口服控释吗啡与透皮芬太尼用于晚期癌痛的比较。

Comparison of oral controlled-release morphine with transdermal fentanyl in terminal cancer pain.

作者信息

Wong J O, Chiu G L, Tsao C J, Chang C L

机构信息

Department of Anesthesiology, St. Joseph's Hospital, Taiwan, R.O.C.

出版信息

Acta Anaesthesiol Sin. 1997 Mar;35(1):25-32.

PMID:9212478

Abstract

BACKGROUND

Controlled-release morphine (MST) given twice daily provides a simpler and more convenient treatment regimen than 4-hourly opioid administration for the control of cancer pain. Recently, a new formulation of transdermal fentanyl (TDF) has been developed which provides a new route for the treatment of cancer pain. The present study was designed to compare the analgesic efficacy, safety and adverse effects of MST and TDF in the management of chronic cancer pain.

METHODS

In this open, comparative and randomized study, patients were treated with oral morphine hydrochloride immediate-release (MHIR) in the stabilization phase and then the prescription was switched to MST or TDF for 14 days in the treatment phase. Oral MHIR was provided as rescue medication for breakthrough pain. Assessments of the pain intensity, pain frequency, degree of pain improvement, profile of mood states, quality of sleep, activity status and adverse effects were performed before and after the stabilization phase and before and after the treatment phase.

RESULTS

Forty of 47 cancer patients completed the study with 20 patients in each group. There were significant (p < 0.05) improvements in pain intensity, pain frequency, mood states and quality of sleep in both groups before and after treatment, while improvement in the activity status was not significant. No specific adverse effects were encountered except for drowsiness which occurred in 6 patients treated with MST and 5 treated with TDF (p < 0.05). Insomnia was significantly improved (p < 0.05) with both regimens compared with that in the period before treatment. There were no significant differences between the two study groups in analgesic efficacy or adverse effects.

CONCLUSIONS

These results suggest that TDF and MSt are safe and effective analgesics for the management of chronic cancer pain. However, TDF provides a simpler and more convenient treatment for those patients with severe nausea, vomiting or dysphagia.

摘要

背景

与每4小时服用一次阿片类药物以控制癌痛相比，每日两次服用控释吗啡（美施康定，MST）提供了一种更简单、更方便的治疗方案。最近，一种新的透皮芬太尼制剂（TDF）已被研发出来，为癌痛治疗提供了一条新途径。本研究旨在比较MST和TDF在慢性癌痛管理中的镇痛效果、安全性和不良反应。

方法

在这项开放、对照和随机研究中，患者在稳定期接受口服速释盐酸吗啡（MHIR）治疗，然后在治疗期将处方改为MST或TDF，持续14天。口服MHIR用作爆发痛的解救药物。在稳定期前后以及治疗期前后，对疼痛强度、疼痛频率、疼痛改善程度、情绪状态、睡眠质量、活动状态和不良反应进行评估。

结果

47例癌症患者中有40例完成了研究，每组20例。两组治疗前后的疼痛强度、疼痛频率、情绪状态和睡眠质量均有显著（p < 0.05）改善，而活动状态的改善不显著。除嗜睡外，未遇到其他特定不良反应，MST治疗组有6例患者出现嗜睡，TDF治疗组有5例患者出现嗜睡（p < 0.05）。与治疗前相比，两种治疗方案的失眠情况均有显著改善（p < 0.05）。两个研究组在镇痛效果或不良反应方面无显著差异。