CLINICAL EFFICACY AND SAFETY OF A NOVEL CONTROLLED-RELEASE MORPHINE SUPPOSITORY AND SUBCUTANEOUS MORPHINE IN CANCER PAIN - A RANDOMIZED EVALUATION

被引:42
作者
BRUERA, E
FAINSINGER, R
SPACHYNSKI, K
BABUL, N
HARSANYI, Z
DARKE, AC
机构
[1] UNIV ALBERTA, DIV PALLIAT CARE MED, EDMONTON, AB, CANADA
[2] PURDUE FREDERICK, DEPT SCI AFFAIRS, PICKERING, ON, CANADA
关键词
D O I
10.1200/JCO.1995.13.6.1520
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: A significant number of cancer patients will require an alternate route Of morphine administration at some point during their illness, This study compared the clinical efficacy and Safety of a novel morphine sulfate controlled-release suppository (MS-CRS) and subcutaneous (SC) morphine in patients With cancer pain. Methods: Thirty patients with cancer pain were randomized in a double-blind crossover study to MS-CRS every 12 hours or SC morphine every 4 hours for 4 days each, using a 2.5:1 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. Evaluations Were made by the patient at 8 AM, noon, 4 PM, and 8 PM and rescue morphine consumption recorded. Results: Twenty-three patients completed the study (13 men and 10 women; mean age, 64.0 +/- 2.0 years) and were treated with mean daily MS-CRS and SC morphine doses of 326 +/- 69 mg and 138 +/- 28 mg, respectively. There was a small but significant difference in overall ordinal pain-intensity scores in favor of MS-CRS (0.7 +/- 0.1 v0.9 +/- 0.1, P = .0459). There were no significant differences between MS-CRS and SC morphine in overall VAS scores for pain intensity (13 +/- 3 v13 +/- 3 mm), sedation (23 +/- 3 v25 +/- 4 mm), and nausea (8 a 2 v9 +/- 2 mm). The mean daily rescue analgesic consumption during MS-CRS and SC morphine did not differ significantly (1.2 +/- 0.4 v1.2 +/- 0.4 doses/d), Conclusion: MS-CRS, administered every 12 hours, provides analgesia comparable to SC morphine and represents a reliable, noninvasive alternative method of pain control for patients unable to take oral morphine. (C) 1995 by American Society of Clinical Oncology.
引用
收藏
页码:1520 / 1527
页数:8
相关论文
共 38 条
[1]  
Cancer Pain Relief and Palliative Care, (1990)
[2]  
Jacox A., Carr D.B., Payne R., New clinical-practice guidelines for the management of pain in patients with cancer, N Engl J Med, 330, pp. 651-655, (1994)
[3]  
Bruera E., Brenneis C., Michaud M., Et al., Use of the subcutaneous route for administration of narcotics in patients with cancer pain, Cancer, 62, pp. 407-411, (1988)
[4]  
Storey P., Hill H.H., St-Louis R.H., Et al., Subcutaneous infusions for control of cancer symptoms, J Pain Sympt Manage, 5, pp. 33-41, (1990)
[5]  
Cole L., Hanning C.D., Review of the rectal use of opioids, J Pain Sympt Manage, 5, pp. 118-126, (1990)
[6]  
McQuay H.J., The logic of alternative routes, J Pain Sympt Manage, 5, pp. 75-76, (1990)
[7]  
Babul N., Darke A.C., Anslow J.A., Et al., Pharmacokinetics of two novel rectal controlled release morphine formulations, J Pain Sympt Manage, 7, pp. 400-405, (1992)
[8]  
Bruera E., Fainsinger R., Spachynski K., Et al., Controlled release suppositories versus intermittent subcutaneous injections of morphine sulfate: A double-blind, crossover clinical efficacy, safety and pharmacokinetic study, Proceedings of the 13th Annual Meeting of the American Pain Society, (1994)
[9]  
Moulin D., Provencher L., Laberge F., Et al., Comparative pharmacokinetics, clinical efficacy and safety of controlled release morphine suppositories and tablets in cancer pain, Proceedings of the 13th Annual Meeting of the American Pain Society, (1994)
[10]  
Bruera E., Brenneis C., Michaud M., Patient-controlled subcutaneous hydromorphone versus continuous subcutaneous infusion for the treatment of cancer pain, J Natl Cancer Inst, 80, pp. 1152-1154, (1988)