Sugaya Nagisa, Ogai Yasukazu, Aikawa Yuzo, Yumoto Yosuke, Takahama Mihoko, Tanaka Miho, Haraguchi Ayako, Umeno Mitsuru, Ikeda Kazutaka
Addictive Substance Project, Tokyo Metropolitan Institute of Medical Science, Tokyo, Japan.
Unit of Public Health and Preventive Medicine, School of Medicine, Yokohama City University, Yokohama, Japan.
Neuropsychopharmacol Rep. 2018 Mar;38(1):9-17. doi: 10.1002/npr2.12001. Epub 2018 Feb 18.
This prospective, randomized, controlled, rater-blinded study investigated the effect of G protein-activated inwardly rectifying potassium (GIRK) channel inhibitor ifenprodil on alcohol use in patients with alcohol dependence.
The participants were 68 outpatients with alcohol dependence who were assigned to an ifenprodil group (administered 60 mg ifenprodil per day for 3 months) or control group (administered 600 mg ascorbic acid and calcium pantothenate per day for 3 months). The participants completed a questionnaire that included the frequency of alcohol drinking and presence of heavy drinking before the study period (time 1) and 3 months after the start of the study period (time 2). The alcohol use score was calculated using these two items.
Valid data were obtained from 46 participants (25 in the ifenprodil group and 21 in the control group). The alcohol use score at time 2 in the ifenprodil group was significantly lower than that in the control group after adjusting for the score at time 1 and some covariates. The intention-to-treat analysis of multiply imputed datasets indicated similar results. Group differences in the frequency of alcohol drinking were significant in the multiply imputed datasets but not in 46 participants. The ifenprodil group had a significantly lower rate of heavy drinking at time 2 than the control group.
This study found an inhibitory effect of ifenprodil on alcohol use in patients with alcohol dependence. The results support the hypothesis that GIRK channel inhibitors ameliorate alcohol dependence.
This trial was registered in the UMIN clinical trial registry (UMIN000006347).
本前瞻性、随机、对照、评估者盲法研究探讨了G蛋白激活的内向整流钾通道（GIRK）抑制剂艾芬地尔对酒精依赖患者饮酒行为的影响。
68例酒精依赖门诊患者被分为艾芬地尔组（每天服用60mg艾芬地尔，共3个月）或对照组（每天服用600mg抗坏血酸和泛酸钙，共3个月）。参与者在研究期开始前（时间1）和研究期开始3个月后（时间2）完成了一份问卷，其中包括饮酒频率和重度饮酒情况。使用这两项计算饮酒得分。
46名参与者（艾芬地尔组25名，对照组21名）获得了有效数据。在调整时间1的得分和一些协变量后，艾芬地尔组时间2的饮酒得分显著低于对照组。对多重填补数据集的意向性分析表明结果相似。多重填补数据集中饮酒频率的组间差异显著，但在46名参与者中不显著。艾芬地尔组在时间2的重度饮酒率显著低于对照组。
本研究发现艾芬地尔对酒精依赖患者的饮酒行为有抑制作用。结果支持GIRK通道抑制剂改善酒精依赖的假说。
本试验已在UMIN临床试验注册中心注册（UMIN000006347）。
