Yee L Y, Lopez J R
Department of Veterans Affairs Martinez Medical Center, CA 94553.
Ann Pharmacother. 1992 Nov;26(11):1393-9. doi: 10.1177/106002809202601113.
To review the use of transdermal fentanyl for the treatment of moderate to severe chronic pain. The article provides background on the pharmacology and pharmacokinetics of the drug, as well as the properties of the transdermal system. In addition, clinical trials, adverse effects, and therapeutic considerations and recommendations are presented.
Clinical trials, review articles, and reference texts.
Comparative clinical trials involving the use of transdermal fentanyl on postoperative and chronic pain patients.
Data from clinical human trials published in the English language were reviewed. Trials were assessed by sample size, opioid dosage regimen, and therapeutic outcome.
Transdermal fentanyl was found to be effective in the control of chronic and postoperative pain. In one trial the overall patient satisfaction with pain control was 79 percent for the transdermal fentanyl group and 44 percent for the placebo group. In another trial, the amount of additional parenteral morphine was significantly lower for the group receiving transdermal fentanyl than for the placebo group (49.9 +/- 4.9 vs. 77.0 +/- 6.3 mg, respectively, p < 0.01). The most common adverse effects recorded were nausea (45-85 percent), pruritus (14-60 percent), and sedation (40-59 percent). The cost of analgesic therapy with this delivery system is higher than that of parenteral opioid analgesia, but less than patient-controlled analgesia.
The transdermal fentanyl formulation offers some minor advantages over other forms of conventional pain management. Results of early clinical trials are promising, but more studies are needed to evaluate its long-term effectiveness and adverse effects. Specifically, comparisons with standard parenteral and patient-controlled opioid analgesia in chronic malignant and nonmalignant pain are necessary for adequate evaluation of transdermal fentanyl.
综述透皮芬太尼在治疗中重度慢性疼痛中的应用。本文提供了该药物的药理学和药代动力学背景，以及透皮给药系统的特性。此外，还介绍了临床试验、不良反应、治疗注意事项及建议。
临床试验、综述文章及参考文献。
涉及透皮芬太尼用于术后和慢性疼痛患者的比较临床试验。
对以英文发表的临床人体试验数据进行综述。通过样本量、阿片类药物给药方案和治疗结果对试验进行评估。
发现透皮芬太尼在控制慢性疼痛和术后疼痛方面有效。在一项试验中，透皮芬太尼组患者对疼痛控制的总体满意度为79%，安慰剂组为44%。在另一项试验中，接受透皮芬太尼的组额外使用胃肠外吗啡的量显著低于安慰剂组（分别为49.9±4.9mg和77.0±6.3mg，p<0.01）。记录到的最常见不良反应为恶心（45%-85%）、瘙痒（14%-60%）和镇静（40%-59%）。这种给药系统的镇痛治疗费用高于胃肠外阿片类镇痛，但低于患者自控镇痛。
透皮芬太尼制剂相对于其他传统疼痛管理形式具有一些微小优势。早期临床试验结果令人鼓舞，但需要更多研究来评估其长期有效性和不良反应。具体而言，为了充分评估透皮芬太尼，有必要将其与慢性恶性和非恶性疼痛中的标准胃肠外及患者自控阿片类镇痛进行比较。
