中药福康片治疗阿片类药物成瘾慢性稽延症状临床疗效观察  

Clinical Observation of Fukang Tablet in Treating Chronic Protracted Symptoms of Opioid Addiction

作　　者：谢仁谦 贺殿[2] 晋玲 周桂芬 李海燕 王道霞 王凯宗 康天霞 王睿 柏新兰 程海英 何欣沂 叶发绿 杨永清 李进峰 程彬 刘豫康 贾永全 念小田 刘博 韩华 兰宗平 郑保福 郝文 吕小石 

机构地区：[1]兰州戒毒康复医院,兰州730108 [2]兰州大学药学院,兰州730000 [3]甘肃中医药大学药学院,兰州730000 [4]甘肃省第一强制隔离戒毒所,兰州730080 [5]甘肃省女子强制隔离戒毒所,兰州730050 [6]甘肃省第三强制隔离戒毒所,张掖734000 [7]酒泉市强制隔离戒毒所,酒泉735000 [8]武威市强制隔离戒毒所,武威733021 [9]定西市强制隔离戒毒所,定西743000 [10]白银市白银区强制隔离戒毒所,白银730900 [11]甘肃省第四强制隔离戒毒所,天水741023 [12]甘肃省第二强制隔离戒毒所,兰州730070 [13]金昌市金川区强制隔离戒毒所,金昌737100 [14]嘉峪关市公安局强制隔离戒毒所,嘉峪关735100 [15]平凉市强制隔离戒毒所,平凉744000 [16]临夏回族自治州强制隔离戒毒所,临夏731100 [17]陇南市强制隔离戒毒所,陇南746010 [18]天水市强制隔离戒毒所,天水741020 [19]庆阳市公安局强制隔离戒毒所,庆阳745000 [20]张掖市甘州区公安局强制隔离戒毒所,张掖734000

出　　处：《中国药物滥用防治杂志》2020年第5期255-260,共6页Chinese Journal of Drug Abuse Prevention and Treatment

摘　　要：目的:探索中药福康片治疗阿片类药物成瘾慢性稽延症状的临床方案,评估其疗效。方法:采用单盲随机对照临床试验方案,337例脱毒后阿片类成瘾者随机分为试验组(n=185)和对照组(n=152)。试验组基于阿片类药物成瘾慢性稽延症状不同病程,临床分型为重症和轻症,分别用高(3~4片/d)、低(1~2片/d)剂量福康片,以3周为疗程,每3天跟进对稽延症状和渴求强度评分。对照组采用对症临床干预模式,疗效观察同试验组。结果:试验组阿片类戒断慢性稽延症状评分和渴求强度降低程度分别达97%和90%以上,比对照组症状缓解程度分别高约61和21倍。不同剂量福康片3周疗程对稽延症状和渴求强度缓解均呈良好时效关系。试验组口干不良反应39.0%。偶见失眠,且多见于高剂量用药者,调整剂量或停药,可自行消退。结论:本试验推荐的福康片治疗阿片类稽延症状临床方案,用药安全,疗效确切。Objective:To investigate the clinical scheme and the efficacy of Fukang tablet for the treatment of the chronic protracted symptoms of opioid addiction.Methods:337 opioid addicts after detoxification were randomly divided into the test group (n=185) and the control group (n=152) via the single-blind randomized controlled clinical trial.In the former group,the cases were classified into the severe and mild clinical phenotypes based on the different phases of the chronic protracted symptoms of the opioid addictions,which were treated with high (3-4 tablets/day) and low (1-2 tablets/day) dosages of Fukang tablets with three-week course,respectively,and then were followed up every 3 days to score both the chronic protracted symptoms and the craving intensity.In the latter group,the therapeutic effects were evaluated the same as those of the test group after the symptomatic standard clinical intervention.Results:In the test group,the scores of the chronic protracted symptoms and the craving intensity of opioid withdrawal were relieved more than 97% and 90%,and 61 and 21 times higher than those in the control group,respectively.Meanwhile,Fukang tablet with three-week course to ease the chronic protracted symptoms and the craving intensity at the different doses gave the favorable time-effect relationships.In addition,there were some adverse reactions,such as 39.0% xerostomia and occasional insomnia,which was more common in the cases with the high doses,and could subside by itself to adjust the doses or discontinue medication.Conclusion:The recommended clinical scheme of Fukang tablet to treat opioid protracted symptoms in this trial is safe and effective.

关 键 词：福康片 阿片类药物成瘾 稽延症状 临床治疗方案 疗效 不良反应 

分 类 号：R749.61[医药卫生—神经病学与精神病学]