Horiot J C, Lipinski F, Schraub S, Maulard-Durdux C, Bensadoun R J, Ardiet J M, Bolla M, Coscas Y, Baillet F, Coche-Dequéant B, Urbajtel M, Montbarbon X, Bourdin S, Wibault M, Alfonsi M, Calais G, Desprez P, Pene F, Lapeyre M, Vinke J, Maral J
Radiation Therapy Department, Centre Georges-François Leclerc, Dijon, France.
Radiother Oncol. 2000 Jun;55(3):233-9. doi: 10.1016/s0167-8140(99)00018-3.
The aim of the study was: (1) to confirm the action of pilocarpine hydrochloride (Salagen) against xerostomia: (2) to correlate the response to dose/volume radiotherapy parameters.
From June 1995 to February 1996, 156 patients with severe radiation induced xerostomia received pilocarpine hydrochloride orally. IS mg per day with a 5 mg optional increase at S weeks up to a daily dose of 25 mg beyond 9 weeks.
One hundred and forty five patients are fully evaluable. Treatment compliance was 75%. Thirty eight patients (26%) stopped treatment before week 12 for acute intolerance (sweating, nausea, vomiting) or no response. No severe complication occurred. Ninety ses en patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup ith normal food intake almost doubled (13-24 patients) while the size of the subgroup with (nearly) impossible solid food ingestion decreased by 38% (47 vs. 29 patients). The impact on quality of life was considered important or very important by 77% of the responders.
No difference was found according to dose/volume radiotherapy parameters suggesting that oral pilocarpine hydrochloride: (1) acts primarily by stimulating minor salivary glands: (2) can be of benefit to patients suffering of severe xerostomia regardless of radiotherapy dose/volume parameters: (3) all responders are identified at 12 weeks.
本研究的目的是：（1）证实盐酸毛果芸香碱（Salagen）对口干症的作用；（2）将反应与剂量/体积放疗参数相关联。
1995年6月至1996年2月，156例严重放射性口干症患者口服盐酸毛果芸香碱。每天15毫克，5周后可选择增加5毫克，9周后每日剂量可达25毫克。
145例患者可进行全面评估。治疗依从性为75%。38例患者（26%）在第12周前因急性不耐受（出汗、恶心、呕吐）或无反应而停止治疗。未发生严重并发症。97例患者（67%）报告在12周时口干症状明显缓解。在12周内，正常食物摄入量亚组的规模几乎翻倍（13 - 24例患者），而（几乎）无法摄入固体食物亚组的规模减少了38%（47例对29例患者）。77%的有反应者认为对生活质量的影响重要或非常重要。
根据剂量/体积放疗参数未发现差异，这表明口服盐酸毛果芸香碱：（1）主要通过刺激小唾液腺起作用；（2）无论放疗剂量/体积参数如何，对严重口干症患者都有益；（3）所有有反应者在12周时可被识别。
