Department of Anesthesiology, Universitätskliniken des Saarlandes, Homburg/Saar, Germany.
Department of Pain Medicine, Ruhr-Universität Bochum, Bochum, Germany.
Eur J Pain. 2020 Feb;24(2):265-278. doi: 10.1002/ejp.1496. Epub 2019 Nov 14.
This updated systematic review evaluated the efficacy, acceptability and safety of long-term opioid therapy (LTOT) for chronic non-cancer pain (CNCP).
Clinicaltrials.gov, CENTRAL and MEDLINE until June 2019. We included open-label extension trials with a study duration ≥26 weeks of RCTs with ≥2 weeks duration. Pooled estimates of event rates of categorical data and standardized mean differences (SMD) of continuous variables were calculated using a random effects model.
We added four new studies with 1,154 participants for a total of 15 studies with 3,590 participants. Study duration ranged between 26 and 156 weeks. Studies included patients with low back, osteoarthritis and neuropathic pain. The quality of evidence for every outcome was very low. 31.1% (95% Confidence interval [CI] 23.0%-40.7%) of patients randomized at baseline finished the open label period. 14.1% (95% CI 10.9%-19.4%) of patients dropped out to due adverse events. In 6.3% (95 CI 3.9%-10.1%) of patients serious adverse events and in 2.7% (95% CI 1.5%-4.7%) aberrant drug behaviour were noted. 0.5% (95% CI 0.2%-1.4%) of patients died.
Within the context of open-label extension studies, opioids maintain reduction of pain and disability and are rather well tolerated and safe. LTOT can be considered in carefully selected and monitored patients with low back, osteoarthritis and neuropathic pain who experience a clinically meaningful pain reduction with at least tolerable adverse events in short-term opioid therapy.
There is very low quality evidence of the long-term efficacy, tolerability and safety of opioids for chronic low back, osteoarthritis and diabetic polyneuropathic pain within the context of open-label extension studies of randomized controlled trials. Drop out rate due to adverse events and deaths increase with study duration. One-third of patients profit from LTOT. Long-term opioid therapy can be considered in some carefully selected and monitored patients.
本更新的系统评价评估了长期阿片类药物治疗（LTOT）慢性非癌性疼痛（CNCP）的疗效、可接受性和安全性。
Clinicaltrials.gov、CENTRAL 和 MEDLINE 截至 2019 年 6 月。我们纳入了研究时间≥26 周的开放标签延伸试验和持续时间≥2 周的随机对照试验（RCT）。使用随机效应模型计算分类数据的事件率和连续变量的标准化均数差（SMD）的汇总估计值。
我们新增了四项研究，共纳入 1154 名参与者，共计 15 项研究，纳入 3590 名参与者。研究持续时间为 26-156 周。研究包括腰痛、骨关节炎和神经病理性疼痛患者。每个结局的证据质量均非常低。基线随机分组的 31.1%（95%置信区间[CI] 23.0%-40.7%）患者完成了开放标签期。14.1%（95%CI 10.9%-19.4%）的患者因不良事件而退出。在 6.3%（95%CI 3.9%-10.1%）的患者中观察到严重不良事件，在 2.7%（95%CI 1.5%-4.7%）的患者中观察到异常药物行为。有 0.5%（95%CI 0.2%-1.4%）的患者死亡。
在开放标签延伸研究中，阿片类药物可以持续减轻疼痛和残疾，并且具有较好的耐受性和安全性。对于接受短期阿片类药物治疗后疼痛有临床意义缓解且至少可耐受不良反应的慢性腰痛、骨关节炎和糖尿病性多发性神经病患者，可考虑长期使用阿片类药物。
在随机对照试验的开放标签延伸研究中，阿片类药物治疗慢性腰痛、骨关节炎和糖尿病性多发性神经病疼痛的长期疗效、耐受性和安全性的证据质量非常低。由于不良事件和死亡导致的脱落率随研究时间的延长而增加。三分之一的患者受益于 LTOT。长期阿片类药物治疗可考虑用于一些精心选择和监测的患者。
