Portenoy R K, Maldonado M, Fitzmartin R, Kaiko R F, Kanner R
Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
Cancer. 1989 Jun 1;63(11 Suppl):2284-8. doi: 10.1002/1097-0142(19890601)63:11<2284::aid-cncr2820631137>3.0.co;2-3.
Fifty-one cancer pain patients with limited opioid exposure participated in a randomized, double-blind, repeated-dose, parallel-group comparison of two dosage strengths of the controlled-release morphine preparation, MS Contin tablets (The Purdue Frederick Company, Norwalk, CT). The patients were first stabilized on immediate-release oral morphine 30 mg every 4 hours, with 15 mg available every 2 hours as needed for breakthrough pain ("rescue" dose). Each patient then received either one 100 mg MS Contin tablet or three 30-mg MS Contin tablets every 12 hours, with rescue medication as needed, for 3 days. Analysis of study power revealed sufficient sensitivity to detect clinically relevant differences in pain intensity and use of rescue medication. The two tablet strengths yielded similar pain relief, use of rescue medication, and frequency of side effects. In addition, pain and use of rescue medication did not change from the beginning to the end of the 12-hour dosing intervals in either group. In the study population as a whole, pain intensity was lower and total morphine intake higher during the period on controlled-release morphine. These data establish comparable analgesic efficacy and side effect potential of these two dosage strengths and confirm a 12-hour duration of effect for both. The improved analgesia on the controlled-release morphine may be attributable to increased consumption of drug resulting from improved compliance.
51名阿片类药物使用受限的癌症疼痛患者参与了一项随机、双盲、重复给药、平行组对照试验，比较两种剂量强度的控释吗啡制剂美施康定片（The Purdue Frederick Company，康涅狄格州诺沃克市）。患者首先以每4小时口服30mg即释吗啡进行剂量稳定，每2小时按需提供15mg用于爆发性疼痛（“解救”剂量）。然后，每位患者每12小时服用一片100mg美施康定片或三片30mg美施康定片，按需服用解救药物，持续3天。研究效能分析显示，该研究有足够的敏感性来检测疼痛强度和解救药物使用方面的临床相关差异。两种片剂强度在疼痛缓解、解救药物使用和副作用发生频率方面产生了相似的结果。此外，两组在12小时给药间隔期间，疼痛和解救药物的使用从开始到结束均无变化。在整个研究人群中，服用控释吗啡期间疼痛强度较低，吗啡总摄入量较高。这些数据证实了这两种剂量强度具有相当的镇痛效果和副作用可能性，并确认两者的作用持续时间均为12小时。控释吗啡镇痛效果的改善可能归因于依从性提高导致药物消耗量增加。
