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甲氧氯普胺单剂量与分剂量联合方案治疗顺铂所致呕吐的双盲交叉试验

Double-blind crossover trial of single vs. divided dose of metoclopramide in a combined regimen for treatment of cisplatin-induced emesis.

作者信息

Roila F, Basurto C, Bracarda S, Sassi M, Lupattelli M, Picciafuoco M, Boschetti E, Tonato M, Del Favero A

机构信息

Medical Oncology Division, Policlinico Hospital, Perugia, Italy.

出版信息

Eur J Cancer. 1991;27(2):119-21. doi: 10.1016/0277-5379(91)90466-q.

Abstract

In a double-blind crossover antiemetic study in cisplatin-treated cancer patients, metoclopramide 4 mg/kg as a single intravenous dose (regimen A) was compared with 3 mg/kg in two doses (regimen B). In both regimens, metoclopramide was combined with dexamethasone and diphenhydramine. 65 consecutive, chemotherapy-naïve inpatients (45 males and 20 females) treated with high doses (at least 50 mg/m2) of cisplatin entered the study and 54 completed both treatments. Complete protection from vomiting and nausea, mean number of emetic episodes, mean maximum intensity of nausea and mean duration of emesis or nausea were similar with the two antiemetic regimens. 23 patients (43%) did not express a treatment preference, while 16 (30%) preferred regimen B and 15 (28%) preferred regimen A. Side-effects were similar with the two metoclopramide schedules. A combined antiemetic regimen of a single high dose of metoclopramide (4 mg/kg) can preserve efficacy and tolerability and thus should be preferred.

摘要

在一项针对顺铂治疗的癌症患者的双盲交叉止吐研究中,将4mg/kg甲氧氯普胺单次静脉注射剂量(方案A)与分两次注射的3mg/kg剂量(方案B)进行了比较。在两种方案中,甲氧氯普胺均与地塞米松和苯海拉明联合使用。65名连续接受高剂量(至少50mg/m²)顺铂治疗的初治住院患者(45名男性和20名女性)进入研究,54名患者完成了两种治疗。两种止吐方案在完全预防呕吐和恶心、呕吐发作的平均次数、恶心的平均最大强度以及呕吐或恶心的平均持续时间方面相似。23名患者(43%)未表达对治疗方案的偏好,而16名(30%)更喜欢方案B,15名(28%)更喜欢方案A。两种甲氧氯普胺给药方案的副作用相似。单次高剂量(4mg/kg)甲氧氯普胺的联合止吐方案可保持疗效和耐受性,因此应优先选择。

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