Nicholson Bruce, Ross Edgar, Weil Arnold, Sasaki John, Sacks Gerald
Pain Specialists of Greater Lehigh Valley, Allentown, Pennsylvania 18103, USA.
Curr Med Res Opin. 2006 Mar;22(3):539-50. doi: 10.1185/030079906X89784.
To demonstrate the efficacy and tolerability of polymer-coated extended-release morphine sulfate (P-ERMS)(KADIAN) for the treatment of chronic, moderate-to-severe, non-malignant pain in a community-based outpatient population not satisfactorily relieved with their current therapies.
Phase IV, prospective, randomized, open-label, blinded endpoint.
Adults (N = 1428) with chronic, moderate-to-severe, non-malignant pain with visual numeric scale scores >or= 4 (0 = no pain; 10 = worst pain).
Patients were randomized to P-ERMS once daily in AM or PM for a 4-week treatment period. Dose increases were allowed; however, switching to twice-daily dosing was reserved until week 2.
Improvement from baseline in pain and sleep scales (0-10) (after weeks 2 and 4), quality of life (physical and mental component summary scores of the SF-36v2 Health Survey) (week 4), and patient (weeks 2 and 4) and clinician (week 4) assessments of current therapy (-4 to +4). Patient satisfaction was assessed again 1 month after the study.
Approximately 70% of patients completed the study, with 2.4% (n = 34) discontinuing due to lack of efficacy, and 9.6% (n = 136) discontinuing due to an adverse event. Improvements were seen in pain and sleep scores, physical and mental component scores of the SF-36v2, and patient and clinician global assessment scores (p < 0.0001, all assessments). Patients attained similar results regardless of AM vs. PM dosing. More than half (55.4%) of patients were maintained on once-daily therapy, with the remainder on a twice-daily regimen, in accordance with the prescribing information. Most adverse events (71.6%) were mild to moderate in severity, the most common being constipation (11.6%) and nausea (9.2%). One-month follow-up indicated continued satisfaction with P-ERMS vs. previous medication (p < 0.0001).
P-ERMS was efficacious and well tolerated in patients with chronic, moderate-to-severe, non-malignant pain when used once or twice daily.
在一个社区门诊人群中，证明聚合物包衣缓释硫酸吗啡（P-ERMS，商品名：奥施康定）治疗慢性中重度非恶性疼痛的疗效和耐受性，这些患者目前的治疗方案未能令人满意地缓解疼痛。
IV期前瞻性随机开放标签盲终点研究。
患有慢性中重度非恶性疼痛、视觉数字评分≥4分（0 = 无疼痛；10 = 最严重疼痛）的成年人（N = 1428）。
患者被随机分为每日上午或下午服用一次P-ERMS，为期4周的治疗期。允许增加剂量；然而，直到第2周才保留改为每日两次给药。
疼痛和睡眠量表（0 - 10分）从基线的改善情况（第2周和第4周后）、生活质量（SF - 36v2健康调查的身体和心理成分汇总评分）（第4周）以及患者（第2周和第4周）和临床医生（第4周）对当前治疗的评估（-4至+4）。研究结束1个月后再次评估患者满意度。
约70%的患者完成了研究，2.4%（n = 34）因缺乏疗效而停药，9.6%（n = 136）因不良事件而停药。疼痛和睡眠评分、SF - 36v2的身体和心理成分评分以及患者和临床医生的整体评估评分均有改善（所有评估，p < 0.0001）。无论上午还是下午给药，患者都取得了相似的结果。超过一半（55.4%）的患者维持每日一次治疗，其余患者根据处方信息采用每日两次给药方案。大多数不良事件（71.6%）为轻度至中度严重程度，最常见的是便秘（11.6%）和恶心（9.2%）。1个月的随访表明，与之前的药物相比，患者对P-ERMS持续满意（p < 0.0001）。
P-ERMS用于慢性中重度非恶性疼痛患者，每日服用一次或两次时，疗效显著且耐受性良好。
