Babul N, Provencher L, Laberge F, Harsanyi Z, Moulin D
Department of Scientific Affairs, Purdue Frederick, Pickering, Ontario, Canada.
J Clin Pharmacol. 1998 Jan;38(1):74-81. doi: 10.1002/j.1552-4604.1998.tb04380.x.
Although the oral route is the preferred method of opioid therapy in patients with cancer pain, many patients will require an alternate route of analgesic administration at some point during the trajectory of their illness. This study compared the efficacy and safety of a novel, controlled-release suppository of morphine (MSC-R) and controlled-release morphine tablets (MSC-T) in patients with cancer pain. In a double-blind crossover study, 27 patients with cancer pain were randomized to receive MSC-R or MSC-T every 12 hours for 7 days each, using a 1:1 analgesic equivalence ratio. Pain intensity was assessed using a visual analog scale (VAS) and the Present Pain Intensity Index of the McGill Pain Questionnaire. Nausea and sedation were also assessed with a VAS. Pharmacodynamic assessments were made by the patient at 8:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM and rescue morphine use recorded in a daily diary. There were no significant differences between MSC-R and MSC-T in overall scores for pain intensity VAS, ordinal pain intensity, and sedation. There was a small but significant difference in overall nausea VAS score in favor of MSC-R. Mean daily rescue analgesic use did not differ significantly during between treatment with MSC-R and MSC-T. MSC-R provides pain control comparable to that provided by MSC-T when given every 12 hours at a 1:1 dose ratio, and represents a reliable alternative method of pain control for patients unable to take oral opioid agents.
尽管口服途径是癌症疼痛患者阿片类药物治疗的首选方法，但许多患者在病程的某个阶段需要采用替代的镇痛给药途径。本研究比较了一种新型吗啡控释栓剂（MSC-R）和控释吗啡片（MSC-T）在癌症疼痛患者中的疗效和安全性。在一项双盲交叉研究中，27例癌症疼痛患者按1:1的镇痛等效比随机分组，每12小时接受一次MSC-R或MSC-T治疗，各治疗7天。使用视觉模拟量表（VAS）和麦吉尔疼痛问卷的当前疼痛强度指数评估疼痛强度。还使用VAS评估恶心和镇静情况。患者在上午8:00、中午12:00、下午4:00和晚上8:00进行药效学评估，并将急救吗啡的使用情况记录在每日日记中。MSC-R和MSC-T在疼痛强度VAS总分、序贯疼痛强度和镇静方面无显著差异。在总体恶心VAS评分方面，MSC-R有微小但显著的差异。在MSC-R和MSC-T治疗期间，平均每日急救镇痛药的使用情况无显著差异。当以1:1的剂量比每12小时给药一次时，MSC-R提供的疼痛控制效果与MSC-T相当，对于无法口服阿片类药物的患者而言，它是一种可靠的替代疼痛控制方法。
