Physical and mental health in severe opioid-dependent patients within a randomized controlled maintenance treatment trial
Physical and mental health in severe opioid-dependent patients within a randomized controlled maintenance treatment trial
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DOI：
10.1111/j.1360-0443.2011.03463.x
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发表时间：
2011-09-01
期刊：
影响因子：
6
通讯作者：
Haasen, Christian
中科院分区：
文献类型：
--
作者：
Reimer, Jens;Verthein, Uwe;Haasen, Christian
目的是评估阿片依赖患者的身心健康，并比较海洛因或美沙酮替代患者的治疗结果。设计为期12个月的开放标签随机对照试验。在德国七个城市设立门诊病人替代诊所。参与者共1015名阿片依赖者。测量阿片类药物治疗指数-健康量表评分(OTI)、体重指数(BMI)、传染性疾病(如乙肝、丙型肝炎和人类免疫缺陷病毒)以及结核病的血清学、卡诺夫斯基表现量表(KPS)、心电图(CG)、超声心动图、症状自评量表(SCL-90-R)、全球功能评估(GAF)、生活质量模块系统和研究与药物相关的严重不良事件(SAE)。结果海洛因和美沙酮替代组的OTI、BMI、KPS、SCL-90-R和GAF均有改善，但海洛因组改善更明显(方差分析，均P=0.000)。病理超声心动图频率海洛因组减少，美沙酮组增加(x(2)检验，t；0.05)。在基线和12个月之间，或在治疗组之间，传染病的标志物和病理心电图的频率没有差异。研究与药物相关的严重不良事件，所有这些事件都得到了成功的治疗，在海洛因组中发生的频率是2.5倍。大多数与海洛因有关的SAE(58例中的41例)发生在注射后几分钟内。结论重度注射吸毒者在美沙酮和海洛因辅助维持治疗中的整合对大多数生理和心理变化敏感变量都有积极影响，其中海洛因效果更好。由于药物相关的不良事件，注射海洛因后应对患者进行15分钟的观察。
Aims To evaluate physical and mental health and compare treatment outcomes in opiate-dependent patients substituted either with heroin or methadone. Design Twelve-month open-label randomized controlled trial. Setting Out-patient substitution clinics in seven German cities. Participants A total of 1015 opiate-dependent individuals. Measurements Opiate Treatment Index-Health Scale Score (OTI), Body Mass Index (BMI), serology for infectious diseases such as hepatitis B, C and human immunodeficiency virus as well as tuberculosis, Karnofsky Performance Scale (KPS), electrocardiogram (ECG), echocardiogram, Symptom Checklist 90-R (SCL-90-R), Global Assessment of Functioning (GAF), Modular System for Quality of Life and study medication-related serious adverse events (SAE). Findings Improvements were found in both heroin and methadone substituted patients regarding OTI, BMI, KPS, SCL-90-R, and GAF, but they were more pronounced for the heroin group (analysis of variance, all P = 0.000). The frequency of pathological echocardiograms decreased in the heroin group and increased in the methadone group (chi(2) test, < 0.05). Markers for infectious diseases and frequencies of pathological ECGs did not differ between baseline and 12 months, or between treatment groups. Studymedication-related serious adverse events, all of which were treated successfully, occurred 2.5 times more often in the heroin group. The majority of heroin-related SAEs (41 of 58) occurred within a few minutes of the injections. Conclusions The integration of severe injection drug users either in methadone or heroin-assisted maintenance treatment has positive effects on most physical and mental change-sensitive variables, with heroin showing superior results. Due to medication-related adverse events, patients should be observed for 15 minutes after a heroin injection.