小剂量芬太尼透皮贴剂治疗阿片未耐受中重度癌性疼痛老年患者62例

目的观察小剂量芬太尼透皮贴剂(12.5μg·h^-1)治疗老年阿片未耐受中重度癌性疼痛(癌痛)的疗效及安全性。方法全国7省市共11家三级医院参与本项单臂、非随机、开放、前瞻性的多中心研究,2017年9月—2019年12月期间共纳入阿片未耐受中重度癌痛患者285例,其中70岁以上老年癌痛患者62例。芬太尼透皮贴剂起始剂量12.5μg·h^-1,3 d为1个疗程,治疗8个疗程。爆发痛时应用10%~20%即释日等效口服吗啡剂量(MEDD)解救。应用疼痛数字评分法、疼痛缓解度、疼痛缓解率以及肿瘤患者生活质量评分EORTC QLQ-C30(V3.0)量表评估小剂量芬太尼透皮贴剂的有效性;观察评估患者用药不良反应等评估其安全性;应用认知功能调查量表(MMSE)评估患者认知功能。结果62例老年癌痛患者中,60例完成研究,2例脱落。中位疼痛评分由5.05降至1.00,疼痛程度较治疗前明显降低(P<0.01)。除头颈部肿瘤外,其余各亚组分析中,如性别、既往治疗、基线疼痛评分、肿瘤原发部位等,疼痛缓解保持一致,治疗前后均差异有统计学意义(P<0.01)。其中重度疼痛组疼痛缓解度(5.49±0.75)较中度疼痛组(3.78±1.25)更明显(P<0.01)。20例患者出现轻中度不良反应,其中呕吐8例(12.90%),恶心6例(9.68%),便秘3例(4.84%),困倦2例(3.23%),尿潴留1例(1.61%)。结论小剂量芬太尼透皮贴剂对于阿片未耐受老年中重度癌痛患者安全有效,不良反应可控,且明显改善患者生活质量,对患者认知功能影响较小。

Effect of Low-dose Transdermal Fentanyl Patch in the Treatment of 62 Elderly Patients with Opioid Intolerant Moderate-to-severe Cancer Pain

Objective To observe the efficacy and safety of low-dose transdermal fentanyl patches(TDF 12.5μg·h^-1)in the treatment of opioid intolerant elderly patients with moderate to severe cancer pain,and to evaluate the effects of low-dose fentanyl transdermal patches on cognitive function and quality of life,in order to provide evidence for the optimal management of cancer pain in elderly patients with cancer.Methods Eleven tertiary hospitals in seven provinces and cities participated in this single-arm,non-random,open and prospective multicenter study.From September 2017 to December 2019,a total of 285 opioid-intolerant patients with moderate to severe cancer pain were included,including 62 patients over 70 years old.The initial dose of TDF is 12.5μg·h^-1.A total of 8 cycles of TDF treatment were completed with 3 days per cycle.An immediate-release form of any strong opioid equivalent to 10%to 20%morphine-equivalent daily dose(MEDD)was allowed for breakthrough pain.The effectiveness of low-dose fentanyl transdermal patches was assessed using the pain numerical score,pain relief,pain relief rate,and tumor patient Quality of Life score EORTC QLQ-C30(V3.0)scale.The adverse events and safety of TDF were observed and evaluated.Meanwhile,cognitive function was assessed by the Cognitive Function Survey Scale(MMSE).Results Of the 62 patients enrolled,60 completed the study and 2 fell off.The median pain score decreased from 5.05 to 1.00,and the pain degree was significantly lower than before(P<0.01).Except for head and neck tumors,in the analysis of other subgroups,such as gender,previous treatment,baseline pain score,primary tumor site.The pain relief was more significant in the severe pain group than in the moderate pain group(5.49±0.75 vs.3.78±1.25,P<0.01).A total of 20 patients presented mild to moderate adverse reactions,including 8 cases of vomiting(12.90%),6 cases of nausea(9.68%),3 cases of constipation(4.84%),2 cases of drowsiness(3.23%)and 1 case of urinary retention(1.61%).Conclusion Low-dose TDF is safe and effective for opioid-nave elderly patients with moderate to severe cancer pain.The adverse reactions are controllable,and the quality of life is significantly improved,with little impact on patients'cognitive function.