Mücke M, Conrad R, Marinova M, Cuhls H, Elsner F, Rolke R, Radbruch L
Klinik für Palliativmedizin, Universitätsklinikum Bonn, Bonn, Deutschland.
Institut für Hausarztmedizin, Universitätsklinikum Bonn, Bonn, Deutschland.
Schmerz. 2016 Dec;30(6):560-567. doi: 10.1007/s00482-016-0106-9.
To date, no studies investigating titration with oral transmucosal fentanyl for the dose-finding of transdermal fentanyl treatment have been published. In an open randomized study 60 patients with chronic malignant (n = 39) or nonmalignant pain (n = 21), who required opioid therapy according to step three of the guidelines of the World Health Organization (WHO), were investigated. In two groups of 30 patients each titration with immediate release morphine (IRM) or oral transmucosal fentanyl citrate (OTFC) was undertaken. For measurement purposes the Brief Pain Inventory (BPI) and Minimal Documentation System (MIDOS) were used. After a 24-h titration phase, in which patients documented the intensity of pain, nausea, and tiredness, treatment with transdermal fentanyl was evaluated over a 10-day period by means of the necessary dose adaptation (responder ≤ 1 dose adaptation; conversion formula 1:1 [OTFC group] vs 100:1 [IRM group]).The pain reduction over the first 24 h (titration phase) did not differ significantly between the groups. The number of responders (17 OTFC vs. 21 IRM) over the 10-day period did not show any difference either. In both groups there was a significant reduction in pain intensity (p < 0.001). Over the course of the study, there were significantly more drop-outs because of adverse effects in the OTFC group than in the IRM group (8 vs 1, p = 0.028).Oral transmucosal fentanyl citrate can be applied for the titration of transdermal fentanyl, but it does not show any clinically relevant advantage. For example, the risk of side effects-induced drop-outs was greater in the present study. Whether the unnecessary opioid switching to treat chronic pain and breakthrough pain is advantageous with regard to minimizing conversion errors cannot be definitively answered within the scope of this study.
迄今为止,尚未发表关于采用口腔黏膜芬太尼进行滴定以确定透皮芬太尼治疗剂量的研究。在一项开放性随机研究中,对60例根据世界卫生组织(WHO)指南第三步需要阿片类药物治疗的慢性恶性疼痛患者(n = 39)或非恶性疼痛患者(n = 21)进行了调查。将60例患者分为两组,每组30例,分别采用即释吗啡(IRM)或口腔黏膜芬太尼枸橼酸盐(OTFC)进行滴定。为了进行测量,使用了简明疼痛量表(BPI)和最小记录系统(MIDOS)。在为期24小时的滴定阶段,患者记录疼痛、恶心和疲劳的强度,之后在10天的时间里通过必要的剂量调整(反应者≤1次剂量调整;换算公式1:1 [OTFC组] 对比100:1 [IRM组])对透皮芬太尼治疗进行评估。两组在最初24小时(滴定阶段)的疼痛减轻情况无显著差异。在10天期间的反应者数量(OTFC组17例对比IRM组21例)也没有差异。两组的疼痛强度均显著降低(p < 0.001)。在研究过程中,OTFC组因不良反应导致的退出人数显著多于IRM组(8例对比1例,p = 0.028)。口腔黏膜芬太尼枸橼酸盐可用于透皮芬太尼的滴定,但未显示出任何临床相关优势。例如,在本研究中,因副作用导致退出的风险更大。在本研究范围内,无法明确回答为治疗慢性疼痛和爆发性疼痛而进行不必要的阿片类药物转换在最小化转换错误方面是否有利。