Lim A K, Haron M R, Yap T M
Institute of Radiotherapy and Oncology, Hospital Kuala Lumpur.
Med J Malaysia. 1994 Sep;49(3):231-8.
This trial was carried out in Hospital Kuala Lumpur. Fifty-two patients who were scheduled to receive their first or subsequent courses of cancer chemotherapy with single dose cisplatinum containing chemotherapy regimens were evaluated. Thirty-four patients were given ondansetron in one group while 18 in the other group received metoclopramide with dexamethasone. The response to treatment was categorised as complete (0 emetic episode), major (1 or 2 emetic episodes), minor (3 to 5 emetic episodes) or failure (> 5 emetic episodes or rescue medication). Among the 52 patients, a complete or major control (0 to 2 emetic episodes) was achieved in 23/34 patients (68%) from the ondansetron group and in 3/18 patients (17%) from the metoclopramide with dexamethasone group (p < 0.002) on day 1. Similarly, the control of nausea was greater in the ondansetron group compared with the metoclopramide with dexamethasone group (p < 0.0009) on day 1. Two patients were excluded (dropped out) after day one from each of the two study groups due to excessive vomiting subsequent to cisplatinum therapy. From days 2 to 6, there was a trend in favour of ondansetron. Both treatments were well tolerated. The results of this trial show that in the prophylaxis of nausea and vomiting induced by cisplatinum containing chemotherapy, the efficacy of ondansetron is superior to that of a standard anti-emetic combination, metoclopramide with dexamethasone.
本试验在吉隆坡医院进行。对52例计划接受含单剂量顺铂化疗方案的首次或后续癌症化疗疗程的患者进行了评估。一组34例患者给予昂丹司琼，另一组18例患者接受甲氧氯普胺联合地塞米松治疗。治疗反应分为完全缓解（0次呕吐发作）、主要缓解（1或2次呕吐发作）、轻微缓解（3至5次呕吐发作）或治疗失败（>5次呕吐发作或使用解救药物）。在这52例患者中，第1天昂丹司琼组23/34例患者（68%）和甲氧氯普胺联合地塞米松组3/18例患者（17%）实现了完全或主要控制（0至2次呕吐发作）（p<0.002）。同样，第1天昂丹司琼组恶心控制情况优于甲氧氯普胺联合地塞米松组（p<0.0009）。由于顺铂治疗后出现过度呕吐，两个研究组各有2例患者在第1天后被排除（退出）。从第2天到第6天，有支持昂丹司琼的趋势。两种治疗耐受性均良好。本试验结果表明，在预防含顺铂化疗引起的恶心和呕吐方面，昂丹司琼的疗效优于标准止吐联合用药甲氧氯普胺联合地塞米松。
