Abstract: Background　Bone metastasis is a common complication among patients with advanced tumors and a difficult issue to treat in clinic.At present，three-step analgesia treatment has achieved a certain effect，but the long-term use of opioid drugs can lead to addiction，constipation and other toxic side effects，which will affect patients' compliance and treatment results seriously.Objective　To evaluate the efficacy and safety of cinobufagin capsule and fentanyl transdermal patch in the treatment of cancer pain from bone metastasis.Methods　A total of 298 patients with bone metastasis diagnosed by pathology and imaging were selected from Yangpu Hospital，Tongji University and Shanghai Dermatological Hospital from April 2016 to June 2018.A double blind randomized controlled trial was used to divide them into two groups：observation group（147 cases） and control group（151 cases）．The observation group was treated with cinobufagin capsule and fentanyl transdermal patch，while the control group was treated with oral placebo and fentanyl transdermal patch.The visual analogue scores（VAS），24 h estazolam usage，quality of life（QoL） score before treatment and at 7，14，30 days after treatment，pain relief rate at 7 days after treatment and side effects during treatment were compared between the two groups.Results　On the 7th，14th and 30th day after treatment，the VAS and the dosage of estazolam in the observation group was lower than those in the control group（P<0.05）．Meantime，the quality of life score in the observation group was higher than that in the control group（P<0.05）．On the 7th day of treatment，the effective rate in the observation group was 72.1%（106/147），which was higher than that in the control group 〔49.7%（75/151）（χ2=15.729，P<0.001）〕.There was no significant difference of the incidence of toxic and side effects between the two groups，which was 12.2%（18/147） in the observation group and 11.9%（18/151） in the control group（χ2=0.007，P=0.932）．In both groups，there were no significant abnormality of the blood test，urine test，fecal test and electrolytes of liver and kidney function before and after treatment.Conclusion　The combination of cinobufagin capsule and fentanyl transdermal patch in the treatment of moderate/severe cancer pain from bone metastasis is more effective and safer than fentanyl transdermal patch solely used in the treatment.

Key words: Cinobufacin, Fentanyli, Analgesia, Metastatic bone cancer pain, Neoplasm metastasis, Treatment outcome

摘要： 背景　恶性肿瘤骨转移是中晚期肿瘤患者常见的并发症，是临床上面临的一大难题。目前三阶梯镇痛治疗取得了一定的疗效，但由于阿片类药物长期使用可导致成瘾、便秘等不良反应，严重影响患者的依从性和治疗效果。目的　评估华蟾素胶囊和芬太尼透皮贴剂联合治疗恶性肿瘤骨转移癌痛患者的有效性和安全性。方法　选取2016年4月—2018年6月由同济大学附属杨浦医院和上海市皮肤病医院各个临床科室收治的经病理学、影像学确诊的恶性肿瘤骨转移患者298例，采用双盲随机对照试验将其分为对照组和观察组，其中观察组147例，对照组151例。观察组予以华蟾素胶囊和芬太尼透皮贴剂联合治疗，对照组予以口服安慰剂和芬太尼透皮贴剂治疗；分别于治疗前、治疗第7、14、30天比较两组患者视觉模拟评分（VAS）、24 h艾司唑仑用量、生存质量评分，治疗第7天评价疼痛缓解率以及治疗期间不良反应发生情况。结果　治疗第7、14、30天，观察组VAS均低于对照组，艾司唑仑用量均小于对照组，生活质量评分均高于对照组（P<0.05）。治疗第7天，观察组治疗有效率为72.1%（106/147），高于对照组的49.7%（75/151）（χ2=15.729，P<0.001）。观察组不良反应发生率为12.2%（18/147），对照组为11.9%（18/151），两组不良反应发生率比较，差异无统计学意义（χ2=0.007，P=0.932）。两组治疗后血常规、尿常规、便常规、肝肾功能、电解质较治疗前均无明显异常。结论　华蟾素胶囊和芬太尼透皮贴剂联合治疗恶性肿瘤骨转移中重度癌痛，较单纯应用芬太尼透皮贴剂有更好的止痛效果，安全性高。

关键词: 华蟾素, 芬太尼, 镇痛, 骨转移癌痛, 肿瘤转移, 治疗结果