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1
題名:雙盲對照實驗評估口服pilocarpine對放射線治療引起頭頸部癌症病患口乾症於馬偕醫院之使用主觀效果及安全性報告     (16點)
A DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SUBJECTIVE EFFICACY AND SAFETY OF ORAL PILOCARPINE FOR TREATMENT OF POST-IRRADIATION XEROSTOMIA IN HEAD AND NECK CANCER PATIENTS AT MACKAY MEMORIAL HOSPITAL
著者:陳舜鼎(Shun-Ting Chen) ;張國華(Kou-Hwa Chang) ;陳裕仁(Yu-Jen Chen) ;鍾昌宏(Chang-Hung Chung) ;吳孟浩(Meng-Hao Wu) ;蘇文浩(Wen-Hao Su) ;陳虹汶(Hong-Wen Chen) ;賴允亮(Yuen-Liang Lai)
出版地區:台灣
出版城市:台北市
學科:醫學綜合
關鍵字:口乾症 ; 頭頸部癌症 ; 放射線治療 ; Xerostomia ; Head and neck cancer ; Radiotherapy ; Pilocarpine
刊名:放射治療與腫瘤學
頁碼:11-18
語言:繁體中文
摘要: 中文摘要PDF ; 英文摘要PDF

且且: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( xe rosto m i a )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P i l o ca r p i ne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P i l o c a r p i ne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。 姐姐盟主法: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4 0 Gy 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5 mg 的Pilocarpine 三灰共+二週, 並於服藥期間使用視覺類比評量表( v i s u a l analog 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C o c h ra n - M a n t e l - H a e n z e l ' stest 做為變異性分析之工具。 益星:於實驗中共有25位患者完成+二週的測試,其中實驗組佔7 1 1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。 益益: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 neck 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 that oral pilocarpine improves the condition of xerostomia in these patients. We designed a double-blinded, placebo-controlled 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 tongue comfort, speaking without fluid, the need for oral comfort agent, chewing and swallowing, and the ability to sleep, by visual analog scale 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 the 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 (18.2-63.6%) though it 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. Further objective evaluations such as different radiation dose, different drug dose, the timing of administration, and saliva amount remain necessary.


    

本卷期目次
放射治療與腫瘤學
固定深度治療對直腸肛門癌放射治療的影響/ 曾雁明范綱行白冰清蔡介生林倩伃陳臣苑曾振淦
Preperative Radiotherapy Concurrent with Chemotherpy for Locally Advaced Rectal Cancer/ Yu-Xuan ChenWilliamChenMu-Tai LiuChih-Yuang ChungCheng-Shyong ChangGer-Hau HsuHong-Chang ChenTung-Hao ChangChu-Ping PiChih-Chiech Hsu
Preoperative Radiotherapy and Chemotherapy for Low or Locally Advaced Rectal Cancer/ I-Chun YehHelen H.W. ChenJeng-Chang LeeWu-Chou SuHong-Ming TsaiHenry W.C. Leung
雙盲對照實驗評估口服pilocarpine對放射線治療引起頭頸部癌症病患口乾症於馬偕醫院之使用主觀效果及安全性報告/ 陳舜鼎張國華陳裕仁鍾昌宏吳孟浩蘇文浩陳虹汶賴允亮
改良式軟片劑量驗證應用於強度調控放射線治療之先期研究/ 蔡忠宏莊克士戴宏旗周志成蕭安成林芳仁
Definitive Radiotherapy for the Patients with Prostatic Adenocarcinoma: Analysis of Short-Term Outcome and Prognostic Factors/ Shena Yu-Hsuan ChenJason Chia-Hsien ChengStella Y. TsaiSkye Hon-Giun ChengDaniel S. ChangAlex Lien-Yen YangJames Jer-Min Jian
AAPMTG-51號議定書光子與電子劑量計算程式/ 郭力誠鄭秀成游浚彥陳妙芬陳文政
DEFINITIVE RADIOTHERAPY FOR THE PATIENTS WITH PROSTATIC ADENOCARCINOMA: ANALYSIS OF SHORT-TERM OUTCOME AND PROGNOSTIC FACTORS/ Shena Yu-Hsuan ChenJason Chia-Hsien ChengStella Y TsaiSkye Hongiun ChengDaniel S ChangAlex Lien-Yen YangJames Jer-Min Jian
雙盲對照實驗評估口服pilocarpine對放射線治療引起頭頸部癌症病患口乾症於馬偕醫院之使用主觀效果及安全性報告/ 陳舜鼎張國華陳裕仁鍾昌宏吳孟浩蘇文浩陳虹汶賴允亮
PREOPERATIVE RADIOTHERAPY CONCURRENT WITH CHEMOTHERAPY FOR LOCALLY ADVANCED RECTAL CANCER/ Yu-Xuan ChenWilliam ChenMu-Tai LiuChih-Yuang ChungCheng-Shyong ChangGer-Hau HsuHong-Chang ChenTung-Hao ChangChu-Ping PiChih-Chiech Hsu
PREOPERATIVE RADIOTHERAPY AND CHEMOTHERAPY FOR LOW OR LOCALLY ADVANCED RECTAL CANCER/ I-Chun YehHelen H. W. ChenJeng-Chang LeeWu-Chou SuHong-Ming TsaiHenry W. C. Leung
固定深度治療對直腸肛門癌放射治療的影響/ 曾雁明范綱行白冰清蔡介生林倩?陳臣苑曾振淦
AAPMTG-51號議定書光子與電子劑量計算程式/ 郭力誠鄭秀成游浚彥陳妙芬陳文政
改良式軟片劑量驗證應用於強度調控放射線治療之先期研究/ 蔡忠宏莊克士戴宏旗周志成蕭安成林芳仁
 
   
 
   

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