Seirei Hospice, Seirei Mikatahara General Hospital, 3453 Mikatahara-Cho, Kita-Ku, Hamamatsu, Shizuoka, 433-8558, Japan,
Support Care Cancer. 2013 Oct;21(10):2777-81. doi: 10.1007/s00520-013-1846-z. Epub 2013 May 31.
The primary aim of this study was to clarify the effect of sublingual scopolamine on the intensity of nausea.
This was an open uncontrolled study, and the study participants were cancer patients consecutively admitted to a palliative care unit in Japan. When the patients had nausea, they were administered a solution of scopolamine at 0.15 mg sublingually. The intensities of nausea were assessed using the 6-point Numerical Rating Scale (NRS 0 = no nausea to 5 = worst nausea) before and 15, 30, and 60 min after administration. Primary endpoints were (1) changes in the NRS of nausea and (2) percentage of patients who achieved a decrease in NRS of 1 or more points 15 min after treatment.
Twenty-six patients were recruited for this study. The median NRS significantly decreased from 3.0 (range, 1-5) to 1.5 (0-5) after 15 min, and 84 % (n = 21) of the patients achieved a decrease in NRS of 1 or more points after 15 min. In addition, the median NRS significantly decreased from 3.0 (before) to 0 (30 min) and 0 (60 min). The percentage of patients who achieved a decrease in NRS over 1 point was 96 % (n = 25) in 30 min and 100 % (n = 26) in 60 min. Fifteen percent (n = 4) showed drowsiness. No other adverse effects were reported.
Sublingually administered scopolamine may be effective for managing nausea in terminally ill cancer patients. Randomized controlled trials are promising.
本研究的主要目的是阐明舌下给予东莨菪碱对恶心强度的影响。
这是一项开放的非对照研究,研究对象为连续入住日本姑息治疗病房的癌症患者。当患者出现恶心时,给予其 0.15 毫克的东莨菪碱舌下溶液。恶心强度采用 6 分制数字评分量表(NRS 0 = 无恶心至 5 = 最严重恶心)进行评估,在给药前和给药后 15、30 和 60 分钟进行评估。主要终点为(1)NRS 恶心评分的变化,(2)治疗后 15 分钟 NRS 评分降低 1 分或更多的患者比例。
本研究共纳入 26 例患者。NRS 中位数在 15 分钟后从 3.0(1-5)显著降低至 1.5(0-5),84%(n=21)的患者在 15 分钟后 NRS 评分降低 1 分或更多。此外,NRS 中位数在 30 分钟和 60 分钟时分别从 3.0(给药前)显著降低至 0 和 0。30 分钟时,NRS 评分降低 1 分以上的患者比例为 96%(n=25),60 分钟时为 100%(n=26)。15%(n=4)的患者出现嗜睡。未报告其他不良反应。
舌下给予东莨菪碱可能对缓解终末期癌症患者的恶心有效。随机对照试验前景可期。