盐酸羟考酮缓释片12小时滴定方案用于中重度癌痛患者的有效性和安全性-前瞻性随机开放多中心平行对照研究  

Efficacy and safety of a 12-hour titration of oxycodone hydrochloride prolongedrelease tablets in patients with moderate to severe cancer pain:a prospective,randomized,open,multicenter,and parallel-controlled study

作　　者：石志永 何钎铖 郭银红 王燕[4] 邵银仙 薛宏怡[6] 林晓骥 陈传军[8] 诸静文[9] 郭俊华[10] 应申鹏 肖建军 赵春花 邢旻琰[14] 陈韵[15] 蔡国英[16] 寿佳威[17] 宋斌斌 余国林 史敏 王永辉[21] 王剑 邵婷婷[23] 黄芳芳 张沂平 Zhiyong Shi;Qiancheng He;Yinhong Guo;Yan Wang;Yinxian Shao;Hongyi Xue;Xiaoji Lin;Chuanjun Chen;Jinwen Zhu;Junhua Guo;Shenpeng Ying;Jianjun Xiao;Chunhua Zhao;Minyan Xing;Yun Chen;Guoying Cai;Jiawei Shou;Binbin Song;Guolin Yu;Min Shi;Yonghui Wang;Jian Wang;Tingting Shao;Fangfang Huang;Yiping Zhang(Department of Thoracic Oncology,Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital),Institute of Basic Medicine and Cancer,Chinese Academy of Sciences,Hangzhou 310000,China;The First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;Zhuji People's Hospital,Zhuji 311800,China;Quzhou People's Hospital,Quzhou 324000,China;Lanxi Hospital of Traditional Chinese Medicine,Lanxi 321100,China;Zhoushan Hospital,Zhoushan 316000,China;The Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;Xinchang People's Hospital,Xinchang 321500,China;Ningbo No.2 Hospital,Ningbo 315000,China;Hangzhou Hospital of Traditional Chinese Medicine,Hangzhou 310000,China;Taizhou Central Hospital,Taizhou 318000,China;Jiande Integrated Traditional and Western Medicine Hospital,Jiande 311600,China;Jiashan Hospital of Traditional Chinese Medicine,Jiashan 314100,China;Haining People's Hospital,Haining 314400,China;Zhejiang Provincial People's Hospital,Hangzhou 310000,China;Shengzhou People's Hospital,Shengzhou 312400,China;Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University,Hangzhou 310000,China;The First Hospital of Jiaxing,Jiaxing 314000,China;The Second People's Hospital of Chun'an,Chun'an 311700,China;Putuo Hospital,Zhoushan 316000,China;Lishui Central Hospital,Lishui 323000,China;Shangyu People's Hospital,Shangyu 312300,China;Hangzhou Cancer Hospital,Hangzhou 310000,China;The Second People's Hospital of Yuhang District,Hangzhou 310000,China)

机构地区：[1]中国科学院大学附属肿瘤医院胸部肿瘤内科(浙江省肿瘤医院)中国科学院基础医学与肿瘤研究所,杭州市310022 [2]温州医科大学附属第一医院 [3]诸暨市人民医院 [4]衢州市人民医院 [5]兰溪市中医院 [6]舟山医院 [7]温州医科大学附属第二医院 [8]新昌县人民医院 [9]宁波市第二医院 [10]杭州市中医院 [11]台州中心医院 [12]建德市中西医结合医院 [13]嘉善县中医院 [14]海宁市人民医院 [15]浙江省人民医院 [16]嵊州市人民医院 [17]浙江大学医学院附属邵逸夫医院 [18]嘉兴市第一医院 [19]淳安县第二人民医院 [20]浙江普陀医院 [21]丽水市中心医院 [22]上虞市人民医院 [23]杭州市肿瘤医院 [24]余杭区第二人民医院

