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缓释口服吗啡作为阿片类药物依赖的维持疗法。

Slow-release oral morphine as maintenance therapy for opioid dependence.

作者信息

Ferri Marica, Minozzi Silvia, Bo Alessandra, Amato Laura

机构信息

Interventions, Best Practice and Scientific Partners, European Monitoring Centre for Drugs and Drug Addiction, Lisbon, Portugal.

出版信息

Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009879. doi: 10.1002/14651858.CD009879.pub2.

Abstract

BACKGROUND

Opioid substitution treatments are effective in retaining people in treatment and suppressing heroin use. An open question remains whether slow-release oral morphine (SROM) could represent a possible alternative for opioid-dependent people who respond poorly to other available maintenance treatments.

OBJECTIVES

To evaluate the efficacy of SROM as an alternative maintenance pharmacotherapy for the treatment of opioid dependence.

SEARCH METHODS

We searched Cochrane Drugs and Alcohol Group's Register of Trials, Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 3, 2013), MEDLINE (January 1966 to April 2013), EMBASE (January 1980 to April 2013) and reference lists of articles.

SELECTION CRITERIA

Randomised controlled trials (RCTs) and quasi-randomised trials assessing efficacy of SROM compared with other maintenance treatment or no treatment.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected articles for inclusion, extracted data and assessed risk of bias of included studies.

MAIN RESULTS

Three studies with 195 participants were included in the review. Two were cross-over trials and one was a parallel group RCT. The retention in treatment appeared superior to 80% in all the three studies (without significant difference with controls). Nevertheless, it has to be underlined that the studies had different durations. One lasted six months, and the other two lasted six and seven weeks. The use of opioids during SROM provision varied from lower to non-statistically or clinically different from comparison interventions, whereas there were no differences as far as the use of other substances was concerned.SROM seemed to be equal to comparison interventions for severity of dependence, or mental health/social functioning, but there was a trend for less severe opiate withdrawal symptoms in comparison with methadone (withdrawal score 2.2 vs. 4.8, P value = 0.06). Morphine was generally well tolerated and was preferred by a proportion of participants (seven of nine people in one study). Morphine appeared to reduce cravings, depressive symptoms (measured using the Beck Depression Inventory; P value < 0.001), physical complaints (measured using the Beschwerde-Liste (BL); P value < 0.001) and anxiety symptoms (P value = 0.008). Quality of life in people treated with SROM resulted in no significant difference or a worst outcome than in those taking methadone and buprenorphine. Other social functioning measures, such as finances, family and overall satisfaction, scored better in people maintained with the comparison substances than in those maintained with SROM. In particular, people taking methadone showed more favourable values for leisure time (5.4 vs. 3.7, P value < 0.001), housing (6.1 vs. 4.7, P value < 0.023), partnerships (5.7 vs. 4.2, P value = 0.034), friend and acquaintances (5.6 vs. 4.4, P value = 0.003), mental health (5.0 vs. 3.4, P value = 0.002) and self esteem (8.2 vs. 5.7, P value = 0.002) compared to people taking SROM; while people taking buprenorphine obtained better scores for physical health.Medical adverse events were consistently higher in people in SROM than in the comparison groups. None of the studies included people with a documented poor response to other maintenance treatment.

AUTHORS' CONCLUSIONS: The present review did not identify sufficient evidence to assess the effectiveness of SROM for opioid maintenance because only three studies meeting our inclusion criteria have been identified. Two studies suggested a possible reduction of opioid use in people taking SROM. In another study, the use of SROM was associated with fewer depressive symptoms. Retention in treatment was not significantly different among compared interventions while the adverse effects were more frequent with the people given SROM.

摘要

背景

阿片类药物替代疗法在帮助人们坚持治疗和抑制海洛因使用方面是有效的。一个悬而未决的问题是,缓释口服吗啡(SROM)对于对其他现有维持治疗反应不佳的阿片类药物依赖者是否可能是一种替代选择。

目的

评估SROM作为阿片类药物依赖替代维持药物疗法的疗效。

检索方法

我们检索了Cochrane药物与酒精试验注册库、Cochrane对照试验中心注册库(CENTRAL - Cochrane图书馆2013年第3期)、MEDLINE(1966年1月至2013年4月)、EMBASE(1980年1月至2013年4月)以及文章的参考文献列表。

选择标准

评估SROM与其他维持治疗或不治疗相比疗效的随机对照试验(RCT)和半随机试验。

数据收集与分析

两位综述作者独立选择纳入的文章,提取数据并评估纳入研究的偏倚风险。

主要结果

该综述纳入了三项有195名参与者的研究。两项是交叉试验,一项是平行组RCT。在所有三项研究中,治疗保留率似乎均高于80%(与对照组无显著差异)。然而,必须强调的是,这些研究的持续时间不同。一项持续了六个月,另外两项分别持续了六周和七周。在提供SROM期间,阿片类药物的使用从低于对照干预到与对照干预无统计学或临床差异不等,而在其他物质的使用方面则没有差异。SROM在依赖严重程度、心理健康/社会功能方面似乎与对照干预相当,但与美沙酮相比,阿片类药物戒断症状有减轻的趋势(戒断评分2.2对4.8,P值 = 0.06)。吗啡总体耐受性良好,一部分参与者(一项研究中的9人中有7人)更喜欢使用它。吗啡似乎能减少渴望、抑郁症状(使用贝克抑郁量表测量;P值 < 0.001)、身体不适(使用症状清单(BL)测量;P值 < 0.001)和焦虑症状(P值 = 0.008)。接受SROM治疗的人的生活质量与接受美沙酮和丁丙诺啡治疗的人相比,没有显著差异或结果更差。其他社会功能指标,如财务状况、家庭情况和总体满意度,接受对照药物维持治疗的人得分高于接受SROM维持治疗的人。特别是,与接受SROM治疗的人相比,接受美沙酮治疗的人在休闲时间(5.4对3.7,P值 < 0.001)、住房(6.1对4.7,P值 < 0.023)、伴侣关系(5.7对4.2,P值 = 0.034)、朋友和熟人(5.6对4.4,P值 = 0.003)、心理健康(5.0对3.4,P值 = 0.002)和自尊(8.2对5.7,P值 = 0.002)方面得分更高;而接受丁丙诺啡治疗的人在身体健康方面得分更高。接受SROM治疗的人的医疗不良事件一直高于对照组。没有一项研究纳入对其他维持治疗反应不佳的记录在案的人群。

作者结论

本综述未找到足够证据来评估SROM用于阿片类药物维持治疗的有效性,因为仅识别出三项符合我们纳入标准的研究。两项研究表明服用SROM的人使用阿片类药物可能减少。在另一项研究中,使用SROM与较少的抑郁症状相关。在比较的干预措施中,治疗保留率没有显著差异,而接受SROM治疗的人不良反应更频繁。

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