CAJ | 학술논문

目的：评价芬太尼透皮贴剂对中重度癌痛患者3日内镇痛的临床疗效及安全性。方法通过开放性多中心临床观察，将234例中重度癌痛患者分为两组：口服盐酸吗啡片滴定后转换为芬太尼透皮贴剂组（A组）；芬太尼透皮贴剂直接滴定组（B组）。评估治疗前和芬太尼使用3天后患者的疼痛程度、生活质量及不良反应。疼痛减轻程度大于初始评估50%以上者判定为疼痛治疗有效。结果 A组和B组疼痛总缓解率分别为87%（87/100）和85.1%（114/134），P=0.675，治疗前和治疗3日后A组患者NRS均值分别为6.55±0.58、2.53±0.93（P=0.000）；B组患者NRS均值分别为6.83±0.81，2.33±1.05（P=0.000）；A组和B组芬太尼透皮贴剂初始剂量均值分别为（59.0±78.5）μg/h和（45.4±77.0）μg/h，使用3日后调整的剂量均值分别为（65.6±78.9）μg/h和（57.9±81.3）μg/h，组间比较差异无统计学意义；3日内A组对芬太尼进行剂量调整的患者占31%（31/100），明显低于B组60.4%（81/134）（P=0.000）；A组1周内出现爆发痛的比例（19%，19/100）亦明显低于B组（52.2%，70/134）（P=0.000）。A、B两组出现的便秘、恶心呕吐、嗜睡、皮肤瘙痒、尿潴留等不良反应差异无统计学意义。A、B两组的生活质量（quality of life，QOL）评分在用药3日后均明显高于治疗前（P=0.000），组间比较差异无统计学意义。结论芬太尼透皮贴剂3日内镇痛效果满意，直接滴定治疗安全有效，但存在爆发痛风险，需调整治疗剂量；推荐即释吗啡滴定联合芬太尼透皮贴剂作为中重度癌痛治疗的首选组合之一。
목적：평개분태니투피첩제대중중도암통환자3일내진통적림상료효급안전성。방법통과개방성다중심림상관찰，장234례중중도암통환자분위량조：구복염산마배편적정후전환위분태니투피첩제조（A조）；분태니투피첩제직접적정조（B조）。평고치료전화분태니사용3천후환자적동통정도、생활질량급불량반응。동통감경정도대우초시평고50%이상자판정위동통치료유효。결과 A조화B조동통총완해솔분별위87%（87/100）화85.1%（114/134），P=0.675，치료전화치료3일후A조환자NRS균치분별위6.55±0.58、2.53±0.93（P=0.000）；B조환자NRS균치분별위6.83±0.81，2.33±1.05（P=0.000）；A조화B조분태니투피첩제초시제량균치분별위（59.0±78.5）μg/h화（45.4±77.0）μg/h，사용3일후조정적제량균치분별위（65.6±78.9）μg/h화（57.9±81.3）μg/h，조간비교차이무통계학의의；3일내A조대분태니진행제량조정적환자점31%（31/100），명현저우B조60.4%（81/134）（P=0.000）；A조1주내출현폭발통적비례（19%，19/100）역명현저우B조（52.2%，70/134）（P=0.000）。A、B량조출현적편비、악심구토、기수、피부소양、뇨저류등불량반응차이무통계학의의。A、B량조적생활질량（quality of life，QOL）평분재용약3일후균명현고우치료전（P=0.000），조간비교차이무통계학의의。결론분태니투피첩제3일내진통효과만의，직접적정치료안전유효，단존재폭발통풍험，수조정치료제량；추천즉석마배적정연합분태니투피첩제작위중중도암통치료적수선조합지일。
Objective To assess the efficacy and safety of transdermal fentanyl in Chinese patients with moder-ate to severe cancer pain during three days. Method A total of 234 patients with moderate to severe cancer pain were enrolled in this open multi-center clinical observation. The patients were divided to 2 groups: transdermal fen-tanyl titrated by oral morphine hydrochloride (Group A) and direct titration of transdermal fentanyl group (Group B). The degree of pain, quality of life (QOL) and adverse reactions were assessed respectively before treatment and after 3 days of fentanyl administration. Effective treatment of pain is defined as pain relief more than 50% of the initial assessment. Result Overall response rates of Group A and Group B were 87% (87/100) and 85.1% (114/134), re-spectively (P =0.675). The mean NRS before and after treatment were 6.55±0.58 and 2.53±0.93 (P =0.000) in Group A; while that were 6.83 ± 0.81 and 2.33 ± 1.05 (P =0.000) in group B; The mean initial dose of transdermal fentanyl was (7.63±12.9) μg/h and (9.91±13.2) μg/h in Group A and B, and were (9.73±13.7) μg/h and (11.03±13.3) μg/h af-ter 3 days, no statistically significant difference between Group A and B was observed; the proportion of dose adjust-ment in Group A was significant lower than that in Group B (31% vs 60.4%, P =0.000); Simultaneously, the propor-tion of breakthrough pain in Group A was significant less than in Group B (19% vs 52.2%, P =0.000); There were no differences in adverse reactions in respect of constipation, nausea and vomiting, sedation, pruritus, urinary reten-tion and others. QOL scores after treatment were significantly higher than before treatment in both groups (P =0.000), while there was no significant difference between group A and B. Conclusion It was satisfactory for pa-tients with cancer pain treated by transdermal fentanyl within 3 days. Direct titration of transdermal fentanyl is safe and effective, but with more breakthrough pain risks as dose adjustments may be needed. Fentanyl transdermal com-bined with immediate-release morphine titration can be recommended as one of first choice in the patients with mod-erate to severe cancer pain.