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一项关于大剂量静脉注射氯丙嗪与大剂量甲氧氯普胺作为癌症化疗止吐药的随机双盲研究。

A randomised double-blind study of high-dose intravenous prochlorperazine versus high-dose metoclopramide as antiemetics for cancer chemotherapy.

作者信息

Olver I N, Wolf M, Laidlaw C, Bishop J F, Cooper I A, Matthews J, Smith R, Buchanan L

机构信息

Department of Medical Oncology, Royal Adelaide Hospital, North Terrace, S.A.

出版信息

Eur J Cancer. 1992;28A(11):1798-802. doi: 10.1016/0959-8049(92)90006-n.

Abstract

High-dose prochlorperazine 0.8 mg/kg administered intravenously 30 min pre and 7 h 30 min post the initial dose of emetogenic chemotherapy was compared to high-dose metoclopramide 2 mg/kg over 20 min every 2 h for five doses starting 30 min prior to chemotherapy in a randomised, double-blind, parallel subjects design study. On the prochlorperazine arm intravenous dextrose placebos every 2 h maintained blinding. Complete suppression of vomiting occurred in 42% on metoclopramide (53% with non-cisplatin regimens) and 36% on prochlorperazine (52% with non-cisplatin-containing regimens) while major responses (2 or less vomits) occurred in 58% on metoclopramide and 54% on prochlorperazine. In patients who vomited after cisplatin, prochlorperazine achieved a significantly shorter duration of vomiting, a median of 5 h compared to 15 h on metoclopramide (P = 0.03). The response rate to prochlorperazine for cisplatin-induced emesis between 12 and 24 h was significantly better than for metoclopramide (prochlorperazine = 0.02). Toxicities were equivalent except for significantly greater sedation and dry mouth on prochlorperazine. Extrapyramidal reactions were recorded equally on both arms but were only severe enough to stop treatment on metoclopramide. The metoclopramide regimen was five times as expensive as prochlorperazine. High-dose prochlorperazine is an active and cost-effective antiemetic.

摘要

在一项随机、双盲、平行受试者设计研究中,比较了在致吐性化疗初始剂量前30分钟静脉注射0.8毫克/千克高剂量丙氯拉嗪以及初始剂量后7小时30分钟静脉注射,与在化疗前30分钟开始每2小时静脉注射2毫克/千克高剂量甲氧氯普胺共5剂(持续20分钟)的效果。在丙氯拉嗪组,每2小时静脉注射葡萄糖安慰剂以维持盲法。甲氧氯普胺组呕吐完全抑制率为42%(非顺铂方案为53%),丙氯拉嗪组为36%(不含顺铂方案为52%);而主要反应(呕吐2次或更少)在甲氧氯普胺组为58%,在丙氯拉嗪组为54%。在接受顺铂治疗后呕吐的患者中,丙氯拉嗪的呕吐持续时间显著缩短,中位数为5小时,而甲氧氯普胺为15小时(P = 0.03)。丙氯拉嗪对顺铂诱导呕吐在12至24小时的反应率显著优于甲氧氯普胺(丙氯拉嗪为0.02)。除丙氯拉嗪的镇静和口干明显更严重外,两组毒性相当。两组均记录到锥体外系反应,但仅甲氧氯普胺组严重到足以停止治疗。甲氧氯普胺方案的费用是丙氯拉嗪的五倍。高剂量丙氯拉嗪是一种有效且具有成本效益的止吐药。

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