芬太尼透皮贴剂治疗4492例癌痛的临床疗效分析

目的　探讨芬太尼透皮贴剂治疗癌痛的止痛疗效及安全性。方法　通过多中心开放性临床试验,对4492例癌痛患者接受芬太尼透皮贴剂止痛治疗的临床疗效进行观察。以数字评分法评估疼痛程度、生活质量及不良反应。结果　治疗前疼痛程度评分均值为7.37;治疗后第1,3,6,9,15,30天疼痛程度评分分别降低至4.04,2.98,2.52,2.19,1.85和1.61,疼痛程度显著减轻(P<0.01),总有效率为96.8%。使用芬太尼透皮贴剂的初始、第15天和第30天用药剂量均值分别为32.37μg/h、42.57μg/h和49.57μg/h (25～225μg/h),患者治疗后生活质量明显改善(P<0.01)。不良反应主要为便秘者占9.8%,恶心13.6%,头晕6.5%,呕吐3.9%,嗜睡2.0%,呼吸抑制0.2%。临床试验后,84.5%的患者选择继续使用芬太尼透皮贴剂。结论　芬太尼透皮贴剂治疗癌痛安全有效,满意度高。推荐芬太尼透皮贴剂作为中重度癌痛治疗的首选药之一。

Transdermal fentanyl for the management of cancer pain: a survey of 4492 patients

OBJECTIVE: To evaluate the efficacy and adverse effects of transdermal fentanyl in management of patients with cancer pain. METHODS: A total of 4492 patients (aged 3-90) with cancer pain were enrolled in this multicenter study. The mean age was 58.5 (3 approximately 90) years old. All patients received transdermal fentanyl. The patients were asked to record the attacks of pain, quality of life, and any side effects of the treatment. RESULTS: Baseline mean pain intensity was 7.37. On days 1, 3, 6, 9, 15, and 30, the mean scores of pain were decreased to 4.04, 2.98, 2.52, 2.19, 1.85 and 1.61, respectively (P < 0.01). The effective rate was 96.8%. The mean doses of fentanyl were 32.37 microg/h (25-200 microg/h) on the initial day, 42.57 microg/h and 49.57 microg/h (25-225 microg/h) on days 15 and 30. The quality of life was significantly improved after treatment (P < 0.01). The common side effects were constipation (9.8%), nausea (13.6%), dizziness (6.5%), vomiting (3.9%), sedation (2.0%) and respiratory depression (0.2%). The incidence of constipation was related to age, and the incidence of vomiting and difficulty of urination was related to gender. The majority (84.5%) of patients preferred continuation of the treatment with transdermal fentanyl. CONCLUSION: Transdermal fentanyl for the patients with cancer pain is effective, safe, convenient and can improve the quality of life. Transdermal fentanyl can be recommended as one of first-line drugs for the treatment of patients with moderate to severe cancer pain.