A randomized, double-blind, placebo-controlled, cross-over pilot study to assess the effects of long-term opioid drug consumption and subsequent abstinence in chronic noncancer pain patients receiving controlled-release morphine
A randomized, double-blind, placebo-controlled, cross-over pilot study to assess the effects of long-term opioid drug consumption and subsequent abstinence in chronic noncancer pain patients receiving controlled-release morphine
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DOI：
10.1111/j.1526-4637.2005.05020.x
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发表时间：
2005-03-01
期刊：
影响因子：
3.1
通讯作者：
Allan, LG
中科院分区：
文献类型：
--
作者：
Cowan, DT;Wilson-Barnett, DJ;Allan, LG
目标。由于对有问题的药物使用的担忧，在慢性非癌症疼痛(CNCP)患者中长期使用强阿片类止痛药仍然存在争议。然而，之前的调查表明，情况并不一定如此。因此，我们设计了一项对照研究，以产生支持这些发现的证据。在某区综合医院疼痛门诊就诊的10例CNCP患者，每日平均服用硫酸吗啡控释片40 mg(平均40 mg，范围10~90，SD 21 mg)，平均2年(平均2.175，2~2.25年，SD 0.2年)。随机、双盲、安慰剂对照的交叉研究。这项研究的前提是，突然停止使用阿片类药物最有可能突出问题使用，并因此无法停止使用阿片类药物。用安慰剂替代吗啡60小时，以比较戒酒和继续使用的效果。通过直接观察、生理测量、问卷调查和简明的疼痛问卷评分来评估吗啡的戒断和戒断效果。在停止和禁欲之后，没有心理依赖或药物渴望的迹象，但有证据表明，疼痛强度对活动、情绪、人际关系、睡眠和生活享受的有害影响。3名患者(30%)报告了阿片类药物的戒断症状。药代动力学数据显示所有患者均依从性戒毒。结果表明，存在一组CNCP患者，他们长期服用阿片类药物可能是有益的，并保持适度，而不会遭受问题阿片类药物使用的后果。
Objectives. The long-term use of strong opioid analgesics among chronic noncancer pain (CNCP) patients remains controversial because of concerns over problematic drug use. However, previous surveys suggest that this is not necessarily the case. Therefore, we designed a controlled study to generate evidence in support of these findings.Patients/Setting. Ten CNCP patients attending the pain clinic in a district general hospital had been taking an average daily dose of 40 mg controlled-release morphine sulphate (mean 40, range 10-90, SD 21 mg), for an average of 2 years (mean 2.175, range 2-2.25, SD 0.2 years).Design. Randomized, double-blind, placebo controlled cross-over study. The study was based on the premise that abrupt cessation of opioid drugs is most likely to highlight problematic use and the consequent inability to stop using opioids. Morphine was substituted with placebo for 60-hour periods to compare the effects of abstinence with those of continued use. Assessment of morphine cessation and abstinence effects was through direct observation, physiological measurements, questionnaire responses, and Brief Pain Inventory scores.Results. Following cessation and abstinence, there were no indications of psychological dependence or drug craving, but there was evidence of the detrimental effects of pain intensity on activity, mood, relationships, sleep, and enjoyment of life. Three patients (30%) reported opioid drug withdrawal symptoms. Pharmacokinetic data demonstrated compliance with abstinence by all patients.Conclusion. The results suggest the existence of a group of CNCP patients whose long-term opioid consumption can be beneficial and remain moderate without them suffering from the consequences of problematic opioid drug use.