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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。
Objective To conduct a multi-center open-label clinical trial of fentanyl transdermal patches for the treatment of moderate-to-severe cancer pain and to study the analgesic effect and tolerance of the drug to Chinese people. Methods A multicenter clinical study of 16 hospitals and 458 patients with moderate and severe cancer pain receiving analgesic treatment of transdermal fentanyl was conducted. All patients treated for at least 15 days (range 15-523 days). Before and after treatment record the degree of pain, quality of life and adverse reactions. Results Before treatment, the pain score of 458 patients with cancer pain was 7.92 (range 4-10). On the 1st, 3rd, 6th, 9th, 15th and 30th days of treatment, the average pain scores were reduced to 6.05, 4.28 and 3.58 , 3.06,2.33,1.29, P values were <0.001. 86.3% of patients with pain relief time on the first day of medication; the first five days of medication for stable analgesic effect. After treatment, the quality of life improved significantly. Compared with other parts of the pain, the degree of bone metastases pain (8.25) heavier, analgesic effect is relatively poor. Fentanyl transdermal patch medication within 30 days, the dose range 25-150μg / h, medication> 30 days patient dose range 25-750μg / h. Common adverse reactions include constipation, nausea, dizziness, drowsiness, stomach upset, vomiting, dysuria. Constipation is related to age and vomiting and dysuria are related to gender. Conclusions Fentanyl transdermal patch has strong analgesic effect, sustained and stable therapeutic effect and safe and convenient medication.