口服控释曲马多与安慰剂治疗疼痛性骨关节炎患者疗效和安全性的随机、双盲、交叉对照研究
A randomized, double-blind, crossover comparison of the efficacy and safety of oral controlled-release tramadol and placebo in patients with painful osteoarthritis.
作者信息
Thorne C, Beaulieu A D, Callaghan D J, O'Mahony W F, Bartlett J M, Knight R, Kraag G R, Akhras R, Piraino P S, Eisenhoffer J, Harsanyi Z, Darke A C
机构信息
Arthritis Program Research Group Inc, Newmarket, Canada.
出版信息
Pain Res Manag. 2008 Mar-Apr;13(2):93-102. doi: 10.1155/2008/165421.
OBJECTIVE
To compare the efficacy and safety of controlled-release (CR) tramadol (Zytram XL, Purdue Pharma, Canada) and placebo in patients with painful osteoarthritis.
METHODS
Patients underwent analgesic washout for two to seven days before random assignment to 150 mg daily of CR tramadol or placebo, and were titrated weekly to 200 mg, 300 mg or a maximum of 400 mg once daily. After four weeks, patients crossed over to the alternate treatment for another four weeks. Plain acetaminophen was provided as a rescue analgesic. All patients who completed the crossover study were eligible to receive open label CR tramadol for six months.
RESULTS
Seventy-seven of 100 randomly assigned patients were evaluable for efficacy. CR tramadol resulted in significantly lower visual analogue scale pain intensity scores (37.4+/-23.9 versus 45.1+/-24.3, P=0.0009). Western Ontario and McMaster Universities osteoarthritis index subscale scores for pain (189.0+/-105.0 versus 230.0+/-115.4; P=0.0001) and physical function (632.4+/-361.3 versus 727.4+/-383.4; P=0.0205) were significantly better with CR tramadol. Total pain and disability (22.8+/-14.5 versus 27.2+/-14.8; P=0.0004), and overall pain and sleep (104.7+/-98.0 versus 141.0+/-108.2; P=0.0005) scores in the Pain and Sleep Questionnaire were significantly lower for CR tramadol. Short-form 36 Health Survey scores were significantly better during CR tramadol treatment for the pain index (38.8+/-10.8 versus 35.6+/-9.0; P=0.0100), general health perception (46.5+/-11.2 versus 44.4+/-11.6; P=0.0262), vitality (43.1+/-13.2 versus 40.2+/-13.7; P=0.0255) and overall physical components (40.8+/-8.9 versus 37.8+/-7.7; P=0.0002). CR tramadol treatment was preferred by 55.8% of patients (P=0.0005) versus 20.8% and 23.4% of patients who chose placebo or had no preference, respectively. These improvements were sustained for up to six months, and 86.5% of patients reported at least moderate benefit from CR tramadol during long-term treatment.
CONCLUSION
CR tramadol is effective for the management of painful osteoarthritis.
目的
比较控释曲马多（Zytram XL，加拿大普渡制药公司）与安慰剂治疗疼痛性骨关节炎患者的疗效和安全性。
方法
患者在随机分配接受每日150 mg控释曲马多或安慰剂治疗前，先进行2至7天的镇痛洗脱期，然后每周递增剂量至每日200 mg、300 mg或最大剂量400 mg。4周后，患者交叉接受另一种治疗4周。提供普通对乙酰氨基酚作为解救镇痛药。所有完成交叉研究的患者均有资格接受为期6个月的开放标签控释曲马多治疗。
结果
100例随机分配的患者中有77例可进行疗效评估。控释曲马多导致视觉模拟评分法疼痛强度得分显著降低（37.4±23.9对45.1±24.3，P = 0.0009）。使用控释曲马多治疗时，西安大略和麦克马斯特大学骨关节炎指数疼痛亚量表评分（189.0±105.0对230.0±115.4；P = 0.0001）和身体功能亚量表评分（632.4±361.3对727.4±383.4；P = 0.0205）明显更好。疼痛与睡眠问卷中的总疼痛和残疾评分（22.8±14.5对27.2±14.8；P = 0.0004）以及总体疼痛和睡眠评分（104.7±98.0对141.0±108.2；P = 0.0005），控释曲马多组显著更低。在控释曲马多治疗期间，简明健康调查问卷的疼痛指数评分（38.8±10.8对35.6±9.0；P = 0.01）、总体健康感知评分（46.5±11.2对44.4±11.6；P = 0.0262）、活力评分（43.1±13.2对40.2±13.7；P = 0.0255）和总体身体成分评分（40.8±8.9对37.8±7.7；P = 0.0002）明显更好。55.8%的患者更喜欢控释曲马多治疗（P = 0.0005），而选择安慰剂或无偏好的患者分别为20.8%和23.4%。这些改善可持续长达6个月，86.5%的患者报告在长期治疗期间从控释曲马多中至少获得中度益处。
结论
控释曲马多对疼痛性骨关节炎的治疗有效。
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