目的:許多頭頸部癌症的病人於放射線治療後多半會遭遇口乾症(xerostomia)的困擾，而一般傳統的治療如:人工唾液，抗菌製劑，氣化物等通常並不能提供一滿意的結果。一些近來的外國實驗發現口服Pilocarpine可以給病患一個有效而安全的治療，但目前仍無台灣病患之臨床資料，所以我們設計了一個臨床雙盲對照實齡去評估口服Pilocarpine對台灣因放射線治療而引發之口乾症病人的療效及安全性。

材料與主法:在這一;欠的實驗中共有48位的患者參與，各有24位患者於實驗組及對照組中。患者必須是曾經接受過40Gy以上的頭頸部放射治療，並於服藥前二個月即已停止接受放射線治療 及化學治療。患者一日服用5mg的Pilocarpine三灰共+二週，並於服藥期間使用視覺類比評量 表(visualanalog scale)為評量口乾症之工具。所評估的項目包括整體情況、口乾程度、口腔及 舌頭的舒適度、說話之l順暢度、口腔溼潤劑之使用程度、咀嚼及吞嘸能力和睡眠品質等七I賞。而安全性則以不良反應產生情形及實驗數據為評量標準。所有結果以Cochran-Mantel-Haenzel'stest做為變異性分析之工具。

結果:於實驗中共有25位患者完成+二週的測試，其中實驗組佔711人。於服藥後的第四週，第八週及第+二週分別收集患者資料以分析比較。於資料中顯示，無論是實驗組或是對照組的患者對於口乾症之情形皆有改善(18.2-63.6% ) ，而對於所評估的六個項目中，只有睡眠品質具有統計學上的差異(p= 0.026)。對於藥物安全性的評估中，除了增加流汗及頻尿之情形外，並沒有發 現具統計意義之不良反應。

結論:對於因放射線治療而引發之口乾症，Pilocarpine在部分病人似乎可以達到治療的效果，尤 其是對於睡眠晶質的改善;且於使用上除7增加頻尿及流汗以外，並無安全上之虞慮;但結果解讀受限於個案數太少及半數研究對象未能完成療程，因而一些更客觀的研究，如不向的放射劑量、藥量、服用時間點及唾液流量的客觀測量是需要的。

Purpose: Many head and ne心k cancer patients suffer from xerostomia after irradiation， General treatments such as saliva substitutes， antimicrobial rinses and fluoride application do not provide a satisfactory result. Some current studies showed血at oral pilocarpine improves the condition of xerostomia in these patients， We designed a double-blinded， placebo-con甘oIled study to evaluate the efficacy and safety of this drug in our hospital.

Materials and Methods : There were 48 patients in this study divided equally into study or control cohort by a randomized way. All of them underwent more than 40 Gray of radiation and stopped the treatment， including radiation and chemotherapy， two months before getting into this study. Patients were administered Pilocarpine 5 mg three times a day for 12 weeks and were evaluated for overall condition， oral dryness， mouth and tongu巴comfort， speaking without fluid， the need for oral comfort agent， chewing and swallowing， and the ability to sleep， by visual analog scal巴questionnaire. The safety was evaluated by examining adverse events and laboratory results. Data were compared using CochranMantel-Haenzel's test and analysis of variance.

Results:Twenty-five patients completed the experiment in this study， including eleven persons in the study group. We collected出巴data in the 4th， 8th， and 12th weeks after administration of drug to evaluate the efficacy of pilocarpine. The data showed that both groups got improvement in xerostomia (18.2吋3.6的thoughit only showed the statistically significant difference in the component of ability to sleep (p= 0.026). There was no statistical difference in adverse events between the two groups， except increased sweating and urinary frequency in study group.

Conclusion:Oral pilocarpine may be effective to treat radiation induced xerostomia in some head and neck cancer patients， especially to improve the ability to sleep， and it is also a safe drug for these patients. The results are limited for interpretation due to few numbers of patients in both arms and half patients excluded from the study with incomplete treatment. Furth巴r objective巴valuations such as different radiation do詞， different drug dos巴， the timing of administration， and saliva amount remain necessary.