JCO:Naldemedine对癌症伴腹泻患者的疗效研究

2017-04-27 MedSci MedSci原创

阿片霉素是一种可诱发便秘、作用于外周的μ-阿片受体拮抗剂。这项研究建立了随机,双盲,多中心实验,在同时患有癌症并伴有阿片药物引起的便秘症状的患者进行随访,评估三种剂量的阿德美他宁与安慰剂的疗效和安全性。

Naldemedine是一种可诱发便秘、作用于外周的μ-阿片受体拮抗剂。这项随机,双盲,多中心实验,在同时患有癌症并伴有阿片药物引起的便秘症状的患者进行随访,评估三种剂量的Naldemedine与安慰剂的疗效和安全性。

该研究随机选择一批成年癌症患者(东方合作肿瘤组的表现状态≤2),并对患者施用阿片类镇痛药方案≥2周以维持稳定状态,筛选服用泻药14天内产生便秘症状(自发肠的运动(SBM)≥1,且SMB≤5)患者。随后,对患者随机分配(1:1:1:1)口服药物(每日一次,每天一次,0.1,0.2或0.4mg,或安慰剂),实验持续14天。实验终点为治疗期间每周SBM频率从基线开始变化。次要终点包括SBM回应率,SBM频率从基线的强直变化,完整SBM。该研究同时对安全进行了评估。

研究结果显示,227名随机分配的患者中,225名患者的疗效评估(naldemedine 0.1 mg,n = 55; 0.2 mg,n = 58; 0.4 mg,n = 56;安慰剂,n = 56),安全性为226。所有的Naldemedine剂量与安慰剂相比,SBM频率变化(主要终点)以及SBM反应者率和完整SBM频率的变化较高(P <0.05,所有比较)。与无安慰剂组相比,Naldemedine0.2mg和0.4mg(而不是0.1mg)SBM频率无变化明显改善(至少P <0.05)。治疗突发性不良事件比安慰剂组(51.8%)更常见于Naldemedine(0.1mg:66.1%; 0.2mg:67.2%; 0.4mg:78.6%);腹泻是最常见的治疗突发性不良事件。

该研究结论为,施用Naldemedine进行14天治疗可显着改善癌症患者因阿片样物质诱发的便秘症状,且耐受性良好。


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    2018-01-11 lidong40
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    2017-04-29 zhangjingnwpu
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    2017-04-28 doctorJiangchao

    继续学习。

    0

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    2017-04-28 ylzr123

    不错的方式,努力学习,刻苦专研,不断总结出来新经验。给点个赞!

    0