华蟾素胶囊和芬太尼透皮贴剂联合治疗肿瘤骨转移中重度癌痛的效果研究  

Efficacy of Cinobufacin Capsule Combined with Fentanyl Transdermal Patch in the Treatment of Moderate and Severe Cancer Pain with Bone Metastasis

作　　者：杨森 赵华新[3] 王朝昕 葛许华 陆媛 金花[1,2] 薄小杰 张含之[1,2] 马乐 潘莹[1,2] 于德华 YANG Sen;ZHAO Huaxin;WANG Zhaoxin;GE Xuhua;LU Yuan;JIN hua;BO Xiaojie;ZHANG Hanzhi;MA Le;PAN Ying;YU Dehua(Department of General Medicine,Yangpu Hospital,Tongji University,Shanghai 200090,China;Department of General Medicine,Tongji University,Shanghai 200092,China;Department of Oncology,Shanghai Dermatological Hospital,Shanghai 200443,China;Department of Social Medicine and Health Management,School of Medicine,Shanghai Jiaotong University,Shanghai 200025,China;Tongji University School of Medicine,Shanghai 200092,China)

机构地区：[1]同济大学附属杨浦医院全科医学科,上海市200090 [2]同济大学全科医学系,上海市200092 [3]上海市皮肤病医院肿瘤科,200443 [4]上海交通大学医学院社会医学与卫生管理系,上海市200025 [5]同济大学医学院,上海市200092

出　　处：《中国全科医学》2019年第32期3993-3996,4001,共5页Chinese General Practice

基　　金：2017年“上海青年医师培养资助计划”（第五批）;基于分级诊疗模式下的恶性肿瘤姑息治疗模式构建与优化策略研究——以上海市为例（Se1201840)

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)(χ~2=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(χ~2=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。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 7 th,14 th and 30 th 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 7 th 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,f

关 键 词：华蟾素 芬太尼 镇痛 骨转移癌痛 肿瘤转移 治疗结果 

分 类 号：R441.1[医药卫生—诊断学]