臺灣博碩士論文加值系統

背景
類固醇用於治療化療病人所引起的嘔吐之真正機轉至今無一定論?本研究是採用隨機對照組試驗，分析南部某醫學中心，43位接低劑量cisplatin治療的化療患者。比較二組：A組為tropisetron併用類固醇；B組為tropisetron單獨使用不加類固醇，用於預防化療引起的嘔吐之成效及安全性。
實驗方法
本實驗病人隨機分配成A、B組給予止吐劑。A組藥的組成是tropisetron 5 mg、 metoclopramide 10 mg、 betamethasone 4 mg。B組藥的組成是tropisetron 5 mg、 metoclopramide 10 mg 。所有病人在4個療程內（C1C2C3C4），必須每週接受cisplatin劑量範圍在30~35 mg/m2的治療。病人施打cisplatin前先給予止吐劑，止吐劑靜脈注射時間需15~30分鐘。20分鐘之後再給予cisplatin靜脈點滴注射，輸注時間至少在一小時以上。依據EORIC量表、Soukop’s 及Simith’s反應表, 評估兩組病人在給藥24小時內，引起噁心程度嘔吐次數及副作用。

實驗結果
納入本實驗的43位病人，在性別年齡上兩組間差異很小。比較二組在預防噁心及嘔吐成效上，完全無噁心症狀：A組—57.1﹪；B組--77.3﹪。有一次以上的噁心症狀：A組--42.9﹪：B組--22.7﹪。嘔吐的發生次數：有一次以上的嘔吐症狀：A組--38.1﹪；B組--18.2﹪。完全沒有嘔吐症狀：A組--61.9﹪；B組--81.8﹪。統計學上在預防嘔吐（p=0.146）及噁心（p=0.159）成效上，兩組p值都大於0.005，所以兩組間並無顯著差異。
副作用的發生都很輕微，並無較嚴重事件發生。A組及B組發生率最高的副作用是疲倦，各別為30﹪、40.9﹪（p=0.46）。其次是頭痛各別為15﹪、36.4﹪（p=0.116）。兩組在統計上並無顯著差異。
結論
Tropisetron併用 betamethasone比較於單獨使用 tropisetron , 並不會降低對於低劑量cisplatin所引起噁心、嘔吐的發生。

Background. The role of steroid in treatment of chemotherapy induced vomiting mechanism is disputed? A randomization controlled study was conducted at a medical hospital in the southern Taiwan. Forty-three patients who received low dose cisplatin chemotherapy were enrolled to compare the efficacy and safety of prevention of emesis by 2 different combinations of antiemetic agents : A group consisting of tropisetron plus steroid. B group consisting of tropisetron alone not steroid.

Method. Patients were randomly assigned into A and B group. antiemetic treatment in group A regimen consist tropisetron 5 mg, metoclopramide 10 mg, betamethasone 4 mg, in group B regimen consist tropisetron 5 mg, metoclopramide 10 mg. All patients received cisplatin at a dose range 30-35 mg/m2 weekly for 4 cycles (C1C2C3C4). The scheduled: antiemetic agent was given in the first, before cisplatin. antiemetic agent IV infusion time over 15-30 minutes. Ending 20 minutes before administration cisplatin. The IV infusion time of cisplatin was 1 hour at least.
Assess the severity of nausea and vomiting by the EORTC criteria, Soukop’s and Simith’s scale of response and side effects of antiemetic agents in two group patients during the first 24 hours after chemotherapy.

Results. A total of Forty-three patients were enrolled and 166 cycle chemotherapy were give. The rate of complete response to nausea was 57.1% in A group, 77.3% in B group. The rate of major response to nausea 42.9% in A group, 22.7% in B group. The rate of complete response to vomiting was 61.9% in A group, 81.8% in B group. The rate of major response to vomiting was 38.1% in A group, 18.2% in B group. It was no significant difference between the two group in the control of nausea and vomiting.
The incidences of side effects were very low in two group and there was no serious event. The most common side effect was fatigue respectively 30%, 40% (p=0.46). The second was headache respectively 15%, 36.4% (p=0.116). It was not significant difference between the two group.

Conclusion. Combination of tropisetron plus betamethasone did not decrease the incidence of nausea and vomiting induced by low dose cisplation than tropisetron used alone.

目錄
頁碼
圖次目錄. . . . . . . . . . . . . . . . . . . . . . . . . . . .I
表次目錄. . . . . . . . . . . . . . . . . . . . . . . . . . . II
中文摘要. . . . . . . . . . . . . . . . . . . . . . . . . . Ⅲ
英文摘要. . . . . . . .. . . . . . . . . . . . . . . . . . . .V
本文
壹、 緒論
一、研究背景. . . . . . . . . . . . . . . . . . . . . . . . 1
二、造成嘔吐之生理機轉. . . . . . . . . . . . . . . . . . . 6
(一) Serotonin (5-HT) 與化療導致嘔吐的相關性. . . .11
(二) 化療引起噁心、嘔吐在定義上分為三種型態. . . . . 12
三、複和式止吐劑治療. . . . . . . . . . . . . . . . 13
四、藥物概述. . . . . . . . . . . . . . . . . . . .18
(一) Tropisetron. . . . . . . . . .. .. . .18
(二)Cisplatin . . . . . . . . . .. . . . .22
(三)Betamethasone. . . . . . . . . . . . . . .. . . . .26
貳、病人及實驗方法. . . . . . . . . . . . . . . . . . . . . . .29
一、實驗目的. . . . . . . . . . . . . . . . . . . . .. . . . .29
二、實驗方法. . . . . . . . . . . . . . . . . . . .. . . . . .30
(一) 實驗病人之篩選. . . . . . . . . . . . .32
(二) 收集條件. . . . . . . . . . . . . . . . . . . . . . . . .33
(三) 排除收集條件. . . . . . . . . . . . .34
(四) 終止治療. . . . . . . . . . . . .. . . .35
(五) 統計分析方式. . . . . . . . . . . . . . .38

參、結果與討論. . . . . . . . . . . . . . . . . . . . . . . . .39
一、病人之基本資料. . . . . . . . . . . . . . . . . . . . . . .39
二、結果. . . . . . . . . . . . . . . . . . . . . . . . . . . .41
(一) 兩組抗噁心症狀成效上的比較. . . . . .. .42
(二) 兩組的抗嘔吐成效上的比較. . . . . . . ..........45
(三) 安全性評估. . . . . . . . . . . . . . . .. . . .49
三、討論. . . . . . . . . . . . . . . . . . . . . .. . . . . .58
肆、結論. . . . . . . . . . . . . . . . . . . . . . . . . . . .60
參考文獻. . . . . . . . . . . . . . . . . . . . . . . . . . . 61

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有岡秀樹、西基、武田、武夫等人Betamethasoneのciaplatinに對すゐ制吐效果の檢討.小兒科診療：昭和63年, 141-144.
堀田知光、大西一功 、津下圭太郎 等人惡性リンパ腫化學療法(Cyclophosphamide, Doxorubicin, Vincristine) に伴ぅ急性副作用す症狀に對るすBetamethasoneの緩和效果: 基礎と臨床 1988, 39-43.