Pelc Isidore, Ansoms Constant, Lehert Philippe, Fischer Felix, Fuchs Werner-Joachim, Landron Frédéric, Pires Preto Anton José, Morgan Marsha Y
Hôspital Universitaire Brugmann, Bruxelles, Belgium.
Alcohol Clin Exp Res. 2002 Oct;26(10):1529-38. doi: 10.1097/01.ALC.0000029584.62149.22.
A multicenter, prospective study was conducted in five European countries to observe outcome in alcohol misusers treated for 24 weeks with acamprosate and various psychosocial support techniques, within the setting of standard patient care.
Patients diagnosed as alcohol dependent using DSM-III-R criteria were treated, for 24 weeks, with acamprosate and appropriate psychosocial support. Potential predictor variables were recorded at inclusion. Drinking behavior was monitored throughout; the proportion of cumulative abstinence days was the principal outcome measure. The influence of baseline clinical and demographic variables on outcome was assessed using multiple regression analysis. Adverse events were recorded systematically.
A total of 1289 patients were recruited; 1230 took at least one dose of the drug and provided at least one set of follow-up data; 543 (42.1%)patients were observed for the full 24-week period. The overall proportion of cumulative abstinence days was 0.48. Multiple physical and psychiatric comorbidities and a history of drug addiction were negatively correlated with outcome, as were, to a lesser extent, multiple previous episodes of detoxification, unemployment, and living alone. Older age and stable employment were positively associated with outcome. The difference in the unadjusted proportion of cumulative abstinence days between countries was significant ( < 0.001) but less so when adjusted for the predictive factors identified in the multivariate model ( < 0.019). Overall, outcome was not influenced by the nature of the psychosocial support provided. Adverse events were generally mild, with gastrointestinal disorders, which occurred in 21.5% of patients, being the most frequent.
This open-label study confirms the efficacy and safety of acamprosate in the treatment of alcohol dependence in the setting of standard patient care. Treatment benefit was observed irrespective of the nature of the psychosocial support provided. Predictors of the response to treatment were identified; their heterogeneous distribution within the study population explained, at least in part, the differences in outcome between countries.
在五个欧洲国家开展了一项多中心前瞻性研究，以观察在标准患者护理环境下，使用阿坎酸及多种心理社会支持技术治疗24周的酒精滥用者的治疗结果。
采用DSM-III-R标准诊断为酒精依赖的患者接受24周的阿坎酸治疗及适当的心理社会支持。纳入时记录潜在的预测变量。全程监测饮酒行为；累积戒酒天数的比例是主要结局指标。使用多元回归分析评估基线临床和人口统计学变量对结局的影响。系统记录不良事件。
共招募了1289例患者；1230例服用了至少一剂药物并提供了至少一组随访数据；543例（42.1%）患者完成了整个24周的观察期。累积戒酒天数的总体比例为0.48。多种躯体和精神合并症以及药物成瘾史与结局呈负相关，在较小程度上，多次既往脱毒发作、失业和独居也与结局呈负相关。年龄较大和稳定就业与结局呈正相关。各国累积戒酒天数的未调整比例差异有统计学意义（P<0.001），但在根据多变量模型确定的预测因素进行调整后差异较小（P<0.019）。总体而言，结局不受所提供心理社会支持性质的影响。不良事件一般较轻，胃肠道疾病最为常见，发生在21.5%的患者中。
这项开放标签研究证实了阿坎酸在标准患者护理环境下治疗酒精依赖的有效性和安全性。无论所提供心理社会支持的性质如何，均观察到治疗益处。确定了治疗反应的预测因素；它们在研究人群中的异质性分布至少部分解释了各国之间结局的差异。