出　　处：《中国肿瘤临床》2021年第20期1040-1046,共7页Chinese Journal of Clinical Oncology

摘　　要：目的:阿片类药物是中、重度癌痛治疗的首选药物。目前以缓释阿片类药物为背景的滴定方法的剂量调整时机和方式还需进一步探索。本研究旨在评估盐酸羟考酮缓释片12 h滴定方案用于中重度癌痛患者的有效性和安全性。方法:选择2018年2月至2019年12月浙江省24家医院收治的中重度阿片类药物未耐受癌痛患者114例[数字分级法(numerical rating scale,NRS)≥4分]作为研究对象。筛选出合并1次以上爆发痛且存在中重度以上疼痛(NRS≥4分)患者87例,按盐酸羟考酮缓释片调整的时间不同分为试验组(12 h滴定组,n=45)和对照组(24 h滴定组,n=42)。试验组起始给予盐酸羟考酮缓释片10 mg并根据疼痛情况给予即释吗啡补救镇痛,12 h后根据即释吗啡量调整剂量,剂量调整为背景剂量+12 h内即释吗啡剂量。对照组起始剂量给予盐酸羟考酮缓释片10 mg q12h,并根据疼痛情况给予即释吗啡补救镇痛,24 h后剂量调整为背景剂量+24 h内即释吗啡剂量/2。比较两组24、48、72 h的疼痛缓解率、不良反应发生率、即释吗啡补救镇痛情况及使用量、生活质量评分,以及镇痛满意度。结果:给药后24、48、72 h,试验组和对照组均显示出较高的疼痛缓解率,组间比较差异无统计学意义(P>0.05)。相对于对照组,试验组在24、48及72 h补救镇痛次数及剂量均显著减少(P<0.05)。两组患者不良反应大多数为轻中度,发生率比较差异无统计学意义(P>0.05)。镇痛满意度水平均较高,组间比较差异无统计学意义(P>0.05)。结论:在中重度癌痛患者应用盐酸羟考酮缓释片为背景的滴定方案中,12 h调整剂量能有效减少补救镇痛次数及剂量,维持较高的镇痛缓解率和镇痛满意度,安全性良好。Objective:Opioids are the first choice for the management of moderate-to-severe cancer pain.However,timing of and method of dose adjustment in the titration of prolonged-release opioids require further exploration.Therefore,This study aimed to evaluate the efficacy and safety of a 12 h titration of oxycodone hydrochloride prolonged-release tablets in patients with moderate-to-severe cancer pain.Methods:We screened 114 patients with moderate-to-severe cancer pain(numerical rating scale score≥4 points)and opioid intolerance who were admitted to 24 hospitals in Zhejiang Province between Febrary 2018 and December 2019.Of these,87 patients who experienced more than one episode of breakthrough cancer pain were selected,and on the basis of the adjustment time of the oxycodone hydrochloride prolonged-release tablets,they were categorized into the experimental(12 h titration,n=45)and control(24 h titration,n=42)groups.The experimental group initially received oxycodone hydrochloride prolonged-release tablets(10 mg)and immediate-release morphine for pain relief according to the pain condition.After 12 h,the dose was adjusted according to the amount of immediate-release morphine as follows:background dose+amount of immediate-release morphine within 12 h.The control group received oxycodone hydrochloride prolonged-release tablets(10 mg:q12h)as the starting dose,and immediate-release morphine was administered according to the pain situation.After 24 h,the dose was adjusted as follows:(background dose+immediate-release morphine dose within 24 h)/2.At 24 h,48 h,and 72 h,the pain relief rate,incidence of adverse reactions,use of immediate-release morphine and its dosage,quality of life score,and satisfaction with analgesia were compared between the two groups.Results:Both the experimental and the control groups had a higher pain relief rate at 24 h,48 h,and 72 h after administration,no statistical differences were noted between the two groups(P>0.05).The frequencies and doses of remedial analgesia at 24 h,48 h,and 72 h were si

关 键 词：缓释阿片类药物 滴定 癌痛 爆发痛 

分 类 号：R730.5[医药卫生—肿瘤]