机构地区:[1]南京医科大学附属无锡第二医院,无锡市第二人民医院麻醉科,214000 [2]中山大学肿瘤防治中心肿瘤内科,广州510000 [3]天津医科大学肿瘤研究所安宁疗护科,300000 [4]华中科技大学同济医学院附属同济医院肿瘤科,武汉430000 [5]解放军总医院肿瘤科,北京100000 [6]南京大学医学院附属金陵医院麻醉科,210000
出 处:《中华麻醉学杂志》2019年第11期1330-1333,共4页Chinese Journal of Anesthesiology
摘 要:目的评价盐酸羟考酮缓释片滴定治疗中重度癌痛的效果:前瞻性、多中心、随机、平行对照研究。方法住院治疗的中重度癌痛患者,年龄18~64岁,体重48~69 kg,NRS评分≥4分,采用多中心分层区组随机化方法分为4组:naive IR组、naive CR组、tolerant IR组和tolerant CR组。采用72 h快速滴定法,初始滴定剂量:naive IR组为即释吗啡片10 mg,naive CR组为盐酸羟考酮缓释片10 mg,tolerant IR组口服前日阿片类药物总量等效即释吗啡片剂量的10%,tolerant CR组口服前日阿片类药物总量等效盐酸羟考酮缓释片总量的10%。滴定方法:至患者临睡前,给药后每小时进行疼痛评估,NRS评分较滴定前增高且≥7分时,等效即释吗啡片剂量较前次增加100%;NRS评分未增加但仍≥7分时,等效即释吗啡片剂量较前次增加50%;NRS评分4-6分时,等效即释吗啡片剂量不变;NRS评分降至≤3分时,不另给药。维持方法:滴定结束后,naive IR组和tolerant IR组将滴定所用即释吗啡片总量(换算成等效剂量盐酸羟考酮缓释片),naive CR组和tolerant CR组以首剂量盐酸羟考酮缓释片+滴定所用即释吗啡片总剂量(换算成等效剂量盐酸羟考酮缓释片),1次/d,口服2 d。出现爆发痛时,口服即释吗啡片5~10 mg,记录给药情况、患者疼痛缓解度、盐酸羟考酮缓释片使用剂量、滴定轮数和滴定总量,记录患者镇痛有效情况及不良反应发生情况。结果与naive IR组比较,naive CR组滴定轮数和滴定总量减少,镇痛有效率升高,疼痛缓解程度更优,口服吗啡片给药次数减少,盐酸羟考酮缓释片使用剂量降低(P<0.05或0.01);与tolerant IR组比较,tolerant CR组滴定轮数减少,镇痛有效率升高,疼痛缓解程度更优,口服吗啡片次数减少(P<0.05或0.01)。4组患者不良反应发生率的比较差异无统计学意义(P>0.05)。结论盐酸羟考酮缓释片滴定治疗中重度癌痛效果好。Objective To evaluate the effect of oxycodone hydrochloride controlled-release tablets for titration in treating moderate to severe cancer pain in a prospective,multicenter,randomized,parallel,controlled study.Methods Hospitalized cancer patients with moderate to severe pain,aged 18-64 yr,weighing 48-69 kg,with numerical rating scale(NRS)score≥4 points,were divided into 4 groups according to the multicenter stratified block randomization:naive IR group,naive CR group,tolerant IR group,and tolerant CR group.A 72-h rapid titration protocol was adopted,the initial dosage:immediate-release morphine tablets 10 mg in naive IR group,oxycodone hydrochloride controlled-release tablets 10 mg in naive CR group,and 10% of the total equivalent dosage of immediate-release morphine tablets(total opioids dosage)used the day before oral administration in tolerant IR group,10% of the total equivalent dosage of oxycodone hydrochloride controlled-release tablets(total opioids dosage)used the day before oral administration in tolerant CR group.Titration method:pain assessment was performed every hour after administration until patients went to bed;when the NRS score was increased and≥7 points,the equivalent immediate-release morphine tablet dose was increased by 100% than the previous dose;when the NRS score was not increased but still≥7 points,the equivalent immediate-release morphine tablet dose was increased by 50% than the previous dose;when the NRS score was 4-6 points,the equivalent immediate-release morphine tablet dose was the same as before;when the NRS score was decreased and≤3 points,patients were continuously observed without additional medication.Maintenance method:after the end of titration,the total amount of immediate-release morphine tablets for titration was converted into an equivalent dose of oxycodone hydrochloride controlled-release tablets and was given once a day for 2 days in naive IR and tolerant IR groups;the initial dose of oxycodone hydrochloride controlled-release tablets plus the total amount of
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