Department of Otolaryngology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Laryngoscope. 2024 Nov;134(11):4542-4548. doi: 10.1002/lary.31544. Epub 2024 May 30.
This study aimed to evaluate the efficacy of as-needed pilocarpine for the management of radiation-induced xerostomia. Additionally, the study sought to assess the side effects associated with an as-needed regimen.
A randomized, double-blinded, placebo-controlled crossover study was conducted on patients who had undergone radiation therapy for head and neck cancers and developed xerostomia. Participants took pilocarpine or placebo as needed for symptom relief at 2 weeks per treatment, which included a one-week washout period. The primary outcome measure was the severity of dry mouth symptoms, quantified using the Xerostomia Inventory (XI). The primary outcome was the change in the XI score.
Among the 20 participants who completed the crossover study, there was a significant reduction in XI scores during the treatment phase with pilocarpine compared to the scores during the placebo phase. The mean difference in XI scores was -18.05 (95% CI: -17.17, -6.13, p < 0.001), with a-49.77 ± 3.22% change (p < 0.001). Only one participant withdrew due to pilocarpine side effects.
As-needed pilocarpine administration is effective in relieving symptoms of radiation-induced xerostomia, with fewer side effects and reduced treatment costs compared to fixed-dose regimens. This study guides the potential shift toward flexible dosing strategies in clinical practice, promoting enhanced patient-centered, tailored care and adherence.
2: According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines Laryngoscope, 134:4542-4548, 2024.
本研究旨在评估按需给予毛果芸香碱治疗放射性口干症的疗效。此外，本研究还评估了按需给药方案相关的副作用。
对头颈部癌症放疗后发生口干症的患者进行了一项随机、双盲、安慰剂对照交叉研究。参与者在 2 周的治疗期内按需服用毛果芸香碱或安慰剂以缓解症状，每个治疗期包括一周的洗脱期。主要结局测量指标是口干症严重程度，采用 Xerostomia Inventory（XI）进行量化。主要结局是 XI 评分的变化。
在完成交叉研究的 20 名参与者中，与安慰剂期相比，毛果芸香碱治疗期的 XI 评分显著降低。XI 评分的平均差值为-18.05（95%置信区间：-17.17，-6.13，p<0.001），变化率为-49.77±3.22%（p<0.001）。仅有 1 名参与者因毛果芸香碱的副作用而退出。
与固定剂量方案相比，按需给予毛果芸香碱可有效缓解放射性口干症的症状，且副作用更少，治疗费用更低。本研究为临床实践中潜在的灵活给药策略提供了指导，促进了以患者为中心的、量身定制的护理和依从性。
2：根据牛津循证医学中心 2011 年证据水平指南，Laryngoscope，134：4542-4548，2024。
