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氟哌利多或胃复安联合地塞米松和苯海拉明的止吐疗效。随机开放平行研究。

Antiemetic efficacy of droperidol or metoclopramide combined with dexamethasone and diphenhydramine. Randomized open parallel study.

作者信息

Aapro M S, Froidevaux P, Roth A, Alberto P

机构信息

Division of Onco-Hematology, University Hospital, Geneva, Switzerland.

出版信息

Oncology. 1991;48(2):116-20. doi: 10.1159/000226908.

DOI:10.1159/000226908
PMID:1997933
Abstract

We have performed an open parallel randomized study of the efficacy of two antiemetic drug combinations. Dexamethasone (10 mg i.v.), diphenhydramine (25 mg i.v.), and metoclopramide (3 mg/kg, 15 min i.v.) or droperidol (1.25 mg slow push) were given 30 min before and 90 min after start of chemotherapy. Thirty-six patients treated with cisplatin-based regimens (30 mg/m2 x 3 days or 60 mg/m2 day 1 only), have been observed for 48 h after their last chemotherapy. Twelve (67%, confidence interval 95%: 41-87%) experienced no vomiting while on metoclopramide and 11 (61%, confidence interval 36-83%) were protected by droperidol. Further patient accrual was stopped because of side effects in one study arm. Moderate sedation (difficulty to keep up a conversation) was observed in 48% of those on metoclopramide versus 14% of those on droperidol (p less than 0.05). We conclude that low-dose droperidol combinations can offer antiemetic protection for patients treated with moderate-dose cisplatin-based chemotherapies. In view of the potential for severe long-term neurologic problems due to metoclopramide or droperidol, these and similar drugs should be used at the lowest possible dose.

摘要

我们进行了一项开放性平行随机研究,比较两种止吐药物组合的疗效。在化疗开始前30分钟和开始后90分钟给予地塞米松(静脉注射10毫克)、苯海拉明(静脉注射25毫克)和甲氧氯普胺(3毫克/千克,静脉注射15分钟)或氟哌利多(缓慢推注1.25毫克)。对36例接受基于顺铂方案(30毫克/平方米×3天或仅第1天60毫克/平方米)治疗的患者,在最后一次化疗后观察48小时。接受甲氧氯普胺治疗的患者中有12例(67%,95%置信区间:41 - 87%)未出现呕吐,接受氟哌利多治疗的患者中有11例(61%,置信区间36 - 83%)得到了保护。由于一个研究组出现副作用,停止了进一步的患者入组。接受甲氧氯普胺治疗的患者中有48%出现中度镇静(难以维持对话),而接受氟哌利多治疗的患者中这一比例为14%(p小于0.05)。我们得出结论,低剂量氟哌利多组合可为接受中度剂量基于顺铂化疗的患者提供止吐保护。鉴于甲氧氯普胺或氟哌利多可能导致严重的长期神经问题,这些药物及类似药物应尽可能以最低剂量使用。

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Cochrane Database Syst Rev. 2014 Nov 27;2014(11):CD006938. doi: 10.1002/14651858.CD006938.pub3.
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Methodological issues in antiemetic studies.止吐研究中的方法学问题。
Invest New Drugs. 1993 Nov;11(4):243-53. doi: 10.1007/BF00874423.