EFFICACY OF CONTROLLED-RELEASE CODEINE IN CHRONIC NONMALIGNANT PAIN - A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL-TRIAL
EFFICACY OF CONTROLLED-RELEASE CODEINE IN CHRONIC NONMALIGNANT PAIN - A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL-TRIAL
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DOI：
10.1016/0304-3959(94)00262-d
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发表时间：
1995-08-01
期刊：
影响因子：
7.4
通讯作者：
DARKE, AC
中科院分区：
文献类型：
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作者：
ARKINSTALL, W;SANDLER, A;DARKE, AC
在慢性非恶性疼痛中使用阿片类镇痛剂的治疗决定主要基于调查数据，因为缺乏来自良好对照临床试验的证据。46例慢性非恶性疼痛患者参加了一项随机、双盲、安慰剂对照的可待因控释（CR）评价。在3-7天的日记熟悉期后，患者被随机分配至CR可待因q12 h或安慰剂治疗7天。根据研究前7天内对乙酰氨基酚+可待因的消耗量确定CR可待因剂量。在这两个阶段，根据需要，每4小时用对乙酰氨基酚+可待因治疗一次爆发性疼痛。在08：00 h和20：00 h使用视觉模拟量表（VAS）和5分分类量表评估疼痛强度，并在使用时记录急救镇痛药消耗量。30例患者（17例女性，13例男性;平均年龄：55.1 ± 13.4岁）完成了研究，并接受了平均每日CR可待因剂量273 ± 78 mg（范围：200-400 mg）治疗。CR可待因治疗导致总体VAS疼痛强度评分（35 +/- 18 vs. 49 +/- 16，P = 0.0001）、分类疼痛强度评分（1.7 +/- 0.6 vs. 2.2 +/- 0.6，P = 0.0001）以及治疗日和一天中不同时间的疼痛评分显著降低。与安慰剂治疗相比，CR可待因组的每日急救镇痛药消耗量显著较低（3.6 +/- 3.5 vs. 6.1 +/- 3.2片/天，P = 0.0001）。与安慰剂相比，CR可待因组的疼痛残疾指数（PDI）也显著降低（25.0 ± 7.7 vs. 35.1 ± 8.2，P = 0.0001）。相对于安慰剂，患者和研究者的盲态治疗偏好显著有利于CR可待因（分别为73% vs. 10%，P = 0.0160和80% vs. 7%，P = 0.0014）。CR可待因组恶心发生率显著高于安慰剂组（32.6% vs. 11.9%，P = 0.013）。完成研究的患者中有93%要求使用CR可待因进行长期开放标签治疗。完成19周长期评价时的疼痛强度评分与双盲CR可待因治疗期间的评分相当。我们的结论是，治疗与CR可待因的结果在减少疼痛和疼痛相关的残疾慢性非恶性疼痛患者。
Treatment decisions for the use of opioid analgesics in chronic non-malignant pain are based primarily on survey data, as evidence from well-controlled clinical trials has been lacking. Forty-six patients with chronic non-malignant pain were enrolled in a randomized, double-blind, placebo-controlled evaluation of controlled-release (CR) codeine. Following a 3-7-day diary familiarization period, patients were randomly assigned to 7 days of treatment each with CR codeine q12h or placebo. The CR codeine dose was determined from the consumption of acetaminophen + codeine in the 7 days preceding the study. During both phases, breakthrough pain was treated with acetaminophen + codeine every 4 h as required. Pain intensity was assessed at 08:00 h and 20:00 h using a visual analogue scale (VAS) and a 5-point categorical scale, and rescue analgesic consumption was recorded at the time of use. Thirty patients (17 female, 13 male; mean age: 55.1 + 13.4 years) completed the study and were treated with a mean daily CR codeine dose of 273 +/- 78 mg (range: 200-400 mg). CR codeine treatment resulted in significantly lower overall VAS pain intensity scores (35 +/- 18 vs. 49 +/- 16, P = 0.0001), categorical pain intensity scores (1.7 +/- 0.6 vs. 2.2 +/- 0.6, P = 0.0001), and in pain scores by day of treatment and by time of day. Daily rescue analgesic consumption was significantly lower on CR codeine, relative to placebo treatment (3.6 +/- 3.5 vs. 6.1 +/- 3.2 tablets/day, P = 0.0001). There was also a significant reduction in the Pain Disability Index (PDI) on CR codeine, compared to placebo (25.0 + 7.7 vs. 35.1 +/- 8.2, P = 0.0001). Patients' and investigators' blinded treatment preference was significantly in favor of CR codeine, relative to placebo (73% vs. 10%, P = 0.0160 and 80% vs. 7%, P = 0.0014, respectively). The incidence of nausea was significantly higher on CR codeine than on placebo (32.6% vs. 11.9%, P = 0.013). Ninety-three percent of patients completing the study requested long-term, open-label treatment with CR codeine. Pain intensity scores at the completion of 19 weeks of long-term evaluation were comparable to those during the double-blind CR codeine treatment. We conclude that treatment with CR codeine results in reduced pain and pain-related disability in patients with chronic non-malignant pain.