.

作者信息

Anton Raymond F, Youngblood Marston

机构信息

Medical University of South Carolina, and Center for Drug and Alcohol Problems, 67 President Street, Charleston, SC 29425, USA.

出版信息

Alcohol Clin Exp Res. 2006 Nov;30(11):1878-83. doi: 10.1111/j.1530-0277.2006.00225.x.

DOI:10.1111/j.1530-0277.2006.00225.x
PMID:17067352
Abstract

BACKGROUND

Carbohydrate-deficient transferrin (CDT) occurs as a higher percentage of normal transferrin (%CDT) in heavy drinkers. %CDT is used as a marker of both alcohol use disorder severity and treatment outcome both clinically and in treatment trials. Nevertheless, little is known about the parameters that predict which patients are %CDT positives at treatment entry. These parameters might include level of drinking, days of abstinence before testing, and severity of alcohol dependence before evaluation.

METHODS

%CDT levels were collected before randomization from participants of the COMBINE Study, a large federally sponsored multisite clinical trial evaluating medications and behavioral therapies in alcohol-dependent outpatients. %CDT (assayed in a central laboratory) was available in 1,193 individuals for whom drinking history in the 30 days before testing and measures of alcoholism severity were documented. The effects of drinking history and alcohol severity were evaluated for prediction of a %CDT-positive test status.

RESULTS

Less percent days abstinent (PDA) and more drinks per drinking day (DDD) were predictive of higher rates of %CDT-positive patients (maximum 67%). Up to 14 days of continuous abstinence before testing did not appear to significantly affect %CDT status. Rates of %CDT positives remained reasonably steady up to about 40% PDA. Years of drinking at dependence levels had an unexpected negative impact on %CDT-positive rates while previous treatment had a small but positive impact of %CDT-positive rates. ADS and DrInC scores had no predictive value over and above recent drinking amounts on %CDT status.

CONCLUSIONS

%CDT is more likely to be positive in those who have more days of drinking and to a lesser degree in those who drink more per drinking day. It can remain positive even in those alcoholic subjects who stop drinking many days before testing. Alcoholic subjects with more treatment experiences appear to have a marginally higher %CDT-positive rate.

摘要

背景

在重度饮酒者中,缺糖转铁蛋白(CDT)占正常转铁蛋白的百分比(%CDT)会升高。在临床及治疗试验中,%CDT被用作酒精使用障碍严重程度及治疗效果的标志物。然而,对于预测哪些患者在治疗开始时%CDT呈阳性的参数却知之甚少。这些参数可能包括饮酒量、检测前的戒酒天数以及评估前酒精依赖的严重程度。

方法

从联合研究的参与者中在随机分组前收集%CDT水平,该研究是一项由联邦政府资助的大型多中心临床试验,旨在评估酒精依赖门诊患者的药物治疗和行为疗法。在1193名个体中可获得%CDT(在中心实验室检测),这些个体有检测前30天的饮酒史及酒精中毒严重程度的测量数据。评估饮酒史和酒精严重程度对%CDT阳性检测状态预测的影响。

结果

戒酒天数百分比(PDA)越少且每个饮酒日饮酒量(DDD)越多,预测%CDT阳性患者的比例越高(最高达67%)。检测前连续戒酒长达14天似乎并未显著影响%CDT状态。在PDA约40%之前,%CDT阳性率保持相对稳定。处于依赖水平的饮酒年限对%CDT阳性率产生意外的负面影响,而先前的治疗对%CDT阳性率有小但积极的影响。酒精依赖严重程度评分(ADS)和饮酒相关问题评分(DrInC)在预测%CDT状态方面,相对于近期饮酒量并无额外的预测价值。

结论

%CDT在饮酒天数较多的人群中更可能呈阳性,而在每个饮酒日饮酒量较多的人群中阳性程度较低。即使在检测前已戒酒多日的酒精性患者中,%CDT也可能呈阳性。治疗经验较多的酒精性患者似乎%CDT阳性率略高。

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