预测腰痛患者对强效阿片类药物的长期反应：一项关于透皮芬太尼和吗啡的随机对照试验的结果
Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine.
作者信息
Kalso Eija, Simpson Karen H, Slappendel Robert, Dejonckheere Joachim, Richarz Ute
机构信息
Pain Clinic, Helsinki University Central Hospital, Helsinki, Finland.
出版信息
BMC Med. 2007 Dec 21;5:39. doi: 10.1186/1741-7015-5-39.
BACKGROUND
Some patients with long-standing low back pain will benefit from treatment with strong opioids. However, it would be helpful to predict which patients will have a good response. A fixed-term opioid trial has been recommended, but there is little evidence to suggest how long this trial should be. We assessed data from a large-scale randomized comparison of transdermal fentanyl (TDF) and sustained-release oral morphine (slow-release morphine; SRM) to determine characteristics of treatment responders.
METHODS
This was a secondary analysis of a previously published 13-month randomized trial involving 680 patients with long-standing low back pain (median age 52 years, 61% women, median duration of back pain 87 months). Pain relief was recorded using visual analogue scales (VAS). Treatment response was defined as pain relief of at least 30% from baseline to any point during the trial. We used a step-wise logistic regression to identify variables that might predict response to treatment. Covariates included treatment group, sex, age, duration of pain, presence of neuropathic pain, baseline pain scores, educational/employment status, use of high doses of opioids, and social functioning (SF)-36 scores.
RESULTS
Over half the patients in both groups (n = 370; 54% TDF, 55% SRM) were treatment responders. There were no differences between the TDF and SRM responders in terms of age, sex, type or duration of pain between responders and non-responders. The difference in response to treatment between responders and non-responders could be detected at 3 weeks. Lack of response after 1 month had a stronger negative predictive value (i.e., ability to detect non-responders) than the presence of response after 1 month. The most influential factors for predicting a response were employment status (chi2 = 11.06, p = 0.0259) and use of high doses of opioids (chi2 = 3.04, p = 0.0811).
CONCLUSION
No clear pattern of baseline pain (type or severity) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment. However, a 1-month trial period appears sufficient to determine response and tolerability in most cases.
背景
一些长期患有腰痛的患者将从强效阿片类药物治疗中获益。然而，预测哪些患者会有良好反应将很有帮助。已推荐进行定期阿片类药物试验，但几乎没有证据表明该试验应持续多长时间。我们评估了一项关于透皮芬太尼（TDF）和缓释口服吗啡（缓释吗啡；SRM）的大规模随机对照试验的数据，以确定治疗反应者的特征。
方法
这是对一项先前发表的为期13个月的随机试验的二次分析，该试验涉及680例长期腰痛患者（中位年龄52岁，61%为女性，腰痛中位持续时间87个月）。使用视觉模拟量表（VAS）记录疼痛缓解情况。治疗反应定义为从基线到试验期间任何时间点疼痛缓解至少30%。我们使用逐步逻辑回归来确定可能预测治疗反应的变量。协变量包括治疗组、性别、年龄、疼痛持续时间、是否存在神经性疼痛、基线疼痛评分、教育/就业状况、高剂量阿片类药物的使用以及社会功能（SF）-36评分。
结果
两组中超过一半的患者（n = 370；TDF组为54%，SRM组为55%）是治疗反应者。TDF组和SRM组的反应者在年龄、性别、疼痛类型或持续时间方面，反应者与无反应者之间没有差异。在3周时可以检测到反应者与无反应者在治疗反应上的差异。1个月后无反应比1个月后有反应具有更强的阴性预测价值（即检测无反应者的能力）。预测反应的最有影响因素是就业状况（卡方 = 11.06，p = 0.0259）和高剂量阿片类药物的使用（卡方 = 3.04, p = 0.0811）。
结论
在阿片类药物治疗开始前，没有出现可用于预测反应者的明确的基线疼痛模式（类型或严重程度）或患者特征。然而，在大多数情况下，1个月的试验期似乎足以确定反应和耐受性。
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