与丁丙诺啡治疗阿片类药物依赖相关的健康相关生活质量变化。
Health-related quality of life changes associated with buprenorphine treatment for opioid dependence.
机构信息
University of New Mexico, Albuquerque, NM, USA.
出版信息
Qual Life Res. 2012 Sep;21(7):1177-83. doi: 10.1007/s11136-011-0027-0. Epub 2011 Oct 11.
BACKGROUND
Few studies have described improvement in health-related quality of life (HRQOL) associated with opioid dependence treatment with buprenorphine (ODT-B).
OBJECTIVE
To evaluate HRQOL changes in domain scores, physical and mental component summaries, and health utilities (HUs) associated with ODT-B using the Short Form 36 (SF-36).
METHODS
We assessed HRQOL changes in a substudy of a pharmacokinetic study that compared buprenorphine oral tablet and liquid dosage formulations over 16 weeks. Individuals, aged 18-65 years, were screened for opioid dependence. They were excluded if they would not agree to birth control or had a serious medical condition. Subjects received psychosocial counseling and weekly group therapy. The SF-36 was administered upon enrollment and at 4-week intervals. We used the SF-6D to estimate HUs. We performed intention to treat (ITT) analyses based on the last observation available for each subject. Paired t tests of each domain and HU, limited to remaining patients at each 4-week interval, were also conducted.
RESULTS
Of 96 subjects enrolled, cumulative dropouts over time resulted in 80, 69, 59, and 44 subjects remaining at 4, 8, 12, and 16 weeks. There were no significant differences in opioid-positive urines, dropout rates, or dosage changes between formulations. In the ITT analyses, HRQOL improvements over time were bodily pain (62.1 vs. 69.1, P = 0.017), vitality (49.8 vs. 56.5, P = 0.001), mental health (59.9 vs. 66.0, P = 0.001), social function (66.4 vs. 74.7, P = 0.001), role emotional (59.4 vs. 71.9, P = 0.003), role physical (60.9 vs. 70.6, P = 0.005), and mental component summary (41.9 vs. 45.4, P<0.001). HU scores also improved (0.674 vs. 0.715, P = 0.001). Results from paired t tests, with only concurrently enrolled patients, showed similar improvements from baseline to 4, 8, 12, or 16 weeks.
CONCLUSION
Buprenorphine, accompanied with psychosocial counseling, was associated with improved HRQOL and HUs.
背景
很少有研究描述丁丙诺啡依赖治疗与丁丙诺啡（ODT-B）相关的健康相关生活质量（HRQOL）的改善。
目的
使用 36 项简短健康调查（SF-36）评估丁丙诺啡口服片剂和液体剂量制剂在 16 周内比较的药物代谢研究的子研究中与 ODT-B 相关的域评分、身体和精神成分摘要以及健康效用（HU）的变化。
方法
我们评估了一项药代动力学研究的子研究中 HRQOL 的变化，该研究比较了丁丙诺啡口服片剂和液体剂量制剂在 16 周内的情况。年龄在 18-65 岁之间的个体被筛选为阿片类药物依赖。如果他们不同意避孕或患有严重疾病，则将其排除在外。受试者接受心理社会咨询和每周小组治疗。SF-36 在入组时和 4 周间隔时进行评估。我们使用 SF-6D 来估计 HUs。我们根据每个受试者的最后观察进行了意向治疗（ITT）分析。还对每个域和 HU 进行了限于每个 4 周间隔内剩余患者的配对 t 检验。
结果
在 96 名入组的受试者中，随着时间的推移，累积辍学导致 80、69、59 和 44 名受试者在 4、8、12 和 16 周时仍然存在。两种制剂之间的尿液阿片阳性、辍学率或剂量变化无显着差异。在 ITT 分析中，HRQOL 随着时间的推移而改善，包括身体疼痛（62.1 对 69.1，P = 0.017）、活力（49.8 对 56.5，P = 0.001）、心理健康（59.9 对 66.0，P = 0.001）、社会功能（66.4 对 74.7，P = 0.001）、情感角色（59.4 对 71.9，P = 0.003）、身体角色（60.9 对 70.6，P = 0.005）和精神成分综合评分（41.9 对 45.4，P<0.001）。HU 评分也有所提高（0.674 对 0.715，P = 0.001）。仅同时入组患者的配对 t 检验结果显示，从基线到 4、8、12 或 16 周时，也有类似的改善。
结论
丁丙诺啡联合心理社会咨询可改善健康相关生活质量和健康效用。
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