Efficacy and Safety of Sublingual Fentanyl Orally Disintegrating Tablet at Doses Determined by Titration for the Treatment of Breakthrough Pain in Japanese Cancer Patients: A Multicenter, Randomized, Placebo-controlled, Double-Blind Phase III Trial. Int.
Efficacy and Safety of Sublingual Fentanyl Orally Disintegrating Tablet at Doses Determined by Titration for the Treatment of Breakthrough Pain in Japanese Cancer Patients: A Multicenter, Randomized, Placebo-controlled, Double-Blind Phase III Trial. Int.
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通过滴定确定剂量的舌下芬太尼口腔崩解片治疗日本癌症患者爆发性疼痛的功效和安全性：一项多中心、随机、安慰剂对照、双盲 III 期试验。
DOI：
10.1007/s10147-014-0697-z
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
M.
中科院分区：
文献类型：
--
作者：
2.Shimoyama;N.;Gomyo;I.;Katakami;N.;Okada;M.;Yukitoshi;N.;Ohta;E.;and Shimoyama;M.
研究背景突破性癌痛通常起病迅速，持续时间相对较短。由于这种时间特征，口服阿片类镇痛药可能无法充分缓解。舌下芬太尼口腔崩解片是一种制剂，通过该制剂，芬太尼可以通过口腔粘膜快速吸收，产生快速起效的镇痛作用，并且可能对突破性疼痛治疗有效。表示“双”之义进行了一项盲法对照研究，以评价舌下芬太尼片剂在治疗癌症患者的突破性疼痛中的有效性和安全性每隔一段时间服用强效阿片类镇痛药通过开放标签剂量滴定确定最佳剂量。还评估了12周延长治疗的有效性和安全性。结果42名接受舌下芬太尼片剂的受试者中有11名出现了药物不良反应。常见反应为嗜睡、便秘、恶心和呕吐。未发生严重不良反应。以双盲方式对37名受试者给予最佳剂量的芬太尼舌下含片和安慰剂。与安慰剂相比，舌下芬太尼片剂在给药后30分钟具有显著的镇痛作用。舌下芬太尼片也是有效和安全的，在延长治疗，其中基础阿片类药物剂量的变化，以及舌下芬太尼片剂量根据需要.ConclusionSublingual芬太尼片在剂量滴定确定的突破性疼痛治疗癌症患者治疗与强阿片类镇痛药在固定的时间间隔。长达12周的延长治疗也是有效和安全的。
BackgroundBreakthrough cancer pain typically has a rapid onset and relatively short duration. Due to this temporal profile, it may not be adequately relieved by oral opioid analgesics. The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia, and which may be effective for breakthrough pain treatment.MethodsA multicenter, randomized, placebo-controlled, double-blind comparative study was conducted to evaluate the efficacy and safety of the sublingual fentanyl tablet at optimized doses for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. The optimal dose was determined by open-label dose titration. The efficacy and safety of a 12-week extended treatment were also evaluated.ResultsEleven of 42 subjects who received the sublingual fentanyl tablet experienced adverse drug reactions. Common reactions were somnolence, constipation, nausea, and vomiting. No serious adverse reactions occurred. Sublingual fentanyl tablets at optimal doses and placebo were administered to 37 subjects in a double-blinded manner. A significant analgesic effect of the sublingual fentanyl tablet was present compared to placebo at 30 min after administration. The sublingual fentanyl tablet was also effective and safe during extended treatment, in which changes in basal opioid doses as well as sublingual fentanyl tablet doses were made as needed.ConclusionSublingual fentanyl tablets at doses determined by titration were effective and safe for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. Extended treatment up to 12 weeks was also effective and safe.