芬太尼透皮贴剂治疗癌症疼痛多中心临床研究

目的 对芬太尼透皮贴剂治疗中重度癌症疼痛进行多中心开放性临床试验,研究该药对国人的止痛疗效及耐受性。方法 16家医院多中心临床研究,458例中度及重度癌症疼痛病人接受芬太尼透皮贴剂止痛治疗。所有病人至少用药15天(范围15-523天)。用药前后记录疼痛程度、生活质量及不良反应。结果 治疗前,458例癌痛病人疼痛程度评分均值为7.92(范围4-10),治疗第1、3、6、9、15、30天,疼痛程度评分平均值分别降低至6.05、4.28、3.58、3.06、2.33、1.29,P值均<0.001。86.3％的病人止痛显效时间在用药第1天;用药第5天达稳定止痛作用。治疗后生活质量明显改善。与其他部位疼痛相比较,骨转移疼痛程度(8.25)较重,止痛疗效相对较差。芬太尼透皮贴剂用药30天内,剂量范围25-150μg/h,用药>30天病人剂量范围25-750μg/h。常见不良反应包括便秘、恶心、头晕、嗜睡、胃不适、呕吐、排尿困难。便秘与年龄因素相关,呕吐及排尿困难与性别相关。结论 芬太尼透皮贴剂止痛作用强、疗效持续稳定、用药安全方便。

Transdermal fentanyl for the treatment of cancer pain: A multicenter study

Objective The multicenter clinical trial is to evaluate the effect and side effects of transdermal fentanyl for patients with cancer pain in China.Methods A total of 458 patients with moderate-to-severe cancer pain enrolled the multicenter study from 16 institutes. They received transdermal fentanyl for at least 15 days (between 15 and 523 days).Results Baseline mean of pain intensity was 7.92 (between 4 and 10).On day 1,3,6,9,15 and 30, the pain mean scores were decreased to 6.05,4.28,3.58,3.06,2.33,1.29 (P<0.001). 86.3% patients reported that the pain intensity decreased was on day 1, and the pain stabilizing control war on day 5. After the pain treatment, the patients' quality of life was significantly improved. The pain intensity (mean score 8.25)was more serious, and the effect of pain treatment was poorer in metastasis bone pain than pain in other anatomic site. The common side effects were constipation, nausea, dizzy, sedation, stomach upset, vomiting and difficulty of urination. The incidence of constipation was related with the age, while the incidence of vomiting and difficulty of urination was related with the gender.Conclusion The transdermal fentanyl patch is proving to be a safe, convenient, well tolerated and sustained effective treatment modality in the control of cancer pain.