Jacobs C D, van der Pas M
Stanford University, School of Medicine, USA.
Oncology (Williston Park). 1996 Mar;10(3 Suppl):16-20.
Two hundred sixty-five patients with head and neck cancer who had previously participated in either a fixed-dose, dose-titration, or dose-ranging trial of oral pilocarpine hydrochloride tablets were enrolled in a 36-month multicenter maintenance study to evaluate the long-term safety and efficacy of oral pilocarpine for the treatment of radiation-induced xerostomia. In this open-label study, the initial drug dose was 5.0 mg tid, with possible adjustments from 2.5 to 10.0 mg tid or bid. Efficacy was evaluated by subjective measures of oral function. Safety evaluations were based on self-report of symptoms (or of adverse effects), various examinations, and laboratory tests. There was significant improvement in all criteria of oral function. Sweating was the most frequent adverse experience (55%). Less frequent side effects, mild to moderate in nature, included increased urinary frequency, lacrimation, and rhinitis. Side effects usually diminished within hours after the cessation of therapy. We conclude that oral pilocarpine at these doses effectively and safely reduces the symptoms of radiation-induced xerostomia.
265例曾参与口服盐酸毛果芸香碱片固定剂量、剂量滴定或剂量范围试验的头颈癌患者被纳入一项为期36个月的多中心维持性研究，以评估口服毛果芸香碱治疗放射性口干症的长期安全性和有效性。在这项开放标签研究中，初始药物剂量为5.0mg每日三次，可能调整为2.5至10.0mg每日三次或每日两次。通过口腔功能的主观指标评估疗效。安全性评估基于症状（或不良反应）的自我报告、各种检查和实验室测试。口腔功能的所有标准均有显著改善。出汗是最常见的不良体验（55%）。较不常见的副作用，性质为轻度至中度，包括尿频增加、流泪和鼻炎。副作用通常在治疗停止后数小时内减轻。我们得出结论，这些剂量的口服毛果芸香碱能有效且安全地减轻放射性口干症的症状。
