Hirata Ayumu, Funato Hiroki, Nakai Megumi, Iizuka Michiro, Abe Noriaki, Yagi Yusuke, Shiraishi Hisashi, Jobu Kohei, Yokota Junko, Hirose Kahori, Hyodo Masamitsu, Miyamura Mitsuhiko
Department of Pharmacy, Kochi Medical School Hospital.
Biol Pharm Bull. 2016;39(7):1107-11. doi: 10.1248/bpb.b15-01045.
We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, optimized the base formulation, and carried out a clinical trial in healthy adults in their 20 s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallowing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eighteen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15 min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15 min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after taking the placebo (p<0.05). Among 10 subjects, one scored 1-3 using the four evaluation criteria. Overall, no aspiration occurred and a significant improvement in the swallowing function score was observed (p<0.05) after taking the ginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function.
我们之前制备了生姜口腔崩解片并对其进行了药学评估，优化了基础配方，并在20多岁和50多岁的健康成年人中进行了临床试验，以测量其对唾液P物质（SP）水平和吞咽功能改善的影响。在本研究中，我们在老年人中使用生姜口腔崩解片进行临床试验，以临床评估该片剂功能成分对吞咽功能的改善情况。生姜口腔崩解片是通过将辅料与等量的甘露醇和蔗糖混合，制成浓度为1%的生姜制剂。18名年龄在63至90岁之间的健康老年志愿者参与了吞咽功能测试。在服用安慰剂和生姜口腔崩解片之前及之后15分钟收集唾液。在服用生姜口腔崩解片之前及之后15分钟，由耳鼻喉科医生进行吞咽内镜检查。采用评分方法评估内镜下吞咽情况。服用生姜口腔崩解片15分钟后，唾液中SP的含量显著高于服药前或服用安慰剂后（p<0.05）。在10名受试者中，根据四项评估标准，一人的评分为1-3分。总体而言，未发生误吸，服用生姜口腔崩解片后吞咽功能评分有显著改善（p<0.05）。我们的研究结果表明，生姜口腔崩解片可增加吞咽功能明显减退的老年人唾液中SP的含量，并改善其吞咽功能。
