SRA International, Merced, California, USA.
J Pain Symptom Manage. 2010 Apr;39(4):712-20. doi: 10.1016/j.jpainsymman.2009.08.013.
Recently, a new oral prolonged-release formulation of morphine sulfate for once-daily dosing has been developed based on an injection-molded matrix (abuse-deterrent, prolonged-release erodible matrix [ADPREM]).
The objective of this double-blind, randomized, exploratory crossover study was to assess the efficacy and safety of once-daily ADPREM compared with twice-daily controlled-release morphine (CRM; MST ContinusNapp Pharmaceuticals, Cambridge, UK).
Thirty-eight adult cancer pain patients participated in the study, which consisted of a run-in period for stabilization and two consecutive fixed-dose treatment periods of two weeks' duration each. Rescue medication, immediate-release morphine sulfate, was available during the entire study for treatment of breakthrough pain (BTP).
There was no difference between the treatments in use of rescue medication. The medians of the average number of rescue doses per day were 1.0 and 0.7 during the ADPREM and CRM treatment periods, respectively, with an estimated median difference of 0.07 dose/day (95% confidence interval: -0.21, 0.29). Likewise, no differences between treatments were found for the number of BTP episodes per day or morning and evening ratings of pain intensity (current, average, minimum, and maximum). Median assessment of the drugs was "good" for both treatments, and neither of the treatments was preferred. Steady-state trough concentrations of morphine and its metabolites in plasma before morning dosing were similar after either treatment period. The adverse events were as expected in an opioid-treated cancer population and showed no differences between ADPREM and CRM.
In this study, dosing with ADPREM at intervals of 24 hours was therapeutically equivalent to CRM dosed at intervals of 12 hours.
最近，一种新的吗啡硫酸盐口服延长释放制剂已基于注射成型基质（防滥用、延长释放可蚀性基质 [ADPREM]）开发出来，用于每日一次给药。
这项双盲、随机、探索性交叉研究的目的是评估每日一次 ADPREM 与每日两次给予控释吗啡（CRM；MST ContinusNapp 制药公司，英国剑桥）的疗效和安全性。
38 名成年癌症疼痛患者参加了这项研究，该研究包括一个稳定期的导入期和两个连续的两周固定剂量治疗期。整个研究期间都可使用即释吗啡硫酸盐作为解救药物，以治疗爆发性疼痛（BTP）。
两种治疗方法在解救药物的使用上没有差异。ADPREM 和 CRM 治疗期间，平均每日解救剂量中位数分别为 1.0 和 0.7，估计每日剂量差异为 0.07 剂（95%置信区间：-0.21，0.29）。同样，两种治疗方法在每日 BTP 发作次数或早晚疼痛强度评分（当前、平均、最小和最大）方面也没有差异。两种治疗方法的药物评估中位数均为“良好”，且两种治疗方法均无偏好。两种治疗方法后，早晨给药前的吗啡及其代谢物在血浆中的稳态谷浓度相似。不良事件与接受阿片类药物治疗的癌症患者的预期情况一致，并且在 ADPREM 和 CRM 之间没有差异。
在这项研究中，ADPREM 每 24 小时给药与 CRM 每 12 小时给药具有相同的治疗效果。
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