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Cisplatin 투여로 인한 구토시 이의 예방을 위한 Ondansetron과 Metoclopramide에 관한 Phase III 연구

A Phase III Study of Ondansetron & Metoclopramide in the Management of Cisplatin-Induced Emesis

대한산부인과학회지 1994년 37권 3호 p.542 ~ 551
민술홍
김두순/조용수/남성원/김인수/임정원/이우영

Abstract


Cancer chemotherapy & radiotherapy are often accompanied by severe nausea & vomiting, which can lead to refusal or delay of treatment by patient. Before the introduction of the 5-HT3 receptor antagonists, metoclopramide was generally regarded as
the
most effective anti-emetic in adult cancer patients. The department of obstetrics & gynecology, Hallym university had 160 randomised phase III single blind studies to compare ondansetron with metoclopramide in the management of cisplatin induced
emesis,
especially on the effectiveness, superiority, adverse effects and the safety.
The antiemetic efficacy of ondansetron was superior to that of high-dose metoclopramide in the control of cisplatin-induced vomiting with 73.2% of patients having complete antiemetic protection and 15.4% of patients experiencing one or two emetic
episodes, Metoclopramide completely prevented emesis in only 32.4% of patients and caused disturbing extrapyramidal side effects such as acute dystonia (4.2%0 and akathisia(2.8%). The adverse events noted with ondansetron were generally mild and
included most prominently sedation (18.3%), headache (16.9%) Elevated transaminase levels(9.9%) were seen but this may be related to cisplatin. No instance of extrapyramidal side effects was seen in patients receiving ondansetron. Based on our
own
studies, ondansetron is more effective than metoclopramide in controlling cisplatin-induced emesis and is found to be a safe, well tolerated antiemetic agent in adults patients receiving cisplatin chemotherapy.
Therefore, ondansetron can be a major advance in the supportive care of cancer patients.

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