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酒精依赖治疗的临床试验是否充分纳入了同时患有独立情绪和焦虑障碍的参与者?对全国酒精及相关疾病流行病学调查(NESARC)数据的分析。

Do clinical trials of treatment of alcohol dependence adequately enroll participants with co-occurring independent mood and anxiety disorders? An analysis of data from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC).

作者信息

Hoertel Nicolas, Falissard Bruno, Humphreys Keith, Gorwood Philip, Seigneurie Anne-Sophie, Limosin Frédéric

机构信息

Hôpital Corentin-Celton, 4 parvis Corentin Celton, 92130 Issy-les-Moulineaux, France

出版信息

J Clin Psychiatry. 2014 Mar;75(3):231-7. doi: 10.4088/JCP.13m08424.

DOI:10.4088/JCP.13m08424
PMID:24569017
Abstract

BACKGROUND

In the care of alcohol-dependent patients, co-occurring independent (ie, not substance-induced) mood and anxiety disorders present a significant challenge. Clinical trials of alcohol dependence treatment could help clinicians meet this challenge, but only if they enroll such complex patients. This study examined whether such individuals are likely to be included in alcohol dependence treatment trials under typical eligibility criteria.

METHOD

Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a national representative sample of 43,093 adults in the United States population. Psychiatric diagnoses were made according to the DSM-IV criteria with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-IV Version (AUDADIS-IV).

RESULTS

Of 1,484 alcohol-dependent participants, 39.22% (SE = 1.67) had a co-occurring independent mood or anxiety disorder; more than 60% of these individuals would be ineligible for an alcohol dependence treatment trial under typical eligibility criteria. Alcohol-dependent individuals with current major depressive episode, mania, dysthymia, panic disorder, and generalized anxiety disorder were particularly likely to be excluded from clinical trials. In a subsample of 185 individuals who had sought alcohol treatment, 52.59% (SE = 4.42) had an independent mood or anxiety disorder. Remarkably, almost all of these individuals (96.93%, SE = 1.97) would have been ineligible for clinical trials.

CONCLUSIONS

Independent mood and anxiety disorders are prevalent in the alcohol-dependent population but not in clinical trial research samples. For alcohol dependence treatment trials to adequately inform clinical practice, the enrollment of patients with co-occurring mood or anxiety disorders must be increased, through trials tailored to this population, a general relaxation of overly stringent eligibility criteria, or both.

摘要

背景

在酒精依赖患者的护理中,同时存在的独立(即非物质所致)情绪和焦虑障碍构成了重大挑战。酒精依赖治疗的临床试验有助于临床医生应对这一挑战,但前提是要纳入这类复杂的患者。本研究探讨了在典型的纳入标准下,这类个体是否有可能被纳入酒精依赖治疗试验。

方法

数据来源于2001 - 2002年全国酒精及相关疾病流行病学调查(NESARC),这是美国43,093名成年人的全国代表性样本。根据《精神疾病诊断与统计手册》第四版(DSM - IV)标准,采用酒精使用障碍及相关残疾访谈表 - DSM - IV版(AUDADIS - IV)进行精神疾病诊断。

结果

在1484名酒精依赖参与者中,39.22%(标准误 = 1.67)同时患有独立的情绪或焦虑障碍;在典型的纳入标准下,超过60%的这类个体不符合酒精依赖治疗试验的条件。目前患有重度抑郁发作、躁狂症、恶劣心境、惊恐障碍和广泛性焦虑障碍的酒精依赖个体尤其可能被排除在临床试验之外。在185名寻求酒精治疗的个体亚组中,52.59%(标准误 = 4.42)患有独立的情绪或焦虑障碍。值得注意的是,几乎所有这些个体(96.93%,标准误 = 1.97)都不符合临床试验的条件。

结论

独立的情绪和焦虑障碍在酒精依赖人群中很普遍,但在临床试验研究样本中并非如此。为了使酒精依赖治疗试验能充分指导临床实践,必须通过针对该人群的试验、普遍放宽过于严格的纳入标准或两者兼而有之,来增加同时患有情绪或焦虑障碍患者的入组率。

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