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J Korean Cancer Assoc > Volume 28(3); 1996 > Article
Journal of the Korean Cancer Association 1996;28(3): 562-573.
Cisplatin 병용 항암화학요법시 발생하는 오심 및 구토에 대한 Tropisetron 단일 요법과 Metoclopramide / Dexamethasone / Diazepam ( MDD ) 복합요법의 효과에 관한 전향적 무작위 비교 연구
박기복, 정동훈, 김종훈, 김병기, 박상윤, 이의돈, 이경희
A Prospective Randomized Study Comparing the Efficacy of Tropisetron Versus Metoclopramide / Dexamethasone / Diazepam (
Ki Bok Park, Dong Hoon Jeong, Jong Hoon Kim, Byoung Kee Kim, Sang Yoong Park, Eui Don Lee, Kyung Hee Lee
Background: Chemotherapy-induced emesis is one of the most disturbing side effects in the cancer chemotherapy. Despite a number of significant advances over the past decade, prevention and treatment of chemotherapy induced emesis remain formidable problems, particularly with cisplatin based regimens. In the prior reports, tropisetron(Navoban, Sandoz Pharma. Ltd., Basel, Switzerland), a 5-HT3-receptor antagonist, was effective in the control of cisplatin induced emesis. In this study, we compared effectiveness of tropisetron (TRP) with metoclopramide/dexamethasone /diazepam(MDD) in the prevention of emetic episodes in patients receiving cisplatin-based combination chemotherapy.
Sixty-three patients with cervical carcinoma receiving 60 mg/§³ of cisplatin (day 1) and 1000mg/§³ of 5-FU(day 1~5) were randomized to two arms(arm I: tropisetron; n=32, arm II: MDD; n=31). In TRP group, tropisetron(5 mg) was given intravenously(i.v.) l5 min before cisplatin on day 1, and per orally(p.o.). 30 min before breakfast from day 2 to 6. In MDD group, metoclopramide(l mg/kg/time, 2 times/day), dexamethasone(20mg) and diazepam(5 mg) were given intravenously before cisplatin infusion on day 1, and from day 2 to 6, metoclopramide(l0 mg) was given p.o, every 6 hours, and dexamethasone was given p.o . every 12 hours at a dose of 8mg on day 2~3 and at a dose of 4mg on day 4~6. Sixty patients were evaluable and 3 patients(arm I, 2 patients; arm II, 1 patient) were excluded from the analysis due to their refusal during study due to emesis.
In TRP group, during first 24 hours(acute emesis), 83.3%(25/30) of patients had fewer than three emetic episodes and 63.3%(19/30) had no emetic episodes. These results were similar to those of MDD group; 90.0%(27/30) and 63.3%(l9/30), respectively. But from that time to day 6, in TRP group, anly 53.3%(16/30) of patients had less than three emetic episodes and 20.0%(6/30) had no emetic episode. These were significantly less than those of MDD group; 86.7%(26/30) and 50.0%(15/30)(p<0.001). The mean nausea ratings per visual analogue scale between two groups on day 1 were similar; 49.0¡¾7.5(mean¡¾S.E.M) for TRP group and 43.3¡¾7.1 for MDD group. But from day 2 to day 5, the mean nausea ratings for MDD group were significantly less than those for TRP group(p<0.05). We could observe various side effects such as gastrointestinal symptoms and sedation in MDD group but no side effects except mild headache(10.0%) were observed in TRP group. Extrapyramidal symptom was not observed in both groups.
These results suggest that TRP was as effective as MDD in controlling the acute emesis but less effective in controlling the delayed emesis induced by cisplatin-based chemotherapy. Although antiemetic effect of tropisetron was not more excellent than that of MDD regimens, it seems to be a clinically efficacious drug due to simplicity of administration and less side effects.
Key words: Cisplatin-based combination chemotherapy, Antiemetics, Tropisetron, MDD(Metoclapramide/dexamethasone/diazepam)
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