芬太尼透皮贴剂治疗537例中重度癌痛疗效及安全性的临床分析

目的: 探讨芬太尼透皮贴剂治疗中重度癌痛的疗效及安全性。 方法: 通过全国多中心、前瞻性、开放无对照研究,对537例均因无法口服、不能耐受或口服止痛药无效等改用芬太尼透皮贴剂治疗的癌痛患者进行临床观察。每三天更换一次,并根据疼痛情况调整剂量,直至患者达到满意的效果。连续观察8周为有效病例,标准观察期为24周。采用视觉模拟评分法记录疼痛强度,参考我国1990年制定的肿瘤患者生活质量评分试行草案对生活质量进行评分,并观察与芬太尼透皮贴剂使用相关的不良事件,记录其表现及发生时间和缓解时间及缓解原因。 结果: 芬太尼透皮贴剂对中度至重度癌性疼痛具有明显的镇痛效果,一般1～3日疼痛迅速得到缓解。治疗前疼痛程度评分均值为6.43±1.44,第1周、2周、4周、6周、8周、12周、16周、20周、24周后观察,治疗后疼痛程度评分均明显降低,疼痛程度显著减轻(P<0.001),第1周疼痛程度评分下降为2.38士2.30,有效率达87.94%,总有效率为96.80%。患者治疗后生活质量明显改善(P<0.001),疗效稳定。不良反应主要为便秘、恶心、头晕、呕吐、嗜睡等,长期使用大部不良反应出现耐受。其它比较少见的不良反应主要为:心动过缓、血压下降、头痛、排尿困难、皮肤搔痒等,减量或停药后症状减轻或消失。未发生国际和国内报道过的严重不良反应甚至致死事件。未出现身体依赖性或精神依赖性病例。 结论: 芬太尼透皮贴剂治疗中重度癌痛疗效稳定,能显著改善肿瘤患者生活质量。大部不良反应出现耐受,是治疗中重度癌痛的首选药之一。

Clinical Study of the Efficacy and Side Effects of Transdermal Fentanyl:A Survey of 537 Patients with Moderate to Severe Cancer Pain

Objective : To evaluate the efficacy and adverse effects of transdermal fentanyl for patients with moder-ate to severe cancer pain. Methods : A total of 537 patients (aged 18-95 years, with an average age of 61.0±13.20) with moderate to severe cancer pain were enrolled in this multicenter prospective trial all over the na-tion. All patients received transdermal fentanyl. Fentanyl patches were replaced every three days. Thedosage was adjusted according to the patient's condition. All patients received transdermal fentanyl for atleast 8 weeks. Analgesic efficacy of transdermal fentanyl therapy was assessed with visual analogue scale(VAS). Patients themselves assessed the pain intensity. Quality of life was evaluated using the trial draft forthe assessment of quality of life for cancer patients in 1990 in China. A score of 1 represents the worst qualityof life, and a score of 5 indicates the best quality of life. The cumulative score of 6 items totaled 30. We ob-served fentanyl-related adverse events, recorded the corresponding manifestation, occurrence time, remis-sion time and relieving factors. Results : Cancer pain was well controlled 1-3 days after administration of trans-dermal fentanyl. The mean scores of pain intensity decreased significantly due to the treatment (P<0.001).One week after the patch placement, the effective rate was 87.94%. The total effective rate was 96.8%. Thequality of life was remarkably improved after the treatment (P<0.001). Common side effects were constipa-tion, nausea, dizziness, vomiting and sedation. Other relatively rare side effects included bradycardia, lowblood pressure, headache, dysuria, and skin allergy. These symptoms were relieved or eliminated after dosage reduction or drug withdrawal. No serious or fatal adverse reactions were observed. Neither physicalnor psychological dependence occurred. Conclusion : Transdermal fentanyl is effective in relieving moderate tosevere cancer pain and can significantly improve the quality of life, with a low incidence of adverse reactions.Transdermal fentanyl can be recommended as one of the first-line drugs for the treatment of patients withmoderate to severe cancer pain.