Palis Heather, Marchand Kirsten, Guh Daphne, Brissette Suzanne, Lock Kurt, MacDonald Scott, Harrison Scott, Anis Aslam H, Krausz Michael, Marsh David C, Schechter Martin T, Oviedo-Joekes Eugenia
Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.
School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.
Subst Abuse Treat Prev Policy. 2017 May 19;12(1):25. doi: 10.1186/s13011-017-0110-9.
To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness.
This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among 202 long-term street opioid injectors in Vancouver (Canada). Given this was a secondary analysis, no a priori power calaculation was conducted. Differences in baseline characteristics and six-month treatment outcomes (illicit heroin use, opioid use, crack cocaine use, non-legal activities, physical and psychological health scores, urine positive for street heroin markers, and retention) were analysed by gender using fitted models. Responses to an open ended question on reasons for treatment effectiveness were explored with a thematic analysis.
Men and women differed significantly on a number of characteristics at baseline. For example, women were significantly younger, presented to treatment with significantly higher rates of prior month sex work (31.5% vs. 0%), and used significantly more crack cocaine (14.71 vs. 8.38 days). After six-months of treatment there were no significant differences in treatment outcomes by gender, after adjusting for baseline values. For both men and women, improved health and quality of life were the most common reasons provided for treatment effectiveness, however women were more specific in the types of health improvements.
Despite presenting to treatment with vulnerabilities not faced to the same extent by men, at six-months women did not differ significantly from men in tested trial efficacy outcomes. While the primary outcome in the trial was the reduction of illicit opioid use, in the open-ended responses both men and women focused their comments on improvement in health and quality of life as reasons for treatment effectiveness. The supervised model of care with injectable medications provides a particularly suitable framework for providing care to opioid-dependent men and women not attracted or retained by other treatments. The absence of statistical differences reported in this secondary analysis may be due to lack of adequate statistical power to detect meaningful effects.
This trial is registered with ClinicalTrials.gov (NCT01447212) Registered: October 4, 2011 at the following link: https://clinicaltrials.gov/ct2/show/NCT01447212 .
为了测试接受注射用阿片类药物治疗长期阿片类药物依赖的患者在治疗结果上是否存在性别差异。该研究还探讨了男性和女性对治疗效果的认知是否不同。
本研究是对SALOME研究的二次分析，SALOME是一项双盲、III期随机对照试验，在加拿大温哥华的202名长期街头阿片类药物注射者中测试注射用氢吗啡酮相对于注射用二乙酰吗啡的非劣效性。鉴于这是一项二次分析，未进行预先的功效计算。使用拟合模型按性别分析基线特征和六个月治疗结果（非法海洛因使用、阿片类药物使用、快克可卡因使用、非法活动、身心健康评分、街头海洛因标志物尿检呈阳性以及留存情况）的差异。通过主题分析探讨对关于治疗效果原因的开放式问题的回答。
男性和女性在基线时的一些特征上存在显著差异。例如，女性明显更年轻，前来治疗时前一个月从事性工作的比例显著更高（31.5%对0%），且使用快克可卡因的频率显著更高（14.71天对8.38天）。在调整基线值后，治疗六个月后按性别划分的治疗结果没有显著差异。对于男性和女性来说，健康和生活质量的改善是认为治疗有效的最常见原因，然而女性在健康改善的类型方面更具体。
尽管女性在接受治疗时面临一些男性未同样面临的脆弱性，但在六个月时，女性在试验疗效结果方面与男性没有显著差异。虽然试验的主要结果是非法阿片类药物使用的减少，但在开放式回答中，男性和女性都将他们的评论集中在健康和生活质量的改善上作为治疗有效的原因。注射用药物的监督式护理模式为向未被其他治疗吸引或留存的阿片类药物依赖男性和女性提供护理提供了一个特别合适的框架。本次二次分析中报告的无统计学差异可能是由于缺乏足够的统计功效来检测有意义的效应。
本试验已在ClinicalTrials.gov注册（NCT01447212）。注册时间：2011年10月4日，链接如下：https://clinicaltrials.gov/ct2/show/NCT01447212 。
