Gallagher Arlene M, Leighton-Scott James, van Staa Tjeerd P
General Practice Research Database, Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
Clin Ther. 2009 Aug;31(8):1707-15. doi: 10.1016/j.clinthera.2009.08.022.
The 7-day, low-dose buprenorphine patch has been available in the United Kingdom since 2005 for the treatment of chronic nonmalignant pain that is unresponsive to nonopioid analgesics. Osteo-arthritis pain, a significant cause of pain and disability in the elderly, is a common reason for prescribing bu-prenorphine patches.
The goals of this study were to investigate utilization and treatment persistence in patients receiving low-dose buprenorphine patches and the expected patterns of treatment 12 months after the initiation of treatment.
This was a retrospective cohort study of patients who were prescribed low-dose buprenorphine patches in general practice in the United Kingdom. Patients in this cohort were matched by age, sex, and practice with comparator cohorts prescribed oral codeine, dihydrocodeine, or tramadol. Data on baseline characteristics, utilization, and adverse events were obtained from the General Practice Research Database, which contains computerized medical records from UK general practice. Treatment persistence was determined based on repeat prescribing within 90 days after the expected end of a prescription; rates of persistence were compared between the buprenorphine and comparator cohorts. Cox proportional hazards regression models were used to compare the incidence of typical opioid adverse effects (constipation, dizziness, and nausea and/or vomiting) between cohorts.
The study cohort included 4968 patients who were prescribed low-dose buprenorphine patches. The majority of patients (64.2%) were aged >65 years, and the most frequently recorded indication for low-dose buprenorphine patches was osteoarthritis (48.7%). Most patients (76.1%) started treatment at the lowest patch strength (5 microg/h). The mean patch strength prescribed over time stabilized at 10 to 12 microg/h. Persistence with low-dose buprenorphine patches over 6 months was significantly higher than with codeine, dihydrocodeine, and tramadol (28.9%, 22.4%, 24.4%, and 23.8%, respectively; P < 0.01). Persistence over 12 months also was significantly higher with low-dose buprenorphine patches compared with the comparators (18.5%, 16.1%, 18.0%, and 17.6%; P < 0.01). After 12 months, the difference in persistence levels between cohorts was not statistically significant. In the Cox proportional hazards regression models, patients using buprenorphine patches had an increased incidence of constipation, dizziness, and nausea and vomiting compared with those who used the comparator opioids (P < 0.05).
Significantly more patients receiving low-dose buprenorphine patches in this study persisted with treatment at 6 and 12 months compared with those receiving other opioid analgesics. Treatment with low-dose buprenorphine patches was most frequently initiated at the lowest patch strength and stabilized at a mean of 10 to 12 microg/h.
自2005年起,7天低剂量丁丙诺啡透皮贴剂在英国上市,用于治疗对非阿片类镇痛药无反应的慢性非恶性疼痛。骨关节炎疼痛是老年人疼痛和残疾的一个重要原因,是开具丁丙诺啡透皮贴剂的常见原因。
本研究的目的是调查接受低剂量丁丙诺啡透皮贴剂患者的使用情况和治疗持续性,以及治疗开始12个月后的预期治疗模式。
这是一项对在英国全科医疗中开具低剂量丁丙诺啡透皮贴剂患者的回顾性队列研究。该队列中的患者按年龄、性别和医疗机构与开具口服可待因、双氢可待因或曲马多的对照队列进行匹配。基线特征、使用情况和不良事件的数据来自全科医疗研究数据库,该数据库包含英国全科医疗的计算机化医疗记录。治疗持续性根据预期处方结束后90天内的重复开药情况确定;比较丁丙诺啡组和对照队列的持续性率。采用Cox比例风险回归模型比较队列间典型阿片类药物不良反应(便秘、头晕、恶心和/或呕吐)的发生率。
研究队列包括4968例开具低剂量丁丙诺啡透皮贴剂的患者。大多数患者(64.2%)年龄>65岁,低剂量丁丙诺啡透皮贴剂最常记录的适应证是骨关节炎(48.7%)。大多数患者(76.1%)以最低贴剂强度(5微克/小时)开始治疗。随着时间推移,开具的平均贴剂强度稳定在10至12微克/小时。低剂量丁丙诺啡透皮贴剂6个月以上的持续性显著高于可待因、双氢可待因和曲马多(分别为28.9%、22.4%、24.4%和23.8%;P<0.01)。与对照药物相比,低剂量丁丙诺啡透皮贴剂12个月以上的持续性也显著更高(18.5%、16.1%、18.0%和17.6%;P<0.01)。12个月后,队列间持续性水平的差异无统计学意义。在Cox比例风险回归模型中,与使用对照阿片类药物的患者相比,使用丁丙诺啡透皮贴剂的患者便秘、头晕、恶心和呕吐的发生率增加(P<0.05)。
与接受其他阿片类镇痛药的患者相比,本研究中接受低剂量丁丙诺啡透皮贴剂的患者在6个月和12个月时坚持治疗的人数显著更多。低剂量丁丙诺啡透皮贴剂治疗最常从最低贴剂强度开始,平均稳定在10至12微克/小时。