Lieber Charles S, Weiss David G, Groszmann Roberto, Paronetto Fiorenzo, Schenker Steven
Bronx Veterans Affairs Medical Center and the Mount Sinai School of Medicine, New York 10468, USA.
Alcohol Clin Exp Res. 2003 Nov;27(11):1757-64. doi: 10.1097/01.ALC.0000093744.12232.34.
This multicenter prospective, randomized, double-blind placebo-controlled trial was designed to evaluate the effectiveness of polyenylphosphatidylcholine against the progression of liver fibrosis toward cirrhosis in alcoholics. Seven hundred eighty-nine alcoholics with an average intake of 16 drinks per day were enrolled. To control excessive drinking, patients were referred to a standard 12-step-based alcoholism treatment program, but most patients refused to attend. Accordingly, study follow-up procedures incorporated the essential features of the brief-intervention approach. An overall substantial and sustained reduction in drinking was observed. Hepatic histological and other findings are described in a companion article.
Patients were randomized to receive daily three tablets of either polyenylphosphatidylcholine or placebo. Monthly follow-up visits included an extensive session with a medical nurse along with brief visits with a study physician (hepatologist or gastroenterologist). A detailed physical examination occurred every 6 months. In addition, telephone consultations with the nurse were readily available. All patients had a liver biopsy before entry; a repeat biopsy was scheduled at 24 and 48 months.
There was a striking decrease in average daily alcohol intake to approximately 2.5 drinks per day. This was sustained over the course of the trial, lasting from 2 to 6 years. The effect was similar both in early dropouts and long-term patients, i.e., those with a 24-month biopsy or beyond.
In a treatment trial of alcoholic liver fibrosis, a striking reduction in alcohol consumption from 16 to 2.5 daily drinks was achieved with a brief-intervention approach, which consisted of a relative economy of therapeutic efforts that relied mainly on treatment sessions with a medical nurse accompanied by shorter reinforcing visits with a physician. This approach deserves generalization to address the heavy drinking problems commonly encountered in primary care and medical specialty practices.
本多中心前瞻性、随机、双盲、安慰剂对照试验旨在评估多烯磷脂酰胆碱对酒精性肝病患者肝纤维化向肝硬化进展的疗效。纳入了789名平均每天饮酒16杯的酗酒者。为控制过度饮酒，患者被转介至基于标准12步戒酒治疗方案，但大多数患者拒绝参加。因此，研究随访程序纳入了简短干预方法的基本特征。观察到饮酒量总体大幅且持续减少。相关肝组织学及其他研究结果在另一篇文章中描述。
患者被随机分为两组，分别每日服用3片多烯磷脂酰胆碱或安慰剂。每月随访包括与医护人员进行一次全面会诊以及与研究医生（肝病专家或胃肠病专家）进行简短会诊。每6个月进行一次详细体格检查。此外，患者可随时与护士进行电话咨询。所有患者在入组前均进行了肝活检；计划在24个月和48个月时重复活检。
平均每日酒精摄入量显著下降至约每天2.5杯。在整个试验过程中（持续2至6年）保持这一水平。早期退出者和长期患者（即有24个月或更长时间活检的患者）的效果相似。
在一项酒精性肝纤维化治疗试验中，采用简短干预方法使酒精摄入量从每日16杯显著降至2.5杯，该方法相对节省治疗资源，主要依靠与医护人员的会诊以及与医生的简短强化会诊。这种方法值得推广，以解决初级保健和医学专科实践中常见的大量饮酒问题。
