Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea
Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea
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DOI：
10.1136/bmj.327.7414.523
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发表时间：
2003-09-06
影响因子：
--
通讯作者：
Bui, C
中科院分区：
文献类型：
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作者：
Abernethy, AP;Currow, DC;Bui, C
目的探讨口服吗啡对缓解呼吸困难的有效性，为临床合理用药提供依据。研究设计：随机、双盲、安慰剂对照、交叉研究。研究对象：南澳某医院的4个门诊。研究对象：48名既往未接受过阿片类药物治疗的患者（平均年龄76岁，SD 5），主要为慢性阻塞性肺病（42，88%），被随机分配到4天的20毫克口服吗啡缓释，然后4天的相同配方的安慰剂，反之亦然。泻药按需提供。主要结果测量呼吸困难在上午和晚上显示在一个100转视觉模拟量表，睡眠质量，幸福，体力消耗的表现，并在四天的治疗期结束时测量的副作用。结果38名参与者完成了研究;三人因为确定而退出，两人因为吗啡可能的副作用（恶心，呕吐和镇静）。当使用吗啡治疗时，参与者报告了显著不同的呼吸困难评分：早晨改善6.6 mm（95%置信区间1.6 mm至11.6 mm），晚上改善9.5 mm（3.0 mm至16.1 mm）（分别为P = 0.011和P = 0.006）。在服用吗啡期间，参与者也报告睡眠更好（P = 0.039）。尽管使用泻药，但更多的参与者报告在服用吗啡时出现令人痛苦的便秘（9例上升1，P = 0.021）。所有其他副作用没有显着恶化与吗啡，虽然这项研究没有权力解决副作用。结论持续释放，口服吗啡在低剂量提供了显着的症状改善难治性呼吸困难在社区设置。
Objective To determine the efficacy of oral morphine in relieving the sensation of breathlessness in patients in whom the underlying aetiology is maximally treated.Design Randomised, double blind, placebo controlled crossover study.Setting Four Outpatient clinics at a hospital in South Australia.Participants 48 participants who had not previously been treated with opioids (mean age 76, SD 5) with predominantly chronic obstructive pulmonary disease (42, 88%) were randomised to four days of 20 mg oral morphine with sustained release followed by four days of identically formulated placebo, or vice versa. Laxatives were provided as needed.Main outcome measures Dyspnoea in the morning and evening as shown on a 100 turn visual analogue scale, quality of sleep, wellbeing, performance on physical exertion, and side effects as measured at the end of the four day treatment period.Results 38 participants completed the study; three withdrew because of definite and two because of possible side effects of morphine (nausea, vomiting, and sedation). Participants reported significantly different dyspnoea scores when treated with morphine: an improvement of 6.6 mm (95% confidence interval 1.6 mm to 11.6 mm) in the morning and of 9.5 mm (3.0 mm to 16.1 mm) in the evening (P = 0.011 and P = 0.006, respectively). During the period in which they were taking morphine participants also reported better sleep (P = 0.039). More participants reported distressing constipation while taking morphine (9 upsilon 1, P = 0.021) in spite of using laxatives. All other side effects were not significantly worse with morphine, although the study was not powered to address side effects.Conclusions Sustained release, oral morphine at low dosage provides significant symptomatic improvement in refractory dyspnoea in the community setting.