A Randomized Comparative Trial of Ondansetron Versus Metoclopramide-Based Combination Regimen in the Prevention of Cisplatin-Induced Emesis

Ondansetron是5-hydroxytryptamine接受體的拮抗劑，它在第一及第二期的臨床試驗已證實對預防化學治療所引起噁心、嘔吐是一有效且安全的藥物。我們實驗的目的是比較Ondansetron與含Metoclopramide的傳統綜合療法（以下簡稱cocktails）在預防Cisplatin所引起嘔吐的效果與安全性，所選的病人條件差不多，共40位病人，隨機分成兩組治療，每組20位病人，皆是第一次接受化學治療，所用的cisplatin劑量≧60 mg/m^2，一組接受單一Ondansetron藥物，另一組則接受cocktails。結果顯示病人在化學治療後24小時內只有嘔吐兩次（包含兩次）以下的，在ondansetron這一組為65％，而在cocktails這一組為60％。治療的失敗率（嘔吐大於5次）分別為15％及20％。沒有或輕微噁心的病人，在ondansetron這一組為12位，而在cocktails這一組為11位。治療的副作用在cocktails這一組為有急性肌肉緊張異常反應的有2位，腹瀉的有6位。在ondansetron這一組出現頭疼的有4位。我們的結論是單一的ondansetron與cocktails在預防Cisplatin所引起嘔吐的效果是一樣的。雖然有較多的病人有頭痛的現象，接受ondansetron的病人不會出現急性肌肉緊張異常反應。接受ondansetron的治療除了效果不錯及副作用少外，在使用上也比cocktails來得方便。

關鍵字

含Metoclopramide的傳統綜合療法（cocktails）；嘔吐

並列摘要

A randomized, comparative study was conducted to compare the efficacy and safety of ondansetron alone with conventional metoclopramide-based combination (cocktails) regimen in the prevention of cisplatin-induced emesis. Forty newly diagnosed cancer patients who were scheduled to receive moderate to high-dose of cisplatin (≥60 mg/m^2) with or without other chemotherapeutic agents were randomized to receive either a loading dose of ondansetron 8 mg IV before cisplatin infusion followed by a continuous infusion of 1 mg/h for 24 hours and then oral dose of 8 mg every 8 hour for 5 days, or metoclopramide 0.75 mg/kg IV, dexamethasone 20 mg IV and diphenhydramine 30 mg IV before cisplatin infusion followed by metoclopramide 0.5 mg/kg IV every 6 hour × 4. A complete plus major response (≤ 2 emetic episodes) was seen in 13 of 20 (65%) ondansetron-treated and 12 of 20 (60%) cocktails-treated patients. The failure rate (＞ 5 emetic episodes) was 15% and 20% of patients in the ondansetron and cocktails group, respectively, Nausea graded none or mild were reported in 12 of 20 patients with ondansetron and 11 of 20 patients with cocktails. The adverse events included acute dystonic reaction in 2 cases and diarrhea in 6 cases with cocktails therapy; and headache in 4 cases with ondansetron. We cocluded that ondansetron alone is as effective as cocktails regimen in the prevention of cisplatin-induced emesis. Patients treated with ondansetron were observed no dystonic reaction, though headache occurred more frequent than those with cocktails. Ondansetron was demonstrated as a single, effective antiemetic agent with safe and convenient for use.

並列關鍵字

Ondansetron ； metoclopramide-based combination regimen (cocktails) ； emesis

國際替代計量

A Randomized Comparative Trial of Ondansetron Versus Metoclopramide-Based Combination Regimen in the Prevention of Cisplatin-Induced Emesis

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