Sass H, Soyka M, Mann K, Zieglgänsberger W
Psychiatric Clinic, Rheinisch Westfalische Technische Hochschule, Aachen, Germany.
Arch Gen Psychiatry. 1996 Aug;53(8):673-80. doi: 10.1001/archpsyc.1996.01830080023006.
The effectiveness of acamprosate (calcium bisacetylhomotaurinate) as a treatment to maintain abstinence in alcohol-dependent patients was assessed for 1 year.
After short-term detoxification, 272 patients participated in a randomized, double-blind, placebo-controlled study. Patients received routine counseling and either the study medication or placebo for 48 weeks; they were followed up for another 48 weeks without medication. Statistical analysis was performed according to the intention-to-treat principle.
Patients who were receiving acamprosate showed a significantly higher continuous abstinence rate within the first 60 days of treatment compared with patients who were assigned to placebo treatment (67% vs 50%) until completion of the treatment period (43% vs 21%, log rank P = .005), and they had a significantly longer mean abstinence duration of 224 vs 163 days, or 62% vs 45% days abstinent (P < .001); however, there was no difference in psychiatric symptoms. Of the patients who were receiving acamprosate, 41% had dropped out, whereas 60% of the placebo-treated patients dropped out of the study. Few side effects (mainly diarrhea and headache) were recorded. At the end of a further 48 weeks without receiving study medication, 39% and 17% of the acamprosate- and placebo-treated patients, respectively, had remained abstinent (P = .003).
Acamprosate proved to be a safe and effective aid in treating alcohol-dependent patients and in maintaining the abstinence of patients during 2 years.
评估了阿坎酸（双乙酰高牛磺酸钙）作为维持酒精依赖患者戒酒治疗药物的有效性，为期1年。
在短期解毒后，272名患者参与了一项随机、双盲、安慰剂对照研究。患者接受常规咨询，并服用研究药物或安慰剂48周；之后在无药物治疗的情况下再随访48周。根据意向性分析原则进行统计分析。
与接受安慰剂治疗的患者相比，接受阿坎酸治疗的患者在治疗的前60天内持续戒酒率显著更高（67%对50%），直至治疗期结束（43%对21%，对数秩检验P = .005），且他们的平均戒酒持续时间显著更长，分别为224天对163天，或戒酒天数的62%对45%（P < .001）；然而，精神症状方面没有差异。接受阿坎酸治疗的患者中有41%退出研究，而接受安慰剂治疗的患者中有60%退出研究。记录到的副作用很少（主要是腹泻和头痛）。在进一步的48周未接受研究药物治疗结束时，接受阿坎酸治疗和安慰剂治疗的患者分别有39%和17%保持戒酒（P = .003）。
阿坎酸被证明是治疗酒精依赖患者并在两年内维持患者戒酒的一种安全有效的辅助药物。
