Johnson R E, Chutuape M A, Strain E C, Walsh S L, Stitzer M L, Bigelow G E
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD 21224, USA.
N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.
Opioid dependence is a chronic, relapsing disorder with important public health implications.
In a 17-week randomized study of 220 patients, we compared levomethadyl acetate (75 to 115 mg), buprenorphine (16 to 32 mg), and high-dose (60 to 100 mg) and low-dose (20 mg) methadone as treatments for opioid dependence. Levomethadyl acetate and buprenorphine were administered three times a week. Methadone was administered daily. Doses were individualized except in the group assigned to low-dose methadone. Patients with poor responses to treatment were switched to methadone.
There were 55 patients in each group; 51 percent completed the trial. The mean (+/-SE) number of days that a patient remained in the study was significantly higher for those receiving levomethadyl acetate (89+/-6), buprenorphine (96+/-4), and high-dose methadone (105+/-4) than for those receiving low-dose methadone (70+/-4, P<0.001). Continued participation was also significantly more frequent among patients receiving high-dose methadone than among those receiving levomethadyl acetate (P=0.02). The percentage of patients with 12 or more consecutive opioid-negative urine specimens was 36 percent in the levomethadyl acetate group, 26 percent in the buprenorphine group, 28 percent in the high-dose methadone group, and 8 percent in the low-dose methadone group (P=0.005). At the time of their last report, patients reported on a scale of 0 to 100 that their drug problem had a mean severity of 35 with levomethadyl acetate, 34 with buprenorphine, 38 with high-dose methadone, and 53 with low-dose methadone (P=0.002).
As compared with low-dose methadone, levomethadyl acetate, buprenorphine, and high-dose methadone substantially reduce the use of illicit opioids.
阿片类药物依赖是一种具有重要公共卫生意义的慢性复发性疾病。
在一项针对220名患者的为期17周的随机研究中，我们比较了醋酸左美沙朵（75至115毫克）、丁丙诺啡（16至32毫克）以及高剂量（60至100毫克）和低剂量（20毫克）美沙酮作为阿片类药物依赖治疗方法的效果。醋酸左美沙朵和丁丙诺啡每周给药三次。美沙酮每日给药。除了分配到低剂量美沙酮组的患者外，其他组的剂量均个体化调整。对治疗反应不佳的患者改用美沙酮。
每组有55名患者；51%的患者完成了试验。接受醋酸左美沙朵（89±6天）、丁丙诺啡（96±4天）和高剂量美沙酮（105±4天）治疗的患者留在研究中的平均（±标准误）天数显著高于接受低剂量美沙酮治疗的患者（70±4天，P<0.001）。接受高剂量美沙酮治疗的患者持续参与研究的频率也显著高于接受醋酸左美沙朵治疗的患者（P=0.02）。醋酸左美沙朵组中连续12次或更多次尿液阿片类药物检测呈阴性的患者百分比为36%，丁丙诺啡组为26%，高剂量美沙酮组为28%，低剂量美沙酮组为8%（P=0.005）。在最后一次报告时，患者在0至100的量表上报告，其药物问题的平均严重程度在醋酸左美沙朵组为35，丁丙诺啡组为34，高剂量美沙酮组为38，低剂量美沙酮组为53（P=0.002）。
与低剂量美沙酮相比，醋酸左美沙朵、丁丙诺啡和高剂量美沙酮可大幅减少非法阿片类药物的使用。
