Hayashi Naoko, Yoshida Mari, Maida Narumi, Kondo Shingo, Ogawa Masanori, Iwata Hiroki, Kobayashi Noriko, Yamaura Katsunori
Division of Social Pharmacy, Center for Social Pharmacy and Pharmaceutical Care Sciences, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
Keio University Community Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
Drugs Real World Outcomes. 2025 Sep 19. doi: 10.1007/s40801-025-00517-7.
Oropharyngeal dysphagia (OD), a dysfunction in swallowing food or drink, can result from various diseases and adverse drug reactions. OD is a risk factor for aspiration pneumonia (AP). However, the specific drugs causing OD and their incidence rates are not fully understood. This study aimed to identify drugs associated with OD, their incidence rates, and AP risk factors in patients taking these drugs on the basis of the information provided in package inserts.
This study identified candidate dysphagia-inducing drugs (CDIDs) from Japanese package inserts that listed OD as an adverse reaction. The age, sex, medications, and comorbidities of patients taking CDIDs were analyzed using the JammNet insurance database, purchased from JammNet Co., Ltd. (Tokyo, Japan).
Overall, 54 ingredients were identified as CDIDs. Out of 24,276 patients taking CDIDs, 146 (0.6%) were diagnosed with OD and 76 (0.3%) with AP. Among those with AP, 23 patients (30%) also had OD. OD or AP occurred in patients taking 28 (52%) of the 54 target ingredients. In addition, 13 ingredients had an adverse reaction incidence of 1% or greater for either condition. The top five CDIDs with the highest incidence rates for each diagnosis were clobazam, baclofen, zonisamide, tiapride hydrochloride, and topiramate. Incidence rates of OD and AP were significantly higher with multiple CDIDs than with a single drug (p < 0.05). Logistic regression analysis showed that AP occurrence was significantly associated with males, late-stage elderly individuals, a diagnosis of OD, and constipation.
The results of this study suggest that careful attention should be given to the risk of AP when prescribing CDIDs, particularly for elderly male patients.
口咽吞咽困难（OD）是一种吞咽食物或饮品的功能障碍，可由多种疾病及药物不良反应引起。OD是吸入性肺炎（AP）的一个危险因素。然而，导致OD的具体药物及其发生率尚未完全明确。本研究旨在根据药品说明书中提供的信息，确定与OD相关的药物、其发生率以及服用这些药物患者的AP危险因素。
本研究从日本药品说明书中列出OD为不良反应的内容里识别出候选吞咽困难诱导药物（CDIDs）。使用从日本JammNet有限公司购买的JammNet保险数据库，分析服用CDIDs患者的年龄、性别、用药情况及合并症。
总体而言，54种成分被确定为CDIDs。在24276名服用CDIDs的患者中，146例（0.6%）被诊断为OD，76例（0.3%）被诊断为AP。在患有AP的患者中，23例（30%）也患有OD。OD或AP发生在服用54种目标成分中28种（52%）的患者身上。此外，13种成分中任何一种情况的不良反应发生率均为1%或更高。每种诊断发生率最高的前五种CDIDs分别是氯巴占、巴氯芬、唑尼沙胺、盐酸硫必利和托吡酯。多种CDIDs导致OD和AP的发生率显著高于单一药物（p < 0.05）。逻辑回归分析表明，AP的发生与男性、老年晚期个体、OD诊断和便秘显著相关。
本研究结果表明，在开具CDIDs处方时，应特别关注AP的风险，尤其是老年男性患者。
