Lux Eberhard Albert, Schwittay Andreas, Kleeberg Ulrich R, Papke Jens
St. Marien-Hospital GmbH, Altstadtstr. 23, 44534, Lünen, Deutschland.
, Böhlen, Deutschland.
MMW Fortschr Med. 2018 Jul;160(Suppl 4):18-23. doi: 10.1007/s15006-018-0728-1. Epub 2018 Jul 4.
Patients with breakthrough cancer pain (BtCP) experience significant limitations in their physical, mental and social functions. Fentanyl buccal tablets (FBT), a rapid onset opioid, are specifically indicated for the treatment of BtCP.
The results of the German cohort of a pan-European study are presented. This included cancer pain patients from 32 German centers. Patients were on continuous opioid medication and had at least 4 BtCP episodes per day. After randomization to 2 groups, 66 patients started the titration of FBT with 100 μg (group A) and 200 μg (group B), respectively. All patients were titrated to their individual EAD, which could be a maximum of 800 μg FBT per episode, regardless of the initial dose. Subsequently, up to 8 BtCP episodes were treated with this EAD. At baseline and after treatment, patients assessed the effects of BtCP on their functional status using the modified BPI-7S and answered questions about the efficacy, simplicity, and ease-of-use of the treatment.
Successful titration was achieved by 49 patients (74.2%). There was no statistically significant difference between group A and group B. The global score of the modified BPI-7S increased by 8.5 (± 12.8) points (from 34.7 ± 13.6 at the beginning to 26.2 ± 15.8 at the end of treatment), from which a statistically significant improvement in the quality of life of patients can be derived. Global patient contentment improved, most notably the rapid onset of 2.4 points to 3.4 points at the end of the study. 76.9% of patients found taking FBT simple or very simple.
爆发性癌痛(BtCP)患者在身体、心理和社会功能方面存在显著限制。芬太尼口腔崩解片(FBT)是一种起效迅速的阿片类药物,专门用于治疗BtCP。
本文展示了一项泛欧洲研究中德国队列的结果。该队列包括来自德国32个中心的癌症疼痛患者。患者正在接受持续的阿片类药物治疗,且每天至少有4次BtCP发作。随机分为两组后,66例患者分别开始使用100μg(A组)和200μg(B组)进行FBT滴定。所有患者均滴定至各自的有效镇痛剂量(EAD),无论初始剂量如何,每次发作的FBT最大剂量可为8mg。随后,使用该EAD治疗多达8次BtCP发作。在基线和治疗后,患者使用改良的BPI-7S评估BtCP对其功能状态的影响,并回答有关治疗效果、简便性和易用性的问题。
49例患者(74.2%)成功完成滴定。A组和B组之间无统计学显著差异。改良BPI-7S的总体评分提高了8.5(±12.8)分(从开始时的34.7±13.6分提高到治疗结束时的26.2±15.8分),由此可得出患者生活质量有统计学显著改善。患者总体满意度提高,最明显的是在研究结束时,起效迅速的评分从2.4分提高到了3.4分。76.9%的患者认为服用FBT简单或非常简单。